Dexamfetamine Sulfate 1mg/ml Oral Solution

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

dexamfetamine sulfate

Available from:

Essential Pharmaceuticals Ltd

ATC code:

N06BA02

INN (International Name):

dexamfetamine sulfate

Dosage:

1mg/ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

Pack size: 150 ml

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Dales Pharmaceuticals Ltd

Therapeutic group:

Psychoanaleptics; psychostimulants, agents used for ADHD and nootropics; centrally acting sympathomimetics

Therapeutic indications:

It is indicated in the treatment of narcolepsy in adults

Authorization status:

Authorised

Authorization date:

2015-05-20

Patient Information leaflet

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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR 
YOU.  
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only.  Do not pass it on
to others.  It may harm them, even if their signs of illness 
are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. 
See section 4. 
Dexamfetamine sulfate
DEXAMFETAMINE SULFATE 1 MG/ML ORAL SOLUTION
Pharmacode
DEXAMFETAMINE SULFATE 1 MG/ML ORAL SOLUTION WITH ALCOHOL
Alcohol must not be consumed while taking this medicine. 
Remember that some foods and medicines contain alcohol.
PREGNANCY AND BREAST-FEEDING
Dexamfetamine 1 mg/ml Oral Solution may affect an unborn 
baby. 
If you or your daughter are pregnant or breast-feeding, may be 
pregnant or are planning to have a baby, ask your doctor or 
pharmacist for advice before using this medicine.
 • Your doctor will discuss contraception.
 • If you or your daughter are pregnant you/she may have to  
stop taking this medicine.
 • It is possible that this medicine is passed into human breast 
milk. Therefore, your doctor will decide whether you or your 
daughter should stop breast-feeding or stop taking this 
medicine.
DRIVING AND USING MACHINES 
You or your child may feel dizzy, have problems focusing, or 
have blurred vision when taking this medicine. 
If so, it may be dangerous to do things such as drive, use 
machines, ride a bike or horse, or climb trees. 
DEXAMFETAMINE SULFATE 1 MG/ML ORAL SOLUTION CONTAINS 
LIQUID MALTITOL
If you have been told by your doctor that you have an 
intolerance to some sugars, contact your doctor before taking 
this medicinal product.

3. HOW TO TAKE DEXAMFETAMINE SULFATE 1 MG/ML 
OR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

This medicinal product is subject to additional monitoring. This will
allow quick 
identification of new safety information.
Healthcare professionals are asked to report 
any suspected adverse reactions. See section 4.8 for how to
report adverse reactions.  

1 
NAME OF THE MEDICINAL PRODUCT 
Dexamfetamine Sulfate 1 mg/ ml Oral Solution 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ml contains 1 mg dexamfetamine sulfate.  
Excipient with known effect: 
1 ml contains 200 mg liquid maltitol. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Oral solution. 

The oral solution is clear and colourless. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Dexamfetamine sulfate is a symphathomimetic amine with central
stimulant and 
anorectic activity.  

Narcolepsy 
Dexamfetamine sulfate is indicated in the treatment
of narcolepsy in adults. 

ADHD 
Dexamfetamine is also indicated as part of a comprehensive
treatment programme for 
attention deficit/hyperactivity disorder (ADHD) in children and
adolescents aged 6 to 
17 years when response to previous methylphenidate treatment
is considered 
clinically inadequate. A comprehensive treatment
programme typically includes 
psychological, educational and social measures. 

Diagnosis should be made according to DSM-5 criteria or the
guidelines in ICD-10 
and should be based on a comprehensive
multidisciplinary evaluation of the patient. 

Dexamfetamine is not indicated in all children with ADHD and
the decision to use 
dexamfetamine must be based on a very thorough assessment of the
severity and 
chronicity of the child’s symptoms in relation to the child’s
age and potential for 
abuse, misuse or diversion. 

Treatment should be under the supervision of a specialist
in childhood and/or 
adolescent behavioural disorders. 

4.