Prometax 9.5 mg/24 h transdermal patch

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.

Do not use 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 you have ever had an allergic reaction to a similar type of medicine. If this applies to you, tell your doctor and do not apply Prometax transdermal patches.

Take special care with Prometax

• if you have, or have ever had, an 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 a severe respiratory disease.
• 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 you have 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 applied a patch for several days, do not apply the next one before 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 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 using Prometax transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

Using Prometax with food and drink

Food or drink do not affect the use of Prometax transdermal patches because rivastigmine enters the bloodstream through the skin.

Pregnancy and breast feeding

Tell your doctor if you are pregnant or planning to become pregnant. If you are pregnant, the benefits of using Prometax transdermal patches must be assessed against the possible effects on your unborn child.

You should not breast-feed during treatment with Prometax transdermal patches.

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 transdermal patches may cause fainting or severe confusion. If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.

Always use Prometax transdermal patches exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

IMPORTANT: Only wear one Prometax patch at a time. You must remove the previous day?s patch before applying a new one. Do not cut the patch into pieces.

How to start treatment

Your doctor will tell you which Prometax transdermal patch is most suitable for you. - Treatment usually starts with Prometax 4.6 mg/24 h.
- The usual daily dose is Prometax 9.5 mg/24 h.
- Only wear one Prometax patch at a time and replace the patch with a new one after 24 hours.

During the course of the treatment your doctor may adjust the dose to suit your individual needs.

If you have not applied a patch for several days, do not apply the next one before you have talked to your doctor.

Where to apply your Prometax transdermal patch

- Before you apply a patch, make sure that your skin is:

• clean, dry and hairless,
• free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly,
• free of cuts, rashes and/or irritations.
• Carefully remove any existing patch before putting on a new one. Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
• Apply only one patch per day to only one of the following locations, as shown in the following diagrams:
• left upper arm or right upper arm
• left upper chest or right upper chest (avoid breast)
• left upper back or right upper back
• left lower back or right lower back

When changing the patch, apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day). Do not apply a new patch to that same location of skin twice within 14 days.

How to apply your Prometax transdermal patch

Prometax patches are thin, opaque, plastic patches that stick to the skin. Each patch is sealed in a sachet that protects it until you are ready to put it on. Do not open the sachet or remove a patch until just before you apply it.

Each patch is sealed in its own protective sachet. You should only open the sachet when you are ready to apply the patch. Cut the sachet along the dotted line with scissors and remove the patch from the sachet.

A protective liner covers the sticky side of the patch. Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.

Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner.

Then press the patch firmly in place with the hand to make sure that the edges stick well.

If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.

The patch should be worn continuously until it is time to replace it with a new one. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.

How to remove your Prometax transdermal patch

Gently pull at one edge of the patch to remove it completely from the skin.

How to dispose of your Prometax transdermal patch

After removing a patch, fold it in half with the sticky sides on the inside and press them together. Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch.

If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish. Otherwise, return used patches to a pharmacy, preferably in the original packaging.

Can you wear your Prometax transdermal patch when you are bathing, swimming, or in the sun?

- Bathing, swimming or showering should not affect the patch. Make sure the patch does not loosen during these activities.
- Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium) for long periods of time.

What to do if a patch falls off

If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.

When and for how long to apply your Prometax transdermal patch

- To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
- Only wear one Prometax patch at a time and replace the patch with a new one after 24 hours.

If you use more Prometax than you should

If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch. 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 use Prometax

If you find you have forgotten to apply a patch, apply one immediately. You may apply the next patch at the usual time the next day. Do not apply two patches to make up for the one that you missed.

If you stop using Prometax

Tell your doctor or pharmacist if you stop using the patch.

If you have not applied a patch for several days, do not apply the next one before you have talked to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Prometax patches 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.

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)

Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:

Uncommon

- Problems with your heartbeat such as slow heartbeat
- Seeing things that are not really there (hallucinations)
- Stomach ulcer

Very rare

- Stiff arms or legs
- Trembling hands

Side effects which have been seen since Prometax patch started to be prescribed Allergic reaction where the patch was used, such as blisters or inflamed skin The signs of Parkinsons disease get worse such as tremor, stiffness and shuffling Inflammation of the pancreas signs include serious upper stomach pain, often with feeling sick nausea or being sick vomiting Fast or uneven heartbeat High blood pressure Fits seizures Falling 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 Take off your patch and tell your doctor straight away, if you notice any of the side effects above.

Other side effects seen with Prometax capsules or oral solution and which may occur with the patch:

Very common

- Feeling dizzy

Common Feeling agitated or sleepy Generally feeling unwell Trembling or feeling confused Increased sweating

Uncommon

- Difficulty sleeping
- Changes in tests which show how well your liver is working
- Accidental falls

Rare Fits seizures Ulcer in the intestine Chest pain this may be caused by heart spasm

Very rare

- Uneven heart rate such as a fast heart rate
- High blood pressure
- 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
- Seeing things that are not there (hallucinations)
- Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)

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 and sachet. The expiry date refers to the last day of the month. Do not store above 25C. Keep the transdermal patch in the sachet until use. Do not use any patch that is damaged or shows signs of tampering.

What Prometax contains

• The active substance is rivastigmine.
• Prometax 4.6 mg/24 h transdermal patches: Each patch releases 4.6 mg of rivastigmine per 24 hours is 5 cm 2 and contains 9 mg of rivastigmine.
• Prometax 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of rivastigmine per 24 hours is 10 cm 2 and contains 18 mg of rivastigmine.
• The other ingredients are: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methyl-methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer-coated.

What Prometax looks like and contents of the pack

Each transdermal patch is a thin patch consisting of three layers. The outer layer is beige and labelled with the following:
- ?Prometax?, ?4.6 mg/24 h? and ?AMCX?,
- ?Prometax?, ?9.5 mg/24 h? and ?BHDI?.

One transdermal patch is sealed in one sachet. The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 (2x 30) or 90 (3x 30) sachets. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

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

Manufacturer

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:

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