Prometax
rivastigmine
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 Prometax is and what it is used for
What you need to know before you take Prometax
How to take Prometax
Possible side effects
How to store Prometax
Contents of the pack and other information
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.
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.
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.
There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer’s disease.
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.
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.
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
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.
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 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 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.
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.
Feeling dizzy
Loss of appetite
Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
Sweating
Headache
Heartburn
Weight loss
Stomach pain
Feeling agitated
Feeling tired or weak
Generally feeling unwell
Trembling or feeling confused
Decreased appetite
Nightmares
Depression
Difficulty in sleeping
Fainting or accidentally falling
Changes in how well your liver is working
Chest pain
Rash, itching
Fits (seizures)
Ulcers in your stomach or intestine
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
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
These patients have some side effects more often. They also have some additional side effects:
Trembling
Fainting
Accidentally falling
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
Uneven heartbeat and poor control of movements
Fever
Severe confusion
Urinary incontinence (inability to retain adequate urine)
Hyperactivity (high level of activity, restlessness)
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.
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.
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.
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 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.
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 red cap and orange body, with a red imprint “ENA 713 6 mg” on the body.
They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic
bottles of 250 capsules, but these may not all be available in your country.
Novartis Europharm Limited Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
Novartis Pharma GmbH Roonstraße 25
D-90429 Nuremberg
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Ireland Limited Tel: +353 1 260 12 55
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Pharma B.V. Tel: +31 88 04 52 111
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis Pharma GmbH Tel: +43 1 86 6570
Sandoz Polska Sp. z o.o. Tel.: +48 22 549 1500
Laboratório Normal - Produtos Farmacêuticos, Lda.
Tel: +351 21 000 8600
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
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Puh/Tel: +358 (0)10 6133 200
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Novartis Ireland Limited
Tel: +44 1276 698370