PACKAGE LEAFLET: INFORMATION FOR THE USER KLABAX 250 mg Tablets KLABAX 500 mg Tablets (clarithromycin)

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER KLABAX 250 mg Tablets KLABAX 500 mg Tablets (clarithromycin) Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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 or pharmacist. In this leaflet: 1. What Klabax Tablets are and what they are used for 2. Before you take Klabax Tablets 3. How to take Klabax Tablets 4. Possible side effects 5. How to store Klabax Tablets 6. Further information 1. WHAT KLABAX TABLETS ARE AND WHAT THEY ARE USED FOR You have been given either Klabax 250 mg Tablets or Klabax 500 mg Tablets. Clarithromycin is the active ingredient in these tablets. It belongs to a group of medicines called macrolide antibiotics. Antibiotics help the body fight infections by destroying the bacteria which cause the infection. Your doctor might have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect. You may have been prescribed Klabax Tablets to treat: Infections of the lungs or lower airways such as bronchitis, pneumonia etc. Infections of the throat or sinus Infections of the skin It is also used in combination with certain acid-reducing medicines to treat duodenal ulcers which are infected with a bacterium known as Helicobacter pylori. 2. BEFORE YOU TAKE KLABAX TABLETS Do not take Klabax Tablets: If you have previously had an allergic (hypersensitivity) reaction to clarithromycin or any other macrolide antibiotics such as erythromycin, azithromycin, etc.; or to

2 any of the other ingredients of Klabax Tablets listed at the end of the leaflet; (An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, tongue and throat and/or breathing difficulties.) If you are taking any drugs derived from ergot such as ergotamine tablets or inhalers (used to treat migraine); If you are taking terfenadine or astemizole (used to treat allergies), cisapride (used to treat digestive problems) or pimozide (used to treat mental illnesses) (see Taking other medicines below). Take special care and inform your doctor before you start to take Klabax Tablets if If you have or have had any kidney or liver problems If you have previously had an allergic (hypersensitivity) reaction to antibiotics called lincomycin or clindamycin (used to treat certain bacterial infections) If you are pregnant or intend to become pregnant, or you are breast-feeding If you suffer from an illness called Myasthenia gravis If you have or have had an illness called porphyria (a blood disorder) or you suffer from problems with your kidney(s); you should not take Klabax tablets alongwith ranitidine bismuth citrate (a drug used to treat acidity and peptic ulcers). If you have problems with your heart rhythm or circulation If you have been told by your doctor that you have low levels of magnesium and/or potassium in your blood. Please consult your doctor, even if these statements were applicable to you at any time in the past. Tell your doctor you are taking Klabax Tablets if you are having any blood tests, because the results may be affected. Taking other medicines: Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including products you do not need a prescription for as they may interfere with this product. Clarithromycin can affect the way some other drugs work. Before you start to take these tablets inform your doctor if you are taking any of the following medicines: Do not take Klabax Tablets if you are taking: Terfenadine or astemizole (used to treat allergies), Cisapride (used to treat digestive problems) Pimozide (used to treat mental illnesses) Drugs derived from ergot such as ergotamine tablets or inhalers (used to treat migraine) Care is needed if you are taking: Warfarin or other anticoagulants (blood thinning medicines) Theophylline (used to treat asthma)

3 Cyclosporin, tacrolimus or sirolimus (used to suppress the immune system after organ transplant) Digoxin (used to treat certain heart conditions) Insulin or other drugs used to treat diabetes Quinidine or disopyramide (used to treat certain abnormal heart rhythms) Benzodiazepines such as midazolam, triazolam or alprazolam (medicines that help you sleep) Phenytoin, phenobarbital or carbamazepine (used to treat epilepsy) The herbal medicine, St John s Wort Rifampicin or rifabutin (used for treatment of tuberculosis) Statins used to lower cholesterol (e.g. simvastatin, atorvastatin, cerivastatin) Zidovudine, efavirenz or ritonavir (used for treatment of Human Immunodeficiency Virus{HIV} infection) If you are taking any such medicines along with clarithromycin, that may cause change in the heart rhythm [like fluconazole (used to treat fungal infections); probucol (used to lower cholesterol); chloroquine, mefloquine (used to treat malaria); clozapine, droperidol, ziprasidone (used to treat mental illness); procainamide, sotalol (used to treat rhythm disorders of the heart); dothiepin, doxepin(used to treat depression)] Sildenafil (used for erectile dysfunction) Colchicine (used for the treatment of acute gout) Clarithromycin does not interact with oral contraceptives. Please inform your doctor or pharmacist if you are taking, or have recently taken any of the above mentioned medicines. Taking Klabax Tablets with food and drink Klabax Tablets should be swallowed with glass of water, and can be taken with or without meals. Pregnancy Clarithromycin does not interact with oral contraceptives. You will not have to change your contraceptives while you are taking Klabax Tablets. You should not take Klabax Tablets if you are pregnant, unless it is clearly needed. Ask your doctor or pharmacist for advice before taking any medicine. Breast-feeding Clarithromycin passes into breast milk. You should not breast feed if you are taking Klabax Tablets. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Clarithromycin can very rarely cause dizziness, vertigo confusion or disorientation and this may affect the ability to drive or operate machinery. Make sure you know how you react to Klabax Tablets before you drive, use machines, or engage in any other activity that could be dangerous if you are not alert.

4 3. HOW TO TAKE KLABAX TABLETS Always take Klabax Tablets exactly as your doctor has told you. You should check with your doctor if you are not sure. The dose of clarithromycin varies with the condition being treated. Klabax Tablets should be taken by mouth with at least half a glass of water, with or without food. Space the doses as evenly as possible through the day. It is not normally necessary to arrange to take a dose in the middle of the night unless your doctor has told you to do so. Take all the tablets your doctor has given you. Dose For treating infections of the lungs/ chest and skin infections: Adults and adolescents: the usual dose is one Klabax 250 mg Tablet twice daily for 7 days. In very severe infections your doctor may tell you to take one Klabax 500 mg Tablet twice daily for up to 14 days. Klabax Tablets are not suitable for children under 12 weighing less than 30 kg. Other formulations of clarithromycin, such as suspension, are more suitable for children. For treating Helicobacter pylori infections associated with duodenal ulcers: There are a number of different treatment regimes in which clarithromycin is used in combination with one or two other drugs. Your doctor will have decided the combination which is best for you and will have told you what medicines to take. Elderly If you are elderly, your dose will be same as that for other adults. Patients with liver or kidney problems If you have any liver or kidney problems your dose may be different from that given here. Do not change unless your doctor tells you to do so. If you take more Klabax Tablets than you should If you have taken too many tablets, or if someone accidentally swallows some, contact your doctor or the nearest hospital for advice. Take your tablets or carton to show to the doctor, if possible. If you forget to take Klabax Tablets If you miss a dose take one as soon as you can. However, if it is almost time for the next dose, do not take the missed dose and continue with your regular dosing schedule. If you miss several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose. Do not stop taking Klabax Tablets before you have finished the course

5 You must take your medicine for as long as your doctor has told you to. This will usually be for 7 to 14 days depending on the type and severity of infection. It is important not to stop taking the medicine just because you feel better as the infection could return. 4. POSSIBLE SIDE EFFECTS Like all medicines, Klabax Tablets can cause side effects, although not everybody gets them. Adverse reactions have been arranged as per seriousness and further ranked under headings of frequency using the following convention: Very commonly reported ( 1 in 10 patients); commonly reported ( 1 in 100 to < 1 in 10 patients); uncommonly reported ( 1 in 1000 to < 1 in 100 patients); rarely reported ( 1 in to < 1 in 1000 patients); very rarely reported (< 1 in patients). Very serious side effects If any of the following happen, stop taking Klabax Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital. You develop rashes, hives, itching, chest constriction, shortness of breath, fever or swelling of face, lips, hands / feet, fainting Very rarely reported You develop severe skin reactions such as blisters, sores or ulceration These are very serious side effects. You may be having a serious allergic reaction or other type of reaction to Klabax Tablets. You may need urgent medical attention or hospitalization. Serious side effects Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: Liver problems with or without jaundice (which may manifest as yellowing of skin and whites of eyes with decreased appetite, abdominal pain); usually these return to normal once treatment with clarithromycin is over. Very rarely the liver problems may be severe and lead to liver failure. Very rarely reported Severe diarrhoea and/or lower abdominal pain (with or without blood in the stools) Sudden severe abdominal pain, nausea and vomiting (inflammation of the pancreas) Any irregular or fast heart beat Convulsions (fits)

6 Sudden drop in blood sugar levels, especially if you are already receiving insulin or oral hypoglycemic drugs (for treatment of diabetes). This may manifest with symptoms such as dizziness, palpitations, sweating, anxiety and sometimes fainting. Unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections; these may be due to decrease the numbers of certain blood cells. Dark discoloration of urine, bloody or cloudy urine or any change in his/ her urine output, swelling of face, ankles or other parts of the body Other side effects Tell your doctor as soon as possible if you develop any of the following: Commonly reported Headache Nausea (feeling sick) or vomiting (being sick), indigestion, pain in the abdomen, mild diarrhoea or loose stools, soreness of mouth, tongue and tooth discoloration (usually reversible with professional tooth cleaning), loss of appetite Impaired sense of taste and smell (usually returns to normal once treatment with clarithromycin is over) White patches inside the mouth or on the tongue (oral thrush) Skin rash, hives Joint and muscle pains Rarely reported ringing in the ears Very Rarely reported Dizziness, tingling numbness over the hand and limbs Tremors, hallucinations (unrealistic sensations/ perception), marked behaviour or mood changes, change in sense of reality, anxiety, mental confusion, disorientation, sleep disorders Hearing loss (usually returns to normal once treatment with clarithromycin is over) There may be changes in the results of certain laboratory tests Commonly reported Increased levels of blood urea nitrogen Increased levels of creatinine Increased Prothrombin Time Abnormal liver function tests Altered blood cell counts

7 Very rarely reported Decreased blood sugar levels If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please consult your doctor, pharmacist or other health care professional for advice. 5. HOW TO STORE KLABAX TABLETS Keep out of reach and sight of children. Do not use this medicine after the expiry date shown on the label. No special storage requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer require. These measures will help to protect the environment. 6. FURTHER INFORMATION What Klabax Tablets contain Clarithromycin Tablets contain the active ingredient clarithromycin. Each Klabax 250 mg Tablet contains 250 of clarithromycin Each Klabax 500 mg Tablet contains 500 of clarithromycin The tablets also contain inactive ingredients Microcrystalline cellulose, Povidone (PVPK - 30), Purified water, Magnesium stearate, Stearic acid, Purified talc, Colloidal silicon dioxide, Croscarmellose sodium, Hydroxypropyl methyl cellulose, Hydroxy propyl cellulose, Propylene glycol, Sorbitan monoloeate, Titanium dioxide, Lake of Quinoline yellow and Vanillin. What Klabax Tablets look like and contents of the Pack Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Manufacturer RANBAXY LABORATORIES LTD., Industrial Area, 3 Dewas Madhya Pradesh (INDIA). This leaflet was last revised in March 2008.