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Document: leaflet ASPIRE PHARMA_PL 17277-0060 change

• leaflet ASPIRE PHARMA_PL 17277-0060
• leaflet MAH BRAND_PL 17277-0060

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Package leaflet: Information for the user

Kerstipon 1.5mg capsules, hard Kerstipon 3.0mg capsules, hard Kerstipon 4.5mg capsules, hard Kerstipon 6.0mg capsules, hard

Rivastigmine

Read all of this leafet 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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Kerstipon is and what it is used for

2.    What you need to know before you take Kerstipon

3.    How to take Kerstipon

4.    Possible side effects

5.    How to store Kerstipon

6.    Contents of the pack and other information

1. What Kerstipon is and what it is used for

The active substance of Kerstipon is rivastigmine.

Kerstipon belongs to a class of substances called cholinesterase inhibitors.

In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Kerstipon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Kerstipon is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.

2.    What you need to know before you take Kerstipon Do not take Kerstipon

-    if you are allergic to rivastigmine, or any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor before taking Kerstipon

-    if you have, or have ever had irregular or slow 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 Kerstipon for more than three days, do not take the next dose until you have talked to your doctor.

Children and adolescents

There is no relevant use of Kerstipon in the paediatric population in the treatment of Alzheimer's disease.

Other medicines and Kerstipon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

Kerstipon should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands. If you have to undergo surgery whilst taking Kerstipon, tell your doctor before you are given any anaesthetics, because Kerstipon may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Kerstipon is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.

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 Kerstipon must be assessed against the possible effects on your unborn child. Kerstipon should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Kerstipon.

Driving and using machines

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

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How to start treatment

Your doctor will tell you what dose of Kerstipon 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 Kerstipon for more than three 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 Kerstipon.

-    Take Kerstipon 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 Kerstipon than you should

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

If you find you have forgotten to take your dose of Kerstipon, 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 our body gets used to the medicine.

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

•    Feeling dizzy

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

•    Loss of appetite.

Common (may affect up to 1 in 10 people)

Heartburn

Stomach pain

Headache

Feeling agitated

Trembling or feeling confused

Feeling tired or weak

Uncommon (may affect up to 1 in 100 people)

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

•    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 (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 associated with 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)

•    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 (may affect up to 1 in 100 people)

•    Uneven heartbeat and poor control of movements

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

•    Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

•    Hyperactivity (high level of activity, restlessness)

If you get any side effects, contact your doctor as you may need medical assistance.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/ yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Kerstipon

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 carton.

The expiry date refers to the last day of that month.

Do not store above 30°C.

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 protect the environment.

6.    Contents of the pack and other information What Kerstipon 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 3.0mg, 4.5mg and 6.0mg capsules).

Each Kerstipon 1.5mg capsule contains 1.5mg of rivastigmine.

Each Kerstipon 3.0mg capsule contains 3.0mg of rivastigmine.

Each Kerstipon 4.5mg capsule contains 4.5mg of rivastigmine.

Each Kerstipon 6.0mg capsule contains 6.0mg of rivastigmine.

What Kerstipon looks like and contents of the pack

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

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

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

Kerstipon 6.0mg 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 SA

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 SA

Dervenakion 6, 15351 Pallini, Attiki, Greece

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

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

Distributor:

Aspire Pharma Limited,

Bellamy House,Winton Road, Petersfield, Hampshire, GU32 3HA, United Kingdom This leafet was last revised in 12/2015