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Package leaflet: and appropriate treatment should be Information for the user urgently initiated. • Concomitant use of clarithromycin Clarithromycin 250 mg with or 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 .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 • , (antiallergic), illness are the same as yours. (antipsychotic), - If you get any side effects, talk to your (gastric medicine), , doctor or pharmacist. This includes (migraine any possible side effects not listed in medicines), lovastatin, simvastatin this leaflet. See section 4. (medicines to lower ) (see What is in this leaflet: “Do not take Clarithromycin”) 1. What Clarithromycin is and what it is • alprazolam, triazolam, used for (hypnotics) 2. What you need to know before you • , 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 Fold: 290 mm 5. How to store Clarithromycin phenprocoumon (blood thinners): 6. Contents of the pack and other concomitant use may increase the information. risk of bleeding. Checking of the blood 1. What Clarithromycin is and what it clotting should be more frequent if is used for Clarithromycin used concomitantly. • , or insulin Clarithromycin belongs to a group of (antidiabetics) medicine called . • carbamazepin, , Antibiotics stop the growth of (medicines to treat epilepsy) which cause infections. • cilostazol (used to improve circulation Clarithromycin is used to treat following in the legs) infections: • (to treat gout) • Chest infections such as bronchitis • cyclosporine, sirolimus, and , (immunosuppressants) • Throat and sinus infections, • digoxin, , , • Skin and soft tissue infections, disopyramide (heart medicines), • infections concomitant use of clarithromycin associated with duodenal ulcers. and these agents may cause cardiac 2. What you need to know before you .. take Clarithromycin • methylprednisolone (a cortisone to treat inflammation) Do not take Clarithromycin if: • (gastric medicine) • you are to clarithromycin, allergic • rifabutin () 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 , • theophylline (antiasthmatic) including ) 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 failure and • medicines with the risk to affect kidney problems at the same time, hearing, especially • You are taking medicines called (group of antibiotics that are given to terfenadine or astemizole (for hay vein) fever or ) 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. • (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 • ((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 • , rifabutin, rifapentine recording of the (antibiotics) heart) called “long • efavirenz, , etravirine QT syndrome”. (medicines to treat HIV) • you are taking any of the following • phenytoin, , 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: • (medicine to treat gout), • ritonavir (antiviral) • or (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 or ,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’ , 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 , 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

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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 last at least two days after the • Serious allergic reaction which disappearance of the symptoms. causes swelling of the face or throat (angioedema) Use in infections with H. pylori: In adult patients with ulcers of stomach • psychosis, a feeling of loss of identity and duodenum by infection with H. Pylori, • confusion, change in sense of reality as a part of triple combination therapy or panicking, administered usual dose is 500 mg twice • depression, nightmares, disorientation, a day. hallucinations, mania • convulsions Patients with kidney problems • disturbed sense of smell, loss of sense If you have severe kidney problems your of smell or taste doctor may need to reduce your dose by • deafness half, i.e. once daily and restrict treatment • tingling or numbness in the hands or to 14 days at the most. feet Children under 12 years • difficulty with your blood clotting Use of Clarithromycin tablets for children • discoloration of the teeth and tongue under the age of 12 years (under 30 kg • acne bodyweight) is not recommended. Your • pain or weakness in muscles doctor will prescribe another medication • Inflammation of the kidneys, renal that is appropriate for your chlid. failure For children with a body weight of more • abnormal urine colour. than 30 kg, the same dose as for adults is Contact a doctor immediately if you used. experience a serious skin reaction: a red, If you feel that the effect of this medicine scaly rash with bumps under the skin and is too strong or too weak? Please contact blisters (exanthematous pustulosis). The your doctor or pharmacist. frequency of this side effect is not known (cannot be estimated from the available If you take more Clarithromycin than data). Half Fold: 290 mm you should If you have taken too much of Reporting of side effects Clarithromycin, contact your doctor or If you get any side effects, talk to your nearest hospital emergency department doctor, pharmacist or nurse. This includes as soon as possible. Overdose can cause any possible side effects not listed in this gastrointestinal discomfort and possibly leaflet. You can also report side effects other complaints. directly (see details below). By reporting side effects you can help provide more If you forget to take Clarithromycin information on the safety of this medicine. If you forget to take a dose of Clarithromycin, take it as soon as you Malta remember. If it is almost time for your ADR Reporting next dose, do not take the missed dose The Medicines Authority and just carry on as before. Do not take Post-Licensing Directorate a double dose to make up for a forgotten 203 Level 3, Rue D’Argens dose. GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt If you stop taking Clarithromycin e-mail: postlicensing.medicinesauthority@ It is important that you take your gov.mt medicine in accordance with the doctor’s instructions. Do not suddenly stop using The United Kingdom Clarithromycin without discussing it first Yellow Card Scheme with your doctor. Otherwise symptoms Website: www.mhra.gov.uk/yellowcard may return. 5. How to store Clarithromycin If you have any further questions on the use of this medicine, ask your doctor or Keep this medicine out of the sight and pharmacist. reach of children. Do not use this medicine after the expiry 4. Possible side effects date which is stated on the blister and Like all medicines, this medicine carton after EXP. The expiry date refers to can cause side effects, although not the last day of that month. everybody gets them. This medicinal product does not require Serious side effects: any special storage conditions. If any of the following happens, stop Do not throw away any medicines via taking this medicine and tell your doctor wastewater or household waste. Ask your immediately or go to the casualty pharmacist how to throw away medicines department at your nearest hospital: you no longer use. These measures will • allergic reactions such as sudden help protect the environment. difficulty in breathing, speaking and swallowing 6. Contents of the pack and other • extreme dizziness or fainting information • severe or itchy skin rash, especially if this shows blistering and there is What Clarithromycin contains soreness of the eyes, mouth or genital - The active substance is clarithromycin. organs Each film-coated tablet contains 250 mg of clarithromycin Take as soon as Each film-coated tablet contains possible, contact your 500 mg of clarithromycin doctor if the following symptoms develop: - The other ingredients are: • diarrhoea that is Microcrystalline cellulose, serious, lasts a long croscarmellose sodium, silica, colloidal time or has blood in anhydrous, magnesium stearate, it, with stomach pain povidone, hypromellose, propylene or fever. This can be glycol, titanium dioxide (E 171), a sign of a serious hydroxypropyl cellulose, vanillin, sorbic bowel inflammation. acid and iron oxide yellow (E 172). Your doctor may discontinue What Clarithromycin looks like and treatment. Do not contents of the pack Film-coated tablet take medicines that reduce bowel Clarithromycin 250 mg film-coated tablets: movements. Light yellow coloured, oval shaped, • Liver function with following possible biconvex film-coated tablets, with ‘D’ symptoms debossed on one side and ‘62’ on the • loss of appetite other side. The size is 15.1 mm x 7.1 mm • yellowing of the skin or whites of the Clarithromycin 500 mg film-coated tablets: eyes (jaundice), Light yellow coloured, oval shaped, • pale stools, dark urine biconvex film-coated tablets, with ‘D’ • Itchy rash debossed on one side and ‘63’ on the • Abdominal pain other side. The size is 18.5 mm x 8.1 mm • Palpitations or irregular heartbeat • severe pain in the abdomen and back, Clarithromycin 250 mg & 500 mg tablets caused by pancreas inflammation are available in clear PVC/PVDC/ Aluminium blister packs of 7, 12, 14 and Other possible side effects: 21 film-coated tablets. Common (may affect up to 1 in 10 people): Not all pack sizes may be marketed. • difficulty sleeping Marketing Authorisation Holder • headache UK_ Milpharm Limited • changes in sense of taste Ares Block, Odyssey Business • abdominal pain, , , Park diarrhoea, indigestion West End Road • abnormal liver function test results Ruislip HA4 6QD • skin rash United Kingdom • excessive sweating. MT_ Aurobindo Pharma (Malta) Limited Uncommon (may affect up to 1 in 100 Vault 14, Level 2, Valletta people): Waterfront • infections (candidiasis) (Eg: in Floriana FRN 1913 the mouth) Malta • infections of the vagina Manufacturer • reduction in the level of certain APL Swift Services (Malta) Limited white blood cells, which can make HF26, Hal Far Industrial Estate, Hal Far infections more likely ( leucopenia and Birzebbugia, BBG 3000 neutropenia) Malta • increased number of certain white blood cells (eosinophilia) or • loss of appetite Milpharm Limited • anxiety, dizziness, difficulty sleeping, Ares Block, Odyssey Business Park chills West End Road • spinning sensation Ruislip HA4 6QD • impaired hearing, ringing in the ears United Kingdom (tinnitus) This leaflet was last revised in 02/2021. • palpitations • inflammation of the stomach, mouth and tongue • Flatulence, constipation and indigestion • dry mouth • chlolestasis • increase of liver enzymes in the blood • itching, hives • muscle pain • generally feeling unwell • weakness • chest pain • chills • fatigue Frequency not known [frequency cannot be estimated from the available data]: • Inflammation of the gut with severe called Pseudomembranous collitus, P15XXXXX