What is it and how is it used?

Rivastigmine Sandoz belongs to a class of substances called cholinesterase inhibitors.

Rivastigmine Sandoz is used for the treatment of memory disorders in patients with Alzheimer?s disease.

Rivastigmine Sandoz is used for the treatment of dementia in patients with Parkinson?s disease.

What do you have to consider before using it?

Before taking Rivastigmine Sandoz it is important that you read the following section and discuss any questions you might have with your doctor.

Do not take Rivastigmine Sandoz

  • if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Rivastigmine Sandoz.
  • if you have severe liver problems.
Take special care with Rivastigmine Sandoz

  • if you have, or have ever had impaired kidney or liver function, irregular heartbeat, an active stomach ulcer, asthma or severe respiratory disease, difficulties in passing urine, or seizures (fits or convulsions).
  • if you have not taken Rivastigmine Sandoz for several days, do not take the next dose until you have talked to your doctor.
  • if you experience gastro-intestinal reactions such as nausea (feeling sick) and vomiting (being sick).
  • if you have a low body weight.
  • if you suffer from trembling. If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

The use of Rivastigmine Sandoz in children and adolescents (age below 18 years) is not recommended.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you have to undergo surgery whilst taking Rivastigmine Sandoz, you should inform the doctor before you are given any anaesthetics, because Rivastigmine Sandoz may exaggerate the effects of some muscle relaxants during anaesthesia.

Rivastigmine Sandoz should not be given at the same time as other medicines with similar effects to Rivastigmine Sandoz. Rivastigmine Sandoz might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson?s disease or to prevent travel sickness).

Pregnancy and breast-feeding

It is preferable to avoid the use of Rivastigmine Sandoz during pregnancy, unless clearly necessary. Tell your doctor if you become pregnant during treatment. Women on Rivastigmine Sandoz should not breast-feed. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your illness may impair your ability to drive or operate machinery and you must not carry out these activities unless your doctor tells you that it is safe to do so. Rivastigmine Sandoz may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience such effects, you should not drive or operate machinery.

How is it used?

Always take Rivastigmine Sandoz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole with a drink, without opening or crushing them.

You should take Rivastigmine Sandoz twice a day with food (in the morning and evening).

Your doctor will tell you what dosage of Rivastigmine Sandoz to take, starting with a low dose and gradually increasing, depending on how you respond to the treatment. The highest dose that should be taken is 6 mg twice a day. If you have not taken Rivastigmine Sandoz for several days, do not take the next dose until you have talked to your doctor.

To benefit from your medicine you should take it every day.

Tell your caregiver that you are taking Rivastigmine Sandoz.

This medicine should only be prescribed by a specialist and your doctor should regularly review whether it is having the desired effect. Your doctor will monitor your weight whilst you are taking this medicine.

If you take more Rivastigmine Sandoz than you should

Tell your doctor if you find you have accidentally taken more Rivastigmine Sandoz than you are told to. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Sandoz have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

If you forget to take Rivastigmine Sandoz

If you find you have forgotten to take your dose of Rivastigmine Sandoz, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

What are possible side effects?

Like all medicines, Rivastigmine Sandoz can cause side effects, although not everybody gets them.

You may tend to get side effects most frequently when you start taking your medicine or increase to a higher dose. Side effects will gradually disappear most probably as your body becomes used to the medicine.
Very common side effects (affects more than 1 patient in 10) are dizziness, nausea (feeling sick), vomiting (being sick), diarrhoea, and loss of appetite.
Common side effects (affects 1 to 10 patients in 100) are: heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, a general feeling of being unwell, weight loss and trembling.
Uncommonly (affects 1 to 10 patients in 1,000), patients have complained of depression, difficulty in sleeping, changes in liver function, fainting or accidentally falling.
Rarely (affects 1 to 10 patients in 10,000), patients have experienced chest pain, seizures (fits or convulsions), rash itching, gastric and intestinal ulcers.
Very rarely (affects less than 1 patient in 10,000), patients have experienced gastrointestinal haemorrhage (blood in stools or when vomiting), urinary tract infection, inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting), problems with heart rhythm (both fast and slow), high blood pressure, hallucinations, worsening of Parkinson?s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements).
Not known (frequency cannot be estimated from the available data): severe vomiting that can lead to a rupture of the oesophagus (the tube that connects the mouth with the stomach).

Patients with dementia associated with Parkinson?s disease experience some side effects more frequently and also some additional side effects: trembling (very common), difficulty in sleeping , anxiety, restlessness, worsening of Parkinson?s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements), abnormally slow or uncontrollable movements, slow heart beat, too much saliva and dehydration (common), irregular heart beat and poor control of movements (uncommon).

Additional side effects which have been reported with rivastigmine transdermal patches: severe confusion, anxiety, fever (common).

Should such symptoms occur, contact your doctor as you may need medical assistance.

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.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Rivastigmine Sandoz after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Further information

What Rivastigmine Sandoz contains

  • The active substance is rivastigmine hydrogen tartrate.
  • The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171).

Each Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine Sandoz 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine Sandoz 6 mg capsule contains 6 mg of rivastigmine.

What Rivastigmine Sandoz looks like and contents of the pack

Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint ?RIV 1.5 mg? on the body.

Rivastigmine Sandoz 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint ?RIV 3 mg? on the body.

Rivastigmine Sandoz 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint ?RIV 4.5 mg? on the body.

Rivastigmine Sandoz 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint ?RIV 6 mg? on the body.

They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.

Marketing Authorisation Holder

Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11
D-83607 Holzkirchen
Germany

Manufacturer

Novartis Farmacéutica, S.A.
Planta de Producción
Ronda de Santa Maria 158
E-08210 Barberà del Vallès, Barcelona
Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Sandoz N.V. Telecom Gardens, Medialaan 40 B-1800 Vilvoorde TélTel 32 02 722 97 97 Representative office Sandoz d.d. Business Park Sofia, buil. 8B, fl. 6 BG-1766 Sofia Te. 359 2 970 47 47 LuxembourgLuxemburg HEXAL AG Industriestraße 25 D-83607 Holzkirchen Tel 49 8024 908-0 E-mail servicehexal.com Magyarország Sandoz Hungária Kft. Tímár u. 20. H-1034 Budapest Tel. 36 1 430 2890 E-mail info.hungarysandoz.com

eská republika Sandoz s.r.o. Jeseniova 30 CZ-13000 Praha 3 Tel 420 221 421 611 E-mail office.czsandoz.com Malta V.J. Salomone Pharma Ltd. 79, Simpson Street MT-Marsa HMR14 Phone 356 21 220 174 E-mail infopharmavjsalomone.com

Danmark Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel 31 36 5241600 E-mail info.sandoz-nlsandoz.com

Norge Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Deutschland Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 D-83607 Holzkirchen Tel 49 8024 902 4000 E-mail infosandoz.de

Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE-11312 Tallinn Tel 372 6652400 Österreich Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Tel 43 053382000

Polska Lek Polska Sp.z o.o. ul. Domaniewska 50 C PL-02-672 Warszawa Tel 48 22 549 15 00 Sambrook Faaet .. aat 4 . atee GR-135 61 . t 30 -210 -85 40053 e- ysotirakousambrook.gr

España Sandoz Farmacéutica, SA Avda. Osa Mayor, 4 E-28023 Aravaca Madrid Tel. 34 917401280 E-mail sandoz.respondesandoz.com Portugal Sandoz Farmacêutica Lda. Alameda da Beloura Edificio 1, 2 andar - Escritório 15 P-2710-693 Sintra Tel 351 21 0008781

France Sandoz SAS România Sandoz Pharma Services S.R.L.

49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél 33 1 4964 4800 Victoria Business Park RO-Soseaua Bucuresti-Ploiesti 73-81 Corp 2, etaj 2, Sector 1 Tel 40 21 4075183

Ireland Rowex Ltd. Newtown IE-Bantry Co. Cork Tel 353 27 50076 Slovenija Lek Pharmaceuticals d.d. Verovkova 57 SI-1526 Ljubljana Tel 386 1 5802111 E-mail info.leksandoz.com

Ísland Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Slovenská republika Sandoz d.d. - organizaná zloka Galvaniho 15C SK-821 04 Bratislava Tel 421 2 48 200 600

Italia Sandoz S.p.a Largo Umberto Boccioni, 1 I-21040 Origgio VA Tel 39 02 96541 SuomiFinland Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com

Sverige Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com .T.ate etaea td Gd 31-3042 ees f 00357 25372425 Fa 00357 25376400 e- hapanicoscytanet.com.cy

Latvija Sandoz d.d. Representative Office in Latvia Meza Str. 4 LV-1048, Riga Tel 371 67892006 United Kingdom Sandoz Ltd 37 Woolmer Way Bordon GU35 9QE UK Tel 44 1420 478301 E-mail uk.drugsafetysandoz.com

Lietuva
Sandoz Pharmaceuticals d.d., Branch Office
Lithuania
Seimyniskiu Str. 3A
LT-09312 Vilnius
Tel: + 370 5 2636037

This leaflet was last approved in

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