1. Name of the medicinal product

Azithromycin Tablets USP 250mg Taj Pharma
Azithromycin Tablets USP 500mg Taj Pharma

  1. Qualitative and quantitative composition

a) Azithromycin Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Azithromycin monohydrate USP
Equivalent to Azithromycin USP 250mg
Excipients: Q.S.

b) Azithromycin Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Azithromycin monohydrate USP
Equivalent to Azithromycin USP 500mg
Excipients: Q.S.

Excipients with known effect

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet.

Azithromycin Taj Pharma 250mg Film-coated Tablets are white to off-white, oblong film-coated tablets and plain on both sides.

  1. Clinical particulars
  • Therapeutic indications

Azithromycin Taj Pharma is indicated for the treatment of the following infections, when caused by microorganisms sensitive to Azithromycin Taj Pharma (see section 4.4 and 5.1):

  • Acute bacterial sinusitis (adequately diagnosed)
  • Acute bacterial otitis media (adequately diagnosed)
  • Pharyngitis, tonsillitis
  • Acute exacerbation of chronic bronchitis (adequately diagnosed)
  • Mild to moderately severe community acquired pneumonia
  • Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas
  • Uncomplicated Chlamydia trachomatis urethritis and cervicitis

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

  • Posology and method of administration

Posology

Azithromycin Taj Pharma tablets should be given as a single daily dose. The duration of treatment in each of the infectious diseases is given below.

Adults, elderly, children and adolescents over 45 kg body weight

The total dosage of Azithromycin Taj Pharma is 1500mg which is spread over three days (500mg once daily).

Alternatively, the dosage can be spread over five days (500mg as a single dose on the first day and thereafter 250mg once daily).

In uncomplicated Chlamydia trachomatis urethritis and cervicitis the dosage is 1000mg as a single oral dose.

For sinusitis, treatment is indicated for adults and adolescents 16 years of age and over.

Children and adolescents 45 kg and under body weight

Tablets are not indicated for these patients. Other pharmaceutical forms of Azithromycin Taj Pharma, e.g. suspensions may be used.

Elderly

No dose adjustments are required for elderly patients. Since elderly patients can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes (see section 4.4).

Patients with renal impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 30-80 ml/min/1.73 m2) (see section 4.4).

Patients with hepatic impairment

A dose adjustment is not necessary for patients with mild to moderately impaired liver function (Child-Pugh class A or B) (see section 4.4).

Method of administration

For oral use.

The tablets can be taken with or without food.

  • Contraindications

Hypersensitivity to the active substance, to erythromycin or any macrolide or ketolide antibiotic.or to any of the excipients listed in section 6.1.

  • Special warnings and precautions for use

Allergic reactions

As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal) have been reported alongside dermatological reactions, including acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms). A certain number of these reactions resulted in recurring symptoms and required an extended period of observation and treatment.

If an allergic reaction occurs, use of this medicinal product must be discontinued and the appropriate treatment initiated. Doctors must be aware that allergic symptoms can recur if symptomatic treatment is discontinued.

Renal impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance > 40 ml/min). In patients with severe renal function impairment (GFR < 10 mL/min), a 33% increase in systemic exposure to Azithromycin Taj Pharma has been observed (see section 5.2).

Hepatic impairment

Since liver is the principal route of elimination for Azithromycin Taj Pharma, the use of Azithromycin Taj Pharma should be undertaken with caution in patients with significant hepatic disease. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with Azithromycin Taj Pharma (see section 4.8). Some patients may have, or have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.

In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/ investigations should be performed immediately. Azithromycin Taj Pharma administration should be stopped if liver dysfunction has emerged.

Liver function disorders, hepatitis, cholestatic jaundice, liver necrosis and renal failure have been reported and have been fatal in a number of cases. Discontinue the use of Azithromycin Taj Pharma if signs and symptoms of hepatitis occur.

Pseudomembranous colitis has been reported following use of macrolide antibiotics. This diagnosis should therefore be taken into consideration in patients who develop diarrhoea after starting treatment with Azithromycin Taj Pharma.

Infantile hypertrophic pyloric stenosis

Following the use of Azithromycin Taj Pharma in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis (IHPS) has been reported. Parents and caregivers should be informed to contact their physician if vomiting or irritability with feeding occurs.

Ergot alkaloids and Azithromycin Taj Pharma

The concurrent use of ergot alkaloids and macrolide antibiotics has been found to accelerate the development of ergotism. The interactions between ergot alkaloids and Azithromycin Taj Pharma have not been studied. The development of ergotism is however possible, so that Azithromycin Taj Pharma and ergot alkaloid derivatives should not be administered simultaneously.

QT prolongation

Prolonged cardiac repolarisation and a prolonged QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides including Azithromycin Taj Pharma (see section 4.8).

Therefore, as the following situations may lead to an increased risk for ventricular arrhythmias (including torsade de pointes) which can lead to cardiac arrest, Azithromycin Taj Pharma should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients) such as:

  • Patients with congenital or documented acquired QT prolongation.
  • Patients currently receiving treatment with other active substances that prolong QT interval such as antiarrhythmics of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone and sotalol), cisapride and terfenadine; antipsychotic agents such as pimozide; antidepressants such as citalopram; and fluoroquinolones such as moxifloxacin and levofloxacin (see section 4.5).
  • Patients with a disrupted electrolyte balance, particularly in cases of hypokalaemia and hypomagnesaemia
  • Patients with clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.

Myasthenia gravis and Azithromycin Taj Pharma

Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving Azithromycin Taj Pharma therapy (see section 4.8).

Superinfections

As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended.

Clostridium difficile associated diarrhoea

Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including Azithromycin Taj Pharma, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

  1. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficilecause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

The following should be considered before prescribing Azithromycin Taj Pharma:

zithromycin film-coated tablets are not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed.

As for other macrolides, high resistance rates of Streptococcus pneumoniae have been reported for Azithromycin Taj Pharma in some European countries (see section 5.1). This should be taken into account when treating infections caused by Streptococcus pneumoniae.

The main causative agent of soft tissue infections, Staphylococcus aureus, is frequently resistant to Azithromycin Taj Pharma. Therefore, susceptibility testing is considered a precondition for treatment of soft tissue infections with Azithromycin Taj Pharma.

Pharyngitis/tonsillitis

Azithromycin Taj Pharma is not the substance of first choice for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes. For this and for the prophylaxis of acute rheumatic fever penicillin is the treatment of first choice.

Sinusitis

Often, Azithromycin Taj Pharma is not the substance of first choice for the treatment of sinusitis.

Acute otitis media

Often, Azithromycin Taj Pharma is not the substance of first choice for the treatment of acute otitis media.

Infected burn wounds

Azithromycin Taj Pharma is not indicated for the treatment of infected burn wounds.

Sexually transmitted disease

In case of sexually transmitted diseases a concomitant infection by T. pallidum should be excluded.

Neurological or psychiatric diseases

Azithromycin Taj Pharma should be administered with caution to patients suffering from neurological or psychiatric diseases.

Long-term use

There is no experience regarding the safety and efficacy of long-term use of Azithromycin Taj Pharma for the mentioned indications. In case of rapid recurrent infections, treatment with another antibiotic should be considered.

Due to cross-resistance existing among macrolides, in areas with a high incidence of erythromycin resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to Azithromycin Taj Pharma and other macrolides (see section 5.1).

Azithromycin Taj Pharma is not the first choice for the empirical treatment of infections in areas where the prevalence of resistant isolates is 10% or more (see section 5.1).

Paediatric population

Safety and efficacy for the prevention or treatment of Mycobacterium Avium Complex in children have not been established.

This medicinal product contains soya oil

Azithromycin Taj Pharma contains soya oil. Patients who are allergic to peanut or soya, must not use this medicinal product.

Azithromycin Taj Pharma contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

  • Interaction with other medicinal products and other forms of interaction

Antacids

When studying the effect of simultaneously administered antacid on the pharmacokinetics of Azithromycin Taj Pharma, no overall change has been observed in the bioavailability, although the peak concentrations of Azithromycin Taj Pharma measured in the plasma reduced by approximately 25 %. In patients receiving both Azithromycin Taj Pharma and antacids, the drugs should not be taken simultaneously. Azithromycin Taj Pharma should be taken at least 1 hour before or 2 hours after the antacid.

Cetirizine

In healthy volunteers, coadministration of a 5-day regimen of Azithromycin Taj Pharma with cetirizine 20mg at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.

Didanosine (Dideoxyinosine)

Coadministration of 1200mg/day Azithromycin Taj Pharma with 400mg/day didanosine in 6 HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared with placebo.

Digoxin and colchicine (P-gp substrates)

Concomitant administration of macrolide antibiotics, including Azithromycin Taj Pharma, with P-glycoprotein substrates such as digoxin and colchicine, has been reported to result in increased serum levels of the P-glycoprotein substrate. Therefore, if Azithromycin Taj Pharma and P-gp substrates such as digoxin are administered concomitantly, the possibility of elevated serum concentrations of the substrate should be considered. During treatment with Azithromycin Taj Pharma and after discontinuation, clinical monitoring, and possible follow-up of serum digoxin levels, is required.

Zidovudine

Single 1000mg doses and multiple 1200mg or 600mg doses of Azithromycin Taj Pharma had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Azithromycin Taj Pharma increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.

Azithromycin Taj Pharma does not interact significantly with the hepatic cytochrome P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with Azithromycin Taj Pharma.

Ergot derivatives

Due to the theoretical possibility of ergotism, the concurrent use of Azithromycin Taj Pharma with ergot derivatives is not recommended (see section 4.4).

Pharmacokinetic studies have been conducted between Azithromycin Taj Pharma and the following medicinal products known to undergo significant cytochrome P450 mediated metabolism.

Astemizole and alfentanil

No data are available on interactions with astemizole and alfentanil. Caution should be exercised with concomitant use of these agents and Azithromycin Taj Pharma in view of the described potentiation of its effect during concomitant use of the macrolide antibiotic erythromycin.

Atorvastatin

Coadministration of atorvastatin (10mg daily) and Azithromycin Taj Pharma (500mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay). However, post-marketing cases of rhabdomyolysis in patients receiving Azithromycin Taj Pharma with statins have been reported.

Carbamazepine

In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant Azithromycin Taj Pharma.

Cisapride

Cisapride is metabolised in the liver by the enzyme CYP 3A4. Because macrolides inhibit this enzyme, concomitant administration of cisapride may cause the increase of QT interval prolongation, ventricular arrhythmias and torsades de pointes.

Cimetidine

In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before Azithromycin Taj Pharma, on the pharmacokinetics of Azithromycin Taj Pharma, no alteration of Azithromycin Taj Pharma pharmacokinetics was seen.

Coumarin-Type Oral Anticoagulants

In a pharmacokinetic interaction study, Azithromycin Taj Pharma did not alter the anticoagulant effect of a single 15mg dose of warfarin administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to coadministration of Azithromycin Taj Pharma and coumarin type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when Azithromycin Taj Pharma is used in patients receiving coumarin-type oral anticoagulants.

Ciclosporin

In a pharmacokinetic study with healthy volunteers that were administered a 500mg/day oral dose of Azithromycin Taj Pharma for 3 days and were then administered a single 10mg/kg oral dose of ciclosporin, the resulting ciclosporin Cmax and AUC0-5 were found to be significantly elevated. Consequently, caution should be exercised before considering concurrent administration of these medicinal products. If coadministration of these medicinal products is necessary, ciclosporin levels should be monitored and the dose adjusted accordingly.

Efavirenz

Coadministration of a 600mg single dose of Azithromycin Taj Pharma and 400mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

Fluconazole

Coadministration of a single dose of 1200mg Azithromycin Taj Pharma did not alter the pharmacokinetics of a single dose of 800mg fluconazole. Total exposure and half-life of Azithromycin Taj Pharma were unchanged by the coadministration of fluconazole, however, a clinically insignificant decrease in Cmax (18%) of Azithromycin Taj Pharma was observed.

Indinavir

Coadministration of a single dose of 1200mg Azithromycin Taj Pharma had no statistically significant effect on the pharmacokinetics of indinavir administered as 800mg three times daily for 5 days.

Methylprednisolone

In a pharmacokinetic interaction study in healthy volunteers, Azithromycin Taj Pharma had no significant effect on the pharmacokinetics of methylprednisolone.

Midazolam

In healthy volunteers, coadministration of Azithromycin Taj Pharma 500mg/day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single 15mg dose of midazolam.

Nelfinavir

Coadministration of Azithromycin Taj Pharma (1200mg) and nelfinavir at steady state (750mg three times daily) resulted in increased Azithromycin Taj Pharma concentrations. No clinically significant adverse effects were observed and no dose adjustment is required.

Rifabutin

Coadministration of Azithromycin Taj Pharma and rifabutin did not affect the serum concentrations of either active.

Neutropenia was observed in subjects receiving concomitant treatment of Azithromycin Taj Pharma and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Azithromycin Taj Pharma has not been established (see section 4.8).

Sildenafil

In normal healthy male volunteers, there was no evidence of an effect of Azithromycin Taj Pharma (500mg daily for 3 days) on the AUC and Cmax, of sildenafil or its major circulating metabolite.

Terfenadine

Pharmacokinetic studies have reported no evidence of an interaction between Azithromycin Taj Pharma and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however there was no specific evidence that such an interaction had occurred.

Theophylline

There is no evidence of a clinically significant pharmacokinetic interaction when Azithromycin Taj Pharma and theophylline are co-administered to healthy volunteers.

Triazolam

In 14 healthy volunteers, coadministration of Azithromycin Taj Pharma 500mg on Day 1 and 250mg on Day 2 with 0.125mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo.

Trimethoprim/sulfamethoxazole

Coadministration of trimethoprim/sulfamethoxazole DS (160mg/800mg) for 7 days with Azithromycin Taj Pharma 1200mg on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Azithromycin Taj Pharma serum concentrations were similar to those seen in other studies.

Protease inhibitors

There are no data available about a possible interaction with protease inhibitors.

  • Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from use of Azithromycin Taj Pharma in pregnant women. In reproduction toxicity studies in animals, Azithromycin Taj Pharma was shown to pass the placenta, but no teratogenic effects were observed. The safety of Azithromycin Taj Pharma has not been confirmed with regard to the use of the active substance during pregnancy. Therefore, Azithromycin Taj Pharma should only be used during pregnancy if the benefit outweighs the risk.

Breast-feeding

Azithromycin Taj Pharma passes into human breast milk, but there are no adequate and well-controlled clinical studies in nursing women that have characterised the pharmacokinetics of Azithromycin Taj Pharma excretion into human breast milk. Because it is not known whether Azithromycin Taj Pharma may have adverse effects on the breast-fed infant, nursing should be discontinued during treatment with Azithromycin Taj Pharma. Among other things diarrhoea, fungus infection of the mucous membrane as well as sensitisation is possible in the nursed infant. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Nursing may be resumed thereafter.

Fertility

In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of Azithromycin Taj Pharma. The relevance of this finding to humans is unknown.

  • Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, the possibility of undesirable effects like dizziness and convulsions should be taken into account when performing these activities.

  • Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions possibly or probably related to Azithromycin Taj Pharma based on clinical trial experience and post-marketing surveillance:

Very CommonCommonUncommonRareVery rareNot Known
Infections and InfestationsCandidiasis,

vaginal infection,

pneumonia,

fungal infection,

bacterial infection,

pharyngitis,

gastroenteritis,

respiratory disorder,

rhinitis,

oral candidiasis

Pseudomembranous colitis (see section 4.4)
Blood and Lymphatic System DisordersLeukopenia,

neutropenia,

eosinophilia

Thrombocytopenia,

haemolytic anaemia

Immune System DisordersAngioedema,

hypersensitivity

Anaphylactic reaction (see section 4.4)
Metabolism and Nutrition DisordersAnorexia
Psychiatric DisordersNervousness,

insomnia

Agitation

Irritability

Aggression,

anxiety,

delirium,

hallucination

Nervous System DisordersHeadache,

dizziness,

somnolence,

dysgeusia,

paraesthesia

HypoaesthesiaSyncope,

convulsion,

psychomotor hyperactivity,

anosmia,

ageusia,

parosmia,

myasthenia gravis (see section 4.4)

Eye DisordersVisual impairment
Ear and Labyrinth DisordersDeafnessEar disorder,

vertigo,

hearing impairment including hearing loss,

tinnitus

Cardiac DisordersPalpitationsTorsades de pointes (see section 4.4),

arrhythmia (see section 4.4) including ventricular tachycardia,

Electrocardiogram QT prolonged (see section 4.4)

Vascular DisordersHot flushesHypotension
Respiratory, thoracic and mediastinal disordersDyspnoea,

epistaxis

Gastrointestinal DisordersDiarrhoea,

abdominal pain,

nausea,

flatulence

Vomiting,

dyspepsia

Constipation,

gastritis,

dysphagia,

abdominal distension,

dry mouth,

eructation,

mouth ulceration,

salivary hypersecretion

Pancreatitis,

tongue discolouration,

tooth discolouration

Hepatobiliary DisordersHepatitis,

abnormal hepatic function

Cholestatic jaundiceHepatic failure (which has rarely resulted in death) (see section 4.4),

fulminant hepatitis,

hepatic necrosis

Skin and Subcutaneous Tissue DisordersRash,

pruritus

Urticaria,

dermatitis,

dry skin,

hyperhidrosis,

Stevens-Johnson syndrome,

Photosensitivity reaction

,

Acute generalised exanthematous pustulosis (AGEP)

DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms)Toxic epidermal necrolysis,

erythema multiforme

Musculoskeletal and Connective Tissue DisordersArthralgiaOsteoarthritis,

myalgia,

back pain,

neck pain

Renal and Urinary DisordersDysuria,

renal pain

Acute renal failure,

interstitial nephritis

Reproductive system and breast disordersMetrorrhagia,

testicular disorder

General Disorders and Administration Site ConditionsFatigueOedema,

asthenia,

malaise,

face oedema,

chest pain,

pyrexia,

pain,

peripheral oedema

InvestigationsLymphocyte count decreased,

eosinophil count increased,

blood bicarbonate decreased,

basophils increased,

monocytes increased,

neutrophils increased

Aspartate aminotransferase increased,

alanine aminotransferase increased,

blood bilirubin increased,

blood urea increased,

blood creatinine increased,

blood potassium abnormal,

blood alkaline phosphatase increased,

chloride increased,

glucose increased,

platelets increased,

haematocrit decreased,

bicarbonate increased,

abnormal sodium

Injury, poisoning and procedural complicationsPost procedural complication

Adverse reactions possibly or probably related to Mycobacterium Avium Complex prophylaxis and treatment based on clinical trial experience and post-marketing surveillance. These adverse reactions differ from those reported with immediate release or the prolonged release formulations, either in kind or in frequency:

Very CommonCommonUncommon
Metabolism and Nutrition DisordersAnorexia
Nervous System

Disorders

Dizziness,

headache,

paraesthesia,

dysgeusia

Hypoaesthesia
Eye DisordersVisual impairment
Ear and Labyrinth DisordersDeafnessHearing impaired,

tinnitus

Cardiac DisordersPalpitations
Gastrointestinal DisordersDiarrhoea,

abdominal pain,

nausea,

flatulence,

abdominal discomfort,

loose stools

Hepatobiliary DisordersHepatitis
Skin and Subcutaneous Tissue DisordersRash,

pruritus

Stevens-Johnson syndrome,

photosensitivity reaction

Musculoskeletal and Connective Tissue DisordersArthralgia
General Disorders and Administration Site ConditionsFatigueAsthenia,

malaise

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. Characteristic symptoms of overdose with macrolide antibiotics include the following: reversible hearing loss, severe nausea, vomiting and diarrhoea.

In the event of overdosage, general symptomatic and supportive measures are indicated as required.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use; macrolides,

Azithromycin Taj Pharma is a macrolide antibiotic belonging to the azalide group.

The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The chemical name of Azithromycin Taj Pharma is 9-deoxy-9a-aza-9a-methyl-9a-homo-erythromycin A. The molecular weight is 749.0.

Mechanism of action

Azithromycin Taj Pharma avoids the translocation of peptide chains from one side of the ribosome to the other by binding to the 50S ribosomal subunit. As a result, RNA-dependent protein synthesis in susceptible organisms is inhibited.

Cardiac electrophysiology:

QTc interval prolongation was studied in a randomised, placebo-controlled parallel trial in 116 healthy subjects, who received chloroquine (1000mg), either alone or in combination with Azithromycin Taj Pharma (500mg, 1000mg and 1500mg once daily). Concomitant administration of Azithromycin Taj Pharma increased the QTc interval in a dose and concentration-dependent manner. Compared to chloroquine alone, the maximum mean (95% upper confidence bound) increases in QTcF were 5 (10) ms, 7 (12) ms and 9 (14) ms with concomitant administration of 500mg, 1000mg and 1500mg Azithromycin Taj Pharma, respectively.

Mechanism of resistance

The two most frequently encountered mechanisms of resistance to macrolides, including Azithromycin Taj Pharma, are target modification (most commonly by methylation of 23S rRNA) and active efflux. The occurrence of these resistance mechanisms varies from species to species, and within a single species, the frequency of resistance varies by geographical location.

The most important ribosomal modification that determines reduced binding of macrolides is post-transcriptional (N6)-dimethylation of adenine at nucleotide A2058 (Escherichia coli numbering system) of the 23S rRNA by methylases encoded by erm (erythromycin ribosome methylase) genes. Ribosomal modifications often determine cross resistance (MLSB phenotype) to other classes of antibiotics whose ribosomal binding sites overlap those of the macrolides: the lincosamides (including clindamycin), and the streptogramin B (which include, for example, the quinupristin component of quinupristin/dalfopristin). Different erm genes are present in different bacterial species, in particular Streptococci and Staphylococci. Susceptibility to macrolides can also be affected by less frequently encountered mutational changes in nucleotides A2058 and A2059, and at some other positions of 23S rRNA, or in the large subunit ribosomal proteins L4 and L22.

Efflux pumps occur in a number of species, including Gram-negatives, such as Haemophilus influenzae (where they may determine intrinsically higher MICs) and Staphylococci. In Streptococci and Enterococci, an efflux pump that recognises 14- and 15-membered macrolides (which include, respectively, erythromycin and Azithromycin Taj Pharma) is encoded by mef (A) genes.

A complete cross-resistance exists among erythromycin, Azithromycin Taj Pharma, other macrolides and lincosamides for Streptococcus pneumoniae, beta-haemolytic streptococci of group A, Enterococcus spp. and Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA).

A decrease in macrolide susceptibility over time has been noted particularly in Streptococcus pneumoniae and Staphylococcus aureus and is also observed in Streptococcus viridans and in Streptococcus agalactiae.

Penicillin-sensitive S. pneumoniae are more likely to be susceptible to Azithromycin Taj Pharma than are penicillin-resistant strains of S. pneumoniae. Methicillin-resistant S. aureus (MRSA) is less likely to be susceptible to Azithromycin Taj Pharma than methicillin-sensitive S. aureus (MSSA).

Susceptibility test breakpoints:

The EUCAST susceptibility criteria are listed in the table below.

EUCAST Susceptibility Breakpoints for Azithromycin Taj Pharma.

EUCAST

MIC (mg/L)
PathogensSusceptibleResistant
Staphylococcus spp.≤ 1> 2
Streptococcus spp. (Group A, B, C, G)≤ 0.25> 0.5
Streptococcus pneumoniae≤ 0.25> 0.5
Haemophilus influenzae≤ 0.12> 4
Moraxella catarrhalis≤ 0.25> 0.5
Neisseria gonorrhoeae≤ 0.25> 0.5

UCAST = European Committee on Antimicrobial Susceptibility Testing; MIC = Minimum inhibiting concentration.

Susceptibility

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Pathogens for which resistance may be a problem: prevalence of resistance is equal to or greater than 10% in at least one country in the European Union.

Table 1: Antibacterial spectrum of Azithromycin Taj Pharma

Species
Commonly susceptible species
Aerobic Gram-positive
Corynebacterium diphteriae
Streptococcus pneumoniae
Erythromycin-sensitive
Penicillin-sensitive
Streptococcus pyogenes
Erythromycin-sensitive
Aerobic Gram-negative
Bordetella pertussis
Escherichia coli-ETEC
Escherichia coli-EAEC
Haemophilus influenzae

Haemophilus ducreyi

Legionella spp.
Moraxella catarrhalis
Erythromycin-sensitive
Erythromycin-intermediate
Pasteurella multocida
Anaerobic
Fusobacterium nucleatum

Fusobacterium necrophorum

Prevotella spp.
Porphyromonas spp.
Propionibacterium spp.
Other micro-organisms
Chlamydia pneumoniae
Chlamydia trachomatis
Listeria spp.
Mycobacterium avium Complex
Mycoplasma pneumoniae
Species for which acquired resistance may be a problem
Aerobic Gram-positive
Staphylococcus aureus
Methicillin-susceptible
Coagulase-neg. staphylococci
Methicillin-susceptible+
Streptococcus pneumoniae
Penicillin-intermediate
Penicillin-resistant
Erythromycin-intermediate
Streptococcus pyogenes
Erythromycin-intermediate
Streptococci viridans group
Penicillin-intermediate
Aerobic Gram-negative
Moraxella catarrhalis

Erythromycin-resistant

Anaerobic
Peptostreptococcus spp.
Inherently resistant organisms
Aerobic Gram positive
Corynebacterium spp.
Enterococcus spp.
Staphylococci MRSA, MRSE
Streptococcus pneumoniae
Erythromycin-resistant
Penicillin & Erythromycin resistant
Streptococcus pyogenes
Erythromycin-resistant
Streptococci viridans group
Penicillin-resistant
Erythromycin-resistant
Aerobic Gram-negative
Pseudomonas aeruginosa
Anaerobic
Bacteroides fragilis group

+ Resistance is greater than 50%.

Following the assessment of studies conducted in children, the use of Azithromycin Taj Pharma is not recommended for the treatment of malaria, neither as monotherapy nor combined with chloroquine or artemisinin based drugs, as non-inferiority to anti-malarial drugs recommended in the treatment of uncomplicated malaria was not established.

  • Pharmacokinetic properties

Absorption

Following oral administration the bio-availability of Azithromycin Taj Pharma is approximately 37%. Peak plasma levels are reached after 2-3 hours. The mean maximum concentration observed (Cmax) after a single dose of 500mg is approximately 0.4 μg/ml.

Distribution

Orally administered Azithromycin Taj Pharma is widely distributed throughout the body. Pharmacokinetic studies have shown considerably higher Azithromycin Taj Pharma concentrations in the tissues (up to 50 times the maximum concentration observed in the plasma). This indicates that the substance is extensively bound in the tissues (steady-state volume of distribution approximately 31 l/kg). The mean maximum observed serum concentration (Cmax) after a single dose of 500mg is approx. 0.4mg/mL, 2-3 hours after administration. With the recommended dosage no accumulation in the serum/plasma occurs. Accumulation does occur in the tissues where the levels are much higher than in the serum/plasma. Three days after administration of 500mg as a single dose or in split doses, concentrations of 1.3 to 4.8mg/g, 0.6 to 2.3mg/g, 2.0 to 2.8mg/g and 0 to 0.3mg/mL were detected in lung, prostate, tonsil and serum respectively. Concentrations in these target tissues exceed the MIC90 for likely pathogens.

In experimental in vitro and in vivo studies, Azithromycin Taj Pharma accumulates in phagocytes; release is promoted by active phagocytosis. In animal models this process appears to contribute to the accumulation of Azithromycin Taj Pharma in tissue.

The binding of Azithromycin Taj Pharma to plasma proteins is variable and varies from 52% at 0.005 μg/ml to 18% at 0.5 μg/ml, depending on the serum concentration.

Biotransformation and Excretion

The terminal plasma elimination half-life follows the tissue depletion half-life of 2 to 4 days.

Approximately 12% of an intravenously administered dose is excreted in unchanged form with the urine over a period of 3 days; the major proportion in the first 24 hours. Concentrations of up to 237 μg/ml Azithromycin Taj Pharma, 2 days after a 5-day course of treatment, have been found in human bile, together with 10 metabolites (formed by N- and O-demethylation, by hydroxylation of the desosamine and aglycone rings, and by splitting of the cladinose conjugate). Investigations suggests that the metabolites do not play a role in the micro-biological activity of Azithromycin Taj Pharma.

Pharmacokinetics in special populations

Renal impairment

Following a single oral dose of Azithromycin Taj Pharma 1g, mean Cmax and AUC0-120 increased by 5.1% and 4.2% respectively, in subjects with mild to moderate renal impairment (glomerular filtration rate of 30-80 ml/min/1.73m2) compared with normal renal function (GFR > 80 ml/min). In subjects with severe renal impairment (GFR < 30 ml/min/1.73m2), the mean Cmax and AUC0-120 increased 61% and 35% respectively compared to normal.

Hepatic impairment

In patients with mild to moderate hepatic impairment, there is no evidence of a marked change in serum pharmacokinetics of Azithromycin Taj Pharma compared to normal hepatic function. There are no data on Azithromycin Taj Pharma use in cases of more severe hepatic impairment.

Elderly

The pharmacokinetics of Azithromycin Taj Pharma in elderly men was similar to that of young adults; however, in elderly women, although higher peak concentrations (increased by 30-50%) were observed, no significant accumulation occurred.

In elderly volunteers (>65 years), higher (29 %) AUC values were always observed after a 5-day course than in younger volunteers (<45 years). However, these differences are not considered to be clinically relevant; no dose adjustment is therefore recommended.

Paediatric population

Pharmacokinetics have been studied in children aged 4 months – 15 years taking capsules, granules or suspension. At 10mg/kg on day 1 followed by 5mg/kg on days 2-5, the Cmax achieved is slightly lower than adults with 224 µg/l in children aged 0.6-5 years and after 3 days dosing and 383 µg/l in those aged 6-15 years. The t1/2 of 36h in the older children was within the expected range for adults.

  • Preclinical safety data

In animal studies using exposures 40 times those achieved at the clinical therapeutic dosages, Azithromycin Taj Pharma was found to have caused reversible phospholipidosis, but as a rule there were no associated toxicological consequences. The relevance of this finding to humans receiving Azithromycin Taj Pharma in accordance with the recommendations is unknown.

Electrophysiological investigations have shown that Azithromycin Taj Pharma prolongs the QT interval.

Carcinogenic potential

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenic potential

There was no evidence of a potential for genetic and chromosome mutations in in vivo and in vitro test models.

Reproductive toxicity

No teratogenic effects were observed in embryotoxicity studies in rats after oral administration of Azithromycin Taj Pharma. In rats, Azithromycin Taj Pharma dosages of 100 and 200mg/kg body weight/day led to mild retardations in fetal ossification and in maternal weight gain. In peri- and postnatal studies in rats, mild retardations following treatment with 50mg/kg/day Azithromycin Taj Pharma and above were observed.

  1. Pharmaceutical particulars
  • List of excipients

Tablet Core:

Cellulose, microcrystalline, Pregelatinised maize starch

Sodium starch glycolate (Type A), Colloidal anhydrous silica, Sodium lauril sulfate, Magnesium stearate

Tablet Film-coating:

Poly (vinyl) alcohol (partially hydrolysed)

Titanium Dioxide, Talc, Soya lecithin

Xanthan gum

  • Incompatibilities

Not applicable.

  • Shelf life

3 years.

  • Special precautions for storage

This medicinal product does not require any special storage conditions.

  • Nature and contents of container

Pack sizes: 4, 6, 12, 24, 50, 100 film-coated tablets.

Not all pack sizes may be marketed.

  • Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Azithromycin Tablet USP 500mg Taj Pharma

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Azithromycin Taj Pharma is and what it is used for
  2. What you need to know before you take Azithromycin Taj Pharma
  3. How to take Azithromycin Taj Pharma
  4. Possible side effects
  5. How to store Azithromycin Taj Pharma
  6. Contents of the pack and other information

1. What Azithromycin Taj Pharma is and what it is used for

Azithromycin Taj Pharma is one of a group of antibiotics known as macrolides. It is used to treat bacterial infections caused by micro organisms such as bacteria. These infections include:

  • Chest infections such as bronchitis and pneumonia
  • Infections in your sinuses, throat, tonsils or ears
  • Mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas)
  • Infections caused by a bacterium called Chlamydia trachomatis. They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix).
  1. What you need to know before you take Azithromycin Taj Pharma

Do not take Azithromycin Taj Pharma:

  • if you are allergic to Azithromycin Taj Pharma , any other macrolide (such as erythromycin or clarithromycin) or ketolide antibiotic or any of the ingredients of this medicine (listed in section 6). An allergic reaction may cause skin rash or wheezing.

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin Taj Pharma if you:

  • have ever had a serious allergic reaction causing swelling of the face and throat, possibly with breathing problems, rash, fever, swollen glands or increase in eosinophils (certain type of white blood cells).
  • have severe kidney problems: your doctor may alter the dose
  • have liver problems: your doctor may need to monitor your liver function or stop the treatment
  • have myasthenia gravis (localised muscle weakness)
  • have been diagnosed with a neurological disease, which is a disease of the brain or nervous system
  • have mental, emotional or behavioural problems
  • are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat migraine: Azithromycin Taj Pharma is not recommended (see ‘Other medicines and Azithromycin Taj Pharma’ below)

Since Azithromycin Taj Pharma  may increase the risk of abnormal heart rhythm please tell your doctor if you have any of the following problems before taking this medicine (especially you are female or elderly):

  • you are aware of ever being diagnosed to have prolonged QT interval (a heart condition, shown on an electro-cardiogram or ECG machine): Azithromycin Taj Pharma is not recommended
  • are aware that you have a slow or irregular heart beat, or reduced heart function (heart failure): Azithromycin Taj Pharma is not recommended
  • know that you have low levels of potassium or magnesium in your blood: Azithromycin Taj Pharma is not recommended
  • are taking medicines known as antiarrhythmics (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol: used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine that is used to treat allergies), or antipsychotic agents (e.g. pimozide), antidepressants (e.g. citalopram), some antibiotics (e.g. moxifloxacin, levofloxacin) that can affect the heart rhythm: Azithromycin Taj Pharma is not recommended (see ‘Other medicines and Azithromycin Taj Pharma’ below)

If you develop severe and persistent diarrhoea during or after treatment, especially if you notice blood or mucus, tell your doctor immediately.

If your symptoms persist after the end of your treatment with Azithromycin Taj Pharma , or if you notice any new and persistent symptoms, contact your doctor.

Other medicines and Azithromycin Taj Pharma

Tell your doctor before taking Azithromycin Taj Pharma, if you are taking any of the medicines listed below:

  • Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the risk of bleeding.
  • Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. itching in the limbs, muscle cramps and gangrene of hands and feet due to poor blood circulation) may occur.

Concomitant use is therefore not recommended.

  • Ciclosporin (used to suppress the immune system to prevent and treat rejection of an organ or bone marrow transplant): if concomitant use is required, your doctor will check your blood levels regularly and may adapt the dose.
  • Digoxin (for heart failure): digoxin levels may increase. Your doctor will check your blood levels.
  • Colchicine (used for gout and familial Mediterranean fever).
  • Antacids (for indigestion): Azithromycin Taj Pharma should be taken at least 1 hour before or 2 hours after the antacid
  • Cisapride (for stomach problems), terfenadine (used to treat hay fever): concomitant use with Azithromycin Taj Pharma may cause heart disorders.
  • Medicines for irregular heart beat (called anti-arrythmics), or to lower cholesterol (called statins) such as atorvastatin.
  • Alfentanil (used for narcosis) or astemizole (used to treat hay fever): concomitant use with Azithromycin Taj Pharma may increase the effect of these medicinal products.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is insufficient information regarding the safety of Azithromycin Taj Pharma  during pregnancy.

Consequently, Azithromycin Taj Pharma is not recommended if you are pregnant or planning to become pregnant.

However, your doctor may prescribe it under serious circumstances.

Breast-feeding

Azithromycin Taj Pharma is excreted in human milk, therefore you should not breast-feed whilst you are taking Azithromycin Taj Pharma, because it may cause side effects including diarrhoea and infection in your baby. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. You may resume nursing two days after stopping your treatment with Azithromycin Taj Pharma.

Driving and using machines

Azithromycin Taj Pharma may cause dizziness and fits. If affected, do not drive or operate machinery.

Azithromycin Taj Pharma contains soya oil

If you are allergic to peanut or soya, do not use this medicinal product (see also section above ‘Do not take Azithromycin Taj Pharma’).

Azithromycin Taj Pharma contains sodium

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodiumfree’.

  1. How to take Azithromycin Taj Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Azithromycin Taj Pharma tablets should be given as a single daily dose. The tablets should be swallowed preferably with a drink of water, and can be taken with or without food.

Azithromycin Taj Pharma 500mg: The tablet can be divided into equal doses.

The recommended dose is:

Adults (including older patients), children and adolescents with a body weight of over 45 kg:

The recommended dose is 1500mg divided over either 3 or 5 days as follows:

  • When taken over 3 days, 500mg once daily.
  • When taken over 5 days, 500mg as a single dose on the first day and then 250mg once daily on days 2 through to 5.

Inflammation of the urethra or cervix caused by Chlamydia: 1000mg taken as a single dose, for one day only.

For infections in your sinuses, treatment is indicated for adults and adolescents 16 years of age and over.

Children and adolescents with a body weight of 45 kg and under:

Tablets are not indicated for these patients. Other pharmaceutical forms of Azithromycin Taj Pharma -containing products (e.g. suspensions) may be used.

Patients with kidney or liver problems:

You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

If you take more Azithromycin Taj Pharma than you should

If you (or someone else) swallow a lot of the tablets altogether, or if you think a child has swallowed any of the tablets, contact your doctor or pharmacist immediately. An overdose is likely to cause reversible hearing loss, severe nausea (feeling sick), vomiting and diarrhoea.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Azithromycin Taj Pharma

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Azithromycin Taj Pharma

Do not stop taking your medicine without talking to your doctor first even if you feel better. It is very important that you keep taking Azithromycin Taj Pharma for as long as your doctor has told you to; otherwise the infection may come back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

Uncommon (may affect up to 1 in 100 people):

  • A severe skin reaction causing blisters/bleeding of the lips, eyes, nose, mouth and genitals (Stevens-Johnson syndrome).
  • yellowing of the skin and whites of the eyes, tiredness and loss of appetite which may be caused by inflammation of the liver (hepatitis).

Rare (may affect up to 1 in 1,000 people):

  • yellowing of the skin or eyes (jaundice).
  • skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid).

Very rare (may affect up to 1 in 10,000 people):

  • skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell).

Not known (frequency cannot be estimated from the available data):

  • an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
  • severe peeling of the skin or an itchy rash with pink-red rings around a pale centre (toxic epidermal necrolysis, erythema multiforme).
  • disturbances in heart rhythm called QT prolongation (delayed conduction of electrical signals which can be seen on an ECG, an electrical recording of the heart). In some people this can develop into a potentially serious heart condition known as Torsades de pointes. This can result in a very fast heartbeat causing a sudden loss of consciousness.
  • an irregular heart beat.
  • feeling weak and breathless with yellowing of the skin which may be due to a reduced number of red blood cells due to destruction (haemolytic anaemia).
  • prolonged diarrhoea with blood and mucus.
  • stomach pain that moves to the back with feeling and being sick which may be caused by inflammation of the pancreas (pancreatitis).
  • pain in the middle of the back and problems passing water, inflammation of the kidney or kidney failure.
  • pain in the upper right of the stomach with feeling and being sick, swelling of the stomach, yellowing of the skin and eyes which may be due to liver failure (rarely life-threatening).

These are very serious side effects. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

  • feeling sick.
  • abdominal pain.
  • flatulence (wind).
  • Common (may affect up to 1 in 10 people):
  • headache
  • dizziness, feeling drowsy (somnolence), taste disturbance, numbness or pins and needles
  • (paraesthesia).
  • visual disturbances.
  • being sick.
  • skin rash.
  • joint pain (arthralgia).
  • changes in white blood cell count in blood tests.
  • low blood bicarbonate.
  • Uncommon (may affect up to 1 in 100 people):
  • reduced sense of touch or sensation (hypoaesthesia).
  • changes in liver function.
  • skin more sensitive to light than normal.
  • yeast infections of the mouth and vagina (thrush), vaginal infections, fungal infections, bacterial infections, inflammation of the throat, inflammation of the stomach and intestine, breathing difficulties, runny or blocked nose.
  • allergic reactions of various severity.
  • loss of appetite.
  • feeling nervous.
  • sleeplessness (insomnia).
  • ear disorder, vertigo.
  • hearing impairment including hearing loss.
  • tinnitus (ringing in your ears).
  • heart palpitations.
  • hot flushes.
  • recurring frequent infections with fever, chills, sore throat, mouth ulcers, which may be caused by a decrease in the number of white cells in the blood.
  • serious lung infection with symptoms such as fever, chills, shortness of breath, cough and phlegm (pneumonia).
  • general swelling.
  • nose bleeds.
  • constipation, , inflammation of the lining of the stomach (gastritis), difficulty swallowing, feeling bloated, dry mouth, belching, mouth ulceration, saliva increased.
  • , hives, inflammation of the skin (dermatitis), dry skin, increased sweating.
  • bone and joint pain, muscle pain, back pain, neck pain.
  • pain when passing urine, kidney pain.
  • abnormal or unexpected bleeding from the vagina.
  • problems with your testicles.
  • general loss of strength, generally feeling unwell, , swelling of the face, chest pain, fever, pain, swelling of the lower limbs.
  • abnormal laboratory test values (e.g. blood or liver tests).
  • post procedural complication.
  • shortness of breath.

Rare (may affect up to 1 in 1,000 people):

  • agitation

Not known (frequency cannot be estimated from the available data):

  • blood taking longer to clot and bruising more easily which may be due to a reduction in number of platelets (thrombocytopenia),
  • aggression, anxiety, severe confusion (delirium), seeing, feeling or hearing things that are not there (hallucination)
  • fainting, feeling hyperactive, loss of smell or altered sense of smell, loss of taste.
  • muscle weakness or worsening of muscle weakness (myasthenia gravis).
  • low blood pressure.
  • tongue discolouration.
  • tooth discolouration.

The following side effects have been reported in prophylactic treatment against Mycobacterium Avium complex (MAC):

Very common (may affect more than 1 in 10 people):

  • abdominal pain.
  • feeling sick.
  • abdominal discomfort.
  • loose stools.
  • Common (may affect up to 1 in 10 people):
  • loss of appetite.
  • numbness or pins and needles (paraesthesia).
  • taste disturbance.
  • visual disturbances
  • skin rash and/or itching.
  • joint pain.
  • Uncommon (may affect up to 1 in 100 people):
  • reduced sense of touch or sensation (hypoaesthesia).
  • poor hearing or ringing in the ears.
  • heart palpitations.
  • skin more sensitive to sunlight than normal.
  • general loss of strength.
  • generally feeling unwell.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Azithromycin Taj Pharma

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions. Do not transfer the tablets to another container. Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Azithromycin Taj Pharma film-coated tablet contains

  • The active substance is Azithromycin Taj Pharma . Each tablet contains either 250mg or 500mg of the active ingredient Azithromycin Taj Pharma (as Azithromycin Taj Pharma  monohydrate).
  • The other ingredients (excipients) are: microcrystalline cellulose pregelatinised maize starch, sodium starch glycolate (Type A), anhydrous colloidal silica), sodium lauryl sulphate, magnesium stearate Tablet Film-coating ingredients are: polyvinyl alcohol (partially hydrolysed), titanium dioxide, talc, soya lecithin (see “Azithromycin Taj Pharma contains soya oil” and xanthan gum.

What Azithromycin Taj Pharma film-coated tablets look like and contents of the pack

The 250mg tablets are available in pack sizes of 4, 6, 12, 24, 50 or 100 tablets in blister strips.

The 500mg tablets are available in pack sizes of 2, 3, 6, 12, 24, 30, 50 or 100 tablets in blister strips.

Not all pack sizes may be marketed.

Manufactured in India by:
CEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com