Package leaflet: Information for the user Rivastigmin 1.5 mg capsules, hard Rivastigmin 3 mg capsules, hard Rivastigmin 4.5 mg capsules, hard Rivastigmin 6 mg capsules, hard Rivastigmin

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Rivastigmin is and what it is used for

1.    What you need to know before you take Rivastigmin

2.    How to take Rivastigmin

3.    Possible side effects

4.    How to store Rivastigmin

5.    Contents of the pack and other information

1. What Rivastigmin is and what it is used for

The active substance of Rivastigmine is rivastigmine.

This medicine is used for:

•    the symptomatic treatment of mild to moderately severe Alzheimer's disease.

•    the symptomatic treatment of mild to moderately severe dementia in patients with Parkinson's disease.

2. What you need to know before you take Rivastigmin

Do not take Rivastigmin

•    if you are allergic to rivastigmine (the active substance in Rivastigmin) or any of the other ingredients of this medicine (listed in section 6).

•    if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine patches

If this applies to you, tell your doctor and do not take rivastigmine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

-    if    you have, or have ever had,    irregular heartbeat.

-    if    you have, or have ever had,    an active stomach ulcer.

-    if    you have, or have ever had,    difficulties in passing urine.

-    if    you have, or have ever had,    seizures.

-    if    you have, or have ever had,    asthma or severe respiratory    disease.

-    if    you have, or have ever had,    impaired kidney function.

-    if    you have, or have ever had,    impaired liver function.

-    if you suffer from trembling.

-    if you have a low body weight.

-    if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

If you have not taken this medicine for several days, do not take the next dose until you have talked to your doctor.

Children and adolescents

There is no relevant use of this medicine in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Rivastigmin

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

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

If you have to undergo surgery whilst taking rivastigmine, tell your doctor before you are given any anaesthetics, because this medicine may exaggerate the effects of some muscle relaxants during anaesthesia.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using rivastigmine must be assessed against the possible effects on your unborn child. Rivastigmine should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with this medicine.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. This medicine may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.

-    Weight loss

-    Stomach pain

-    Feeling agitated

-    Feeling tired or weak

-    Generally feeling unwell

-    Trembling or feeling confused Uncommon (may affect up to 1 in 100 people)

-    Depression

-    Difficulty in sleeping

-    Fainting or accidentally falling

-    Changes in how well your liver is working Rare (may affect up to 1 in 1,000 people)

-    Chest pain

-    Rash, itching

-    Fits (seizures)

-    Ulcers in your stomach or intestine

Very rare (may affect up to 1 in 10,000 people)

-    High blood pressure

-    Urinary tract infection

-    Seeing things that are not there (hallucinations)

-    Problems with your heartbeat such as fast or slow heartbeat

-    Bleeding in the gut - shows as blood in stools or when being sick

-    Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

-    The signs of Parkinson’s disease get worse or getting similar signs - such as stiff muscles, difficulty in carrying out movements

Not known (frequency cannot be estimated from the available data)

-    Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)

-    Dehydration (losing too much fluid)

-    Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

-    Aggression, feeling restless

-    Uneven heartbeat

Patients with dementia and Parkinson’s disease

These patients have some side effects more often. They also have some additional side effects:

Very common (may affect more than 1 in 10 people)

-    Trembling

-    Fainting

-    Accidentally falling

Common (may affect up to 1 in 10 people)

-    Anxiety

-    Feeling restless

-    Depression

-    Seeing things that are not there (hallucinations, visual)

-    High blood pressure

-    Slow and fast heartbeat

-    Difficulty in sleeping

-    Too much saliva and dehydration

-    Unusually slow movements or movements you cannot control

-    The signs of Parkinson’s disease get worse or getting similar signs - such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

-    Uneven heartbeat and poor control of movements

-    Low blood pressure

Other side effects seen with Rivastigmine transdermal patches and which may occur with the hard capsules:

Common (may affect up to 1 in 10 people)

-    Fever

-    Severe confusion

-    Decreased appetite

-    Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

-    Hyperactivity (high level of activity, restlessness)

Not known (frequency cannot be estimated from the available data)

-    Allergic reaction where the patch was used, such as blisters or skin inflammation. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rivastigmin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help

doctor or pharmacist if you are not sure.

How to start treatment

Your doctor will tell you what dose of rivastigmine to take.

-    Treatment usually starts with a low dose.

-    Your doctor will slowly increase your dose depending on how you respond to treatment.

-    The highest dose that should be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst you are taking this medicine.

If you have not taken Rivastigmin for several days, do not take the next dose until you have talked to your doctor.

Taking this medicine

-    Tell your caregiver that you are taking Rivastigmin.

-    To benefit from your medicine, take it every day.

-    Take this medicine twice a day, in the morning and evening, with food.

-    Swallow the capsules whole with a drink.

-    Do not open or crush the capsules.

If you take more Rivastigmin than you should

If you accidentally take more of your medicine than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much of this medicine have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

If you forget to take Rivastigmin

If you find you have forgotten to take your dose of your medicine, 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You may have side effects more often when you start your medicine or when your dose is increased. Usually, the side effects will slowly go away as your body gets used to the medicine.

If you experience the following serious side effects, tell your doctor or pharmacist immediately or go to the nearest hospital:

•    Gastrointestinal haemorrhage (blood in stools or when vomiting / being sick)

•    Inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting)

•    Worsening of Parkinson’s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements)

Other possible side effects include:

Very common (may affect more than 1 in 10 people)

-    Feeling dizzy

-    Loss of appetite

-    Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea Common (may affect up to 1 in 10 people)

-    Anxiety

-    Sweating

-    Headache

-    Heartburn

What Rivastigmin contains

-    The active substance is rivastigmine. Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg, 3 mg, 4.5 mg or 6 mg Rivastigmin respectively.

-    The other ingredients are:

Capsule content: microcrystalline cellulose, hypromellose, silica, colloidal anhydrous, magnesium stearate.

Capsule coating: gelatin, sodium laurilsulfate, purified water.

Colorants: The capsules contain ferric oxide yellow (E 172) and titanium dioxide (E171). The 3 mg, 4.5 mg and 6 mg hard capsules also contain ferric oxide red (E 172).

What Rivastigmin looks like and contents of the pack

Rivastigmin 1.5 mg capsules, hard, are opaque yellow and contain off-white to slightly yellow powder.

Rivastigmin 3 mg capsules, hard, are opaque orange and contain off-white to slightly yellow powder.

Rivastigmin 4.5 mg capsules, hard, are opaque red and contain off-white to slightly yellow powder.

Rivastigmin 6 mg capsules, hard, have an opaque red cap and opaque orange body, and contain off-white to slightly yellow powder.

Rivastigmin capsules, hard, are packed in PCV/PVdC/Aluminium blisters. They are available in packages containing 2, 4, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 112 and 120 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Torrent Pharma (UK) Ltd.

Unit 4, Charlwood Court,

County Oak Way Crawley

West Sussex. RH11 7XA

United Kingdom

Telephone: (01293) 574180

Fax: (01293) 533003

E-mail: drugsafety@torrentpharma.co.uk

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany    Rivastigmin Heumann 1,5 mg / 3 mg / 4,5 mg / 6 mg    Hartkapseln

Lithuania    Rivastigmino Torrent 1,5 mg / 3 mg / 4,5 mg / 6 mg

Romania:    Rivastigmina Torrent 1,5 mg / 3 mg / 4,5 mg / 6 mg

UK:    Rivastigmine 1.5 mg / 3 mg / 4.5 mg / 6 mg capsules,    hard

This leaflet was last revised in 05/2013.

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