METHADONE TEVA 1 Mg/Ml Oral Solution

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

METHADONE HYDROCHLORIDE

थमां उपलब्ध:

Teva Pharma B.V.

ए.टी.सी कोड:

N07BC02

INN (इंटरनेशनल नाम):

METHADONE HYDROCHLORIDE

डोज़:

1 Mg/Ml

फार्मास्यूटिकल फॉर्म:

Oral Solution

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Drugs used in opioid dependence

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2011-08-19

सूचना पत्रक

PRODUCT
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METHADONE T
EVA 1MG/ML ORAL 
SOL. ALL (BOTTLE) TEI V2 (OPAVA)
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METHADONE TEVA 
1 MG/ML ORAL SOLUTION
METHADONE HYDROCHLORIDE
PACKAGE LEAFLET: 
INFORMATION FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE 
YOU START TAKING THIS MEDICINE.
•  Keep this leafl et. 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. Do not pass it on to others. It 
may harm them, even if their 
symptoms are the same as yours.
•  If any of the side effects get serious, 
or if you notice any side effects not 
listed in this leafl et, please tell your 
doctor or pharmacist.
IN THIS LEAFLET:
1.  WHAT METHADONE TEVA 1 MG/ML ORAL 
SOLUTION IS AND WHAT IT IS USED FOR
2.  BEFORE YOU TAKE METHADONE TEVA 
1 MG/ML ORAL SOLUTION
3.  HOW TO TAKE METHADONE TEVA 
1 MG/ML ORAL SOLUTION
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE METHADONE TEVA 
1 MG/ML ORAL SOLUTION
6. FURTHER INFORMATION
   WHAT METHADONE TEVA 
1 MG/ML ORAL SOLUTION IS 
AND WHAT IT IS USED FOR
This medicine contains methadone 
hydrochloride, which belongs to a 
group of medicines called narcotic 
analgesics. It is used to treat opioid 
drug ad

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methadone Teva 1 mg/ml Oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One millilitre of oral solution contains 1 mg of methadone hydrochloride.
_Excipients_
One millilitre of oral solution contains 1.2 mg methyl parahydroxybenzoate, 0.3 mg propyl parahydroxybenzoate and
300 mg of maltitol liquid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, green liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the treatment of opioid addictions (as a narcotic abstinence syndrome suppressant).
Local guidance on the management of opioid addiction should be followed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Local guidance may differ from the posology described hereafter and should be followed.
Methadone should preferably be prescribed in special treatment institutions in view of the great risks that such
treatment involves. In cases where this is not possible, contact should be made with the nearest drugs advice centre.
_Addiction_
_Adults_
Initially 10-20 mg per day. A supplementary dose on the same day may be considered when there is evidence of
persistent opioid withdrawal provided that the person has been fully assessed by a clinician with appropriate skills and
experience. The dose should be increased by 10 mg per day until there are no signs of withdrawal or intoxication. The
usual dose is 60-100 mg per day. The dose is adjusted according to the degree of dependence with the aim of gradual
reduction at a speed dependent on the individual person _e.g. _3% per week.
_Elderly_
In the case of elderly or ill patients repeated doses should only be given with extreme caution.
_Children_
Not recommended for children.
HEA