PACKAGE LEAFLET Page 1 of 6

Transcription

1 PACKAGE LEAFLET Page 1 of 6

2 PACKAGE LEAFLET: INFORMATION FOR THE USER Clarithromycine Mylan 250 mg film coated Tablets Clarithromycine Mylan 500 mg film coated 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, 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 Clarithromycine Mylan is and what it is used for 2. Before you take Clarithromycine Mylan 3. How to take Clarithromycine Mylan 4. Possible side effects 5. How to store Clarithromycine Mylan 6. Further information 1. WHAT CLARITHROMYCINE MYLAN IS AND WHAT IT IS USED FOR Clarithromycine Mylan belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. Clarithromycine Mylan is an antibiotic used to treat a variety of different infections. These include infections of the skin and soft tissue or the respiratory system (nose, throat, chest, lungs). Clarithromycine Mylan 250 mg/500 mg film-coated tablets are indicated in adults and children of 12 years and older. 2. BEFORE YOU TAKE CLARITHROMYCINE MYLAN Do not use Clarithromycine Mylan if you are allergic (hypersensitive) to clarithromycin or a similar antibiotic such as erythromycin, or any of the other ingredients of this medicine are already taking any of the following medicines: o ergotamine or dihydroergotamine (for migraine) o cisapride (for stomach disorders) o pimozide (for psychiatric conditions) o terfenadine (for hay fever or allergy) o statins (for high cholesterol) have a history of QT prolongation, ventricular cardiac arrhythmia including torsades de pointes have hypokalemina (low blood levels of potassium) have severe liver failure in combination with kidney problems Take special care with Clarithromycine Mylan You should tell your doctor before taking this medicine if you: have heart, kidney or liver problems have myasthenia gravis (a disease causing muscle weakness) hypomagnesia (low magnesium levels) coronary heart disease, severe cardiac insufficiency or bradycardia (slow heart beat) Page 2 of 6

3 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following: digoxin, quinidine, verapamil or disopyramide (heart drugs) warfarin or other drugs to thin the blood ergotamine or dihydroergotamine (for migraine) carbamazepine, phenobarbitol, valproate or phenytoin (drugs for epilepsy) theophylline (helps breathing) terfenadine or astemizole (for hay fever or allergy) triazolam, alprazolam or midazolam (sedatives) simvastatin, lovastatin, atorvastatin, rosuvastatin or cerivastatin (for high cholesterol) cisapride (for stomach disorders) ciclosporin, tacrolimus or sirolimus (immune suppressant) pimozide (for psychiatric conditions) zidovudine, ritonavir, atazanavir, saquinavir, nevirapine or efavirenz (anti-viral agents also known as anti-hiv drugs) rifabutin, rifapentine or rifampicin (for treatment of some infections) fluconazole or itraconazole (antifungal) colchicine (for gout, painful inflammation of the joints) omeprazole, ranitidine and antacids (for heartburn and stomach ulcers) St Johns wort (for depression) other antibiotics such as erythromycin insulin or oral anti-diabetic drugs (to reduce blood sugar levels) cilostazole (to improve blood circulation) methylprednisolone (anti-inflammatory) sildenafil, tadalafil or vardenafil (for erectile dysfunction) vinblastine (an anti-cancer drug) tolterodine (for urinary incontinence) aminoglycosides (antibiotics) Pregnancy and breast-feeding Clarithromycine Mylan should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine. Do not breast-feed your baby, as small amounts of clarithromycin can pass into breast milk. Driving and using machines Do not drive or operate machinery if you feel dizzy, confused or disorientated while taking this medicine. 3. HOW TO TAKE CLARITHROMYCINE MYLAN Always take Clarithromycine Mylan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole with some liquid. Tablets can be taken with or without food 500 mg tablets should not be halved The usual dose is: Adults, Elderly and children over 12 years old Page 3 of 6

4 The usual dose is 250 mg twice a day for 6 to 14 days. For severe infections your doctor may increase the dose to 500 mg twice a day for up to 14 days. Children (under 12 years old) Do not give this medicine to children under 12 years old. Patients with kidney problems The usual dose is 250 mg once a day. For severe infections your doctor may increase the dose to 250 mg twice a day. If you take more Clarithromycine Mylan than you should Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include feeling or being sick, diarrhoea, indigestion or stomach pains. If you forget to take Clarithromycine Mylan Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Clarithromycine Mylan Keep taking your medicine until the course is finished. Do not stop taking your medicine just because you feel better. If you stop too soon the infection may come back again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Clarithromycine Mylan can cause side effects, although not everybody gets them. If any of the following happen, stop taking Clarithromycine Mylan and tell your doctor immediately or go to your nearest hospital emergency department: Allergic reactions such as skin rashes or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing Severe pain in the abdomen and back caused by inflammation of the pancreas Severe diarrhoea with blood in the stools Liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), feeling sick, weight loss, which can lead to liver failure Severe skin reactions, blistering of the skin, mouth, eyes and genitals These side effects are rare but serious. You may need medical attention. Common side effects (affecting fewer than 1 in 10 people): feeling or being sick, diarrhoea, indigestion or stomach pains painful, sore mouth or tongue, change in colour of tongue or teeth headache smell alteration or taste disturbance, i.e. metallic or bitter taste changes in blood urea nitrogen levels difficulty sleeping rash increased perspiration altered liver function tests oral thrush Page 4 of 6

5 Uncommon side effects (affecting fewer than 1 in 100 people): change in your creatinine or blood sugar levels (you may look pale and feel faint) feeling dizzy, vertigo, feeling anxious, shaking, drowsiness loss of appetite or weight loss, constipation, dry mouth, flatulence, feeling bloated or burping skin rash or itching liver problems which may cause dark urine, pale stools weakness, fatigue, chills, chest pain blood disorders yeast infections in the mouth or vagina ringing in the ears, hearing loss which is reversible on stopping treatment allergic reactions such as a nettle-like rash, hives serious allergic reaction causing difficulty breathing or dizziness change in some blood cells (you may notice that you are bruising easily or have frequent nose bleeds, or more sore throats and infections than usual tell your doctor who may give you a blood test) changes in heart rhythm (palpitations, abnormally fast, slow or irregular pulse, shortness of breth, chest pain) Very rare side effects (affecting fewer than 1 in 10,000 people): blood disorders which may result in unusual bleeding or unexplained bruising numbness, prickling or tingling sensation in arms and legs bad dreams severe pain in the abdomen and back caused by inflammation of the pancreas low sugar (glucose) levels in the blood in patients treated with antidiabetic medicinal products (including insulin) you may experience sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat. Other possible side effects (how often these side effects occur is not known): hallucinations, abnormal dreams, depression, convulsions, feeling disorientated or confused, mental illness or depersonalisation kidney failure (you may notice a change in your urine function) hearing loss muscular weakness change in urine colour acne infections of skin Stevens-Johnson syndrome (severe skin reactions, blistering of the skin, mouth, eyes and genitals) toxic epidermal necrolysis (a serious illness with blistering of the skin) If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE CLARITHROMYCINE MYLAN This medicinal product does not require any special storage conditions. Keep out of the reach and sight of children. Page 5 of 6

6 Do not use Clarithromycine Mylan after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Clarithromycine Mylan contains The active substance is clarithromycin. The other ingredients are Microcrystalline Cellulose, Pregelatinised Starch, Croscarmellose Sodium, Povidone, Silica, Colloidal Anhydrous, Stearic Acid, Magnesium Stearate. The coating includes Hypromellose (E464), Hyprolose (E463), Titanium Dioxide (E171), Propylene Glycol (E1520), Vanillin, Quinoline Yellow Lake (E104) What Clarithromycine Mylan looks like and contents of the pack Your medicine comes as a yellow, oval shaped, film coated tablet and is available in two strengths. The 250 mg tablets are marked C250 on one side and G on the other and the 500 mg tablets are marked C500 on one side and G on the other. Clarithromycine Mylan is available in blisters and plastic bottles of 4, 6, 7, 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 42, 50, 60, 100, 250, 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder <To be completed Nationally> Mylan bvba/sprl Terhulpsesteenweg 6a B-1560 Hoeilaart Manufacturer <To be completed Nationally> Generics [UK], Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK McDermott Laboratories (trading as Gerard Laboratories), 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Mylan dura GmbH, Wittichstr. 6, D Darmstadt, Germany This medicinal product is authorised in the Member States of the EEA under the following names: Austria Clarithromycin Arcana Filmtabletten Belgium Clarithromycine Mylan filmomhulde tabletten Denmark Clarithromycin Mylan filmovertrukne tabletter Germany Clarithromycin dura Filmtabletten Luxembourg Clarithromycine Mylan comprimes pellicules Portugal Claritromicina Laquifa Comprimidos revestidos This leaflet was last approved in <[To be completed nationally]> Page 6 of 6