Prometax - patient leaflet, side effects, dosage

1. What Prometax is and what it is used for

The active substance of Prometax is rivastigmine.

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, Prometax 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.

Prometax 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 Prometax

Do not take Prometax

• – if you are allergic to rivastigmine (the active substance in Prometax) or any of the other

ingredients of this medicine (listed in section 6).

• – if you have 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 transdermal patch.

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

Warnings and precautions

Talk to your doctor before taking Prometax:

• – 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, 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 Prometax 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 Prometax in the paediatric population in the treatment of Alzheimer’s di­sease.

Other medicines and Prometax

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

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

Prometax 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 Prometax, tell your doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.

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

You should not breast-feed during treatment with Prometax.

Driving and using machines

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

Always take this medicine exactly as your doctor 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 Prometax 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 Prometax 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 Prometax.
• To benefit from your medicine, take it every day.
• Take Prometax 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 Prometax than you should

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

If you forget to take Prometax

If you find you have forgotten to take your dose of Prometax, 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.

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
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
• Decreased appetite
• Nightmares

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
• 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

Other side effects seen with Prometax 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)

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

• Allergic reaction where the patch was used, such as blisters or 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 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 Prometax

• 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 after EXP. 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 Prometax contains

• – The active substance is rivastigmine hydrogen tartrate.

• – The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose,

colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and shellac.

Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.

Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine.

Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.

Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.

What Prometax looks like and contents of the pack

• – Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a

yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on the body.

• – Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an

orange cap and orange body, with a red imprint “ENA 713 3 mg” on the body.

• – Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a

red cap and red body, with a white imprint “ENA 713 4,5 mg” on the body.

• – Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a