Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Methadone hydrochloride

Disponibbli minn:

Rosemont Pharmaceuticals Ltd

Kodiċi ATC:

N07BC; N07BC02

INN (Isem Internazzjonali):

Methadone hydrochloride

Dożaġġ:

1 milligram(s)/millilitre

Għamla farmaċewtika:

Oral solution

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Drugs used in opioid dependence; methadone

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1998-07-27

Fuljett ta 'informazzjoni

METHADONE HYDROCHLORIDE 1MG/1ML ORAL SOLUTION MODULE 1.3.1
LEAFLET
VERSION: AUGUST 2018
PAGE 1
GLASS BOTTLE PACKS (ROSEMONT)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
WHAT IS IN THIS LEAFLET
1. What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is
and what is it used for?
2. What you need to know 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. Contents of the pack and other information
1. WHAT METHADONE HYDROCHLORIDE SUGAR FREE 1MG/1ML ORAL SOLUTION IS
AND
WHAT IS IT 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 drug addiction.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHADONE HYDROCHLORIDE SUGAR
FREE 1MG/1ML ORAL SOLUTION
DO NOT TAKE METHADONE SOLUTION AND TELL YOUR DOCTOR IF:

you are allergic to methadone or any other ingredients of this
medicine (listed in section 6). 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

Karatteristiċi tal-prodott

Health Products Regulatory Authority
04 October 2018
CRN008LVG
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 1mg Methadone Hydrochloride
Includes Excipients:
Liquid Maltitol (E965) - 0.4 ml/ml
Methyl Hydroxybenzoate (E218) - 1.2mg/ml
Propyl Hydroxybenzoate (E216) - 0.3mg-ml
Propylene Glycol (E1520) - 0.02ml/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
A green solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the treatment of opioid drug addictions (as a narcotic
abstinence
syndrome suppressant), as substitution or maintenance therapy, within
a broader
treatment protocol/programme, accompanied by regular reviews and
reassessment.
This treatment must be supervised by specialist services.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The subject formulation contains 2.5 times the concentration of
methadone found in
methadone linctus and is suitable ONLY for use as substitution or
maintenance
therapy of narcotic dependence.
Adults:Initial dosage is usually 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.
Health Products Regulatory Authority
04 October 2018
CRN008LVG
Page 2 of 14
The dose is individually adjusted according to the degree of
dependence with the
aim of gradual reduction, and bearing in mind the clinical status,
including hepatic
and renal function of the patient.
Dosage in Pregnancy: Drug withdrawal needs to be achieved 4 – 6
weeks before
delivery if neonatal abstinence syndrome is to be certain to be
avoided, but abrupt
withdrawal can cause intrauterine death. Detoxification to abstinence
is least stressful
to mother and foetus if undertaken during the mid trimester.
Abstinence syndrome may not occur in the neonate for some days after
birth. In the
event that withdrawal is