Package leaflet: Information for the patient. Clarithromycin Kern Pharma 500 film-coated tablets Clarithromycin

Transcription

1 Package leaflet: Information for the patient Clarithromycin Kern Pharma 500 film-coated tablets Clarithromycin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Clarithromycin Kern Pharma is and what it is used for 2. What you need to know before you take Clarithromycin Kern Pharma 3. How to take Clarithromycin Kern Pharma 4. Possible side effects 5. How to store Clarithromycin Kern Pharma 6. Contents of the pack and other information 1. What Clarithromycin Kern Pharma is and what it is used for Clarithromycin is a medicine that belongs to a group of drugs called macrolide antibiotics. Clarithromycin Kern Pharma 500 mg is used to treat infections caused by sensitive microorganisms in: Adults Upper respiratory tract infections, such as pharyngitis, tonsillitis and sinusitis. Lower respiratory tract infections, such as acute bronchitis, acute exacerbations of chronic bronchitis and bacterial pneumonia. Skin and soft tissue infections, such as folliculitis, cellulitis and erysipelas. Mycobacterial infections (a type of bacteria). Eradication of the Helicobacter pylori bacterium in gastric or duodenal ulcer patients. Children Upper respiratory tract infections, such as pharyngitis. Lower respiratory tract infections, such as bronchitis and bacterial pneumonia. Acute otitis media. Skin and soft tissue infections, such as impetigo, folliculitis, cellulitis and abscesses IB2 P ClariKern 500 mg film-coated tablets 1

2 2. What you need to know before you take Clarithromycin Kern Pharma Do not take Clarithromycin Kern Pharma If you are allergic to macrolide antibiotics (the group that clarithromycin belongs to) or any of the excipients. If you are taking any of the following medicines: cisapride, pimozide and terfenadine, as they may cause an irregular heartbeat when they are administered in combination with clarithromycin. Warnings and precautions Given that clarithromycin is eliminated via the liver and the kidney, it should be taken with caution by patients with liver disorders or with mild to severe renal failure and by elderly patients. In the event of severe or persistent diarrhoea, contact your doctor immediately for advice. Children Not applicable. Other medicines and Clarithromycin Kern Pharma Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Clarithromycin may interact with the following drugs. Therefore, your doctor will take the necessary precautions when administering them in combination with clarithromycin and may even adjust their doses: - theophylline - carbamazepine - warfarin - ergotamine alkaloids - triazolam, midazolam - lovastatin, simvastatin - disapyromide - phenytoin - cyclosporine - cisapride, pimozide and terfenadine (see section Do not take Clarithromycin Kern Pharma ) - zidovudine Clarithromycin Kern Pharma with food and drink Not applicable. Pregnancy and Breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy It has not been established whether it is safe to take clarithromycin during pregnancy. Your doctor should consider the benefits of taking it very carefully in view of the potential risk, IB2 P ClariKern 500 mg film-coated tablets 2

3 especially during the first 3 months of pregnancy. For this reason, if you are pregnant or think you may be pregnant, please advise your doctor before taking this medicine. Breast-feeding Clarithromycin is excreted in human milk. Therefore, breast-feeding should be discontinued during treatment with clarithromycin. Driving and using machines Given that clarithromycin can cause dizziness, patients undergoing treatment with Clarithromycin Kern Pharma should exercise caution when driving or operating dangerous machinery. 3. How to take Clarithromycin Kern Pharma Follow these instructions unless your doctor has instructed differently. Remember to take your medicine. Clarithromycin Kern Pharma is supplied as tablets for oral administration. Take the tablets at the same time every day. Clarithromycin is usually recommended in the following doses: Adults and children over 12 years of age: the recommended dose is of 250 mg twice a day. In the case of severe infections the dose can be increased up to 500 mg twice a day. The duration of the treatment is usually 6 to 14 days. Children under 12 years of age: The recommended dose is of 7.5 mg/kg twice a day, up to a maximum of 500 mg twice a day. The duration of the treatment is usually 5 to 10 days depending on the type and the severity of the infection. The tablet pharmaceutical form is not suitable for administration in doses of less than 250 mg, or for patients who have difficulties swallowing. Patients with Helicobacter pylori-associated gastric or duodenal ulcers The recommended dose of clarithromycin for the eradication of the Helicobacter pylori bacteria is 500 mg twice or three times a day, in combination with omeprazole and another antibiotic over 7 to 14 days. Patients with renal failure The dose of clarithromycin must be halved in patients with renal failure. Please tell your doctor or pharmacist if you feel that the action of Clarithromycin Kern Pharma is too strong or too weak. If you take more Clarithromycin Kern Pharma than you should In the event of an overdose or accidental ingestion, consult immediately your doctor or pharmacist indicating the medicine and the amount ingested IB2 P ClariKern 500 mg film-coated tablets 3

4 The most common symptoms in case of overdose are gastrointestinal disorders. If you forget to take Clarithromycin Kern Pharma Do not take a double dose to make up for a forgotten dose. Take the tablet as soon as you remember and continue leaving a 12-hour period between each dose. If you stop taking Clarithromycin Kern Pharma Your doctor will advise you on the duration of the treatment with Clarithromycin Kern Pharma 500 mg. Do not discontinue the treatment earlier, even if you feel better, as your condition could worsen or reappear. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Clarithromycin Kern Pharma can cause side effects, although not everybody gets them. The most common side effects that may appear are associated with the digestive system, such as nausea, gastric discomfort or indigestion, diarrhoea, vomiting and abdominal pain. Other adverse reactions include headaches, changes in the sense of taste and a transient increase in liver enzymes. It is less common to observe: impaired liver function (which is generally reversible); allergic reactions, which can be anything from itchiness or mild skin eruptions to serious allergies; transient adverse reactions of the central nervous system (blurred vision, anxiety, insomnia, nightmares, confusion, hallucinations and behavioural disorders); hearing loss (can usually be reversed by discontinuing the treatment); changes in the sense of smell, which are usually accompanied by changes in the sense of taste; inflammation of the gums; inflammation of the surface of the tongue; fungal infections in the mouth and a discoloured tongue and discoloured teeth (this usually disappears after the teeth have been cleaned by a professional). On rare occasions low sugar levels in the blood have been reported, which in some cases is associated with the use of diabetes medication. Exceptionally, low white blood cell or platelet counts and increased blood creatinine levels have been observed. Electrocardiographic changes or an irregular heartbeat have rarely been described. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine IB2 P ClariKern 500 mg film-coated tablets 4

5 5. How to store Clarithromycin Kern Pharma Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Clarithromycin Kern Pharma contains - The active substance is clarithromycin. Each tablet contains 500 mg of clarithromycin. - The other ingredients are: For the core: pregelatinised starch, croscarmellose sodium, povidone 25, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. For the coating: hypromellose, titanium dioxide (E-171), talc and propylene glycol. What Clarithromycin Kern Pharma looks like and contents of the pack This medicine is supplied as white capsular-shaped film-coated tablets, packaged in blister of aluminium/pvc and in a cardboard box containing 14 units. Other presentations Clarithromycin Kern Pharma 250 mg film-coated tablets. Marketing Authorisation Holder and Manufacturer Kern Pharma, S.L. Polígono Ind. Colón II Venus, Terrassa (Barcelona). Spain IB2 P ClariKern 500 mg film-coated tablets 5