Methadone Hydrochloride Oral Solution 1mg/1ml Sugar Free

Maa: Malta

Kieli: englanti

Lähde: Malta Medicines Authority

Aktiivinen ainesosa:

METHADONE HYDROCHLORIDE

Saatavilla:

Rosemont Pharmaceuticals Limited Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds LS11 9XE, United Kingdom

ATC-koodi:

N07BC02

INN (Kansainvälinen yleisnimi):

METHADONE HYDROCHLORIDE 1 mg/ml

Lääkemuoto:

ORAL SOLUTION

Koostumus:

METHADONE HYDROCHLORIDE 1 mg/ml

Prescription tyyppi:

POM

Terapeuttinen alue:

OTHER NERVOUS SYSTEM DRUGS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2005-09-07

Pakkausseloste

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PACKAGE LEAFLET – GLASS BOTTLE PACK (ROSEMONT)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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 only 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 gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is
and what it is used for
2. Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral
Solution
3. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral
Solution
4. Possible side effects
5. How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral
Solution
6. Further information
1. WHAT METHADONE HYDROCHLORIDE SUGAR FREE 1MG/1ML ORAL SOLUTION IS
AND
WHAT IT IS USED FOR
The name of your medicine is Methadone Hydrochloride Sugar Free
1mg/1ml Oral Solution
(referred to as Methadone Solution in this leaflet). It contains
methadone hydrochloride. This
belongs to a group of medicines called Narcotic Analgesics.
Methadone is used:

to treat opioid drug addiction

to treat moderate to severe pain
2. BEFORE YOU TAKE METHADONE HYDROCHLORIDE SUGAR FREE 1MG/1ML ORAL
SOLUTION
DO NOT TAKE METHADONE SOLUTION AND TELL YOUR DOCTOR IF:

you are allergic (hypersensitive) to methadone or any other
ingredients in this liquid (see section
6 below). An allergic reaction can include a rash, itching or
shortness of breath

you have severe breathing problems or a history of asthma. You must
not use this medicine
during an asthma attack. If you give this medicine to yourself
(self-administration), wait until
the asthma attack has passed and you are fully recovered

you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat
depression or if you have
taken

Valmisteyhteenveto

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1.
NAME OF THE MEDICINAL PRODUCT
Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution
Metharose Sugar Free Green 1mg/1ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methadone Hydrochloride Ph.Eur 1mg/1ml
3.
PHARMACEUTICAL FORM
Green solution for oral administration
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For use in the treatment of opioid drug addictions (as a narcotic
abstinence syndrome
suppressant).
For use as an analgesic for moderate to severe pain
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Addiction:
Adults:
Initially 10 - 20mg per day, increasing by 10 - 20mg per day until
there are no
signs of withdrawal or intoxication. The usual dose is 40 - 60mg per
day. The
dose is adjusted according to the degree of dependence with the aim of
gradual
reduction.
Elderly:
In the case of elderly or ill patients repeated doses should only be
given with
extreme caution.
Children:
Not recommended for children.
Pain:
Adults:
Usual single dose, 5 to 10mg orally. Owing to its long plasma half
life, caution
with repeated dosage should be observed in the very ill or elderly.
The usual
initial dose should be 5 to 10mg, 6 to 8 hourly, later adjusted to the
degree of
pain relief obtained.
Elderly:
Use caution with repeated dosage in elderly and ill patients.
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Children:
Not suitable
4.3.
CONTRAINDICATIONS
Respiratory depression, obstructive airways disease. Use during an
asthma attack is not
recommended.
Concurrent administration with MAO inhibitors or within 2 weeks of
discontinuation of
treatment with them.
Patients dependent on non-opioid drugs.
Use during labour is not recommended, the prolonged duration of action
increases the risk of
neonatal depression.
Methadone is not suitable for children.
Known hypersensitivity to the hydroxybenzoates or methadone.
Raised intracranial pressure or head injury.
Phaeochromocytoma.
Risk of paralytic ileus (including drug induced gastrointestinal
hypotonia).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caut