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Clarithromycin 250 Mg Film-Coated Tablets Clarithromycin 500 Mg Film Package leaflet: and appropriate treatment should be Information for the user urgently initiated. • Concomitant use of clarithromycin Clarithromycin 250 mg with lovastatin or simvastatin is film-coated tablets contraindicated (see section “Do not take Clarithromycin if”). Caution Clarithromycin 500 mg should be exercised when using film-coated tablets clarithromycin with other statins.If you also use oral anticoagulants besides Clarithromycin clarithromycin. There is a risk of serious bleeding. Read all of this leaflet carefully before If any of these apply to you, consult you start taking this medicine because your doctor before taking Clarithromycin it contains important information for tablets. you. Other medicines and Clarithromycin - Keep this leaflet. You may need to Certain other medicines may affect the read it again. effectiveness of Clarithromycin or vice- - If you have any further questions, ask versa. your doctor or pharmacist. - This medicine has been prescribed for Clarithromycin may increase the effect you only. Do not pass it on to others. It of the following medicines: may harm them, even if their signs of • astemizole, terfenadine (antiallergic), illness are the same as yours. pimozide (antipsychotic), cisapride - If you get any side effects, talk to your (gastric medicine), ergotamine, doctor or pharmacist. This includes dihydroergotamine (migraine any possible side effects not listed in medicines), lovastatin, simvastatin this leaflet. See section 4. (medicines to lower cholesterol) (see What is in this leaflet: “Do not take Clarithromycin”) 1. What Clarithromycin is and what it is • alprazolam, triazolam, midazolam used for (hypnotics) 2. What you need to know before you • atorvastatin, rosuvastatin (cholesterol take Clarithromycin lowering agents) 3. How to take Clarithromycin • warfarin or any other anticoagulant e.g. 4. Possible side effects dabigatran, rivaroxaban, apixaban, Half 5. How to store Clarithromycin phenprocoumon (blood thinners): 6. Contents of the pack and other concomitant use may increase the Fold: information. risk of bleeding. Checking of the blood 1. What Clarithromycin is and what it clotting should be more frequent if 290 is used for Clarithromycin used concomitantly. • Nateglinide, repaglinide or insulin mm Clarithromycin belongs to a group of (antidiabetics) medicine called macrolide antibiotics. • carbamazepin, phenytoin, valproate Antibiotics stop the growth of bacteria (medicines to treat epilepsy) which cause infections. • cilostazol (used to improve circulation Clarithromycin is used to treat following in the legs) infections: • colchicine (to treat gout) • Chest infections such as bronchitis • cyclosporine, sirolimus, tacrolimus and pneumonia, (immunosuppressants) • Throat and sinus infections, • digoxin, verapamil, quinidine, • Skin and soft tissue infections, disopyramide (heart medicines), • Helicobacter pylori infections concomitant use of clarithromycin associated with duodenal ulcers. and these agents may cause cardiac 2. What you need to know before you arrhythmias.. take Clarithromycin • methylprednisolone (a cortisone to treat inflammation) Do not take Clarithromycin if: • omeprazole (gastric medicine) • you are to clarithromycin, allergic • rifabutin (antibiotic) other macrolide antibiotics or any of • sildenafil, tadalafil, vardenafil the other ingredients of this medicine (listed in section 6). (medicines to treat erectile • you have a history of certain abnormal dysfunction) heart rhythms (ventricular arrhythmia, • theophylline (antiasthmatic) including torsades de pointes) or • tolterodine (to treat overactive bladder changes in the heart activity as syndrome) measured in the electro-cardiogram • vinblastine (medicine for cancer called “QT prolongation”, therapy) • you suffer from severe liver failure and • medicines with the risk to affect kidney problems at the same time, hearing, especially aminoglycosides • You are taking medicines called (group of antibiotics that are given to terfenadine or astemizole (for hay vein) fever or allergies) or cisapride or • atypical antipsychotics (e.g. pimozide tablets as combining these quetiapine) drugs can sometimes cause serious disturbances in heart rhythm. Consult Both, the effect of Clarithromycin and your doctor for advice on alternative the effect of the following medicines medicines. may be increased when taken together: • You are taking other medicines • atazanavir, saquinavir (medicines to which are known to cause serious treat HIV) disturbances in heart rhythm. • itraconazole (medicine to treat fungal • you have abnormally infections) low levels of If your doctor has specifically potassium or recommended to take Clarithromycin and magnesium any of the above mentioned medicines at in your blood (hypokalaemia or the same time, your doctor may need to hypomagnesaemia) monitor you more closely. • You or someone Clarithromycin may weaken the effect in your family has of following medicines: a history of heart • zidovudine ((used to treat HIV rhythm disorders infection). In order to avoid this you (ventricular cardiac should leave a 4 hour interval between arrhythmia, including taking these medicines. torsade de pointes) or abnormality of The following medicines may weaken electrocardiogram the effect of Clarithromycin: (ECG, electrical • rifampicin, rifabutin, rifapentine recording of the (antibiotics) heart) called “long • efavirenz, nevirapine, etravirine QT syndrome”. (medicines to treat HIV) • you are taking any of the following • phenytoin, carbamazepine, medicines phenobarbitone (antiepileptic) • ergotamine, dihydroergotamine • St John’s Wort (a herbal product used (medicines to treat migraine) to treat depression) • lovastatin, simvastatin (medicines to The following medicines may lower cholesterol), strengthen the effect of Clarithromycin: • colchicines (medicine to treat gout), • ritonavir (antiviral) • ticagrelor or ranolazine (medicines to • fluconazole (medicine to treat fungal prevent stroke or heart attack). infections) • You are taking a medicine containing lomitapide. The use of clarithromycin at the same time as digoxin, quinidine, disopyramide Consult your doctor and take this medicine or verapamil (heart medicines), or other if any of the above cases apply to you, or macrolide antibiotics may cause cardiac that in the past. arrhythmia. Warnings and precautions Tell your doctor or pharmacist if you are Talk to your doctor or pharmacist before taking, have recently taken or might take taking Clarithromycin, any other medicines. • if you are allergic to lincomycin or clindamycin Pregnancy,breast-feeding and fertility • if you have reduced liver or kidney If you are pregnant or breast-feeding, function, think you may be pregnant or are planning • if you have, or have had, heart to have a baby, ask your doctor or problems pharmacist for advice before taking this • if you are pregnant (see section medicine. “Pregnancy, breast-feeding and fertility”) If you are pregnant or breast-feeding do not take Clarithromycin before consulting • if you develop severe or prolonged your doctor. diarrhoea (pseudomembranous colitis) during or after taking Driving and using machines Clarithromycin, consult your doctor Clarithromycin has generally no effect immediately. Inflammation of the colon on the ability to drive or use machines. (Pseudomembranous colitis) has been However, if side effects, such as reported with nearly all antibacterial dizziness, confusion and disorientation, medicines including clarithromycin. your reaction may be adversely affected. • if you have used clarithromycin before Use caution when driving or operating on several occasions or for a long machinery until you know how you react to time. this medicine. • Patients should be advised to stop Clarithromycin contains sodium treatment and contact their doctor This medicine contains less than 1 mmol if signs and symptoms of hepatic sodium (23 mg) per tablet, that is to say disease develop, such as anorexia, essentially ‘sodium-free’ jaundice, dark urine, pruritus, or tender abdomen. 3. How to take Clarithromycin • if you take combination a combination of clarithromycin and benzodiazepines, Always take this medicine exactly as your such as alprazolam, triazolam and doctor has told you. You should check midazolam (see section “Other with your doctor or pharmacist if you are medicines and Clarithromycin”) not sure. • if you take other drugs which affect your Clarithromycin may be taken with or auditory function. Loss of hearing will without food be checked during and after treatment. Clarithromycin 500 mg film-coated tablet • In the event of severe acute is not suitable for doses below 500 hypersensitivity reactions, such mg. There are other options for this as anaphylaxis, Stevens-Johnson strength available on the market. Syndrome, and toxic epidermal necrolysis, clarithromycin therapy The recommendations for the usual should be discontinued immediately doses are given below: P15XXXXX Black Version: 07 Date & Time: 11.02.2021 & 6.00 PM Submission: N04563 Adults including the elderly and • Saint Anthony’s fire (erysipelas), acne adolescents (children over 12 years) • severe reduction of white blood cells The usual dose is 250 mg twice a day. associated with sudden high fever, The usual dose is 250 mg twice daily. severe sore throat and mouth ulcers In severe infections, your doctor may (agranulocytosis) increase the dose to 500 mg twice daily. • unusual bruising or bleeding caused The treatment takes 7-14 days and by low blood platelets should
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