Nalorex 50mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Naltrexone hydrochloride

Dostupné z:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC kód:

N07BB04

INN (Medzinárodný Name):

Naltrexone hydrochloride

Dávkovanie:

50mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04100300; GTIN: 5012712002901

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NALOREX
® 50MG
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 or
nurse.
- 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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Nalorex is and what it is used for
2. What you need to know before you take Nalorex
3. How to take Nalorex
4. Possible side effects
5. How to store Nalorex
6. Contents of the pack and other information
1. WHAT NALOREX IS AND WHAT IT IS USED FOR
The name of your medicine is Nalorex. Nalorex contains the active
ingredient naltrexone
hydrochloride. Naltrexone hydrochloride belongs to a group of
medicines called opioid
antagonists.
NALOREX is used together with your other forms of treatment such as
counselling to help you to
remain free from your dependence on heroin, methadone and other
similar opiate drugs of
addiction.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NALOREX
DO NOT TAKE NALOREX IF YOU:
•
Are allergic (hypersensitive) to naltrexone hydrochloride or any of
the other ingredients of
Nalorex
•
Are currently dependent on opiate drugs or going through withdrawal
•
If your urine tests are positive for opiates
•
Have liver failure or hepatitis (inflammation of the liver),
•
If you have kidney failure
•
Are currently taking any medicines which contain any opioids which
include certain cough
medicines (e.g. mixtures containing dextromethorphan), analgesic pain
killers (e.g.
morphine, codeine) and some medicines used to treat diarrhoea (e.g.
kaolin)
•
Attempts to overcome the effects of Nalorex with high doses of o

Súhrn charakteristických

OBJECT 1
NALOREX
Summary of Product Characteristics Updated 19-Mar-2014 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
NALOREX 50mg Film-Coated Tablets
2. Qualitative and quantitative composition
Naltrexone hydrochloride 50 mg per tablet.
Also contains lactose monohydrate, 204 mg per tablet.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Pale yellow, film coated, capsule-shaped tablet debossed on one side
with 'R11' and scored and debossed
with '50' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Nalorex is indicated as an adjunctive prophylactic therapy in the
maintenance of detoxified, formerly
opioid-dependent patients.
4.2 Posology and method of administration
Route of administration - oral.
Administration of Nalorex must not be started before a naloxone
challenge test is performed and a
negative result obtained
_Naloxone test_
- Intravenous: Administer 0.2 mg naloxone IV. If no adverse reactions
appear after 30 seconds,
administer another dose of 0.6 mg naloxone iv. Continue observing the
patient over 20 minutes for signs
of withdrawal.
- Subcutaneous: Administer 0.8 mg naloxone subcutaneously Observe the
patient for 20 minutes for signs
and symptoms of withdrawal.
Confirmation of the test: If there is any doubt that the patient is
opioid-free, treatment with Nalorex
should be delayed 24 hours. In this case, the test should be repeated
with 1.6 mg naloxone.
If there is no evidence of a reaction, Nalorex administration may be
initiated with 25 mg by mouth (half a
tablet).
Before starting Nalorex treatment, this test must be confirmed by
urine screening. Treatment must begin
with low doses of naltrexone, according to the treatment induction
schedule.
The initial dose of Nalorex should be 25 mg (half a tablet) followed
by 50 mg (one tablet) daily.
A three-times-a-week dosing schedule may be considered if it is likely
to result in better compliance e.g.
100 mg on Monday, 100 mg on Wednesday and 150 mg on Friday.
A dose of over 150 mg