Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamfetamine sulfate
Martindale Pharmaceuticals Ltd
N06BA02
Dexamfetamine sulfate
1mg/1ml
Oral solution
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04040000
If you have any doubts about whether this medicine is suitable for you please discuss this with your doctor. DEXAMFETAMINE ORAL SOLUTION WITH ALCOHOL Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol. PREGNANCY AND BREAST-FEEDING Dexamfetamine Oral Solution must not be taken until you have spoken to your doctor for advice if you are pregnant, think you may be pregnant or are planning to have a baby, or are breast feeding. Dexamfetamine passes into breast milk; therefore your doctor will decide whether you should breast-feed while taking Dexamfetamine Oral Solution. DRIVING AND USING MACHINES You may feel drowsy or dizzy, have problems focussing, or have blurred vision when taking Dexamfetamine Oral Solution. If these happen, it may be dangerous to do things such as drive, use machines, ride a bike or horse or climb trees. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS Dexamfetamine Oral Solution contains the following ingredients: • Liquid maltitol (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine. • Methyl hydroxybenzoate sodium (E219) and propyl hydroxybenzoate sodium (E217). These may cause an allergic reaction which could occur even if you have been taking Dexamfetamine Oral Solution for a while, or if you have stopped taking it. This information is to help you learn the main things about your medicine called Dexamfetamine Oral Solution. If you don’t enjoy reading, someone like your mum, dad or carer (sometimes called ‘your guardian’) can read it to you and answer any questions. It may help if you read small bits at a time. WHY HAVE I BEEN GIVEN THIS MEDICINE? This medicine can help children and young people with ‘ADHD’. • ADHD can make you: - run about too much - not be able to pay attention - act quickly without thinking about what will happen next (impulsive). • It affects Olvassa el a teljes dokumentumot
OBJECT 1 DEXAMFETAMINE SULFATE 1MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 14-Nov-2014 | Martindale Pharma 1. Name of the medicinal product Dexamfetamine Sulfate 1mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml of the oral solution contains 1mg of dexamfetamine sulfate. Each 1 ml of solution contains 2 mg of Sodium Methyl Hydroxybenzoate and 0.25mg of Sodium Propyl Hydroxybenzoate. 3. Pharmaceutical form Oral solution 4. Clinical particulars 4.1 Therapeutic indications Dexamfetamine sulfate is a symphathomimetic amine with central stimulant and anorectic activity. It is indicated in narcolepsy. It is also indicated for children with refractory hyperkinetic states under the supervision of a physician specialising in child psychiatry. 4.2 Posology and method of administration ADULTS: In narcolepsy, the usual starting dose is 10mg dexamfetamine a day, given in divided doses. Individual dose titration is recommended, and dosage may be increased if necessary, by 10mg a day at weekly intervals to a suggested maximum of 60mg a day. ELDERLY: Start with 5mg a day, and increase by increments of 5mg at weekly intervals. CHILDREN: In hyperkinetic states, individualisation of treatment is important. The usual starting dosage for children aged 3-5 years is 2.5mg a day, increased if necessary by 2.5mg a day at weekly intervals; for children aged 6 years and over, the usual starting dose is 5-10mg a day, increasing if necessary by 5mg at weekly intervals. The usual upper limit is 20mg a day, though some older children have needed 40mg or more for optimal response. 4.3 Contraindications Hypersensitivity to dexamfetamine or other amfetamine derivatives or any of the excipients. Patients with symptomatic cardiovascular disease, structural cardiac abnormalities and/or moderate or severe hypertensive disease. Patients with advanced arteriosclerosis. During or for 14 days after treatment with an MAO inhibitor. Patients with a history of drug abuse or alcohol abuse. Patients Olvassa el a teljes dokumentumot