Naltrexone Hydrochloride 50mg film-coated Tablet

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

NALTREXONE HYDROCHLORIDE

Tilgjengelig fra:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC-kode:

N07BB04

INN (International Name):

NALTREXONE HYDROCHLORIDE 50 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

NALTREXONE HYDROCHLORIDE 50 mg

Resept typen:

POM

Terapeutisk område:

OTHER NERVOUS SYSTEM DRUGS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2016-04-12

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
NALTREXONE HYDROCHLORIDE 50 MG FILM-COATED TABLETS NALTREXONE HYDROCHLORIDE
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 Naltrexone Hydrochloride film-coated tablets is and what it is
used for
2. What you need to know before you take Naltrexone Hydrochloride
film-coated tablets
3. How to take Naltrexone Hydrochloride film-coated tablets
4. Possible side effects
5. How to store Naltrexone Hydrochloride film-coated tablets
6. Contents of the pack and other information
1. WHAT NALTREXONE HYDROCHLORIDE FILM-COATED TABLETS IS AND WHAT IT IS
USED FOR
The active ingredient, naltrexone hydrochloride, belongs to a group of
medicines other nervous system drugs;
drugs used in addictive disorders
WHAT IS NALTREXONE HYDROCHLORIDE FILM-COATED TABLETS USED FOR
Naltrexone hydrochloride is used in combination with other medicines
or therapy to help those who are
dependent on drugs such as heroin (opioids), overcome their addiction
It is indicated as supportive therapy in maintaining abstinence (self
denial) in alcohol-dependent patients.
Naltrexone acts by blocking receptors in the brain to block the action
of opioids. Individuals will no longer
experience the euphoria previously experienced after taking opioids.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NALTREXONE HYDROCHLORIDE
FILM-COATED TABLETS
DO NOT TAKE NALTREXONE HYDROCHLORIDE FILM-COATED TABLETS
•
if you are allergic to naltrexone hydrochloride or any of the other
ingredients of this medicine (liste

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Naltrexone Hydrochloride 50 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50.00 mg naltrexone hydrochloride
Excipient(s) with known effect: Each film-coated tablet contains
192.85 mg of lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow colored, oval, biconvex, film coated tablets with breakline on
one side and plain on
other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use as an additional therapy within a comprehensive treatment
program including
psychological guidance for detoxified patients who have been
opioid-dependent (see section
4.2 and 4.4) & alcohol dependence to support abstinence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
USE IN ADULTS
Naltrexone treatment should be initiated and supervised by suitable
qualified physicians.
The initial dose of naltrexone
_ _
hydrochloride should be 25 mg (half a tablet) for opioid-
dependent patient followed by the usual dose of one tablet per day (=
50 mg naltrexone
hydrochloride)
A missed dose can be managed by providing 1 tablet per day each day
till the next regular
dosage-administration.
Naltrexone administered to opioid-dependent persons can cause
life-threatening withdrawal
symptoms. Patients suspected of using or being addicted to opioids
must undergo a naloxone
provocation test (see section 4.4), unless it can be verified that the
patient has not taken any
opioids for 7-10 days (urine test) prior to the initiation of
treatment with naltrexone.
As Naltrexone is an adjunctive therapy and the full recovery process
in opioid-dependent
patients is individually variable, no standard duration of treatment
can be stated; an initial
period of three months should be considered. However, prolonged
administration may be
necessary.
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The recommended dose for alcohol dependence to support abstinence is
50 mg per d