Rivastigmine HEXAL 2 mg/ml oral solution

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

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

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

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

Do not take Rivastigmine HEXAL

• if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Rivastigmine HEXAL.
• if you have severe liver problems.

Take special care with Rivastigmine HEXAL

• 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 HEXAL 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 HEXAL 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 HEXAL, you should inform the doctor before you are given any anaesthetics, because Rivastigmine HEXAL may exaggerate the effects of some muscle relaxants during anaesthesia.

Rivastigmine HEXAL should not be given at the same time as other medicines with similar effects to Rivastigmine HEXAL. Rivastigmine HEXAL 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 HEXAL during pregnancy, unless clearly necessary. Tell your doctor if you become pregnant during treatment. Women on Rivastigmine HEXAL 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 HEXAL 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.

Important information about some of the ingredients of Rivastigmine HEXAL

One of the inactive ingredients in Rivastigmine HEXAL oral solution is sodium benzoate. Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.

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

Remove the oral dosing syringe provided from its protective case. Using this syringe, withdraw the prescribed amount of Rivastigmine HEXAL oral solution from the container. Each dose of Rivastigmine HEXAL oral solution may be swallowed directly from the syringe.

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

Your doctor will tell you what dosage of Rivastigmine HEXAL 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 HEXAL 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 HEXAL.

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 HEXAL than you should

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

If you forget to take Rivastigmine HEXAL

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

Like all medicines, Rivastigmine HEXAL 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.

Keep out of the reach and sight of children.

Do not use Rivastigmine HEXAL 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. Do not refrigerate or freeze.

Store in an upright position.

Use Rivastigmine HEXAL oral solution within 1 month of opening the bottle.

What Rivastigmine HEXAL contains

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
• The other ingredients are sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.

What Rivastigmine HEXAL looks like and contents of the pack

Rivastigmine HEXAL oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug. The oral solution is packaged with an oral dosing syringe in a plastic tube container.

Marketing Authorisation Holder

HEXAL AG
Industriestraße 25
D-83607 Holzkirchen
Germany

Manufacturer

Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68333 Huningue
France

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 Tel 32 02 722 97 98 LuxembourgLuxemburg HEXAL AG Industriestraße 25 D-83607 Holzkirchen TélTel 49 8024 908 0 E-mail servicehexal.com

Representative office Sandoz d.d. Magyarország Sandoz Hungária Kft.

Business Park Sofia, buil. 8B, fl. 6 BG-1766 Sofia Tel. 359 2 970 47 48 Tímár u. 20. H-1034 Budapest Phone 36 1 430 2890 E-mail info.hungarysandoz.co

eská republika Sandoz s.r.o. Jeseniova 30 CZ-13000 Praha 3 E-mail office.czsandoz.com Tel 420 221 421 612 Malta V.J. Salomone Pharma Ltd. 79, Simpson Street MT-Marsa HMR14 Phone 356 21 220 174 E-mail infopharmavjsalomone.co

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 info.sandoz-nlsandoz.co

Norge Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Deutschland HEXAL AG Industriestraße 25 D-83607 Holzkirchen Tel 49 8024 908 0 E-mail servicehexal.com

Eesti Sandoz d.d. Eesti filiaal, Pärnu mnt 105, EE-11312 Tallinn, Tel 372 6652401 Österreich HEXAL Pharma GmbH Carlbergergasse 44 A-1235 Wien Tel 43 01 486 96 22

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

España Bexal Farmaceutica S.A. AvOsa Mayor no 4, Area B E-28023 Aravaca Madrid E-mail sandoz.respondesandoz.com Portugal Sandoz Farmacêutica Lda. Alameda da Beloura Edifício 1, 2 andar - Escritório 15 2710-693 Sintra Phone 351 21 0008782

France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tel 33 1 4964 4801 România Sandoz Pharma Services S.R.L. Victoria Business Park RO-Soseaua Bucuresti-Ploiesti 73-81 Corp 2, etaj 2, Sector 1 Phone 40 21 4075184

Ireland Rowex Ltd. Newtown IE - Bantry Co. Cork Slovenija Lek Pharmaceuticals d.d. Verovkova 57 SI-1526 Ljubljana

Tel 353 27 50077 Tel 386 1 5802111 E-mail info.leksandoz.co

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 48 200 601

Italia Hexal S.p.A. co Sandoz S.p.A. Largo Umberto Boccioni 1 I-21040 Origgio VA Tel 39-02-96 541 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 Phone 371 67892007 United Kingdom Sandoz Ltd 37 Woolmer Way Bordon GU35 9QE UK Tel 44 0 1420 478301 E-mail uk.drugsafetysandoz.co

Lietuva
Sandoz Pharmaceuticals d.d.,
Branch Office Lithuania
Seimyniskiu Str. 3A
LT-09312 Vilnius
Phone: +370 5 2636038

This leaflet was last approved in

Instructions for Use: Rivastigmine HEXAL oral solution

1. Remove oral dosing syringe from its protective case. Push down and turn child resistant closure to open bottle.

2. Insert nozzle of syringe into opening of white stopper.

3. Withdraw prescribed amount of Rivastigmine HEXAL oral solution from bottle.

4. Before removing syringe containing prescribed dose from bottle, expel any large bubbles by depressing and withdrawing plunger a few times. The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.

5. Swallow Rivastigmine HEXAL oral solution directly from the syringe or first mix in a small glass with water. Stir and drink the entire mixture.

6. After use, wipe outside of syringe with a clean tissue and replace it in its protective case. Close bottle using child resistant closure.