PACKAGE LEAFLET: INFORMATION FOR THE USER

Loristiven 1.5 mg capsules, hard Loristiven 3.0 mg capsules, hard Loristiven 4.5 mg capsules, hard Loristiven 6.0 mg capsules, hard 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 Loristiven is and what it is used for

2.    Before you take Loristiven

3.    How to take Loristiven

4.    Possible side effects

5.    How to store Loristiven

6.    Further information

1. WHAT LORISTIVEN IS AND WHAT IT IS USED FOR

The active substance of Loristiven is rivastigmine.

Loristiven belongs to a class of substances called cholinesterase inhibitors.

Loristiven is used for the treatment of memory disorders in patients with Alzheimer’s disease. It is also used for the treatment of dementia in patients with Parkinson’s disease.

2. BEFORE YOU TAKE LORISTIVEN

Do not take Loristiven

-    if you are allergic (hypersensitive) to rivastigmine, to carbamate derivatives or any of the other ingredients of Loristiven listed in section 6 of this leaflet.

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

Take special care with Loristiven

-    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 asthma or severe respiratory disease.

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

-    if you    have,    or have ever had seizures.

-    if you have gastro-intestinal 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 you have a low body weight.

-    if you suffer from trembling.

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

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

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

The use of Loristiven 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 Loristiven, you should inform the doctor before you are given any anaesthetics, because Loristiven may exaggerate the effects of some muscle relaxants during anaesthesia.

Loristiven should not be given at the same time as other medicines with similar effects to Loristiven. Loristiven 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 Loristiven during pregnancy, unless clearly necessary. Tell your doctor if you become pregnant during treatment. You should not breast-feed during treatment with Loristiven. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely . Loristiven 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.

3. HOW TO TAKE LORISTIVEN

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

How to start treatment

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

-    Treatment usually starts with a low dose.

-    Your doctor will slowly increase your dose depending on how you respond to the 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 Loristiven for several days, do not take the next dose until you have talked to your doctor.

Taking this medicine

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

-    Tell your caregiver that you are taking Loristiven

-    Take Loristiven 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 Loristiven than you should

If you accidentally take more Loristiven than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Loristiven 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 Loristiven

If you find you have forgotten to take your dose of Loristiven, 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Loristiven 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.

The frequencies are defined as:

Very common (affects more than 1 patient in 10)

Common (affects 1 to 10 patients in 100)

Uncommon (affects 1 to 10 patients in 1,000)

Rare (affects 1 to 10 patients in 10,000)

Very rare (affects less than 1 patients in 10,000)

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

Very common

-    Feeling dizzy

-    Stomach problems such as feeling sick (nausea), being sick (vomiting) , diarrhoea

-    Loss of appetite.

Common

-    Heartburn

-    Stomach pain

-    Headache

-    Feeling agitated

-    Trembling or feeling confused

-    Feeling tired or weak

-    Sweating

-    Generally feeling unwell

-    Weight loss

-    Anxiety

Uncommon

-    Depression

-    Difficulty in sleeping

-    Changes in liver function

-    Fainting or accidentally falling

Rare

-    Chest pain

-    Fits (seizures)

-    Rash, itching

-    Ulcers in your stomach or intestine Very rare

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

-    Urinary tract infection

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

-    Problems with your heartbeat such as fast or slow heartbeat

-    High blood pressure

-    Seeing things that are not there (hallucinations)

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

Not known

-    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 eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

-    Aggression, feeling restless

-    Uneven heartbeat

Patients with dementia associated with Parkinson’s disease

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

Very common

-    Trembling

-    Fainting

-    Accidentally falling

Common

-    Difficulty in sleeping

-    Anxiety

-    Feeling restless

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

-    Unusually slow movements or movements you cannot control

-    Slow and fast heartbeat

-    Too much saliva and dehydration

Uncommon

-    Uneven heartbeat and poor control of movements

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

Common

•    Fever

•    Severe confusion

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 LORISTIVEN

Keep out of the reach and sight of children.

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

Do not store above 30°C.

6.    FURTHER INFORMATION What Loristiven contains

-    The active substance is rivastigmine.

Each Loristiven 1.5 mg capsule contains 1.5 mg of rivastigmine.

Each Loristiven 3.0 mg capsule contains 3.0 mg of rivastigmine.

Each Loristiven 4.5 mg capsule contains 4.5 mg of rivastigmine.

Each Loristiven 6.0 mg capsule contains 6.0 mg of rivastigmine.

-    The other ingredients are:

o Granules: Microcrystalline cellulose, hypromellose, silica colloidal anhydrous, magnesium stearate

o Body/cap: 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).

What Loristiven looks like and contents of the pack

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

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

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

Loristiven 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

Pharmathen S.A

6 Dervenakion str. 153 51 Pallini Attiki Greece

tel.: +30 210 666 4300 fax: +30 210 666 6749 e-mail: info@pharmathen.com

Manufacturer

Pharmathen S.A., Dervenakion 6, 15351 Pallini, Attiki, Greece tel.: +30 210 666 4300 fax: +30 210 666 6749 e-mail: info@pharmathen.com &

Pharmathen International S.A

Industrial Park Sapes Rodopi Perfecture, Block 5, Rodopi 69300, Greece tel: +30 25320 31376 fax: +30 25320 31471 e-mail: info@pharmathen.com

This leaflet was last revised in

01/2013