国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLONAZEPAM
DKSH MALAYSIA SDN BHD
CLONAZEPAM
60 Tablets; 60 Tablets
Recipharm Leganes S.L.U.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ RIVOTRIL ® _Clonazepam (0.5 mg, 2 mg) _ 1 WHAT IS IN THE LEAFLET 1. What Rivotril is used for 2. How Rivotril works 3. Before you take Rivotril 4. How to take Rivotril 5. While you are using Rivotril 6. Side effects 7. Storage and disposal of Rivotril 8. Product Description 9. Manufacturer & product registration holder 10. Date of revision 1. WHAT RIVOTRIL IS USED FOR Rivotril tablets are used for the treatment of epilepsy in infants, children and adults. Your doctor, however, may have prescribed Rivotril for another purpose. Ask your doctor if you have any questions why Rivotril has been prescribed for you. This medicine may be addictive. This medicine is available only with a doctor’s prescription. 2. HOW RIVOTRIL WORKS Rivotril belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. 3. BEFORE YOU TAKE RIVOTRIL − _When you must not take it _ 1. You have had an allergic reaction to Rivotril, any other benzodiazepine medicine or any ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • Shortness of breath • Wheezing or difficulty breathing • Swelling of the face, lips, tongue or other parts of the body • Rash, itching or hives on the skin 2. You have severe lung disease 3. You have severe liver disease. 4. The expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. If you are not sure if you should be taking Rivotril, talk to your doctor. − _Before you start to take it _ Tell your doctor if: 1. If you are pregnant or plan to become pregnant It is not known whether Rivotril is harmful to an unborn baby when taken by a pregnant woman. If there is a need to take Rivotril when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby. 2. If you are breastfeeding or plan to breastfeed Rivotril passes into breast milk and theref 完全なドキュメントを読む
Leaflet 0,5 mg Rivotril MY DRAFT (DATE) 21.09.2021 [08:20 uhr] (2) COLOURS Pantone Black linework DIMENSIONS 148 x 420 mm PR003-1 MATERIAL NUMBER 90006115/10 FONT SIZE 6 pt MATERIAL NUMBER RECIPHARM 50001105 LAETUS CODE 189 PACK INSERT FOR MALAYSIA RIVOTRIL ® Clonazepam 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Antiepileptic agent 1.2 TYPE OF DOSAGE FORM Tablets 1.3 ROUTE OF ADMINISTRATION Oral 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _clonazepam. _Tablets:_ 0.5 mg (break-mark) and 2 mg (cross-break-mark) The tablets are cylindrical, biplanar and of a white to slightly yellowish colour (2 mg) or of a pale orange colour (0.5 mg). Rivotril tablets contain lactose. For warning related to lactose, see 2.4.1 General (Warnings and Precautions)). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Most clinical forms of epilepsy in infants and children, in particular typical and atypical absences (Lennox-Gastaut syndrome), nodding spasms, primary or secondary generalized tonic-clonic spasms. Rivotril may also be used in adult epilepsy and focal seizures. 2.2 DOSAGE AND ADMINISTRATION The dosage of Rivotril must be individually adjusted according to the patient’s clinical response and tolerance. Rivotril tablets 0.5 mg can be divided into equal halves to facilitate dosing. Rivotril tablets 2 mg can be divided into equal halves or quarters to facilitate dosing. Tablets are scored to allow administration of lower doses. To break the tablet, hold it with the score facing up and apply downward pressure. _Standard dosage in Epilepsy_ Before adding Rivotril to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects. To ensure optimum dosage adjustment, infants should be given the drops and children the 0.5 mg tablets. The 0.5 mg tablets facilitate the administration of lower daily doses to adults in the initial stages of treatment. A single oral dose of Rivotril begins to take effect within 完全なドキュメントを読む