Package leaflet: Information for the user

XYPATCH XL 4.6mg/24h TRANSDERMAL PATCH XYPATCH XL 9.5mg/24h 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. Y ou 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. See section 4.

What is in this leaflet

1.    What Xypatch XL is and what it is used for

2.    What you need to know before you use Xypatch XL

3.    How to use Xypatch XL

4.    Possible side effects

5.    How to store Xypatch XL

6.    Contents of the pack and other information

1. What Xypatch XL is and what it is used for

The active substance of Xypatch XL is rivastigmine.

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, Xypatch XL allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease.

Xypatch XL 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 Xypatch XL DO NOT use Xypatch XL

•    if you are allergic to rivastigmine 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 Xypatch XL transdermal patches.

Warnings and precautions

Talk to your doctor before using Xypatch XL

•    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 more than three days, do not apply the next one before you have talked to your doctor.

Children and adolescents

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

Other medicines and Xypatch XL

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

Xypatch XL 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).

Xypatch XL 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 using Xypatch XL transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Xypatch XL is given 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.

Xypatch XL with food, drink and alcohol

Xypatch XL can be used with food, drink and alcohol.

Pregnancy, breast-feeding

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

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

Driving and using machines

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

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

IMPORTANT:

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

•    Only one 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 Xypatch XL transdermal patch is most suitable for you.

•    Treatment usually starts with Xypatch XL 4.6 mg/24 h.

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

•    Only wear one Xypatch XL 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 more than 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 Xypatch XL 4.6 mg/24 h.

Where to apply your Xypatch XL 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 ONE patch per day to ONLY ONE of the possible locations 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

Front

Ml	or	Ml	or	1 °ft k A\	or	ll\	ft
Back			or
( O i ML	or	1 i oj ML	or	ML	or	(l	11

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 skin area twice within 14 days.

How to apply your Xypatch XL transdermal patch

Xypatch XL patches are thin, translucent, 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 for at least 30 seconds using the palm of 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 Xypatch XL transdermal patch

Gently pull at one edge of the patch to remove it slowly from the skin. In case the adhesive residue is left over on your skin, gently soak the area with warm water and mild soap or use baby oil to remove it. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.

You should wash your hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your Xypatch XL 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 Xypatch XL transdermal patch

•    To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.

•    Only wear one Xypatch XL patch at a time and replace the patch with a new one after 24 hours.

If you use more Xypatch XL 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 rivastigmine have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

If you forget to use Xypatch XL

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 Xypatch XL

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

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.

Take off your patch and tell your doctor straight away, if you notice any of the following side

Common (may affect up to 1 in 10 people)

•    Loss of appetite

•    Feeling dizzy

•    Feeling agitated or sleepy

•    Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

•    Problems with your heartbeat such as slow heartbeat

•    Seeing things that are not really there (hallucinations)

•    Stomach ulcer

•    Dehydration (losing too much fluid)

•    Hyperactivity (high level of activity, restlessness)

•    Aggression

Rare (may affect up to 1 in 1,000 people)

•    Falling

Very rare (may affect up to 1 in 10,000 people)

•    Stiff arms or legs

•    Trembling hands

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

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

•    The signs of Parkinson’s 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)

•    Liver disorders (yellow skin, yellowing of the whites of eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

•    Changes in tests which show how well the liver is working

•    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 capsules or oral solutions containing rivastigmine and which may occur with the patch:

Common (may affect up to 1 in 10 people)

•    Too much saliva

•    Loss of appetite

•    Feeling restless

•    Generally feeling unwell

•    Trembling or feeling confused

•    Increased sweating

Uncommon (may affect up to 1 in 100 people)

•    Uneven heart rate (e.g. fast heart rate)

•    Difficulty sleeping

•    Accidental falls

Rare (may affect up to 1 in 1,000 people)

•    Fits (seizures)

•    Ulcer in the intestine

•    Chest pain - this may be caused by heart spasm

Very rare (may affect up to 1 in 10,000 people)

•    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)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Xypatch XL

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 and sachet after {EXP}. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Keep the transdermal patch in the sachet until use.

This medicinal product does not require any special temperature storage conditions.

Do not use any patch that is damaged or shows signs of tampering.

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.

6.    Content of the pack and other information

What Xypatch XL contains

The active substance is rivastigmine.

Xypatch XL 4.6 mg/24 h transdermal patch:

Each patch releases 4.6 mg rivastigmine per 24 hours is 5 cm² and contains 9 mg rivastigmine. Xypatch XL 9.5 mg/24 h transdermal patch:

Each patch releases 9.5 mg rivastigmine per 24 hours is 10 cm² and contains 18 mg rivastigmine.

The other ingredients are:

Film:    Polyester film

Fluoro-coated polyester film

Drug matrix:    Acrylic    adhesive,    Acrylates    copolymer

poly(butyl methacrylat-co-methyl methacrylat) (80:20)

Adhesive matrix:    Silicone adhesive

Printing ink:    Black printing ink

What Xypatch XL looks like and contents of the pack

Each transdermal patch is a thin patch consisting of three layers. The outer layer is translucent, white and imprinted with black printing ink as follows:

Xypatch XL 4.6 mg/24 h transdermal patch:

“Rivastigmine”, “4.6 mg/24 h”

Xypatch XL 9.5 mg/24 h transdermal patch:

“Rivastigmine”, “9.5 mg/24 h”

One transdermal patch is packed in one child-resistant and heat-sealed sachet. The patches are available in packs containing 7, 10, 30, 50, 60 and 90 sachets and in multipacks containing 60 (2 x 30), 90 (3 x 30) and 100 (2 x 50) sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

PL 06831/0249    Xypatch XL 4.6mg/24h

Transdermal patch

PL 06831/0250    Xypatch XL 9.5mg/24h

Transdermal patch

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Genus Pharmaceuticals

Linthwaite

Huddersfield

HD75QH

UK

Manufacturer:

Phast GmbH

Kardial- Wendel Strasse 16, 66424 Homburg, Germany Centrafarm Services B.V.

Nieuwe Donk 9, NL- 879 Etten Leur, Netherlands

Labratoires Plasto Sante

42 rue de Longvic, 21300 Chenove, France

This leaflet was last revised in 06/2015.

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