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Acomplia (rimonabant) – Package leaflet - A08AX01

Updated on site: 11-Jul-2017

Medication nameAcomplia
ATC CodeA08AX01
Substancerimonabant
Manufacturersanofi-aventis
Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. How to take ACOMPLIA

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ACOMPLIA 20 mg film-coated tablets

 

(rimonabant)

 

Read all of this leaflet carefully before you start taking this medicine.

- Keep this leaflet. 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 side 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 ACOMPLIA is and what it is used for

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2.

Before you take ACOMPLIA

 

4.

Possible side effects

 

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 in the brain and fat tissues called CB1 receptors. ACOMPLIAno 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 ACOMPLIAproduct

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

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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 are less than 18 years of age. There is no information available on the use of ACOMPLIA in people under 18 years of age.Medicinal

Serious psychiatric events including depression or mood changes have been reported in patients taking ACOMPLIA (see section POSSIBLE SIDE EFFECTS).

If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.

Signs and symptoms associated with depression could be:

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Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability;

slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.

You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.

Taking other medicines

The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:

itraconazole (antifungal medicine)

 

ketoconazole (antifungal medicine)

 

ritonavir (medicine for the treatment of HIV infections)

telithromycin (antibiotic)

 

clarithromycin (antibiotic)

 

nefazodone (anti-depressor)

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Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned medicines or any other medicines, including those obtained without a prescription such as St John’s wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or depression.

Pregnancy and breast-feeding

ACOMPLIA should not be taken during pregnancy.

Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ACOMPLIA.

Do not take this medicine when breast-feeding. Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.

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Driving and using machines

At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use machines.

Important information about some of the ingredients of ACOMPLIA

ACOMPLIA tablets include lactose. If you are intolerant to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE ACOMPLIA

MedicinalAlways take ACOMPLIA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one 20 mg tablet to be taken once daily in the

morning before breakfast. Swallow the tablet whole.

You need to start and continue a reduced calorie diet and a physical activity program to get best results. Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health.

Taking ACOMPLIA with food and drink

ACOMPLIA should be taken once daily in the morning before breakfast.

If you take more ACOMPLIA than you should

If you take more ACOMPLIA than you should tell a doctor or pharmacist.

If you forget to take ACOMPLIA

Take it as soon as you remember but do not take a double dose to make up for any forgotten dose. If you have any further questions on the use of this product ask your doctor or your pharmacist.

4. POSSIBLE SIDE EFFECTS

ACOMPLIA include:

Like all medicines, ACOMPLIA can cause side effects, although not everybodyauthorisedgets them Very common side effects, that affect more than 1 per 10, that have occurred in patients on

nausea and upper respiratory tract infection.

Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ACOMPLIA include:

upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint sprain.

Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in patients on ACOMPLIA include:

Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).

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Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ACOMPLIA

include: hallucinations.

 

During post-marketing experience the following side effects have also been reported (frequency not

known):

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Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach

pain.

 

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ACOMPLIA

Keep out of the reach and sight of children.

MedicinalDo not use ACOMPLIA after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What ACOMPLIA contains

The active substance is rimonabant. One film-coated tablet contains 20 mg rimonabant. The other ingredients are:

Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000

Tablet polishing: carnauba wax (E903)

What ACOMPLIA looks like and contents of the pack

ACOMPLIA 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.

ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit

dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.

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Not all pack sizes may be marketed.

 

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Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

 

sanofi-aventis

 

174, avenue de France

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F-75013 Paris

France

 

Manufacturers

 

Sanofi Winthrop Industrie

 

30-36, avenue Gustave Eiffel – BP 27166

 

 

 

F-37071 Tours Cedex 2

 

 

France

 

 

sanofi-aventis S.p.A.

 

 

Strada Statale 17, Km 22

 

 

67019 Scoppito (AQ)

 

 

Italy

 

 

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

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België/ Belgique/ Belgien sanofi-aventis Belgium Tél/Tel: +32 (0)2 710 54 00

България

sanofi-aventis Bulgaria EOOD Тел.: +359 (0)2 970 53 00

Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111

Danmark

sanofi-aventis Denmark A/S Tlf: +45 45 16 70 00

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel: +49 (0)180 2 222010

Eesti

sanofi-aventis Estonia OÜ Tel: +372 627 34 88

Ελλάδα sanofi-aventis AEBE

Τηλ: +30 210 900 16 00

España

 

sanofi-aventis, S.A.

 

Tel: +34 93 485 94 00

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France

 

sanofi-aventis France

 

Tél: 0 800 222 555

 

Appel depuis l’étranger : +33 1 57 63 23 23

Ireland

sanofi-aventis Ireland Ltd. Tel: +353 (0) 1 403 56 00

Ísland

MedicinalVistor hf.

Sími: +354 535 7000

Italia sanofi-aventis S.p.A. Tel: +39 02 393 91

Κύπρος

sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600

Latvija

sanofi-aventis Latvia SIA Tel: +371 67 33 24 51

Luxembourg/Luxemburg

sanofi-aventis Belgium

authorised

Tlf: +47 67 10 71 00

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Magyarország

sanofi-aventis zrt., Magyarország Tel.: +36 1 505 0050

Malta

sanofi-aventis Malta Ltd. Tel: +356 21493022

Nederland

sanofi-aventis Netherlands B.V. Tel: +31 (0)182 557 755

Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0

Norge sanofilonger-aventis Norge AS

Polska

sanofi-aventis Sp. z o.o. Tel.: +48 22 541 46 00

noPortugal

sanofi-aventis - Produtos Farmacêuticos, S.A. Tel: +351 21 35 89 400

România

sanofi-aventis România S.R.L. Tel: +40 (0) 21 317 31 36

Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 48 00

Slovenská republika

sanofi-aventis Pharma Slovakia s.r.o. Tel: +421 2 57 103 777

Suomi/Finland sanofi-aventis Oy

Puh/Tel: +358 (0) 201 200 300

Sverige sanofi-aventis AB

Tel: +46 (0)8 634 50 00

United Kingdom sanofi-aventis

Tel: +44 (0) 1483 505 515

Lietuva

UAB sanofi-aventis Lietuva

Tel: +370 5 2755224

 

 

 

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This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.

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