Adipex Retard Capsule 15mg

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

PHENTERMINE HYDROCHLORIDE

Commercializzato da:

GERMAX SDN. BHD.

INN (Nome Internazionale):

PHENTERMINE HYDROCHLORIDE

Confezione:

100 Capsule Capsules; 500Capsule Capsules

Prodotto da:

Catalent Germany Eberbach GmbH

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ADIPEX
®
RETARD CAPSULES
Phentermine Hydrochloride (15mg)
___________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What ADIPEX Capsule is used for
2. How ADIPEX Capsule works
3. Before you use ADIPEX Capsule
4. How to use ADIPEX Capsule
5. While you are using it
6. Side effects
7. Storage and Disposal of ADIPEX
Capsule
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT ADIPEX CAPSULE IS USED
FOR
ADIPEX Capsule is a centrally
stimulating medicine, used as an
adjunctive therapy to diet, in
people with obesity and a body
mass index (BMI) of 30 or higher,
who have not responded to an
appropriate weight reducing
regimen alone.
HOW ADIPEX CAPSULE WORKS
Phentermine is a centrally
stimulating medicine that has an
anorectic effect. This medicine
works by inhibiting excessive
appetite. It represses the sensation
of hunger, thus making it easier to
follow dietary restrictions and
achieve a decrease in weight.
BEFORE YOU USE ADIPEX
CAPSULE
-
_When you must not use it _
DO NOT TAKE ADIPEX CAPSULE
- If you are allergic
(hypersensitive) to phentermine
or other similar medicine or
other ingredients of ADIPEX
Capsule.
- If you currently have pulmonary
high blood pressure.
- If you have or have had a
history of blood vessels in the
heart or brain related disease.
- If you have kidney problem.
- If you have overactive thyroid
gland, pheochromocytoma
(tumor of adrenal gland),
glaucoma (raised eye pressure)
and prostatic tumor.
- If you are propensity towards
drug abuse, known alcoholism.
-
If
you
are
taking
MAO-
inhibitors,
for
depression
or
within
2
weeks
after
the
withdrawal.
-
If
you
have
or
have
had
medical
history
of
mental
disorders,
including
eating
disorder and depression.
- If you are elderly.
-
If
you
are
aged
below
12
years old.
- If you are in first 3 months
of
pregnancy
or
during
breastfeeding.
If any of these applies to you,
you
should
not
be
given
ADI

Scheda tecnica

Composition:
1 capsule contains 15 mg phentermine as the polystyrene sulphonate,
0.17 mg propyl-4-hydroxy benzoate
sodium and 0.34 mg ethyl-4-hydroxybenzoate sodium as stabilisers.
_Inert ingredients: _
yellow beeswax, hydrated soybean oil, rape-seed oil, soybean lecithin,
gelatin, glycerol 85%, Karion 83, ester of
castor oil fatty acid with ethoxylated glycerin (Cremophor EL),
titanium dioxide E 171, Sunset Yellow E 110,
Quinoline Yellow E 104, ethyl vanillin, p-methoxy-acetophenon.
Characteristics and Action:
Adipex retard contains phentermine, a centrally stimulating substance
that also has an anorectic effect. This
effect is transient and decreases with the continued use of the drug
after a few weeks. The active ingredient is
bound to a non-absorbable ion exchanger on a resinate basis and is
slowly released in the intestines. The
anorectic effect sets in after 1–3 hours and lasts for at least 8
hours. Phentermine is barely metabolised and does
not form any active metabolites. About 60% of the ingested phentermine
dose are excreted unchanged on the
first day. 5% of the administered dose are metabolised by N-oxidation,
with primarily N-hydroxyphentermine and
to a lesser degree the nitro metabolite being formed, which – after
passing the enterohepatic blood flow – are
mainly excreted by the kidneys. Plasma half-life is 20 to 25 hours.
Adipex retard has been shown to inhibit
excessive appetite. It represses the sensation of hunger, thus making
it easier to follow dietary restrictions and
achieve a decrease in weight.
Indications:
Adjunctive therapy to diet, in patients with obesity and a body mass
index (BMI)* of 30 or higher, who have not
responded to an appropriate weight reducing regimen alone.
Note: Short-term efficacy only has been demonstrated with regard to
weight reduction. No significant data on
changes in morbidity or mortality are yet available.
* How to calculate the body mass index (BMI):
The BMI is the quotient of body weight (in kilograms) and the square
of body height (in meters):
body weigh