Package leaflet: Information for the user

Rivastigmine 1.5 mg capsules, hard Rivastigmine 3 mg capsules, hard Rivastigmine 4.5 mg capsules, hard Rivastigmine 6 mg capsules, hard

Rivastigmine

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:

1.    What Rivastigmine is and what it is used for

2.    What you need to know before you take Rivastigmine capsules

3.    How to take Rivastigmine capsules

4.    Possible side effects

5.    How to store Rivastigmine capsules

6.    Contents of the pack and other information

1.    What Rivastigmine is and what it is used for

Rivastigmine 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, rivastigmine 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.

Rivastigmine 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. It 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 Rivastigmine capsules

Do not take these capsules if:

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

•    you have suffered a reaction to previous use of a Rivastigmine skin patch i.e. a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the patch.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking these capsules if:

•    you have, or have ever had, irregular or slow heartbeat

•    you have, or have ever had, a stomach ulcer

•    you have, or have ever had, difficulties in passing urine

•    you have, or have ever had, seizures

•    you have, or have ever had, asthma or severe respiratory disease

• you have, or have ever had, impaired kidney function

• you have, or have ever had, impaired liver function

•    you suffer from trembling

•    you have a low body weight

•    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 these capsules for more than three days, do not take the next dose until you have talked to your doctor.

Use in children and adolescents

There Is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Rivastigmine capsules

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

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

Rivastigmine 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 Rivastigmine capsules, tell your doctor before you are given any anaesthetics, because rivastigmine may exaggerate the effects of some muscle relaxants during anaesthesia. Caution when rivastigmine 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

It is preferable to avoid the use of these capsules during pregnancy, unless clearly necessary. Tell your doctor if you become pregnant during treatment. Women taking these capsules should not breast-feed.

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.

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 sleepiness, 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 Rivastigmine capsules

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

How to start treatment

Your doctor will tell you what dose of these capsules to take.

■    Treatment usually starts with a low dose of 1.5 mg twice a day (morning and night).

■    Your doctor may gradually increase your dose after a period of at least 2 weeks, depending on how you respond to treatment.

•    The maximum dose that your doctor will increase the dose to 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 these capsules for more than three days, do not take the next dose until you have talked to your doctor.

Taking this medicine

•    Tell your caregiver that you are taking these capsules.

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

•    Take the capsules 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 Rivastigmine capsules than you should

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

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

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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.

Tell your doctor straight away if you notice any of the following effects:

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

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

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

•    fits (convulsions)

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

The following other side effects have been reported: 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

•    anxiety

•    sweating

•    weight loss

•    feeling tired or weak

•    generally feeling unwell

•    trembling or feeling confused

•    nightmares

•    decreased appetite

•    sleepiness.

Uncommon (may affect up to 1 in 100 people)

•    depression

•    difficulty in sleeping

•    changes in how well your liver is working

•    fainting or accidentally falling.

Rare (may affect up to 1 in 1,000 people)

•    chest pain

•    rash

•    ulcers in your stomach or intestine.

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

•    high blood pressure

•    urinary tract infection

•    problems with your heartbeat such as fast or slow heartbeat

•    seeing things that are not there (hallucinations).

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)

•    aggression, feeling restless

•    uneven heartbeat

•    itching

•    allergic skin reaction such as blistering, swelling and redness.

Patients with dementia and Parkinson’s disease

These patients may have some of the side effects referenced above more often.

They may also have some additional side effects as follows:

Common (may affect up to 1 in 10 people)

•    too much saliva

•    unusually slow movements or movements you cannot control

•    shuffling walk (Parkinson’s type walk)

•    cogwheel rigidity (stiffness in which the muscle responds with little jerks to the use of force to stretch the muscle)

•    changes in the way you walk

•    muscle weakness.

Uncommon (may affect up to 1 in 100 people)

•    low blood pressure

•    abnormal muscle 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

•    decreased appetite

•    agitation

•    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)

■ liquid filled blisters, redness and itching

•    allergic reaction where the patch was used, such as blisters and skin inflammation.

If you get any of these 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 at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Rivastigmine capsules

Keep this medicine out of the sight and reach of children. Do not store above 30°C.

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 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 Rivastigmine capsules contain

The active substance is Rivastigmine hydrogen tartrate. Capsules of 1.5 mg, 3 mg, 4.5 mg and 6 mg strengths are available. Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg, 3 mg,

4.5 mg and 6 mg rivastigmine respectively.

The other ingredients in each strength of capsule are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) (E172 only for the 3, 4.5 & 6 mg capsule shells), and printing ink containing shellac, propylene glycol, concentrated ammonia solution, iron oxide black and potassium hydroxide.

What Rivastigmine capsules look like and contents of the pack

Rivastigmine capsules contain a white to off-white powder.

Rivastigmine 1.5 mg capsules have a yellow cap and body and are imprinted with “RIVA 1.5mg” on the body with black ink.

Rivastigmine 3 mg capsules have a light orange cap and body and are imprinted with “RIVA 3mg” on the body with black ink.

Rivastigmine 4.5 mg capsules have a caramel cap and body and are imprinted with “RIVA 4.5mg” on the body with black ink.

Rivastigmine 6 mg capsules have a caramel cap and light orange body and are imprinted with “RIVA 6mg” on the body with black ink.

They are packed in blister packs containing 14,28, 56 or 112 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Crescent Pharma Ltd,

Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton, Hampshire RG25 3ED

Manufacturer:

Genepharm S.A.,

18 Km, Marathon Avenue, 15351, Pallini, Greece Date leaflet revised: November 2015

If you require this leaflet in a different format please contact the licence holder at the address above.

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