Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Nimodipine
Bayer Limited
C08CA; C08CA06
Nimodipine
30 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; nimodipine
Marketed
1994-02-15
BP22036_REC30610 Not for commercial use 1 RESTRICTED PACKAGE LEAFLET – INFORMATION FOR THE USER NIMOTOP 30 MG FILM-COATED TABLETS NIMODIPINE 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 more 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 effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT NIMOTOP TABLETS ARE 2. BEFORE YOU TAKE NIMOTOP TABLETS 3. HOW YOU TAKE NIMOTOP TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NIMOTOP TABLETS 6. FURTHER INFORMATION 1. WHAT NIMOTOP TABLETS ARE Nimotop contains nimodipine, which belongs to a group of medicines called _calcium antagonists_. NIMOTOP TABLETS ARE USED TO PREVENT CHANGES IN BRAIN FUNCTION after bleeding around the brain (_subarachnoid haemorrhage). _ 2. BEFORE YOU TAKE NIMOTOP TABLETS DO NOT TAKE NIMOTOP TABLETS: • AT THE SAME TIME AS YOU ARE GETTING NIMOTOP STERILE CONCENTRATE THROUGH A DRIP. The tablets have been prescribed as a convenient way to continue your treatment after the drip is stopped. • IF YOU ARE ALLERGIC TO NIMODIPINE or any of the ingredients in this product. The ingredients are listed in section 6. • IF YOU ARE TAKING RIFAMPICIN (an antibiotic), PHENOBARBITAL, PHENYTOIN OR CARBAMAZEPINE (three medicines most commonly used to treat epilepsy). → TELL YOUR DOCTOR AND DO NOT TAKE NIMOTOP TABLETS if any of these apply to you. YOUR DOCTOR WILL TAKE SPECIAL CARE: • WHILE YOU ARE HAVING A HEART ATTACK. • IF YOU HAVE HAD A HEART ATTACK within the last month. • IF YOU SUFFER FROM ANGINA and notice an increase in the frequency and severity of attacks. • IF YOU HAVE FLUID IN THE BRAIN OR SEVERELY RAISED PRESSURE IN YOUR SKULL. Your doctor will be able to advise you about this. • IF YOU HAVE LOW BLOOD PRESSURE. Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 21 November 2022 CRN00D8K3 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nimotop 30 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30mg nimodipine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (Tablet). Yellow, film-coated tablet, about 10 mm in diameter, marked with the Bayer cross on one face and with ‘SK’ on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nimotop tablets are recommended for the prevention of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ANEURYSMAL SUBARACHNOID HAEMORRHAGE POSOLOGY: Unless otherwise prescribed the following dosage is recommended: The recommended procedure is administration of Nimotop solution for infusion for 5 to 14 days followed by a total daily dose of 360 mg by taking 2 Nimotop tablets at 4 hourly intervals, i.e. 6 times a day. Alternatively, prophylactic therapy may be initiated using Nimotop tablets. The recommended total daily dose is 360 mg by taking 2 Nimotop tablets at 4 hourly intervals, i.e. 6 times a day. In patients who develop adverse reactions the dose should be reduced as necessary or the treatment discontinued. Upon co-administration with cytochrome P450 3A4 inhibitors or inducers, a dose adaption may be necessary (see sections 4.4 and 4.5). METHOD OF ADMINISTRATION: Administration of Nimotop tablets is recommended for about 7 days following the end of the 5 to 14 days intravenous therapy with Nimotop solution for infusion. Alternatively, prophylactic therapy may be initiated using Nimotop tablets. In general, the tablets should be swallowed whole with a little liquid, with or without meals. Grapefruit juice is to be avoided (see section 4.5). The interval between successive doses must not be less than 4 hours. DURATION OF USE: Prophylactic Use Health Products Regulatory Authority 21 November 2022 CRN00D8K3 Page 2 o Lesen Sie das vollständige Dokument