280 mm

460 mm

Package leaflet: Information for the user Alzest 4.6 mg/24 h Transdermal Patch Alzest 9.5 mg/24 h Transdermal Patch

Rivastigmine

Read all of this leaflet carefully before you start using 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.

What is in this leaflet:

1.    What Alzest is and what it is used for

2.    What you need to know before you use Alzest

3.    How to use Alzest

4.    Possible side effects

5.    How to store Alzest

6.    Contents of the pack and other information

1. What Alzest is and what it is used for

The active substance of Alzest is rivastigmine.

IMPORTANT:

•    Take off the previous patch before putting ONE new patch on.

•    Only wear one Alzest patch per day.

•    Do not cut the patch into pieces.

•    Press the patch firmly in place for at least 30 seconds using the palm of the hand.

How to start treatment

Your doctor will tell you which Alzest transdermal patch is most suitable for you.

•    Treatment usually starts with Alzest 4.6 mg/24 h.

•    The recommended usual daily dose is Alzest 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h (The

13.3 mg/24 h dose strength cannot be achieved with this product. For conditions where this strength should be used, please refer to other rivastigmine products for which transdermal patches of the 13.3 mg/24 h strength are available).

•    Only wear one transdermal 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 three days, do not apply the next one before you have talked to your doctor. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise your doctor will restart your treatment on Alzest 4.6 mg/24 h.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia, 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.

Alzest 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.

2. What you need to know before you use Alzest Do not use Alzest

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

•    if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives)

•    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 apply Alzest transdermal patches. Warnings and precautions

Talk to your doctor or pharmacist before using Alzest

•    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.

Use in children and adolescents

There is no relevant use of Alzest in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Alzest

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

Alzest might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson’s disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

If you have to undergo surgery whilst using Alzest transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

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

You should not breast-feed during treatment with Alzest transdermal patches. Driving and using machines

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

; 3. How to use Alzest

I Always use this medicine exactly as I described in this leaflet and as your doctor has told you. Check with your doctor or ; pharmacist if you are not sure.

Alzest can be used with food, drink and alcohol.

Where to apply Alzest transdermal patches

•    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 ONE patch per day to ONLY ONE of the following locations shown in the following diagram:

-    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

Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.

When changing the patch, you must remove the previous day’s patch before you 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 Alzest transdermal patches

Alzest patches are thin, tan coloured, 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.

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Carefully remove the existing patch before putting on a new one.

For patients starting treatment for the first time and for patients restarting rivastigmine after treatment interruption, please begin with the second picture.

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 at both scissors marks, but not further than the indicated line. Tear the sachet to open. Do not cut the entire length of the sachet in order to avoid damaging of the patch.

Remove the patch from the sachet.

Remove the cover sheet from the top, skin-coloured side of the patch and discard it.

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 or upper arm or chest and then peel off the second side of the protective liner.

Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.