Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clonazepam
Kent Pharma (UK) Ltd
N03AE01
Clonazepam
2mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04080100
CLONAZEPAM AUDEN 500 MICROGRAM AND 2 MG TABLETS EAS3565a EAS3565a PACKAGE LEAFLET: INFORMATION FOR THE USER 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 Clonazepam is and what it is used for 2. What you need to know before you take Clonazepam 3. How to take Clonazepam 4. Possible side effects 5. How to store Clonazepam 6. Contents of the pack and other information 1. WHAT CLONAZEPAM IS AND WHAT IT IS USED FOR The name of your medicine is Clonazepam Auden 500 microgram and 2 mg Tablets (called Clonazepam in this leaflet). Clonazepam belongs to a group of medicines called ‘benzodiazepines’. It is used to treat epilepsy. Clonazepam works by preventing seizures or fits. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONAZEPAM DO NOT TAKE CLONAZEPAM: • if you are allergic to clonazepam or any of the other ingredients of this medicine (listed in section 6). • if you are allergic to other benzodiazepine medicines. These include diazepam, chlordiazepoxide, bromazepam and flurazepam. • if you have lung disease. • if you have myasthenia gravis (severe muscle weakness) • if you suffer from sleeping disorders, such as difficulty breathing while asleep (sleep apnoea) • if you have a severe liver condition • if you have problems with alcohol or drug (prescription or recreational) use WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Clonazepam if: - you have a lung, liver or kidney condition - you have a history of depression or have attempted suicide - you have Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonazepam Auden 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg clonazepam. Excipients with known effect: Each tablet contains 142mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round white tablets with cross-score break line, marked ‘CLN 2’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS All clinical forms of epileptic disease and seizures in infants, children and adults, especially absence seizures (petit mal), including atypical absence; primary or secondarily generalised tonic-clonic seizures (grand mal); partial (focal) seizures with elementary or complex symptomatology; various forms of myoclonic seizures, myoclonus and associated abnormal movements. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Mode of administration: _ Treatment should be started with low doses. The dose may be increased progressively until the maintenance dose suited to the individual patient has been found. The cross- scored tablets facilitate the administration of lower daily doses in the initial stages of treatment. The dosage of clonazepam must be adjusted to the needs of each individual and depends on the individual response to therapy. The maintenance dosage must be determined according to clinical response and tolerance. The daily dose should be divided into 3 or 4 doses throughout the day. If doses are not equally divided, the largest dose should be given before retiring. Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening. Simultaneous administration of more than one antiepileptic drug is a common practice in the treatment of epilepsy and may be undertaken with clonazepam. The dosage of each drug may be required to be adjusted to obtain the optimum effect. If status epilepticus occurs in a patient receiving oral clonazepam, intravenous clonazepam may still control the status. Before adding clonazepam to Baca dokumen lengkap