PACKAGE LEAFLET: INFORMATION FOR THE USER [Rivastigmine] 1.5 mg hard capsules [Rivastigmine] 3.0 mg hard capsules [Rivastigmine] 4.5 mg hard capsules [Rivastigmine] 6.0 mg hard capsules Rivastigmine

Read all of this leaflet carefully before you start taking this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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.

In this leaflet:

1.    What [Rivastigmine] is and what it is used for

2.    Before you take [Rivastigmine]

3.    How to take [Rivastigmine]

4.    Possible side effects

5.    How to store [Rivastigmine]

6.    Further information

1.    WHAT [RIVASTIGMINE] IS AND WHAT IT IS USED FOR

[Rivastigmine] belongs to a class of substances called cholinesterase inhibitors.

[Rivastigmine] is used for the treatment of memory disorders in patients with Alzheimer’s disease.

[Rivastigmine] is used for the treatment of dementia in patients with Parkinson’s disease.

2.    BEFORE YOU TAKE [RIVASTIGMINE]

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

Do not take [Rivastigmine]

-    if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of [Rivastigmine].

-    if you have severe liver problems.

Take special care with [Rivastigmine]

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

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

3. HOW TO TAKE [RIVASTIGMINE]

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

Your doctor will tell you what dosage of [Rivastigmine] 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 6.0 mg twice a day. If you have not taken [Rivastigmine] 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].

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] than you should

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

If you forget to take [Rivastigmine]

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, [Rivastigmine] 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), rashes, 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, fainting, accidentally falling (very common), difficulty in sleeping, anxiety, restlessness, worsening of Parkinson’s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements and muscle weakness), abnormally slow or uncontrollable movements, slow and fast 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.

5.    HOW TO STORE [RIVASTIGMINE]

Keep out of the reach and sight of children.

Do not use [Rivastigmine] 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.

6.    FURTHER INFORMATION What [Rivastigmine] contains

-    The active substance is rivastigmine hydrogen tartrate.

-    The other ingredients are Microcrystalline cellulose, Hydroxypropyl methyl cellulose, Colloidal Silicon Dioxide, magnesium stearate, gelatin, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172 - only in 3.0 mg, 4.5 mg and 6.0 mg capsules).

Each [Rivastigmine] 1.5 mg capsule contains 1.5 mg of rivastigmine.

Each [Rivastigmine] 3.0 mg capsule contains 3.0 mg of rivastigmine.

Each [Rivastigmine] 4.5 mg capsule contains 4.5 mg of rivastigmine.

Each [Rivastigmine] 6.0 mg capsule contains 6.0 mg of rivastigmine.

What [Rivastigmine] looks like and contents of the pack

[Rivastigmine] 1.5 mg hard capsules are presented as hard gelatine capsules with opaque yellow cap and opaque yellow body with off-white powder.

[Rivastigmine] 3.0 mg hard capsules are presented as hard gelatine capsules with opaque orange cap and opaque orange body with off-white powder.

[Rivastigmine] 4.5 mg hard capsules are presented as hard gelatine capsules with opaque red cap and opaque red body with off-white powder.

[Rivastigmine] 6.0 mg hard capsules are presented as hard gelatine capsules with opaque red cap and opaque orange body with off-white powder.

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

Marketing Authorisation holder

[to be completed nationally]

Manufacturer PHARMATHEN S.A.

Dervenakion 6 Pallini 15351 Attiki Greece

This leaflet was last approved in Nov. 2012

[to be completed nationally]