Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Methadone hydrochloride

Dostupné s:

Perrigo Pharma International Designated Activity Company

ATC kód:

N07BC; N07BC02

INN (Mezinárodní Name):

Methadone hydrochloride

Dávkování:

1 milligram(s)/millilitre

Léková forma:

Oral solution

Terapeutické oblasti:

Drugs used in opioid dependence; methadone

Stav Autorizace:

Marketed

Datum autorizace:

1998-07-27

Informace pro uživatele

METHADONE HYDROCHLORIDE 1MG/1ML ORAL SOLUTION MODULE 1.3.1 LEAFLET
VERSION: DECEMBER 2020
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.

you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat

Charakteristika produktu

Health Products Regulatory Authority
11 December 2020
CRN00C0ZS
Page 1 of 10
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 contains1mg methadone hydrochloride
Excipients with known effect:
Liquid Maltitol (E965) – 0.55g/ml
Methyl parahydroxybenzoate (E218) – 1.2mg/ml
Propyl parahydroxybenzoate (E216) – 0.3mg/ml
Propylene Glycol (E1520) – 20.7mg/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.
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 not possible prior
to delivery, methadone administer