Voleze 4.6 mg/24 h transdermal patch

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Voleze is and what it is used for
2. What you need to know before you use Voleze
3. How to use Voleze
4. Possible side effects
5. How to store Voleze
6. Contents of the pack and other information

• 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 Voleze transdermal patches.

Talk to your doctor, pharmacist or nurse before using Voleze

• if you have or have ever had, irregular or slow heartbeat
• if you have or have ever had, an active stomach or duodenal 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 (less than 50 kg)
• 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 Voleze patch for three days, do not apply the next one before you have talked to your doctor.

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

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

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

Food, drink and alcohol do not affect the use of Voleze transdermal patches because rivastigmine enters the bloodstream through the skin.

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

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

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

• 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.

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

• Treatment usually starts with Voleze 4.6 mg/24 h
• The usual daily dose is Voleze 9.5 mg/24 h
• Only wear one Voleze 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 Voleze patch for three days, do not apply the next one before you have talked to your doctor.

• 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 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.

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 skin area twice within 14 days.

Voleze 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.

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

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.

• 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.

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.

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

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 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.

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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.

The active substance is rivastigmine.

Voleze 4.6 mg/24 h transdermal patches:

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

Voleze 9.5 mg/24 h transdermal patches:

Each patch releasing 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)

Adhesive matrix: Silicone adhesive

Printing ink: Black printing ink

Each transdermal patch is a thin patch consisting of three layers. The outer layer is translucent, white and black-printed with the following:

• Voleze 4.6 mg/24 h transdermal patches:
  “Rivastigmine”, “4.6 mg/24 h”
• Voleze 9.5 mg/24 h transdermal patches:
  “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, 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.