Rivastigmine Actavis 4.5 mg hard capsules

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

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

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

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

Do not take Rivastigmine Actavis

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

Take special care with Rivastigmine Actavis

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

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

Always take Rivastigmine Actavis 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 Actavis twice a day with food (in the morning and evening).

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

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 Actavis than you should

Tell your doctor if you find you have accidentally taken more Rivastigmine Actavis than you are told to. You may require medical attention. Some people who have accidentally taken too much

Rivastigmine Actavis have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

If you forget to take Rivastigmine Actavis
If you find you have forgotten to take your dose of Rivastigmine Actavis, 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 Actavis 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 Actavis after the expiry date which is stated on the carton, blister or capsulse container. The expiry date refers to the last day of that month.

Do not store above 30°C.

What Rivastigmine Actavis contains

• The active substance is rivastigmine hydrogen tartrate.
• The other ingredients are: Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and microcrystalline cellulose. Capsule shell: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatine. Printing ink: Shellac glaze, Antifoam DC 1510-US and titanium dioxide (E171).

Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.

What Rivastigmine Actavis looks like and contents of the pack

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

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

Marketing Authorisation Holder

Actavis Group PTC ehf.Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland

Manufacturer
Actavis hf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland

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

BelgiëBelgiqueBelgien ALL-in-1 bvba TélTel 32 032 86 88 88 LuxembourgLuxemburg ALL-in-1 bvba BelgiqueBelgien TélTel 32 032 86 88 88

Te. 359 2 9321 680 Magyarország Actavis Hungary Kft Tel. 36 1 501 7001

eská republika Actavis CZ a.s. Tel 420251001680 Malta Actavis Ltd. Tel 35621693533

Danmark Actavis AS Tlf 45 72 22 30 00 Nederland Actavis B.V. Tel 035 -54 299 33

Deutschland Actavis Deutschland GmbH Co. KG Telefon 49 089 558909 0 Norge Actavis Norway AS Tlf 47 815 22 099

Eesti UAB Actavis Baltics Eesti Filiaal Tel 372 6100 565 Österreich Actavis GmbH Tel 43 0662 435 235 00

Polska Actavis Polska Sp. z o.o. Tel. 48 22 512 29 00 PharOS - Pharmaceutical Oriented Services Ltd Tel 30 210 66 64 667 8

España Actavis Spain, S.A. Tfno. 34 91 630 86 45 Portugal Actavis AS Sucursal Tel 351 21 722 06 50

France Actavis France Tél 33 1 40 83 77 77 România Actavis SRL Tel 40 21 318 17 77

Slovenija Apta Medica d.o.o. Tel 386 01 475 5503 Ireland Actavis UK Limited United Kingdom Tel 441271311200

Ísland Actavis Group PTC ehf Sími 354-550 3300 Slovenská republika Actavis s.r.o. Tel 421 2 3255 3800

Italia Actavis Italy S.p.A. Tel 39 0331 583111 SuomiFinland Actavis Oy PuhTel 358 09 348 233

A. Potamitis Medicare Ltd 35722313611 Sverige Actavis AB Tel 46 8 13 63 70

Latvija Actavis Baltics prstvniecba Latvij Tel 371 67067873 United Kingdom Actavis UK Limited Tel 441271311200

Lietuva
UAB ?Actavis Baltics?
Tel: +370 5 260 9615

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