Acomplia
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-01-2009
Charakterystyka produktu
(SPC)
30-01-2009
Sprawozdanie z oceny publicznego
(PAR)
30-01-2009
Składnik aktywny:
rimonabant
Dostępny od:
sanofi-aventis
Kod ATC:
A08AX01
INN (International Nazwa):
rimonabant
Grupa terapeutyczna:
Antiobesity preparations, excl. diet products
Dziedzina terapeutyczna:
Obesity
Wskazania:
As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Withdrawn
Data autoryzacji:
2006-06-19
Ulotka dla pacjenta
Medicinal product no longer authorised
B. PACKAGE LEAFLET
23
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACOMPLIA 20 MG FILM-COATED TABLETS
(rimonabant)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You m
ay need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the s
ide effects ge
t serious, or if you notice any side effect not listed in this
leaflet, please
tell your doctor or pharmacist.
-
You are advised to share the information in this leaflet with
relatives or other relevant persons.
IN THIS LEAFLET:
1.
What ACOMPLIA is and what it is used for
2.
Before you take ACOMPLIA
3.
How to take ACOMPLIA
4.
Possible side effects
5
How to store ACOMPLIA
6.
Further information
1.
WHAT ACOMPLIA IS AND WHAT IT IS USED FOR
The active ingredient of ACOMPLIA is rimonabant. It works by
blocking specific receptors i
n the
brain and fat tissues called CB1 receptors. ACOMPLIA is indicated in
the treatment of obese or
overweight patients with additional risk factors such as diabetes or
high levels of fatty substances in
the blood called lipids (dyslipidaemia; mainly cholesterol and
triglycerides) as adjunct to diet and
exercise.
2.
BEFORE YOU TAKE ACOMPLIA
DO NOT TAKE ACOMPLIA
−
if you currently suffer from depression
−
if you are currently being treated for depression
−
if you are allergic (hypersensitive) to rimonabant, or any of the
other ingredients of ACOMPLIA
−
if you are breast-feeding
.
TAKE SPECIAL CARE WITH ACOMPLIA
Tell your doctor before you start to take this medicine
−
if you have previously suffered from depression or have had suicidal
thoughts
−
if you have impaired liver function
−
if you have severely impaired renal function
−
if you have diabetes (see section 4)
−
if you are currently being treated for epilepsy
−
if you ar
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Charakterystyka produktu
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
ACOMPLIA 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg rimonabant.
Excipients:
The tablets contain approx. 115 mg lactose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Biconvex, teardrop-shaped, white tablets debossed with “20” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an adjunct to diet and exercise for the treatment of obese patients
(BMI
≥
30 kg/m
2
), or overweight
patients (BMI > 27 kg/m
2
) with associated risk factor(s), such as type 2 diabetes or
dyslipidaemia (see
section 5.1).
4.2
POSOLOGY AN
D METHOD OF ADMINISTRATION
In adults, the recommended dosage is one 20 mg tablet daily
to be taken in the morning before
breakfast.
The treatment should be introduced with a mildly reduced calorie diet.
The safety and efficacy of rimonabant have not been evaluated beyond 2
years.
•
Special Popul
ations
_Elderly: _
No dosage adjustment is required in elde
rly (see section 5.2). ACOMPLIA should be used with
caution in patients over 75 years of age (see section 4.4).
_Patients with hepatic insufficiency: _
No dosage adjustment is required for patients with m
il
d or moderate hepatic impairment_._ ACOMPLIA
should be used with caution in patients with moderate hepatic
impairment. ACOMPLIA should not be
used in patients with severe hepatic impairment (see section 4.4 and
5.2).
_Patients with renal impairment: _
No dosage adjustment is required for patients with mild and moderate_
_renal im
pairm
ent (see section
5.2). ACOMPLIA should not be used in patients with severe renal
impairment (see section 4.4 and
5.2).
_Paediatrics: _
ACOMPLIA is not recommended for use in children below age 18 due to a
lack
of data on efficacy
and safety.
2
Medicinal product no longer authorised
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to
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