Zimulti
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
30-01-2009
Produktets egenskaber
(SPC)
30-01-2009
Offentlige vurderingsrapport
(PAR)
30-01-2009
Aktiv bestanddel:
rimonabant
Tilgængelig fra:
sanofi-aventis
ATC-kode:
A08AX01
INN (International Name):
rimonabant
Terapeutisk gruppe:
Antiobesity preparations, excl. diet products
Terapeutisk område:
Obesity
Terapeutiske indikationer:
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).
Produkt oversigt:
Revision: 8
Autorisation status:
Withdrawn
Autorisation dato:
2006-06-19
Indlægsseddel
B. PACKAGE LEAFLET
23
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIMULTI 20 MG FILM-COATED TABLETS
(RIMONABANT)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaf
let. 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. 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 get 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 ZIMULTI is and what it is used for
2.
Before you take ZIMULTI
3.
How to take ZIMULTI
4.
Possible side effects
5
How to store ZIMULTI
6.
Further information
1.
WHAT ZIMULTI IS AND WHAT IT IS USED FOR
The active ingredient of ZIMULTI is rimonabant. It works by
blocking specific receptors in the brain
and fat tissues called CB1 receptors. ZIMULTI 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 ZIMULTI
DO NOT TAKE ZIMULTI
−
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 ZIMULTI
−
if you are breast-feeding
.
TAKE SPECIAL CARE WITH ZIMULTI
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 are less than 18 years of age. There is no information
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Produktets egenskaber
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
ZIMULTI 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 AND 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 elderly (see section 5.2). ZIMULTI
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
ild or moderate hepatic impairment_._ ZIMULTI
should be used with caution in patients with moderate hepatic
impairment. ZIMULTI 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
pairment (see section
5.2). ZIMULTI should not be used in patients with severe renal
impairment (see section 4.4 and 5.2).
_Paediatrics: _
ZIMULTI 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 any of the excipients
Lactation.
Ongoing major d
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