Package Leaflet: Information for the User. CLARIPEN granules for oral suspension 250mg/5ml (Clarithromycin)

Transcription

1 Package Leaflet: Information for the User CLARIPEN granules for oral suspension 250mg/5ml (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 Claripen is and what it is used for 2. Before you use Claripen 3. How to use Claripen 4. Possible side effects 5. How to store Claripen 6. Further information 1. WHAT CLARIPEN IS AND WHAT IT IS USED FOR Antibiotic for the treatment of infections caused by susceptible microorganisms to clarithromycin. Paediatric suspension Claripen 250mg/5ml is indicated for the treatment of infections caused by susceptible microorganisms to clarithromycin. Such infections are: Lower respiratory tract infections (e.g. bronchitis, pneumonia) Upper respiratory tract infections (e.g. streptococcal pharyngitis) Acute medial purulent otitis Infections of the skin and soft tissues (e.g. impetigo, folliculitis, abscess, cellulitis) Adjuvant treatment for generalized or sited infections caused by atypical mycobacteria (e.g. Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii). 2. BEFORE YOU USE CLARIPEN Do not take Claripen : - In case your child has an allergy (hypersensitivity) to macrolide antibiotics or any of the other ingredients of Claripen. - With medicines containing astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine. Take special care with Claripen Inform your doctor in case your child: - Suffers from renal failure - Has hepatic problems - Has hypokalaemia - Has diarrhoea - In case of simultaneous administration with colchicine - Has severe and prolonged infection - Has exacerbation of symptoms in severe myasthenia

2 Adult women should consult their doctor in case of pregnancy or breast feeding before taking Claripen. Safety and efficacy of clarithromycin has not been established in children under 6 months. Safety of clarithromycin has not been established in children under 20 months suffering from mycobacterial infections. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including any medicines obtained without prescription. The following interactions which are related to enzyme CYP3A have been observed postmarketing with erythromycin and/or clarithromycin. Please tell your doctor, if you are taking medicines containing theophylline, valproate, carbamazepine, cilostazol, cizapride, digoxin, colchicine, oral anticoagulants (e.g. warfarin), ergotamine derivatives, dihydroergotamine, triazolam, midazolam, alprazolam, methylprednisolone, disopyramide, phenytoin, astemizole, terfenadine, tacrolimus, cyclosporine, pimozide, quinidine, rifabutin, sildenafil, tadalafil, vardenafil, tolterodine, lovastatin, simvastatin, omeprazole, vinblastine, efavirenz, nevirapine, rifampicin, rifabutin, rifapentin, fluconazole, atazanavir, itraconazole and saquinavir. During treatment with clarithromycin, modification of the dosage of these medicines may be necessary (see Take special care with Claripen ). If you suffer from renal failure and concurrently receive treatment with ritonavir and clarithromycin, inform your doctor as reduction of the dosage of clarithromycin may be needed. In adults, in case that Claripen is simultaneously administered with a medicine which contains zidovudine, these two medicines should be taken at different hours. Taking Claripen with food and drinks Claripen shoud be taken regardless food. Pregnancy and breast-feeding Consult your doctor or pharmacist before taking any medicine. Driving and using machines If you feel dizzy during therapy with Claripen caution is necessary, as dizziness may affect the ability to drive or use machines. 3. HOW TO USE CLARIPEN Always use Claripen exactly as your doctor has told you. If you have doubts consult your doctor or your pharmacist. The recommended daily dosage in children is 15mg/kg of body weight in two doses, with a maximum dosage of 500mg per day for all infections, except for those caused by mycobacterium.

3 Indicative common doses per kg of body weight for infants over 6 months (it is not administered under 6 months): Body weight Dosage* Dose number 16 kg 2.5 ml (125 mg) 2 20 kg 3 ml (150)mg 2 30 kg 4 ml (200 mg) 2 40 kg 5 ml (250 mg) 2 * The package contains a dosimetric syringe of 10ml graduated per ml and an adaptor which is placed on the bottle neck. The syringe is suitable for the oral administration of the medicinal product and it is positioned in the adaptor, on top of the bottle. The dosimetric syringe should be removed and cleaned immediately after use. It is not required to remove the bottle adaptor after each use. The usual duration of treatment is 5 to 10 days. Suspension should be taken before or after meals or with milk. If your child suffers from renal failure Claripen suspension dosage is reduced by half, reaching a maximum daily dosage of 250mg or 250mg twice daily for severe infections and its administration should not be prolonged for more than 14 days. Consult your doctor. Even if your child s health condition has improved or has recovered before the end of treatment, do not stop taking Claripen. Continue therapy for as many days as your doctor has recommended. Dosage for children for infections caused by mycobacterium In children with generalized or cited infection caused by mycobacterium (M. Avium, M. Intracellulare, M. Chelonae, M. Fortuitum and M. Kansasii) a daily dosage of 15-30mg/kg of body weight is recommended, in two doses. In these cases treatment with Claripen continues for as long as clinical improvement is observed. Clarithromycin must be taken in combination with other antimycobacterial medicines. Indicative doses per kg of body weight for children over 20 months: Body weight Dosage* Dose number 10 kg ml (75-150mg) 2 15 kg 2-4ml ( mg) 2 20 kg 3-6 ml ( mg) 2 30 kg 4-8 ml ( mg) 2 40 kg 5-10 ml ( mg) 2 * The package contains a dosimetric syringe of 10ml graduated per ml and an adaptor which is placed on the bottle neck. The syringe is suitable for the oral administration of the medicinal product and it is positioned in the adaptor, on top of the bottle. The dosimetric syringe should be removed and cleaned immediately after use. It is not required to remove the bottle adaptor after each use.

4 SUSPENSION PREPARATION The addition of water for the preparation of the suspension can be done either by using the dosimetric syringe or by using the mark on the vial. At the beginning add a small quantity of water into the bottle and shake well. Then, add more water up to the engraved line on the bottle. The suspension formed contains sizeable granules. The density of clarithromycin in the reconstituted suspension is 250mg/5ml. Suspension is stored out of fridge, at room temperature below 25 C up to 14 days. Bottle should be shaken vigorously before each use. If you use more Claripen than you should If your child takes by mistake large amounts of paediatric Claripen suspension can be expected to produce gastro-intestinal symptoms and adverse reactions. In such cases, inform your doctor or the Center for Information on Poisons (Athens): Tel Immediate removal of the medicine that has not yet been absorbed or other measures may be needed. If you forget to use Claripen If you have missed a dose, it must be taken as soon as possible and proceed with the regular dosage scheme as your doctor has told you. Do not take double dose in order to replenish the missed dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Claripen can cause side effects, although not everybody gets them. If any of the side effect becomes serious, or if you notice any side effect not listed in this leaflet, please inform your doctor or pharmacist. Paediatric suspension Claripen is usually safe and does not cause serious side effects. The most commonly reported side effects are: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, skin rashes, headache or taste alteration. The following side effects have been reported post marketing: - oral candidiasis - leukopenia, thrombocytopenia - anaphylactic reaction, hypersensitivity - hypoglycaemia - phychotic disorder, hallucination, disorientation, confusional state, depersonalisation, depression, anxiety, insomnia, abnormal dreams - convulsions, dizziness, ageusia, anosmia, dysgeusia, parosmia - deafness, vertigo, tinnitus - torsades de pointes, electrocardiogram QT prolonged, ventricular tachycardia - pancreatitis acute, glossitis, stomatitis, tongue discolouration, tooth discolouration - hepatic failure, hepatitits, cholestasis, jaundice cholestatic, jaundice hepatocellular, abnormal hepatic function - stevens-johnson syndrome, toxic epidermal necrolysis, urticaria, rash - nephritis interstitial - increased blood creatine, increased hepatic enzymes There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. In such patients deaths have been reported.

5 Side effects on immunosuppressed patients Patients with infections caused by mycobacteria receiving long-term treatment with Claripen must be put under close medical surveillance, both clinical and laboratorial. If a side effect occurs during therapy, you should inform your doctor. 5. HOW TO STORE CLARIPEN Keep out of the reach and sight of children. Do not use Claripen after the expiry date which is stated on the carton. 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 Claripen contains The active substance is clarithromycin. 5ml of reconstituted suspension contains 250mg of clarithromycin. The other ingredients are: Silicon dioxide colloidal, carbomer 974P, methacrylic acid copolymer dispersion 30%, talc, macrogol 1500, xanthan gum, titanium dioxide (E171), potassium sorbate, citric acid anhydrous, maltodextrin, sucrose, flavour strawberry. What Claripen looks like and contents of the pack Amber glass bottles scored at 60ml. Marketing Authorisation Holder and Manufacturer ELPEN PHARMACEUTICAL Co., Inc. 95 Marathonos Ave., Pikermi, Attika 19009, Greece Tel: Fax: Marketing Authorisation Holder in Cyprus: C. Tsisios and Co Ltd, 56495, Limassol. This leaflet was last revised in