国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MIDAZOLAM MALEATE
DKSH MALAYSIA SDN BHD
MIDAZOLAM MALEATE
100 Tablets
Recipharm Leganes S.L.U.
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DORMICUM ® _ _ _Midazolam (7.5 mg) _ 1 WHAT IS IN THIS LEAFLET 1. What Dormicum is used for 2. How Dormicum works 3. Before you take Dormicum 4. How to take Dormicum 5. While you are using Dormicum 6. Side effects 7. Storage and disposal of Dormicum 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of revision 1. WHAT DORMICUM IS USED FOR Dormicum tablets are used for the short term treatment of insomnia (inability to sleep). Dormicum tablets may also be given to you before an operation to produce sleepiness or drowsiness and to relieve anxiety. Your doctor, however, may have prescribed Dormicum for another purpose. Ask your doctor if you have any questions about why Dormicum has been prescribed for you. This medicine is available only with a doctor’s prescription. 2. HOW DORMICUM WORKS Dormicum belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. Dormicum tablets will cause sedation and help you sleep. 3. BEFORE YOU TAKE DORMICUM - _WHEN YOU MUST NOT TAKE IT _ • You have had an allergic reaction to Dormicum, any other benzodiazepine medicine, or any of the ingredients listed at the end of this leaflet. • You have severe muscle weakness, also known as myasthenia gravis • You have respiratory problems • You have a condition called sleep apnea syndrome • You have severe liver damage or liver disease • You are taking antifungal medicines such as ketoconazole, itraconazole or voriconazole • You are taking HIV protease inhibitor medicines including ritonavir-boosted protease inhibitors. If you are not sure whether you should be given Dormicum, talk to your doctor. Do not give Dormicum to children. Do not take Dormicum if the expiry date printed on the pack has passed. If the pharmacist has repacked the medicine for you, there may not be an expiry date on the pack. - _BEFORE YOU START TO TAKE IT_ Your doctor must know about all the following before you receive D 完全なドキュメントを読む
PACK INSERT FOR MALAYSIA DORMICUM ® TABLETS MIDAZOLAM 1. DESCRIPTION 1.1 THERAPEUTIC/ PHARMACOLOGIC CLASS OF DRUG Dormicum Tablet is a sleep-inducing agent belonging to the benzodiazepines. 1.2 TYPE OF DOSAGE FORM Tablets. 1.3 ROUTE OF ADMINISTRATION Oral use. 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ midazolam as the maleate. Tablets containing midazolam maleate equivalent to 7.5 mg of midazolam. The 7.5 mg tablet is oval, cylindrical, biconvex and of a white to almost white colour. _Excipients:_ described as per local requirements (Dormicum tablets contain anhydrous lactose. For warning related to lactose monohydrate, see section 2.4.1). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATIONS Disturbances of sleep rhythm and all forms of insomnia, particularly difficulty in falling asleep either initially or after premature awakening. Sedation in premedication before surgical or diagnostic procedures. 2.2 DOSAGE AND ADMINISTRATION Duration of treatment should be as short as possible. Generally, the duration of treatment varies from a few days to a maximum of 2 weeks. The tapering-off process should be tailored to the individual. Treatment with Dormicum should not be terminated abruptly (see section 2.4.2). In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without reevaluation of the patient’s status. Owing to the rapid onset of action, Dormicum tablets should be taken immediately before going to sleep, and swallowed whole with fluid. Dormicum can be taken at any time of the day, provided the patient is subsequently assured of at least 7-8 hours undisturbed sleep. _Standard dosage_ Dosage range: 7.5-15 mg. Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded because of the increased risk of CNS adverse effects possibly including clinically relevant respiratory and cardiovascular depression. _Premedication_ In premedication, Dormicum should be given 30-60 minutes before the proce 完全なドキュメントを読む