Naltrexone Hydrochloride 50mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Naltrexone hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N07BB; N07BB04

INN (International Name):

Naltrexone hydrochloride

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Drugs used in alcohol dependence; naltrexone

Authorization status:

Marketed

Authorization date:

2010-05-21

Patient Information leaflet

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 (lis

Summary of Product characteristics

HealthProductsRegulatoryAuthority
10May2019
CRN008WYG
Page1of12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NaltrexoneHydrochloride50mg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�