Roxithromycin Tablets BP 150mg/300mg Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Roxithromycin Tablets BP 150mg/300mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Roxithromycin Tablets BP 150mg
Each tablet contains:
Roxithromycin BP                          150 mg
Excipients                                         q.s.

Roxithromycin Tablets BP 300mg
Each tablet contains:
Roxithromycin BP                          300 mg
Excipients                                         q.s.

For a full list of excipients see section 6.

3.PHARMACEUTICAL FORM

Film-coated tablet.

4.CLINICAL PARTICULARS

Therapeutic indications

For the treatment of infections caused by microorganisms sensitive to roxithromycin e.g: ENT bronchopulmonary, genital and skin manifestations.

Posology and method of administration

Posology

Adults: 300 mg per day, i.e. 1 x 150 mg tablet in the morning and evening, preferably before meals.

Treatment duration

Treatment duration for throat infections is 10 days.

5. CONTRAINDICATIONS

Hypersensitivity to macrolides or to any of the excipients.

Coadministration with:

vasoconstrictive ergot alkaloids: dihydroergotamine, ergotamine.

Colchicine.

Concomitant use with drugs that may cause ventricular arrhythmias (torsades de pointes, prolonged QT interval) is contraindicated. Such drugs include for example terfenadine, astemizole, cisapride or pimozide.

Women breast-feeding an infant who is treated with cisapride.

Special Warnings and Precautions for use

Special Warnings

Excipient with known effect

This medicinal product contains glucose. It should therefore not be used in patients with glucose-galactose malabsorption syndrome.

Liver failure

Administration of roxithromycin is not recommended in patients with severe liver failure. In patients with mild to moderate liver failure, roxithromycin should be used with caution. If it must be administered in these subjects, regular liver function tests are required and if necessary, the dose should be reduced.

Renal insufficiency

The amount of active substance and its metabolites eliminated by the urinary route are small (10% of the oral dose). There is therefore no need to adjust dosage in patients with kidney failure.

Elderly subjects

The elimination half-life is longer in elderly subjects. However, after repeated administration of 150 mg every 12 hours, peak plasma concentrations, area under the curve and steady state in the interval between 2 roxithromycin doses are no different to those found in young subjects.

It is therefore not necessary to adjust the dose in elderly subjects.

Duration of treatment

In young animals, bone growth plate abnormalities were observed at doses at least 10 times higher than therapeutic doses. It is therefore recommended to limit dosage to 5-8 mg/kg/day for a period not exceeding 10 days.

Co-administration with ergot alkaloids

Severe vasoconstriction (ergotism), potentially leading to peripheral necrosis, has been reported when macrolides are co-admonistered with vasoconstrictive ergot alkaloids.

Before prescribing roxithromycin, the physician should make sure that the patient is not receiving treatment with these alkaloids.

Coadministration of roxithromycin with colchicine or dopaminergic ergot alkaloids is not recommended .

Severe bullous reactions

Cases of severe bullous skin reactions such as Stevens Johnson syndrome or toxic epidermal necrolysis have been reported with roxithromycin ).

If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, Rulid treatment should be discontinued.

Precautions for use

Prolongation of the QT interval

In certain conditions, macrolides, including roxithromycin, have the potential to prolong the QT interval. Therefore, roxithromycin should be used with caution in patients with congenital prolonged QT syndrome and proarrhythmic conditions (e.g. uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia), and in patients receiving treatments which may prolong the QT interval such as Class IA and III antiarrhythmic agents and drugs such as astemizole, cisapride or pimozide.

Myasthenia

As with other macrolides, roxithromycin may aggravate myasthenia.

Clinical monitoring in long-term treatment

Monitoring of liver function, renal function and blood count is particularly recommended in long-term treatment (e.g. treatment duration exceeding 2 weeks) .

Clostridium difficile infection

Cases of Clostridium difficile-associated diarrhea (CDAD) have been reported with the use of almost all antibiotics, including roxithromycin . Severity of the disorder can vary from mild diarrhea to life-threatening pseudomembranous enterocolitis.

Antibiotic treatment modifies colon flora, thus leading to an excessive proliferation of C. difficile.

  1. difficile produces A and B toxins which contribute to the development of CDAD. These toxin-producing strains increase morbidity and mortality since these infections may be refractory to the antibiotic treatment and the patient may require a colectomy. The possibility of CDAD should be considered in all patients who develop diarrhea following the use of antibiotics and treatment with roxithromycin should be stopped immediately. It is important that CDAD be considered as a possible diagnosis in patients who have diarrhea during or following antibiotic treatment.

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations (see 4.3 Contraindications)

+ Colchicine

Potentiation of colchicine-induced adverse effects, which may be fatal.

+ Cisapride

Increased risk of ventricular arrhythmias, especially torsades de pointes.

+ Ergotamine/Dihydroergotamine

Ergotism, potentially leading to peripheral necrosis (decreased hepatic elimination of ergotamine and inhibition of hepatic elimination of dihydroergotamine).

Concomitant use of roxithromycin and ergotamine or hidydroergotamine, may cause perfusion disturbances, especially in the fingers and toes.

Inadvisable combinations

+Dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride, pergolide)

Increased plasma concentrations of the dopaminergic agent with possible increased in activity or occurrence of symptoms of overdose.

+ Terfenadine

Certain macrolides are capable of a pharmacokinetic interactions with terfenadine leading to increased serum concentrations of terfenadine. This may result in severe ventricular arrhythmias, typically torsade de pointes. Although such a reaction has not been demonstrated with roxithromycin and studies in a limited number of healthy volunteers have not shown any pharmacokinetic interaction or relevant ECG changes, the association of roxithromycin and terfenadine is not recommended.

+ Astemizole and Pimozide

Other drugs, such as astemizole or pimozide, which are metabolized by hepatic CYP3A isozyme have been associated with QT interval prolongation and/or cardiac arrhythmias (typically torsades de pointe) 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, association of roxithromycin with such drugs is not recommended.

+ Class IA and III antiarrhytmic agents

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

Combinations requiring precautions for use

+ Drugs likely to induce torsades de pointes (amiodarone, amisulpride, arsenic compounds, bepridil, chlorpromazine, citalopram, cyamemazine, diphemanil, disopyramide, dofetilide, dolasetron, domperidone, dronedarone, droperidol, erythromycin, escitalopram, flupentixol, fluphenazine, halofantrine, haloperidol, hydroquinidine, ibutilide, levofloxacin, levomepromazine, lumefantrine, mequitazine, methadone, mizolastine, moxifloxacin, pentamidine, pimozide, pipamperone, pipotiazine, prucalopride, quinidine, sertindole, sotalol, spiramycin, sulpiride, sultopride, tiapride, toremifene, vandetanib, vincamine, zuclopenthixol).

This serious cardiac rhythm disorder can be caused by a number of antiarrhythmic and non-antiarrhythmic drugs. Hypokalemia (especially induced by potassium-depleting agents) is a promoting factor, as is bradycardia (especially induced by bradycardia- inducing agents) or pre-existing congenital or acquired QT interval prolongation. The medicinal products which cause this adverse effect include class la and III antiarrhythmic agents, and certain neuroleptics. Other agents not belonging to these classes are also involved.

Increased risk of ventricular arrhythmias, especially torsades de pointes.

When co-administering these agents, clinical and ECG monitoring are required.

+ Bradycardia-inducing agents

Increased risk of ventricular arrhythmias, especially torsades de pointes. Clinical and ECG monitoring required.

+ Vitamin K antagonists (acenocoumarol, fluindione, phenindione, warfarin) Increased vitamin K antagonist effect and increased risk of hemorrhage. INR should be monitored more frequently. Dose adjustment of the vitamin K antagonist during treatment with the macrolide and after treatment discontinuation may be necessary.

Special INR imbalance-related issues

Numerous cases of increased oral anticoagulant activity have been reported

in patients receiving antibiotic therapy. The severity of the infection or inflammation, patient’s age and general health status appear to be predisposing risk factors.

Under these circumstances, it seems difficult to determine to what extent the infection itself or its treatment play a role in the INR imbalance.

However, certain classes of antibiotics are more involved, particularly: fluoroquinolones,

macrolides, cyclins, cotrimoxazole, and certain cephalosporins.

+ Atorvastatin, simvastatin

Increased risk of adverse (concentration-dependent) effects such as rhabdomyolosis. Lower doses of the cholesterol-lowering drug should be used.

+ Oral anticoagulants

Increased oral anticoagulant effect and increased risk of bleeding.

INR should be monitored more frequently. Dosage adjustment of the

oral anticoagulant may be necessary during treatment with the macrolide and after its discontinuation.

+ Ciclosporin

Risk of increased blood ciclosporin and creatinine concentrations.

Blood ciclosporin concentrations should be assayed, renal function tests carried out and dosage adjustments made during coadministration and after discontinuation of treatment with the macrolide.

+ Disopyramide

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

+ Digoxin and other cardiac glycosides

Increased blood digoxin levels due to increased absorption.

Clinical monitoring (symptoms and ECG) and, possibly, monitoring of blood digoxin levels during and after treatment with azithromycin.

This clinical monitoring is mandatory if symptoms suggestive of digitalis glycoside overdose are present. Symptoms of the cardiac toxicity of digitalis glycosides may include nausea, vomiting, diarrhea, headache or vertigo, arrhythmia or heart conduction disorders.

Combinations to be taken into account

+ Midazolam

Slightly increase in the sedative effects of midazolam.

+ Theophylline (and, by extrapolation, aminophylline)

Risk of increased blood theophylline concentrations, especially in children. However, this does not usually require any adjustment of the usual dose.

+ Roxithromycin is a weak CYP3A inhibitor. The effect of roxithromycin on exposure to drugs predominantly cleared by CYP3A metabolism would be expected to be 2-fold or less. Caution should be exercised when roxithromycin is concomitantly prescribed with drug metabolized by CYP3A (such as, rifabutin and bromocriptine).

Pregnancy and lactation

Pregnancy

As a precaution, roxithromycin should preferably not be used during pregnancy. Although there is no evidence of teratogenic or fetotoxic effects from animal studies at doses higher than 200 mg/kg/day or 40 times the therapeutic dosage in humans, the clinical data are insufficient.

Lactation

Most macrolides have been found to be excreted in breast milk, at concentrations equal to or higher than plasma concentrations. However, the amounts ingested by the breast- fed newborn are low compared to pediatric doses. The highest risk for the infant is intestinal flora imbalance. Breast-feeding during treatment is therefore possible. If the breast-fed infant develops gastro-intestinal disorders (intestinal candidiasis, diarrhea), breast-feeding must be stopped (or treatment with the drug discontinued).

If the breast-fed newborn or infant is being treated with cisapride, use of macrolides in the mother is contraindicated as a precaution due to the potential risk of interaction in the infant (torsades de pointes).

Effects on the ability to drive vehicle or to use machine

Vehicle drivers or machine users should be informed about risk of vertigo.

Undesirable effects:

The table below summarizes the undesirable effects reported during clinical trials and recorded in the pharmacovigilance database, categorized by system organ class and by frequency. The categories of frequency are defined by applying the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); and Frequency Unknown (cannot be estimated from the available data).

System Organ Class Very common (≥1/10) Common (≥1/100 to

<1/10)

Uncommon (≥1/1,000 to

<1/100)

Frequency Unknown (cannot be estimated from the available data)
 

Infections and infestations

      Superinfection (in long-term use): colitis due to Clostridium difficile

(Pseudomembranous enterocolitis.

Blood and

lymphatic system disorders

    Eosinophilia Thrombocytopenia, neutropenia,

agranulocytosis.

 

Immune system disorders

      Hypersensitivity reactions such as urticaria, angioedema, bronchospasm, anaphylactoid reactions or anaphylactic shock
Psychiatric disorders       Hallucinations, Confusion
Nervous system disorders   Headache, dizziness,   Paresthesia, ageusia, dysgeusia, parosmia, anosmia.
Gastrointestinal disorders   Nausea, vomiting,   Bloody diarrhea pancreatitis Dyspepsia.

 

    gastric pain, diarrhea    
Hepatobiliary disorders       Jaundice, cholestatic hepatitis or cytolytic hepatitis
 

Skin and subcutaneous tissue disorders

  Rash Bollous skin reactions including erythema multiforme, Urticaria Stevens-Johnson Syndrome (SJS ) and Toxic Epidermal Necrolysis (TEN).

Lyell syndrome,Purpura, Angioedema

 

Investigations

      Elevation in AST, ALT transaminases.

Elevation in serum alkaline phosphatase

Ear and labyrinth disorders       Transient deafness, Hypoacusia, Vertigo, tinnitus
 

Cardiovascular disorders

      Prolongation of the QT interval. Ventricular arrhythmia such as torsades de pointe or ventricular tachycardia which may cause ventricular fibrillation or cardiac

arrest.

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.

Any suspected adverse events should be reported.

Overdose:

In case of overdosage: gastric lavage and symptomatic treatment: there is no specific antidote.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: ANTIBACTERIALS FOR SYSTEMIC USE(J: anti-infective)

Roxithromycin is an antibiotic of the macrolide group.

SPECTRUM OF ANTIMICROBIAL ACTIVITY

The critical concentrations differentiating susceptible strains from intermediate strains and the latter from resistant strains are as follows:

S ≤1 mg/I and R > 4 mg/I.

The prevalence of acquired resistance in certain species can vary geographically and over time. It is therefore useful to have local information on resistance, especially in treating severe infections. These data are only guidelines indicating the probability of susceptibility of a bacterial strain to this antibiotic.

When the prevalence of resistance of a bacterial species is known in France, it is indicated in the table below:

Category Incidence of acquired resistance in France (> 10%) (range)
SUSCEPTIBLE SPECIES  
Gram-positive aerobic  
Bacillus cereus  
Corynebacterium diptheriae  
Enterococci 50 – 70 %
Rhodococcus equi  
Staphylococcus meti-S  
Staphylococcus meti-R* 70 – 80 %
Streptococcus B  
Unclassified streptococcus 30 – 40 %
Streptococcus pneumoniae 35 – 70 %
Streptococcus pyogenes 16 – 31 %
Gram-negative aerobic  
Bordetella pertussis  
Branhamella catarrhalis  
Campylobacter  
Legionella  
Moraxella  
Anaerobic  
Actinomyces  
Bacteroides 30 – 60 %
Eubacterium  
Mobiluncus  
Peptostreptococcus 30 – 40 %
Porphyromonas  
Prevotella  
Propionibacterium acnes  

 

 

Category

Incidence of acquired resistance in France (> 10%) (range)
Miscellaneous Borrelia burgdorferi Chlamydia

Coxiella Leptospires

Mycoplasma pneumoniae Treponema pallidum

 
MODERATELY SUSCEPTIBLE SPECIES

(intermediate susceptibility in vitro)

 

Gram-negative aerobic

Haemophilus Neisseria gonorrhoeae

 
Anaerobic

Clostridium perfringens

 

Miscellaneous

Ureaplasma urealyticum

 
 

RESISTANT SPECIES

 

Gram-positive aerobic Corynebacterium jeikeium Nocardia asteroïdes

 

Gram-negative aerobic Acinetobacter Enterobacteries Pseudomonas

 

Anaerobic

Fusobacterium

 

Miscellaneous

Mycoplasma hominis

 
   

Roxithromycin has in vitro and in vivo activity on Toxoplasma gondii.

In vitro, roxithromycin shows moderate activity on Mycobacterium avium.

* The incidence of methicillin resistance is approximately 30 to 50% for all staphylococci, and is mainly found in the hospital setting.

Pharmacokinetic properties

A bioequivalence study has shown a bioequivalence between the pharmaceutical forms:

50 mg sachets (powder for oral suspension)

50 mg tablets

150 mg tablets

The 100 mg tablet form being homothetic with the 150 mg tablet form no bioequivalence study has been performed.

Absorption

It is rapid. Roxithromycin is stable in acid media and present in the serum as soon as the 15th minute:

C max is reached 2.2 hours after a fasting dose of 150 mg

The absorption is not modified by food; it has been shown that the product administered ¼ hour before meal does not entail any modification on the pharmacokinetics in normal subject.

Distribution and excretion

Pharmacokinetic parameters after administration of a single tablet of 150 mg in healthy subjects, are as follows:

maximal serum concentration (C max) is on average 6.6 mg/l

serum concentration 12 hours after administration is on average 1.8 mg/l

mean elimination half-life is 10.5 hours

After administration of repeated doses in the healthy subject (150 mg every 12 hours during 10 days) the steady state is reached between the 2nd and the 4th day.

The serum concentrations in steady state are as follows:

Cmax 9.3 mg/ml

Cmax 3.6 mg/ml

Because there is no accumulation of the product, the daily dosage may be administered in two doses, every 12 hours. By such a way the antibiotic plasma concentration is effective on the sensitive strains for 24 hours.

Tissue penetration

It is satisfying, especially in lung, tonsil and prostate, 6 to 12 hours after repeated 150 mg doses administration.

Macrolides enter and gather into the phagocytes (neutrophil polynuclear, monocytes, alveolar and peritoneal macrophage).

Intra-phagocytic concentrations are high in man. These properties explain the activity of roxithromycin on intra-cellular bacteria

Plasma binding

Binding to plasma proteins is 96%. Roxithromycin is bound principally to 1-alpha-1- acid-glycoprotein. Plasma binding is saturable and is max with a roxithromycin plasma concentration above 4 mg/ml.

There is a slight passage of roxithromycin into milk, less than 0.05 % of the administered dose.

Biotransformation:

Roxithromycin undergoes only slight biotranformation, more than half being excreted unchanged. Three compounds have been identified in the urine and faeces:

  • descladinose roxithromycin, the most abundantly found metabolite
  • two minor metabolites, N-monodemethylroxithromycin and N-didemethylroxithromycin. These three derivatives are found in the same proportions in the urine and

Excretion:

Elimination is principally by the faeces (65%). After roxithromycin C14 oral administration the urinary radioactivity is only 12 % of the whole excreted quantity in 72 hours.

6. PHARMACEUTICAL PARTICULARS

List of excipients:
Hydroxypropyl cellulose, Poloxamer, Povidone, Colloidal anhydrous silica, Magnesium stearate, Talc, Maize starch, Hypromellose, Anhydrous glucose, Titanium dioxide, Propylene glycol.

Special precaution for storage
Do not store above 25°C.

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 Tablets BP 150mg/300mg Taj Pharma

(Roxithromycin tablets)

What is in this leaflet

This leaflet answers some common questions about Roxithromycin Tablets.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Roxithromycin Tablets against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

1.What Roxithromycin Tablets is used for

Roxithromycin Tablets Tablets are used to treat infections in different parts of the body caused by bacteria, such as:

  • acute pharyngitis (sore throat and discomfort when swallowing)
  • tonsillitis
  • sinusitis
  • acute bronchitis (infection of the bronchi causing coughing)
  • pneumonia (lung infection characterised by fever, malaise, headache)
  • skin and soft tissue infections
  • non-gonoccocal urethritis
  • impetigo (bacterial infection causing sores on the skin).

Roxithromycin Tablets is an antibiotic that belongs to a group of medicines called macrolides. These antibiotics work by killing or stopping the growth of the bacteria that are causing your infection.

Roxithromycin Tablets, like other antibiotics, does not work against viral infections such as flu.

Your doctor may have prescribed Roxithromycin Tablets for another reason. Ask your doctor if you have any questions about why Roxithromycin Tablets has been prescribed for you.

There is no evidence that Roxithromycin Tablets is addictive.

Roxithromycin Tablets is available only with a doctor’s prescription.

2. Before you take Roxithromycin Tablets

When you must not take it

Do not take Roxithromycin Tablets if you are allergic to medicines containing roxithromycin, any other macrolides antibiotic eg, azithromycin, clarithromycin, erythromycin or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the

Do not take Roxithromycin Tablets if you have severe liver problems.

Do not take Roxithromycin Tablets if you are taking certain medicines for migraine headache called ergot alkaloids (eg. Cafergot, Ergodryl, Dihydergot).

Ask your doctor if you are not sure whether you are taking one of these medicines.

Do not take Roxithromycin Tablets if the expiry date (Exp.) printed on the pack has passed.

Do not take Roxithromycin Tablets if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of taking ROXITHROMCYIN during pregnancy.

Tell your doctor if you are breastfeeding or intend to breastfeed. Roxithromycin Tablets passes into the breast milk. Your doctor will discuss the risks and benefits of taking Roxithromycin Tablets while breastfeeding.

Tell your doctor if you have or have ever had any other health problems/medical conditions, including:
  • kidney problems (impaired function)
  • liver problems (hepatic cirrhosis with jaundice and/or ascites).
If you have not told your doctor about any of the above, tell him/her before you starting Roxithromycin Tablets.

Taking other medicines

Tell your doctor if you are taking any other medicines, including those you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Roxithromycin Tablets, or may affect how well it works. These include:

  • theophylline, a medicine used to treat asthma
  • some medicines for migraine headache such as ergotamine or dihydroergotamine
  • disopyramide, a medicine to treat irregular heart rhythms
  • terfenadine and astemizole, over the counter medicines used to treat allergies
  • warfarin, a medicine used to prevent blood clots
  • digoxin, a medicine used to treat heart failure and/or irregular heart rhythms
  • midazolam, a medicine used to induce sleep before operations
  • cyclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
  • cisapride, a medicine used to treat gastrointestinal problems
  • pimozide, an antipsychotic

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Roxithromycin Tablets.

3. How to take Roxithromycin Tablets

How much to take

The recommended adult dose is 300 mg per day which may be taken according to one of the following regimes:

  • one 300 mg tablet once a day, or
  • one 150 mg tablet twice a day, or
  • two 150 mg tablets once a

However, depending on your condition and how you react to the medicine, your doctor may ask you to take a different dose.

The recommended dosage for children more than 40 kg is one 150 mg tablet twice daily.

The dosage of Roxithromycin Tablets given to children is dependant on the child’s weight.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take Roxithromycin Tablets

Swallow the tablet whole with a glass of water.

When to take Roxithromycin Tablets

Roxithromycin Tablets should be taken at least 15 minutes before food or on an empty stomach (i.e. more than 3 hours after a meal). Roxithromycin Tablets works best if you take it on an empty stomach. Food in the stomach can reduce the absorption of Roxithromycin Tablets.

Take the tablet at about the same time of each day.

Taking your tablet at the same time each day will have the best effect on your infection. It will also help you to remember when to take it.

How long to take Roxithromycin Tablets for

For treating infections, Roxithromycin Tablets is usually taken for 5 to 10 days. However, your doctor may prescribe Roxithromycin Tablets for longer periods. Check with your doctor if you are not sure how long you should be taking it.

Keep taking Roxithromycin Tablets until you finish your pack or until your doctor recommends.

Do not stop taking Roxithromycin Tablets, even if you feel better after a few days, unless advised by your doctor.

Your infection may not clear completely if you stop taking your medicine too soon.

If you forget to take Roxithromycin Tablets

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed. If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much Roxithromycin Tablets (overdose)

Immediately telephone your doctor, or the

Emergency department at your nearest hospital, if you think that you or anyone else may have taken too many Roxithromycin Tablets.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

4.While you are taking Roxithromycin Tablets

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Roxithromycin Tablets.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Roxithromycin Tablets.

If you become pregnant while taking Roxithromycin Tablets, tell your doctor immediately.

If your symptoms do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking Roxithromycin Tablets.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without checking with your doctor.

If you get a sore, white mouth or tongue while taking or soon after stopping Roxithromycin Tablets, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.

This may mean you have a fungal/yeast infection called thrush. Sometimes, the use of Roxithromycin Tablets allows fungi/yeast to grow and the above symptoms to occur. Roxithromycin Tablets does not work against fungi/yeast.

Things you must not do

Do not stop taking your tablets because you are feeling better, unless advised by your doctor.

If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.

Do not use Roxithromycin Tablets to treat any other conditions unless your doctor tells you to.

Do not give Roxithromycin Tablets to anyone else, even if they have the same condition as you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Roxithromycin Tablets.

Like other medicines, Roxithromycin Tablets Tablets can cause some side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you:
  • oral thrush – white, furry, sore tongue and mouth
  • vaginal thrush – sore and itchy vagina and/or discharge
  • nausea, vomiting, stomach pain, diarrhoea, flatulence
  • loss of appetite
  • red and/or itchy skin
  • headache, dizziness, ringing in the ears
  • tiredness
  • altered
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following 
  • swelling of the face, lips, mouth and tongue
  • severe persistent diarrhoea
  • an allergic reaction (eg. itchy skin, rash, swelling, asthma) These may be signs of a serious allergic
Other side effects not listed above may also occur in some patients. Tell

your doctor if you notice anything that is making you feel unwell.

After finishing Roxithromycin Tablets, tell your doctor immediately if you notice any of the following side effects:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the

These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention.

However, this side effect is rare. Do not take any diarrhoea medicine without first checking with your doctor.

5.After taking Roxithromycin Tablets

Storage

Keep Roxithromycin Tablets where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep Roxithromycin Tablets in a cool, dry place where the temperature stays below 25°C, and protect from light and moisture.

Keep your tablets in the blister packs until it is time to take them. If you take the tablets out of the blister pack, they may not keep well.

Do not store Roxithromycin Tablets or other medicines in the bathroom or near a sink. Do not leave the tablets in the car or on window sills.

Heat, light and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Roxithromycin Tablets, or your tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

6. Product description

What Roxithromycin Tablets looks like

Roxithromycin Tablets comes in 2 strengths of tablets:

  • Roxithromycin Tablets 150 – white, round film-coated tablets. Each pack contains 10 tablets
  • Roxithromycin Tablets 300 – white, round film-coated tablets. Each pack contains 5

Ingredients

The active ingredient in Roxithromycin Tablets is roxithromycin.

  • each Roxithromycin Tablets BP 150 tablet contains 150 mg of roxithromycin BP.
  • each Roxithromycin Tablets BP 300 tablet contains 300 mg of roxithromycin BP.

The tablets also contain: Hydroxypropyl cellulose (hyprolose), colloidal anhydrous silica, purified talc, povidone, maize starch, magnesium stearate, Hypromellose, anhydrous glucose, titanium dioxide, propylene glycol.

The tablets do not contain gluten, sucrose, tartrazine or any azo dyes.

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