Nimvastid 6 mg orodispersible tablets

Nimvastid belongs to a class of substances called cholinesterase inhibitors.

Nimvastid is used for the treatment memory disorders in patients with Alzheimer?s disease.

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

Do not take Nimvastid

• if you are allergic (hypersensitive) to rivastigmine, other carbamate derivatives or to any of the other ingredients of Nimvastid.
• if you have severe liver problems.

Take special care with Nimvastid

• if you have, or ever had impaired kidney or liver function, irregular heartbeat, an active stomach ulcer, asthma or severe respiratory disease, difficulties in passing urine, seizures (fits or convulsions).
• if you have not taken Nimvastid 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 Nimvastid 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 Nimvastid, you should inform the doctor before you are given any anaesthetics, because Nimvastid may exaggerate the effects of some muscle relaxants during anaesthesia.

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

Nimvastid contains sorbitol E420. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

Your doctor will tell you what dosage of Nimvastid 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 Nimvastid for several days, do not take the next dose until you have talked to your doctor.

You should take Nimvastid twice a day, once with your breakfast and once with your evening meal. Your mouth should be empty before taking the tablet.

Nimvastid orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a tablet from the package as follows:

1. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it,

2. Pull up the edge of the foil and peel foil off completely,

3. Tip the tablet out onto your hand.

4. Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed without water. The mouth should be empty before placing the tablet on the tongue.

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

Tell your caregiver that you are taking Nimvastid .

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

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

If you stop taking Nimvastid

Do not stop taking your tablets. It is important that you carry on taking Nimvastid for as long as your doctor tells you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

You may tend to get side effects most frequently when you start your medication or increase to a higher dose. Side effects will gradually disappear most probably as your body becomes used to the medicine.

The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)
• common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user in 10,000)
• not known (frequency cannot be estimated from the available data).
• Very common side effectsare dizziness, nausea (feeling sick), vomiting (being sick), diarrhoea and loss of appetite.
• Common side effectsare heartburn, stomach pain,headache, agitation, confusion, weakness, fatigue, sweating, a general feeling of being unwell, weight loss and trembling.
• Uncommonly patients have complained of depression, difficulty in sleeping, changes in liver function, fainting or accidentally falling.
• Rarely, patients have experienced chest pain, seizures (fits or convulsions), rash, itching, gastric and intestinal ulcers.
• Very rarely, 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).

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 Nimvastid after the expiry date which is stated on the packaging. 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.

What Nimvastid contains

• The active substance is rivastigmine hydrogen tartrate. Each Nimvastid 1.5 mg orodispersible tablet contains 1.5 mg of rivastigmine as rivastigmine hydrogen tartrate. Each Nimvastid 3 mg orodispersible tablet contains 3 mg of rivastigmine as rivastigmine hydrogen tartrate. Each Nimvastid 4.5 mg orodispersible tablet contains 4.5 mg of rivastigmine as rivastigmine hydrogen tartrate. Each Nimvastid 6 mg orodispersible tablet contains 6 mg of rivastigmine as rivastigmine hydrogen tartrate.
• The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, spearmint flavour (peppermint oil, maize maltodextrin), peppermint flavour (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol), crospovidone, calcium silicate, magnesium stearate.

What Nimvastid looks like and contents of the pack

Orodispersible tablets are round and white tablets.

14 x 1 (only for 1.5 mg), 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Al/PVC foil film and PET/Al peel off foil perforated unit dose blister packs are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

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

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52

KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490

eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Danmark KRKA Sverige AB Tlf 46 08 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE

Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 08 643 67 66 SE

Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 597 365 Österreich TAD Pharma GmbH Tel 49 0 4721 6060

KRKA, d.d., Novo mesto 30 0210 9581143 Polska KRKA Polska Sp.z.o.o Tel. 48 022 573 7500

España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650

France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 România KRKA, d.d., Novo mesto Reprezentana pentru România Tel 402 01 310 66 05 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100

Ísland KRKA Sverige AB Sími 46 08 643 67 66 SE Slovenská republika KRKA Slovensko, s.r.o., Tel 421 0 2 571 04 501

Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 08 643 67 66 SE

KRKA, d.d., Novo mesto 30 0210 9581143 EL Sverige KRKA Sverige AB Tel 46 08 643 67 66 SE

Latvija KRKA, d.d., Novo mesto Tel 371 0733 8610 United Kingdom KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Lietuva

KRKA, d.d., Novo mestoTel: + 370 5 236 27 40

This leaflet was last approved in