Naltrexone Hydrochloride Tablet, film coated 50mg

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

NALTREXONE HYDROCHLORIDE

Pieejams no:

Accord Healthcare Limited

ATĶ kods:

N07BB04

SNN (starptautisko nepatentēto nosaukumu):

NALTREXONE HYDROCHLORIDE

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

NALTREXONE HYDROCHLORIDE 50 mg

Receptes veids:

POM

Ārstniecības joma:

OTHER NERVOUS SYSTEM DRUGS

Autorizācija statuss:

Authorised

Lietošanas instrukcija

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

Produkta apraksts

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.
The recommended dose for alcohol dependence to support abstinence is
50 mg
per
day
(1
tablet).
A
dose
of