Alzest 13.3 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.

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

• 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 Alzest transdermal patches.

Talk to your doctor before using Alzest

• if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
• 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.

There is no relevant use of Alzest 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.

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).

Alzest should not be used at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Using the two medicines together could cause problems such as stiff limbs and trembling hands.

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

Caution is advised when Alzest is used together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Using the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.

Caution when Alzest is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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.

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Alzest 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 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.
• 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 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 Alzest 4.6 mg/24 h.

Alzest can be used with food, drink and alcohol.

• 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

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 the same skin area twice within 14 days.

Alzest patches are thin, tan coloured, 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.

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.

Additionally for Alzest 4.6 mg/24 h // 9.5 mg/24 h transdermal patches:

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, 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. 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.

• 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 Alzest 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 heartbeat 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.

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 the 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
• nightmares

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

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)

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 website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is rivastigmine.
  • Alzest 4.6 mg/24 h transdermal patch: Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours. Each transdermal patch of 4.6 cm² contains 6.9 mg of rivastigmine.
  • Alzest 9.5 mg/24 h transdermal patch: Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours. Each transdermal patch of 9.2 cm² contains 13.8 mg of rivastigmine.
  • Alzest 13.3 mg/24 h transdermal patch: Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours. Each transdermal patch of 12.8 cm² contains 19.2 mg of rivastigmine.
• The other ingredients are:
  • Alzest 4.6 mg/24 h // 9.5 mg/24 h transdermal patch: poly [(2-ethylhexyl)acrylate,vinylacetate] (50:50), medium and high molecular weight polyisobutene, silica, colloidal anhydrous, paraffin, light liquid, pigmented polyethylene/thermoplastic resin/aluminium coated polyester film, polyester film, fluoropolymer-coated and printing ink.
  • Alzest 13.3 mg/24 h transdermal patch: poly [(2-ethylhexyl)acrylate,vinylacetate] (50:50), medium and high molecular weight polyisobutene, silica, colloidal anhydrous, paraffin, light liquid, pigmented polyethylene/thermoplastic resin/aluminium coated polyester film, polyester film (polyethylene terephthalate) fluoropolymer-coated and printing ink.

Alzest 4.6 mg/24 h transdermal patch: Each transdermal patch is a circular, thin, matrix-type transdermal patch of diameter of approx. 2.4 cm consisting of four layers. The outer layer is tan coloured with orange printing “RIV-TDS 4.6 mg/24 h”.

Alzest 9.5 mg/24 h transdermal patch: Each transdermal patch is a circular, thin, matrix-type transdermal patch of diameter of approx. 3.4 cm consisting of four layers. The outer layer is tan coloured with orange printing “RIV-TDS 9.5 mg/24 h”.

Alzest 13.3 mg/24 h transdermal patch: Each transdermal patch is a circular, thin, matrix-type patch of diameter of approx. 4 cm consisting of four layers. The outer layer is tan coloured with orange printing: “RIV-TDS 13.3 mg/24 h”.

Each transdermal patch is sealed in one child-resistant sachet.

Alzest is available in packs containing 7, 30 or 42 sachets and in multipacks containing 60 (2 x 30), 84 (2 x 42) or 90 (3 x 30) sachets. Not all pack sizes may be marketed.