Naltrexone 50mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Naltrexone hydrochloride

Հասանելի է:

Accord-UK Ltd

ATC կոդը:

N07BB04

INN (Միջազգային անվանումը):

Naltrexone hydrochloride

Դոզան:

50mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 04100300; GTIN: 5060149314258

Տեղեկատվական թերթիկ

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

Ապրանքի հատկությունները

OBJECT 1
NALTREXONE HYDROCHLORIDE 50 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 05-Mar-2014 | Accord
Healthcare Limited
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.
Th