Dexamfetamine 5mg/5ml oral solution sugar free

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Letöltés Betegtájékoztató (PIL)
23-06-2018
Letöltés Termékjellemzők (SPC)
23-06-2018

Aktív összetevők:

Dexamfetamine sulfate

Beszerezhető a:

Martindale Pharmaceuticals Ltd

ATC-kód:

N06BA02

INN (nemzetközi neve):

Dexamfetamine sulfate

Adagolás:

1mg/1ml

Gyógyszerészeti forma:

Oral solution

Az alkalmazás módja:

Oral

Osztály:

Schedule 2 (CD)

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04040000

Betegtájékoztató

                                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 
                                
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Termékjellemzők

                                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
                                
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