Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NITRAZEPAM
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
NITRAZEPAM
1000 Tablets
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ __________________________________________________________________________________________________________ 1 NITRAPAM TABLETS 5MG Nitrazepam (5mg) WHAT IS IN THIS LEAFLET: 1. What Nitrapam Tablets is used for 2. How Nitrapam Tablets works 3. Before you use Nitrapam Tablets 4. How to use Nitrapam Tablets 5. While you are using it 6. Side Effects 7. Storage and Disposal of Nitrapam Tablets 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT NITRAPAM TABLETS IS USED FOR Nitrazepam is the active ingredient of Nitrapam Tablets. It belongs to a group of medicines called benzodiazepine which is widely used as a sedative/hypnotic and in the management of myoclonic seizures (fits or convulsions with quick, involuntary muscle jerk). HOW NITRAPAM TABLETS WORKS Nitrazepam works by affecting the way certain brain chemicals (neurotransmitter) transmit messages. This has a calming effect which helps you to sleep. BEFORE YOU USE NITRAPAM TABLETS _- When you must not use it _ If you have an eye problem called acute narrow angle glaucoma (increased pressure in the eye). _- Before you start to use it _ You must tell your doctor if: you have allergies to any medicine which you have taken previously to treat your current condition. You have impaired liver function. You are pregnant, trying to become pregnant or breast-feeding. It is found in breast milk, use with caution in nursing women. - _Taking other medicines _ Always inform your doctor and pharmacist if you are taking any other medicines, including herbal tonics, supplements and medicines that you buy without prescription. Central nervous system (CNS) depressants, other such as alcohol, analgesics (pain killer), general anaesthetics and tricyclic antidepressants – concurrent use may increase the effect of benzodiazepines including Nitrapam. Concurrent use of benzodiazepine with a narcotic analgesic, the dosage of narcotic should be reduced by at least one-th Baca dokumen lengkap
7039-07 NITRAPAM TABLETS 5MG NAME AND STRENGTH OF ACTIVE SUBSTANCE: Each tablet contains: Nitrazepam………………………………………………5mg PRODUCT DESCRIPTION: A blue, round, flat of 11mm diameter tablet with ‘MPI’ logo. PHARMACODYNAMICS : Nitrazepam is a benzodiazepine hypnotic which enhances or facilitates the inhibitory neurotransmitter action of gamma- aminobutyric acid (GABA) receptors. It mediates both pre- and post-synaptic inhibition in all regions in the central nervous system, following interaction between the benzodiazepine and a specific neuronal membrane receptor. PHARMACOKINETICS: Nitrazepam is 80% bioavailable after oral administration. Peak concentrations are reached in 0.5 to 5 hours. It is widely distributed in the body; 10 to 15% is found in cerebrospinal fluid and 85 to 90% is bound to plasma proteins. It also crosses the placenta and is found in breast milk. It is extensively metabolized to inactive substances that are excreted in the urine. The elimination half-life is approximately 30 hours. INDICATION: Nitrazepam is a benzodiazepine widely used as a sedative/hypnotic and in the management of myoclonic seizures. RECOMMENDED DOSAGE: Adults: as hypnotic the usual dose is 5 to 10mg at night Children: dosage in children up to 12 years is not established. ROUTE OF ADMINISTRATION: To be taken orally. CONTRAINDICATIONS: It is contraindicated in patients with acute narrow angle glaucoma. WARNINGS AND PRECAUTIONS: 1. Abrupt drug withdrawal may result in rebound insomia, an abstinence syndrome similar to barbiturate withdrawal seizures or rarely, psychosis 2. Use with caution in patient with impaired hepatic function. 3. Nitrazepam should be used with caution in patient with chronic obstructive lung disease or respiratory failure. 4. This preparation may be habit forming on prolonged use. 5. Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) which can occur as early as the first time the product is taken. 6. Complex sleep-related behaviour which may Baca dokumen lengkap