Prometax 2 mg/ml oral solution

The active substance of Prometax is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors.

Prometax 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.

Do not take Prometax

• if you are allergic (hypersensitive) to rivastigmine (the active substance in Prometax) or to any of the other ingredients of Prometax listed in section 6 of this leaflet. If this applies to you, tell your doctor and do not take Prometax.

Take special care with Prometax

• 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, 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 doctormayneed to monitor you more closely while you are on this medicine.

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

The use of Prometax 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.

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).

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 somemuscle relaxants during anaesthesia.

Pregnancy and breast-feeding
Tell your doctor if you become pregnant during treatment. It is preferable to avoid the use of Prometax during pregnancy, unless clearly necessary.

You should not breast-feed during treatment with Prometax.

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. 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.

Important information about some of the ingredients of Prometax

One of the inactive ingredients in Prometax oral solution is sodium benzoate. Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.

Always take Prometax 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 Prometax 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 Prometax for several 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.

How to use this medicine

1. Preparing the bottle and syringe Take the syringe out of its protective case. Push down and turn the child resistant cap to open bottle. 2. Attaching the syringe to the bottle Push the nozzle of the syringe into the hole in the white stopper. 3. Filling the syringe Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed. 4. Removing bubbles Push down and pull up the plunger a few times to get rid of any large bubbles. A few tiny bubbles are not important and will not affect your dose in any way. Check the dose is still correct. Then, remove the syringe from the bottle.

5. Taking your medicine Swallow your medicine straight from the syringe. You can also mix your medicine with water in a small glass. Stir and drink all of the mixture. 6. After using the syringe Wipe the outside of the syringe with a clean tissue. Then, put the syringe back in its protective case. Put the child resistant cap back on the bottle to close it.

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.

Like all medicines, Prometax 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 awayas 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 patient in 10,000)
Not known (frequency cannot be estimated from the available data)

Very common
- Feeling dizzy
- Loss of appetite
- Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea

Common Anxiety Sweating Headache Heartburn Weight loss Stomach pain Feeling agitated Feeling tired or weak Generally feeling unwell Trembling or feeling confused

Uncommon Depression Difficulty in sleeping Fainting or accidentally falling Changes in how well your liver is working

Rare Chest pain Rash, itching Fits seizures Ulcers in your stomach or intestine

Very rare 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 Parkinsons 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 and Parkinson?s disease

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

Very common

- Trembling

Common Anxiety Feeling restless Slow heartbeat Difficulty in sleeping Too much saliva and dehydration Unusually slow movements or movements you cannot control The signs of Parkinsons disease get worse or getting similar signs such as stiff muscles, difficulty in carrying out movements

Uncommon

- Uneven heartbeat and poor control of movements

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

Common

- Fever
- Severe confusion

If you get any of these side effects, 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.

Keep out of the reach and sight of children.

Do not use Prometax 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 refrigerate or freeze.

Store in an upright position.

Use Prometax oral solution within 1 month of opening the bottle.

What Prometax contains

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
• The other ingredients are: sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.

What Prometax looks like and contents of the pack

Prometax oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug. The oral solution is packaged with an oral dosing syringe in a plastic tube container.

Marketing Authorisation holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer
Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68333 Huningue
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 375 4888

España Laboratorios Dr. Esteve, S.A. Tel 34 93 446 60 00 Portugal MediBIAL, Produtos Médicos e Farmacêuticos, S.A. Tel 351 22 986 6100

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Romania SRL Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Biofutura Pharma S.p.A. Tel 39 02 8027171 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in