Methadone Mixture DTF Sugar-Free

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

METHADONE HYDROCHLORIDE

Disponibil de la:

Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

Codul ATC:

N07BC02

INN (nume internaţional):

METHADONE HYDROCHLORIDE 0.1 % (W/V)

Forma farmaceutică:

ORAL SOLUTION

Compoziție:

METHADONE HYDROCHLORIDE 0.1 % (W/V)

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

OTHER NERVOUS SYSTEM DRUGS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2007-01-29

Prospect

IN THIS LEAFLET: 
1.  What Methadone Mixture (Sugar Free) is and what it is
used for
2.  Before you take Methadone Mixture (Sugar Free)
3.  How to take Methadone Mixture (Sugar Free)
4.  Possible side effects
5.  Storing Methadone Mixture (Sugar Free)
6. Further 
information
This leaflet contains a summary of the information available
for this medicine. You should ask your doctor or pharmacist
if you are unsure about any aspect of this medicine.
1.  WHAT METHADONE MIXTURE (SUGAR FREE) IS
AND WHAT IT IS USED FOR
Methadone is a synthetic opiate (a morphine-like drug)
used in the treatment of addiction in order to reduce
withdrawal symptoms.
2.  BEFORE YOU TAKE METHADONE MIXTURE
(SUGAR FREE)
DO NOT TAKE METHADONE MIXTURE (SUGAR FREE) IF:
• you are allergic (hypersensitive) to methadone or any of
the ingredients of this medicine (listed in section 6) 
• you have a head injury and the pressure inside your
brain is higher than it should be (check this with your
doctor). You might be getting bad headaches
• you are suffering from alcoholism
• you are in labour 
• you are taking, or have recently stopped taking, a type of
medicine called Monoamine Oxidase Inhibitors (MAOIs)
which are used to treat depression
• you are at risk of developing an obstruction of the
intestine
• you have any problems with your breathing or any
chronic lung disease
• you are having an asthma attack.  Do not take your dose
until you have completely recovered.
METHADONE MIXTURE (SUGAR FREE) IS NOT SUITABLE FOR CHILDREN.
TAKE SPECIAL CARE WITH METHADONE MIXTURE (SUGAR FREE)
TELL YOUR DOCTOR IF: 
• you have history of asthma or breathing difficulties 
• you have bowel problems
• you have liver or kidney problems
• you have a history of convulsions, fits or epilepsy
• you have a history of low blood pressure
• you have a history of under-active thyroid gland, or
problems with your adrenal glands
• you have a history of enlarged prostate gland
• 

Caracteristicilor produsului

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Methadone Mixture DTF (Sugar Free) 1mg in1ml Oral Solution 
Physeptone Mixture SF 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains methadone hydrochloride 1mg. 
Contains  excipients  Liquid  Maltitol  (E  965)  0.4  ml/ml  and  Sunset  Yellow  (E110)  0.008 
mg/ml.   
For full list of excipients, see section 6.1 

3. 
PHARMACEUTICAL FORM 

Oral solution 
A clear, green oral solution 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

The treatment of Opioid drug addiction as a narcotic abstinence syndrome suppressant. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use only. 

The  dose  is  adjusted  according  to  the  degree  of  dependence  with  the  aim  of  gradual 
reduction. 

Adults 

Initially  10  -  20mg  per  day,  increasing  by  10  -  20mg  daily  until  there  is  no  sign  of 
withdrawal or intoxication.  

The elderly 

In  the  case  of  the  elderly  or  ill  patients,  repeated  doses  should  be  given  with  extreme 
caution. 

Children 

Not recommended 

4.3. 
CONTRA-INDICATIONS 

Contraindications are: 
Page 2 of 5 

Respiratory  depression,  obstructive  airways  disease,  concurrent  administration  of  MAO 
Inhibitors or within 2 weeks of discontinuation of treatment with them.  Hypersensitivity to 
any of the product ingredients. Use during an acute asthma attack is not advisable. 

Obstetric use not recommended during labour, as the prolonged duration of action increases 
the risk of neonatal depression.  Methadone is not suitable for children. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

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