Naltrexone 50 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Naltrexone hydrochloride

Disponible des:

Aop Orphan Pharmaceuticals GmbH

Codi ATC:

N07BB; N07BB04

Designació comuna internacional (DCI):

Naltrexone hydrochloride

Dosis:

50 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

Drugs used in alcohol dependence; naltrexone

Estat d'Autorització:

Not marketed

Data d'autorització:

2005-03-11

Informació per a l'usuari

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NALTREXONE 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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If you get any of the 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 is and what it is used for
2.
What you need to know before you take Naltrexone
3.
How to take Naltrexone
4.
Possible side effects
5.
How to store Naltrexone
6.
Contents of the pack and other information
1.
WHAT NALTREXONE IS AND WHAT IT IS USED FOR
Naltrexone is used as part of a treatment programme to help you stop
taking opiates and remain off of
them.
Naltrexone belongs to a group of medicines called opiate antagonists.
It blocks the euphoric feelings
(highs) that you may experience after taking opiates. In treatment for
withdrawal from opiates it will
reduce the craving.
Naltrexone tablets do not cause dependency.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NALTREXONE
DO NOT TAKE NALTREXONE IF:
-
you are allergic to naltrexone hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
-
you have severe liver problems or acute hepatitis
-
you have severe kidney problems
-
you are taking opioid-containing drugs
-
you are taking methadone
-
you are opioid-addicted (without successful withdrawal)
-
you experience acute symptoms of opioid withdrawal
-
you experience withdrawal symptoms after a naloxone injection or your
urine tests positive for
opiates.
WARNINGS AND PRECAUTIONS
Your treatment should be started by a physician experienced in
treatment of addictions.
-
DON’T
take opiates whilst taking Naltrexone tabl

Fitxa tècnica

Health Products Regulatory Authority
14 February 2024
CRN00DVGF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naltrexone 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg naltrexone hydrochloride.
One film-coated tablet contains 126.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Capsule shaped, beige film-coated tablets with a break-score on each
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 4.2 and 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Naltrexone treatment should be initiated and supervised by suitable
qualified physicians.
Naltrexone administered to opioid-dependent persons can cause
life-threatening withdrawal symptoms. Administration of
Naltrexone must not be started before a naloxone challenge test is
performed and a negative result obtained (see section 4.4).
Treatment with Naltrexone should be considered only in patients who
have remained opioid-free for a minimum of 7-10 days.
Before starting Naltrexone treatment, this test must be confirmed by
urine screening.
Posology
_Use in adults_
Treatment must begin with low doses of naltrexone, according to the
treatment induction schedule.
The recommended initial dose of naltrexone hydrochloride is 25 mg
(half a tablet) followed by 50 mg per day (one tablet).
The dosage-regimen can be modified in order to improve compliance to a
three-times-a-week dosing schedule as follows:
administration of 2 tablets (= 100 mg naltrexone hydrochloride) on
Monday and on Wednesday and 3 tablets (= 150 mg
naltrexone hydrochloride) on Friday.
A missed dose can be managed by providing 1 tablet per day till the
next regular dosage-administration.
A dose of over 150 mg on any single day is not reco