Rivaldo 4,6 mg/24 u pleister voor transdermaal gebruik

The active substance of RIVALDO 4,6mg/24h TDS is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. Rivastigmine

Apotex is used for the treatment of memory disorders in adult patients with Alzheimer’s disease.

Do not use RIVALDO 4,6mg/24h TDS

• 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.
• 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 RIVALDO 4,6mg/24h TDS.

Warnings and precautions

Talk to your doctor or pharmacist before using RIVALDO 4,6mg/24h TDS

• 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 reaction such as feeling sick (nausea), being sick (vomiting) and diarrhea. You may become dehydrated (loosing too much fluid) if vomiting or diarrhea 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 RIVALDO 4,6mg/24h TDS in children and adolscents (age below 18 years) is not recommened.

Other medicines and RIVALDO 4,6mg/24h TDS

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

RIVALDO 4,6mg/24h TDS with food and drink

Food or drink do not affect the use of RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS must be assessed against the possible

effects on your unborn child.

You should not breast-feed during treatment with RIVALDO 4,6mg/24h TDS.

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.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. RIVALDO 4,6mg/24h TDS 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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

IMPORTANT: Only wear one RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS is most suitable for you.

• Treatment usually starts with 4,6mg/24h TDS

• The usual daily dose is 9.5 mg/24 h TDS per day.
• Only wear one RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS

• 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 RIVALDO 4,6mg/24h TDS

RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS

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

How to dispose of your RIVALDO 4,6mg/24h TDS

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 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.

• 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 RIVALDO 4,6mg/24h TDS

• To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
• Only wear one RIVALDO 4,6mg/24h TDS patch at a time and replace the patch with a new one after 24 hours

If you use more RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS 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 RIVALDO 4,6mg/24h TDS

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 <Rivastigmine>

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, 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 sued 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 in10,000)

Very rare (affects less than 1 treated patient of 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 RIVALDO 4,6mg/24h TDS patch started to be prescribed

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)

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)

Changes in tests which show how well the liver is working

Agression, feeling restless

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

Other side effects with rivastigmine capsules or oral solution which may occur with the patch:

Very common:

• Feeling dizzy Common:
• Too much salvia
• Loss of appetite
• Feeling restless
• Feeling agitated or sleepy
• Generally feeling unwell,

- Trembling or feeling confused

• Increased sweating

Uncommon:

• Uneven hart rate
• Difficulty in sleeping
• Accidental falls

Rare:

• Fits (seizures)
• Ulcer in the intestine
• Chest pain (probably caused by coronary spasm)

Very rare:

• 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 ar 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 RIVALDO 4,6mg/24h TDS after the expiry date, which is stated on the carton and sachet. The expiry date refers to the last day of the month.

Keep the transdermal patch in the sachet until use

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

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

What RIVALDO 4,6mg/24h TDS contains

The active substance is rivastigmine.

Each patch releases 4.6 mg of rivastigmine per 24 hours is 5 cm2 and contains 9 mg of rivastigmine.

The other ingredients are:

Film: Polyester film

Fluoro-coated polyester film

Drug matrix: Acrylic adhesive

Acrylates copolymer poly(butyl methacrylate-co-methyl methacrylate)

Adhesive matrix: Silicone adhesive

What RIVALDO 4,6mg/24h TDS 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 labelled with the following: “<Rivastigmine>”and “4.6 mg/24 h”

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

Not all pack sizes may be marketed in your country

.

Marketing Authorisation Holder and Manufacturer

Vergunninghouder

Adamed Sp. z o.o. Pieńków 149 05-152 Czosnów Polen

Fabrikant

PHAST Gesellschaft für Pharmazeutische Qualitätsstandards mbH Kardinal-Wendel-Strasse 6

66424 Hamburg Duitsland

ACC GmbH Analytical Clinical Concepts

Schöntalweg 9

63849 Leidersbach

Duitsland

In het register ingeschreven onder nummer:

RVG 111075

This medicinal product is authorised in the Member States of the EEA under the following names:

Poland

RIVALDO TDS

Deze bijsluiter is voor het laatst goedgekeurd in maart 2013