Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Dexamfetamine sulfate 5mg; ;
Noumed Pharmaceuticals Limited
Dexamfetamine sulfate 5 mg
5 mg
Tablet
Active: Dexamfetamine sulfate 5mg Excipient: Acacia Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Purified talc
Bottle, glass, 100 tablets
Class B1 Controlled Drug
Class B1 Controlled Drug
Cambrex Charles City Inc
The treatment of well-established and proven narcolepsy.
Package - Contents - Shelf Life: Bottle, glass, 30 ml amber glass - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, glass, - 1000 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
1969-12-30
New Zealand Consumer Medicine Information 1 DEXAMFETAMINE TABLETS _DEXAMFETAMINE SULFATE _ _ _ Tablet, uncoated 5 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Dexamfetamine Tablets. This leaflet answers some common questions about Dexamfetamine Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Dexamfetamine Tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT DEXAMFETAMINE TABLETS ARE USED FOR Dexamfetamine belongs to a group of medicines called stimulants. These work by increasing activity in the brain. Dexamfetamine works by affecting some of the natural chemicals that are found in the brain. In particular, it increases the activity of chemicals called dopamine and noradrenaline in areas of the brain that play a part in controlling attention and behaviour. Dexamfetamine stimulates activity in the brain, helping to keep people alert and active during the day. Dexamfetamine Tablets are used for: The treatment of well-established and proven narcolepsy. It is also indicated for children with refractory hyperkinetic states under the supervision of a physician specialising in child psychiatry. Your doctor may have prescribed Dexamfetamine Tablets for another reason. Ask your doctor if you have any questions about why Dexamfetamine Tablets has been prescribed for you. This medicine is available only with a doctor's prescription. It is possible to develop tolerance to Dexamfetamine so that more tablets have to be taken to achieve the same effect. This, in turn, can lead to dependence on New Zealand Consumer Medicine Information 2 Dexamfetamine. With increasing doses and dependence, mental instability and behavioural changes can occur. If any of the side ef Läs hela dokumentet
NEW ZEALAND DATA SHEET Page 1 of 12 1. PRODUCT NAME Dexamfetamine Tablets, Tablet, 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NAME AND STRENGTH OF THE ACTIVE SUBSTANCE: Dexamfetamine sulfate 5 mg EXCIPIENT(S) WITH KNOWN EFFECT: Lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral – tablet PRESENTATION White, 8 mm, normal convex tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the treatment of well-established and proven narcolepsy. It is also indicated for children with refractory hyperkinetic states under the supervision of a physician specialising in child psychiatry. 4.2. DOSE AND METHOD OF ADMINISTRATION Dexamfetamine should be started at the lowest possible dose and should then be individually and slowly adjusted to the lowest effective dose for each individual. Time of administration should receive special attention because of insomnia. FOR NARCOLEPSY: Adults: Oral, 5 to 20 mg a day in divided doses as needed and tolerated. The usual starting dose is 5 mg a day, given in divided doses. Doses may be increased, if necessary, by 5 mg a day at weekly intervals to a suggested maximum of 20 mg a day. Elderly: Start with 5 mg a day and increase by increments of 5 mg at weekly intervals to a suggested maximum of 20 mg a day. Children: • _Children up to 6 years of age: _ Dosage has not been established. NEW ZEALAND DATA SHEET Page 2 of 12 • _Children 6 to 12 years of age: _ Oral, 5mg a day, the dosage being increased by 5 mg a day at one-week intervals until the desired response is obtained or until the adult dose is reached. FOR ATTENTION-DEFICIT HYPERACTIVITY DISORDERS: Where possible, drug administration should be interrupted occasionally to determine if there is an occurrence of behaviour symptoms sufficient to require continued therapy. If therapy is recommenced after discontinuation, it should not be started at the dose that had been reached prior to treatment interruption but should be re-titrated from the usual starting dose. Children: Läs hela dokumentet