NALTREXONE GH naltrexone hydrochloride 50mg film coated tablets blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

naltrexone hydrochloride, Quantity: 50 mg

Disponibbli minn:

Generic Health Pty Ltd

INN (Isem Internazzjonali):

naltrexone hydrochloride

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

Excipient Ingredients: titanium dioxide; powdered cellulose; lactose monohydrate; microcrystalline cellulose; iron oxide black; crospovidone; iron oxide yellow; colloidal anhydrous silica; iron oxide red; hypromellose; macrogol 4000; magnesium stearate

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

30 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

NALTREXONE GH is indicated for use within a comprehensive treatment programme for alcohol dependence. NALTREXONE GH is also indicated as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine.

Sommarju tal-prodott:

Visual Identification: The Natrexone 50mg filmcoated tablets are beige, capsule-shaped tablets with a score on each side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2007-08-31

Fuljett ta 'informazzjoni

CONSUMER MEDICINE INFORMATION
NALTREXONE GH
(NALTREXONE HYDROCHLORIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Naltrexone GH. It does not
contain all of the available
information.
All medicines have risks and
benefits. Your doctor has
weighed the risks of your taking
Naltrexone GH against the
benefits they expect it will have
for you. If you have any
concerns about taking
Naltrexone GH, ask your doctor
or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may want to
read it again.
WHAT NALTREXONE GH IS
USED FOR
Naltrexone GH is used to help
opiate drug addicts kick the
habit. It is also used to help
alcoholics dry out and remain
abstinent.
Naltrexone GH tablets contain
the active ingredient, naltrexone
hydrochloride. It is an opiate
antagonist. This means it fights
the effects of opiate drugs like
heroin on the body, and blocks
euphoria (or “high”) due to these
opiates.
Your doctor may have
prescribed Naltrexone GH for
another use. Ask your doctor if
you have any questions about
why Naltrexone GH has been
prescribed for you.
Naltrexone GH is not addictive.
BEFORE YOU TAKE
NALTREXONE GH
Naltrexone GH is not suitable for
everyone.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NALTREXONE GH IF
YOU HAVE HAD AN ALLERGIC
REACTION TO NALTREXONE GH OR
ANY OF THE INGREDIENTS.
Symptoms of an allergic reaction
may include, but are not limited
to, swelling of the face or
tongue, difficulty in breathing,
wheezing or an itchy skin rash.
DO NOT TAKE NALTREXONE GH IF
YOU ARE STILL USING HEROIN OR
DRUGS LIKE IT.
If you take Naltrexone GH right
after taking an opiate you will
suffer withdrawal symptoms
(cold turkey) (such as nausea,
vomiting, shakiness, sweating
and anxiety) which may be
severe.
DO NOT TAKE NALTREXONE GH IF
YOU ARE ON CERTAIN PAIN KILLERS.
Ask your doctor or pharmacist.
DO NOT TAKE NALTREXONE GH IF
YOU HAVE HEPATITIS OR LIVER
FAILURE.
Hepatitis is liver disease with
nausea, vomiting, loss of
appetite, feeling generally
unwell, fever, itching, yellowing
of the s

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION – NALTREXONE GH
(NALTREXONE HYDROCHLORIDE), FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Naltrexone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of naltrexone hydrochloride.
List of excipients with known effects: sugars (as lactose).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Naltrexone GH is presented as beige, film-coated, capsule-shaped
tablets, with a score on each side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Naltrexone GH is indicated for use within a comprehensive treatment
program for alcohol dependence.
Naltrexone GH is also indicated as adjunctive therapy in the
maintenance of formerly opioid-dependent
patients who have ceased the use of opioids such as diamorphine
(heroin) and morphine.
4.2 DOSE AND METHOD OF ADMINISTRATION
DO NOT ATTEMPT TREATMENT WITH NALTREXONE GH UNLESS, IN THE MEDICAL
JUDGEMENT OF THE PRESCRIBING
PHYSICIAN, THERE IS NO REASONABLE POSSIBILITY OF OPIOID USE WITHIN THE
PAST 7-10 DAYS. IF THERE IS ANY
QUESTION OF
OCCULT
OPIOID
DEPENDENCE, PERFORM A NARCAN CHALLENGE
TEST
AND DO
NOT
INITIATE
NALTREXONE GH THERAPY UNTIL THE NARCAN CHALLENGE IS NEGATIVE.
TREATMENT OF ALCOHOL DEPENDENCE
A dose of 50 mg once daily is recommended for most patients. The
placebo-controlled studies that
demonstrated the efficacy of naltrexone hydrochloride as an adjunctive
treatment of alcoholism used a
dose regimen of naltrexone hydrochloride 50 mg once daily for up to 12
weeks. Other dose regimens or
durations of therapy were not evaluated in these trials.
A patient is a candidate for treatment with Naltrexone GH if:
•
the patient is willing to take a medicine to help with alcohol
dependence;
•
the patient is opioid free for 7-10 days;
Naltrexone GH v5
Page 2 of 16
(naltrexone hydrochloride) tablets
•
the patient does not have severe or active liver or kidney problems
(typical guidelines suggest liver
function tests no greater than 3 times the upper limits of normal, and
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