Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Methadone hydrochloride

Disponibbli minn:

Taw Pharma (Ireland) Limited

Kodiċi ATC:

N07BC; N07BC02

INN (Isem Internazzjonali):

Methadone hydrochloride

Dożaġġ:

1 milligram(s)/millilitre

Għamla farmaċewtika:

Oral solution

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 2023
PAGE 1
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
depression or if you have
taken

Karatteristiċi tal-prodott

Health Products Regulatory Authority
01 August 2023
CRN00DLGX
Page 1 of 11
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
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.
The decision to maintain a patient on a long-term
opioid prescription should be an active decision agreed between the
clinician and patient with review at regular intervals
(usually at least three-monthly, depending on clinical progress).
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 i