1.NAME OF THE MEDICINAL PRODUCT
a) Roxithromycin 150mg Film Coated Tablets USP Taj Pharma.

b) Roxithromycin 300mg Film Coated Tablets USP Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a)Each Film Coated Tablet contains

Roxithromycin USP                            150 mg
Lactose monohydrate                           1.8mg 
Excipients                                                q.s.

b)Each Film Coated Tablet contains
Roxithromycin USP                            300 mg
Lactose monohydrate                           3.6mg
Excipients                                                q.s.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Film-coated tablet
Roxithromycin 150 mg:
Round white, biconvex bevelled coated tablet with off white core.
Roxithromycin 300 mg:
Oblong white, capsule shaped coated tablet with off white core with a score line on one side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Roxithromycin is indicated for the treatment of infections due to roxithromycin-susceptible microorganisms. Such infections include:

Respiratory infections: Community-acquired pneumonia, in particular pneumonia caused by Mycoplasma pneumoniae, Chlamydophila psittaci (ornithosis) or Chlamydophila pneumoniae (TWAR).

Tonsillitis, pharyngitis and acute otitis media in patients with hypersensitivity to beta lactam antibiotics, or when such treatment is considered unsuitable for other reasons.

Urogenital infections caused by Chlamydia trachomatis.

Skin and soft tissue infections such as furunculosis, pyodermia, impetigo, erysipelas in patients with hypersensitivity to beta lactam antibiotics, or when such treatment is considered unsuitable for other reasons.

Consideration should be given to official/national guidance regarding antibacterial resistance and the appropriate use and prescription of antibacterial agents.

4.2  Posology and method of administration
Posology
The tablet should be taken at least 15 minutes before a meal to ensure maximal absorption. Normal dosage is 150 mg twice daily (every 12th hour).

Patients with pneumonia may be treated with the dosage regimen 300 mg once daily.

Renal impairment
In patients with renal insufficiency no change in dosage is necessary.

Hepatic impairment
Roxithromycin should be used with caution in subjects with mild to moderate hepatic insufficiency. The use of roxithromycin is not recommended in patients with severe hepatic insufficiency (see section 4.4). If use of roxithromycin is essential because of clinical reasons in this patient group, half of the usual dose a day (= 150 mg) may be administered.

Parameters of hepatic function must be controlled regularly in patients with signs of liver dysfunction or in case hepatic functional impairment has occurred on previous therapy with roxithromycin. If the parameters deteriorate during administration of Roxithromycin, discontinuation of therapy should be considered.

Elderly patients
No change in dosage is necessary.

Paediatric patients
In children with a body weight of more than 40 kg the dosage should be the same as in adults. In children with a body weight of less than 40 kg, Roxithromycin is not recommended. Roxithromycin tablets are not suitable for administration to children under 6 years, for whom other pharmaceutical forms are available.

Method of administration
For oral use.

Duration of treatment
As a rule Roxithromycin is administered for a further 3 or 4 days after improvement of the clinical symptoms.
Therapy over at least 10 days is indicated in the treatment of infections with ß-haemolytic streptococci in order to prevent late complications (e.g. rheumatic fever, glomerulonephritis).

4.3 Contraindications
Hypersensitivity to macrolides or to any of the excipients listed in section 6.1.

Concomitant administration of roxithromycin and any of the following substances is contraindicated:
· Vasoconstrictive ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) (see section 4.5)
· Medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 (cisapride, pimozide, astemizole and terfenadine (see sections 4.4 and 4.5).

Roxithromycin is contraindicated in patients with a history of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation (see also section 4.4).

4.4 Special Warnings and precautions for use
Warnings
Severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities has been reported when macrolides antibiotics have been associated with vasoconstrictive ergot alkaloids. Absence of treatment by these alkaloids must always be checked before prescribing roxithromycin (see section 4.4).

Precautions
As with other macrolides, due to a potential to increase QT interval, roxithromycin should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, bradycardia (< 50 bpm).

Caution is warranted when roxithromycin is administered to patients taking:
·  QT interval prolonging agents (see section 4.5). These include Class IA (e.g. quinidine, procainamide, disopyramide) and Class III (e.g. dofetilide, amiodarone) antiarrhythmic agents, citalopram, tricyclic antidepressants, methadone, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungals (e.g. fluconazole, pentamidine), and some antiviral drugs (e.g. telaprevir).
·  Potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.

The use of roxithromycin is not recommended in patients with severe hepatic insufficiency (e.g. cirrhosis of the liver with hepatitis and/or ascites). If use of roxithromycin is essential because of clinical reasons in this patient group please refer for dosage to section 4.2. Parameters of hepatic function must be controlled regularly in patients with signs of liver dysfunction or in case hepatic functional impairment has occurred on previous therapy with roxithromycin. If the parameters deteriorate during administration of roxithromycin i.e. increase in liver enzymes and/or bilirubin (jaundice), discontinuation of therapy should be considered.
Roxithromycin should be used with caution in patients with mild-moderate liver impairment.

Clostridium difficile-associated disease: Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with roxithromycin, may be symptomatic of pseudo-membranous colitis. If pseudo-membranous colitis is suspected, roxithromycin therapy must be stopped immediately. Antiperistaltics are contraindicated.

Anaphylactic reactions including angioedema have been reported for roxithromycin. Anaphylactic reactions can progress to a life threatening shock, even after the first administration. In these cases roxithromycin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.

Cases of severe bullous skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis (AGEP), have been reported with roxithromycin. If symptoms or signs of AGEP, SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, roxithromycin treatment should be discontinued.

Roxithromycin has been shown to prolong the QT interval on the electrocardiogram in some patients and to cause ventricular tachycardia (e.g. torsade de pointes). If signs of cardiac arrhythmia occur during treatment with roxithromycin, treatment should be stopped and an ECG should be performed.

As with other macrolide antibiotics, roxithromycin may exacerbate or aggravate myasthenia gravis. Patients with myasthenia gravis taking roxithromycin should be advised to immediately seek medical attention if they experience exacerbation of their symptoms. Roxithromycin must then be discontinued and supportive care administered as medically indicated.

Renal excretion of roxithromycin and its metabolites accounts for approximately 10 % of an oral dose. The dosage should be kept unchanged in renal insufficiency.

It is not necessary to adjust the dosage in the elderly.

The effects of the medicinal product in children have not been documented. Roxithromycin 150/300 mg is not intended for use in children and patients with a body weight of less than 40 kg.

Especially during therapy exceeding a period of 14 days, routine kidney, liver and blood laboratory tests should be performed regularly (see section 4.8).

Roxithromycin contains lactose-monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction with other medicinal products and other forms of interaction
Associations contraindicated
Roxithromycin is a weak inhibitor of CYP3A4, increasing midazolam AUC by 47 %. A possible clinical relevant inhibition of CYP3A4, leading to increased exposure of concomitantly administered medicines that are substrates of this enzyme, cannot be excluded in some individuals, Therefore, coadministration of cisapride, ergot alkaloid derivatives, pimozide, astemizole and terfenadine is contraindicated, and caution is warranted when roxithromycin is co-administered with other medicinal products with narrow therapeutic window metabolised by CYP3A .

Astemizole/cisapride/pimozide
Other drugs, such as astemizole, cisapride or pimozide, which are metabolised by hepatic CYP3A isozyme have been associated with QT interval prolongation and/or cardiac arrhythmias (typically Torsades de pointes) as a result of increase in their serum level subsequent to interaction with significant inhibitors of this isozyme, including some macrolide antibacterials. Although roxithromycin has no or limited ability to complex CYP3A and therefore to inhibit the metabolism of other drugs processed by this isozyme, a potential for clinical interaction of roxithromycin with the above mentioned drugs cannot be either ascertained or ruled out in confidence therefore, concomitant use of these substances with roxithromycin is therefore contraindicated (see section 4.3).

Terfenadine
Some macrolides interact with terfenadine, with increased serum concentration of terfenadine as a consequence. This may cause serious ventricular arrhythmia, such as Torsade de pointes. Although this kind of reaction has not been demonstrated with roxithromycin and studies with a limited number of healthy volunteers have shown no pharmacokinetic interaction or relevant ECG-changes, the combination of roxithromycin and terfenadine is contraindicated (see section 4.3).

Ergot alkaloids
Concomitant medication of roxithromycin and ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities. The combination is contraindicated (see section 4.3).

Associations not recommended

Medicinal products with a potential to prolong the QT interval
Caution is warranted when roxithromycin is administered to patients taking other medicinal products with the potential to prolong the QT interval (see section 4.4). These include Class IA (e.g. quinidine, procainamide, disopyramide) and Class III (e.g. dofetilide, amiodarone) antiarrhythmic agents, citalopram, tricyclic antidepressants, methadone, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungals (e.g. fluconazole, pentamidine), and some antiviral drugs (e.g. telaprevir).

Warfarin and other anticoagulantia
No interaction with warfarin has been found in studies of healthy volunteers, however, increases in prothrombin time or International Normalised Ratio (INR), which may be explained either as an interaction with roxithromycin or by the infectious episode (per se), have been reported in patients treated with roxithromycin and vitamin K antagonists. It is prudent practice to monitor INR during combined treatment with roxithromycin and vitamin K antagonists.

Disopyramide
An in-vitro study has shown that roxithromycin can displace protein bound disopyramide. Such an effect in vivo may result in increased serum levels of free disopyramide. Therefore the ECG and, if possible, the serum levels of disopyramide should be controlled.

Precautions for use

Digoxin and other cardiac glycosides
A study in healthy volunteers has shown that roxithromycin may increase the absorption of digoxin. A similar phenomenon has been described for other macrolides and may very rarely result in cardiac glycoside toxicity. This may be manifested by symptoms such as nausea, vomiting, diarrhoea, headache or dizziness; cardiac glycoside toxicity may also elicit heart conduction and/or rhythm disorders. Consequently, in patients treated with roxithromycin and digoxin or any other cardiac glycoside, ECG and, if possible, the serum level of the cardiac glycoside should be monitored. This is mandatory if symptoms suggesting cardiac glycoside overdosage have occurred.

Roxithromycin, like other macrolides, should be used with caution in patients receiving Class IA and III antiarrhythmics.

HMG-CoA Reductase Inhibitors
When roxithromycin and an HMGCoA reductase inhibitor (statin) are combined, there is a potential risk of muscle related adverse events, such as rhabdomyolysis due to a possible increase of the statin exposure.
Caution should be exercised when a statin is combined with roxithromycin and patients should be monitored for signs and symptoms of myopathy.

Associations to be taken into account

Cyclosporine
In a clinical study to assess the effects of roxithromycin on cyclosporine exposure, 8 heart transplant recipients treated with cyclosporine for at least 1 month received roxithromycin 150 mg bid for 11 days. Roxithromycin caused a 50 % increase in plasma cyclosporine concentrations that progressively decreased on roxithromycin discontinuation. Cyclosporine dosage adjustment is in general not necessary.

Midazolam
Co-administration of roxithromycin (300 mg daily) and midazolam (15 mg orally) increased the midazolam (a sensitive CYP3A4 substrate) AUC by 47 %, which may lead to enhanced midazolam effects.

Theophylline
A slight increase has been detected in plasma concentrations of theophylline, but this does not generally require alteration of the usual dosage.

Roxithromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potentiate theophylline toxicity. Therapeutic drug monitoring of theophylline concentrations is recommended, especially when pre-treatment levels of g/ml.mtheophylline are higher than 15

Bromocriptine
Roxithromycin may increase the AUC and plasma concentrations of bromocriptine, which could lead to an increased risk for adverse effects of the compound.

Rifabutin
Roxithromycin can increase the plasma concentration of rifabutin.

Others

Carbamazepine, ranitidine, aluminium or magnesium hydroxide
There is no clinically significant interaction with carbamazepine, ranitidine, aluminium or magnesium hydroxide.

Contraceptives
Some antibiotics could in rare cases decrease the effect of oral contraceptives by interference with the bacterial hydrolysis of steroid conjugates in the intestine, thereby reducing the reabsorption of unconjugated steroid. The plasma levels of active steroid may then decrease. This rare interaction could occur in women with high biliary elimination of steroid conjugates. About 60 pregnancies have occurred in English women on oral contraceptives when antibiotics have been taken concomitantly, in particular ampicillin, amoxicillin and tetracyclines.
There are negative studies of clinical interactions to assess the effects of trimethoprimsulphamethoxazole, roxithromycin and clarithromycin and oral contraceptives containing oestrogens and progestogens, although in very few subjects.

4.6 Fertility, Pregnancy and lactation
Pregnancy
Studies in several animal species have not shown any teratogenic or foetotoxic effects at doses up to 200 mg/kg/day, or 40 times the human therapeutic dose. The safety of roxithromycin for the foetus has not been established in human pregnancy.
Roxithromycin should not be used during pregnancy unless clearly indicated.

Breast-feeding
There is no clinical experience on use during lactation: only very small amounts of roxithromycin (less than 0.05 % of the dose taken) are excreted into maternal milk. Breast-feeding or treatment of the mother should therefore be discontinued as necessary.

4.7 Effects on ability to drive and use machines
Car drivers and machine users should be informed about the risk of dizziness. Visual impairment and vision blurred may also have an effect on a patient’s ability to drive or operate machinery (see section 4.8).

4.8 Undesirable Effects
The total frequency of side effects is about 4 % (150 mg x 2) and 10 % (300 mg x 1) respectively. 3 % and 7 % respectively are gastrointestinal side effects, i.e. the frequency is increased with dosing once daily.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:
Very common (³ 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)
Not known (cannot be estimated from the available data).

System organ classCommonUncommonRareNot known (Post-marketing experiences)
Infections and infestationsSuperinfections with resistant bacteria or fungi on long-term use,
Clostridium difficile colitis (pseudo membranous colitis; see section 4.4).
Blood and lymphatic system disordersEosinophilia.Changes in blood count.Agranulocytosis, Neutropenia, Thrombocytopenia.
Immune system disordersAngioedema, Anaphylactic reaction (see section 4.4).Anaphylactic shock.
Psychiatric disordersConfusional state (confusion), Hallucination, Psychosis.
Nervous system disordersHeadache, Dizziness.Taste disorders (dysgeusia, ageusia),
Smell disorders (parosmia, anosmia).
Paraesthesia.
Eye disordersVisual impairment,
Vision blurred.
Ear and labyrinth disordersDeafness transitory,
Hypoacusis,
Vertigo,
Tinnitus.
Cardiac disorders (1)QT-prolongation,
Ventricular tachycardia and Torsade de pointes (see section 4.4).
Respiratory, thoracic and mediastinal disordersBronchospasm.
Gastrointestinal disordersNausea, Epigastric pain, Dyspepsia, Diarrhoea (see section 4.4).Vomiting, Obstipation, Flatulence.Anorexia, Haemorrhagic pancreatitis.
Hepatobiliary disordersCholestatic hepatitis, Hepatocellular acute hepatitis (see section 4.4), Pancreatitis.Jaundice (see section 4.4).
Skin and subcutaneous tissue disordersRash.Redness, Urticaria, Erythema multiforme.Eczema.Pruritus, Purpura, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalised exanthematous pustulosis (AGEP).
Musculoskeletal and connective tissue disorderMyasthenia gravis (see section 4.4).
General disorders and administration site conditionsWeakness, Discomfort.
InvestigationsIncreased transaminases and/or alkaline phosphatases and/or bilirubin (see section 4.4).

 

(1) As with other macrolides, cases of QT prolongation, ventricular tachycardia and torsades de pointes were rarely reported for roxithromycin.

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.

4.9 Overdose
Toxicity
Low acute toxicity, but there is limited experience of overdose.

Symptoms
Nausea, vomiting and diarrhoea. Undesirable effects such as headache and dizziness may appear and become potentiated by overdose.

Treatment
If necessary gastric lavage and treatment with carbon. Symptomatic treatment. No specific antidote exists.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group:
Roxithromycin a semi-synthetic macrolide with a 14-membered lactone ring.

Mechanism of action
Roxithromycin’s mode of action is exerted by inhibiting protein synthesis through binding to the 50S subunit of the bacterial ribosome. The antibacterial effect results herefrom.

PK/PD relationship
Primarily, the effectivity depends on the duration during which the serum level is above the Minimum Inhibitory Concentration (MIC) for the microorganism.

Mechanisms of resistance
Resistance against roxithromycin can be due to the following mechanisms:
· Efflux: Increase in the number of efflux pumps in the cytoplasmic membrane can result in resistance. Only 14- and 15-membered lactone rings (M-phenotype) are affected by this.
· Alteration of target structure: Methylation of the 23S rRNS decreases the affinity for ribosomal binding site. This results in resistance against macrolides (M), lincosamides (L) und streptogramin B (MLSB-phenotype).
· The enzymatical deactivation of macrolides is only of secondary clinical relevance.

Among M phenotype there is complete cross-resistance between roxithromycin, azithromycin, clarithromycin, and erythromycin, respectively. Among MLSB phenotype cross-resistance with clindamycin and streptogramin B exists additionally.

Breakpoints
Minimum inhibitory concentration (MIC) breakpoint established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

Staphylococcus spp. S ≤ 1.0 mg/L and R > 2.0 mg/L
Streptococcus spp., group A, B, C and G S ≤ 0.5 mg/L and R > 1.0 mg/L
Streptococcus pneumoniae S ≤ 0.5 mg/L and R > 1.0 mg/L
Haemophilus influenzae* S ≤ 1.0 mg/L and R > 16 mg/L
Moraxella catarrhalis S ≤ 0.5 mg/L and R > 1.0 mg/L
*The correlation between H. influenzae macrolide MICs and clinical outcome is weak. Therefore, breakpoints for macrolides and related antibiotics were set to categorise wild type H. influenzae as intermediate

Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species. Therefore, 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 roxithromycin in at least some types of infections is questionable.

Commonly susceptible species
Aerobic Gram-positive microorganisms
Streptococcus pyogenes1
Aerobic Gram-negative microorganisms
Haemophilus influenzae
Moraxella catarrhalis
Other microorganisms
Chlamydia trachomatis°
Chlamydophila pneumoniae°
Chlamydophila psittaci
Legionella pneumophila°
Mycoplasma pneumoniae°
Species for which acquired resistance may be a problem
Aerobic Gram-negative microorganisms
Staphylococcus aureus (Methicillin-susceptible)
Staphylococcus aureus (Methicillin-resistant)+
Streptococcus pneumoniae
Inherently resistant organisms
Aerobic Gram-negative microorganisms
Escherichia coli
Klebsiella spp.
Pseudomonas aeruginosa
Other microorganisms
Mycoplasma hominis

$ Natural intermediate susceptibility.
+ High rates of resistance (> 50 %) have been observed in one or more regions within the EU.
1Resistance rate in some studies ³ 10 %

5.2 Pharmacokinetic properties
Absorption
For maximal absorption the tablet should be taken at least 15 minutes before a meal. Roxithromycin displays non-linear kinetics, and AUC and Cmax do not increase in proportion to dose. Following singles doses of 150 mg and 300 mg to healthy volunteers mean Cmax values were in the range of 5.8 – 10.1 µg/ml and 7.2 – 12.0 µg/ml, respectively; under multiple dosing for up to 15 days there is marginal accumulation with mean Cmax values of 6.57 – 9.3 µg/ml (150 mg) and 10.4 – 10.9 µg/ml (300 mg). Maximum plasma concentration is reached after about 1-2 hours.

The binding to plasma proteins at clinically relevant concentrations is 80-96 %. Roxithromycin binds with high affinity mainly to acid alpha-1-glycoproteins (saturated binding) and with low affinity to albumin (unsaturated binding): The binding is concentration dependent at concentrations above 4 mg/ml.

Distribution
Roxithromycin exhibits good penetration into various tissues and body fluids. High tissue concentrations have been observed in lungs, tonsils, sinus mucosa, prostate and uterus, 6 and 12 hours after administration in multiple dose studies. Roxithromycin accumulates into macrophages and polymorphonuclear neutrophils; intracellular/extracellular concentration ratios range from 14 to 190. The passage over the blood-brain-barrier is limited.

The half-life following single doses is reported to range from 6.3-16 h at doses of 150-450 mg. Following multiple dosing the half-life is reported to be 12-13 h, resulting in therapeutic plasma concentrations at the recommended dosages.

Biotransformation and elimination
More than half of the administered dose is excreted unchanged. Roxithromycin is mainly metabolised by the liver. Three metabolites have been identified in faeces and urine; descladinose roxithromycin, N-monodemethylroxithromycin and N-dimethylroxithromycin.

After oral dosage, roxithromycin is mainly eliminated in faeces and partly by the lungs. Only a small part of the dose is excreted in the urine. The dose should therefore be kept unchanged for patients with renal insufficiency.

In patients with impaired liver function, the half-life can be prolonged to about 25 hours and Cmax increases after an oral dosage of 150 mg (see section 4.2). In end-stage renal disease Cmax was not altered as compared to healthy subjects.

In infants or children receiving roxithromycin 2.5 mg/kg bid for 6 days mean Cmax values were 10.1 µg/ml (5 – 13 months of age), 8.7 µg/ml (2 – 4 years of age), and 8.8 µg/ml (5 – 12 years of age), respectively.

5.3 Preclinical safety data
Roxithromycin, like erythromycin, has been shown in vitro to cause a concentration-dependent QRS prolongation. Such effects have not been seen in humans, but have been regarded as possible in clinical use.

There are no other preclinical data concerning general toxicity, reproduction effects and genotoxicity, relevant for the prescriber, except those already included under other headings in the summary of product characteristics.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, polaxamer 188, povidone, talc, magnesium stearate.

Coat: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171)

6.2 Incompatibilities
Not applicable

6.3  Shelf life
5 years

6.4 Special precautions for storage
Do not store above 30 °C.

6.5 Nature and contents of container
PVC aluminium blister Pack sizes: 150 mg: 5, 10, 12, 14, 16, 20, 28, 30, 50, 60, 90, 100, 250 and 500 tablets 300 mg: 5, 6, 7, 10, 14, 16, 20, 28, 30, 50, 60, 90, 100, 250 and 500 tablets

6.6 Special precautions for disposal and other handling
No special requirements

7. 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

Roxithromycin 150mg Film Coated Tablets USP Taj Pharma

Package leaflet: Information for the patient

a) Roxithromycin 150mg Film Coated Tablets USP Taj Pharma.
b) Roxithromycin 300mg Film Coated Tablets USP Taj Pharma.

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Roxithromycin is and what it is used for
2. Before you are given Roxithromycin
3. How you will be given  Roxithromycin
4. Possible side effects
5. How Roxithromycin is stored
6. Further Information

1. What Roxithromycin is and what it is used for
Roxithromycin is a macrolide antibiotic. Roxithromycin prevents bacteria from growing, by interfering with their protein synthesis.

It is used to treat infections caused by roxithromycin-sensitive bacteria like respiratory tract infections, genito-urinary tract infections, soft tissue infections and infections in the skin.

Your doctor may have prescribed other use. Always follow your doctor’s instructions.

2. Before you are given Roxithromycin
Do not take Roxithromycin
– if you are allergic to roxithromycin, to any of the other ingredients of this medicine (listed in section 6) or to other macrolide antibiotic, like erythromycin
– if you are concurrently taking ergotalkaloids (anti-migraine medicine)
– if you are concurrently taking drugs containing terfenadine or astemizole (anti-allergy medicine), cisapride (stomach medicine), or pimozide (anti-psychotic medicine)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Roxithromycin:
– if you suffer from hypokalaemia (low plasma potassium concentration)
– if you have a heart disease
– if you have an impaired hepatic function
– if you have diarrhoea
– if you a body weight of less than 40 kg since no documented effect has been shown
– if you have an intolerance to some sugars

Other medicines and Roxithromycin
Roxithromycin has the potential to interact with other drugs. Talk to your doctor if you are taking or have recently taken any of the following medicines :
· terfenadine or astemizole (anti-allergy medicine)
· cisapride (stomach medicine)
· pimozide (antipsychotic medicine)
· digoxin or other heart glucosid (cardiac medicine)
· disopyramide (medicine treating abnormal heart rhythms)
· ergotamine or dihydoergotamine (anti-migraine medicine)
· midazolam or triazolam (sleeping medicine)
· ciclosporin (used in organ transplantations)
· theophylline (asthma medicine)
· bromocriptine (medicine for Parkinson’s disease)
· statin (cholesterol lowering medicine)

Antacids containing both aluminium and magnesium may possibly reduce the efficacy of Roxithromycin. Take antacids 2 hours before or after Roxithromycin.

Roxithromycin may possibly reduce the efficacy of contraceptives.

Please tell your doctor or pharmacist if you are taking, have recently taken or migth take any other medicines, including medicines obtained without a prescription, natural medicines and strong vitamins and minerals.

Roxithromycin with food and drink
Take the Roxithromycin on an empty stomach at least 15 minutes before a meal. The tablets should be administered with a sufficient amount of water.

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
Do not take Roxithromycin while you are pregnant without your doctor’s prescription.

Breast-feeding
Do not take Roxithromycin while breast-feeding without your doctor’s prescription. Roxithromycin (the active ingredient) will be excreted in the breast milk.

Driving and using machines
Caution should be exercised when driving and using machines as Roxithromycin can cause dizziness.

Roxithromycin contains glucose
The tablets contain a small amount of glucose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How you will be given Roxithromycin
Always take this medicine exactly as your doctor has told you. Ccheck with your doctor or pharmacist if you are not sure.

Take the Roxithromycin on an empty stomach at least 15 minutes before a meal. The tablets should be administered with a sufficient amount of water.

Adults and children with a body weight of more than 40 kg: Your doctor will prescribe an individual dose. The usual dose is 150 mg twice a day (every 12 hours) or 300 mg once daily. It is imperative that you continue treatment until the course prescribed by your doctor is completed. Do not stop even if the symptoms disappear before the end of the course.

Impaired liver function:
Roxithromycin should be used with caution in cases of liver insufficiency, dosage should be reduced.

Always follow your doctor’s instructions. Each individual has different needs. You should not change or stop your treatment without consulting your doctor.

If you take more Roxithromycin than you should
If you take more Roxithromycin than you should, you can experience nausea, vomiting and diarrhoea. Undesirable effects such as headache and dizziness may appear and become potentiated by overdose.
If you take more Roxithromycin than you should, tell a doctor or pharmacist.

If you forget to take Roxithromycin
Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Roxithromycin
You should not change or stop your treatment without consulting your doctor. It is vital to take the tablets according to your doctor’s instructions as regards the duration of treatment.

If you do not follow the treatment for the days fixed, there is a risk that the bacteria will survive and trigger a new infection.

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

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

Common (may affect up to 1 in 10 people)
– Nausea, stomach ache

Uncommon (may affect up to 1 in 100 people)
– Diarrhoea, indigestion, vomiting, constipation, wind
– Elevated liver
-enzyme levels
– Redness, rash, urticaria
– Headache, dizziness

Rare (may affect up to 1 in 1,000 people)
– Changes in blood count
– Transitory deafness, loss of hearing, vertigo, tinnitus
– Asthma-like symptoms
– Impairment of liver and pancreas
– Eczema, rash, Stevens Johnson syndrome (symptoms with fever, rash or infection).
– Weakness, discomfort, oedema, severe allergic response
– Disturbances of taste and/or smell.

On long-term use, secondary infection (supra-infection) with resistant bacteria or fungi is possible.

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

5. How Roxithromycin is stored
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton 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 to protect the environment.

6. Further information

What Roxithromycin contains
– The active substance is roxithromycin.
a)Each Film Coated Tablet contains
Roxithromycin USP                            150 mg
Lactose monohydrate                           1.8mg 
Excipients                                                q.s.

b)Each Film Coated Tablet contains
Roxithromycin USP                            300 mg
Lactose monohydrate                           3.6mg
Excipients                                                q.s.

– The other ingredients are:
Tablet core: Maize starch, hydroxypropyl cellulose, water free colloidal silica, sodium starch glycolate (type A and B), poloxamer 188, povidone (K30), magnesia stearate, and talcum.
Coating : Propylene glycole, water free glucose, hypromellose, and titanium dioxide (E171).

What Roxithromycin looks like and contents of the pack
Roxithromycin 150 mg; white or almost white, round, convex film-coated tablet. Diameter: 9 mm
Roxithromycin 300 mg; white or almost white, round, convex film-coated tablet. Diameter: 11 mm
Packs size: 7, 14, 28, 30, 50, 90, 100 and 500 tablets

Not All Packs May Me Be Marketed.

7. 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