Prometax 4.6 mg/24 h transdermal patch

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Prometax 4.6 mg/24h Transdermal Patch

Prometax 9.5 mg/24h Transdermal Patch

Prometax 13.3 mg/24h Transdermal Patch

rivastigmine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Prometax is and what it is used for

The active substance in Prometax is rivastigmine.

Rivastigmine belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells in the brain die, leading to low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Prometax increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.

Prometax is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, and behaviour.

2. What you need to know before using Prometax

Do not use Prometax

• if you are allergic to rivastigmine (the active substance in Prometax) or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to a similar medicine (carbamate derivatives).
• if you develop a skin reaction that spreads beyond the size of the patch, if you experience a more intense local reaction (such as blisters, increasing skin inflammation, swelling), or if there is no improvement within 48 hours after removing the transdermal patch.

If any of these situations apply to you, inform your doctor and do not use Prometax transdermal patches.

Warnings and precautions

Talk to your doctor before starting to use Prometax:

• if you have or have ever had heart problems such as irregular or slow heartbeat (pulse), QTc prolongation, family history of QTc prolongation, torsade de pointes, or if you have low blood levels of potassium or magnesium.

• if you have or have ever had an active stomach ulcer.

• if you have or have ever had difficulties urinating.

• if you have or have ever had seizures.

• if you have or have ever had asthma or a serious respiratory disease.

• if you suffer from tremors.

• if you have low body weight.

• if you experience gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting), or diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

• if you have liver problems (hepatic insufficiency).

If any of these situations apply to you, your doctor may consider it necessary to monitor you more closely during treatment.

If you have not used the patches for more than three days, do not apply a new one without first consulting your doctor.

Children and adolescents

Prometax must not be used in the pediatric population for the treatment of Alzheimer's disease.

Other medicines and Prometax

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

Prometax may interfere with anticholinergic medicines, some of which are used to relieve stomach cramps or spasms (e.g. dicycloverine), for the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

Prometax transdermal patches must not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while using Prometax transdermal patches, inform your doctor that you are using this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is required when using Prometax transdermal patches together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decrease in heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Caution is also required when using Prometax together with other medicines that may affect heart rhythm or the heart's electrical system (QT prolongation).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, the benefits of using Prometax must be weighed against the potential adverse effects on the fetus. Prometax must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Prometax transdermal patches.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Prometax transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, operate machinery, or engage in any other activity that requires your attention.

3. How to use Prometax

Follow exactly the administration instructions for Prometax transdermal patches provided by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

• Remove the previous patch before applying a NEW patch.
• One patch only per day.
• Do not cut the patch into pieces.
• Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds.

How to start treatment

Your doctor will determine the most appropriate Prometax transdermal patch dose for your individual case.

• Treatment is usually started with Prometax 4.6 mg/24 h.
• The usual recommended daily dose is Prometax 9.5 mg/24 h. If this dose is well tolerated, your treating doctor may consider increasing the dose to 13.3 mg/24 h.
• Wear only one Prometax patch at a time and replace the patch with a new one every 24 hours.

During treatment, your doctor may adjust the dose according to your individual needs.

If you have not used the patches for more than three days, do not apply a new patch until you have consulted your doctor. Transdermal patch treatment may be restarted at the same dose if the treatment interruption is no longer than three days. Otherwise, your doctor will instruct you to restart treatment with Prometax 4.6 mg/24 h.

Prometax may be used with food, drink, and alcohol.

Where to apply your Prometax transdermal patch

• Before applying a patch, ensure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that could prevent proper adhesion of the patch, and free of cuts, redness, or irritation.

• Carefully remove any existing patch before applying a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medication, which could be potentially dangerous.

• Apply only ONE patch per day to ONE of the following areas, as shown in the diagrams below:

• upper left or upper right arm

• upper left or upper right side of the chest (avoiding breasts in women)

• upper left or upper right back

• lower left or lower right back

Each time you change the patch, you must remove the previous day's patch before applying a new patch to a different area of skin (for example, one day on the right side of the body and the next day on the left side; or one day on the upper part of the body and the next day on the lower part). Wait at least 14 days before applying a new patch to the exact same skin area.

How to apply your Prometax transdermal patch

Prometax patches are thin, opaque plastic patches that adhere to the skin. Each patch is enclosed in a protective pouch until ready for use. Do not open the pouch or remove the patch until the moment of application.

You must wear the patch continuously until it is time to replace it with a new one. When applying a new patch, you may try different areas to find those that are most comfortable for you and where clothing does not rub against the patch.

How to remove your Prometax transdermal patch

Gently pull one edge of the patch to slowly peel it off the skin. If adhesive residue remains on the skin, soak the area with warm water and mild soap or use baby oil to remove it. Do not use alcohol or other solvent liquids (such as nail polish remover or other solvents).

After removing the patch, wash your hands with soap and water. If contact with the eyes occurs or if the eyes become red after handling the patch, immediately rinse thoroughly with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your Prometax transdermal patch while bathing, swimming, or being exposed to sunlight?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.

• Do not expose the patch to external sources of heat (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if your patch falls off

If your patch falls off, apply a new one to cover the remainder of that day, and change it at your usual time the next day.

When and for how long you should apply your Prometax transdermal patch

• To benefit from your treatment, you must apply a new patch every day, preferably at the same time each day.
• Wear only one Prometax patch at a time and replace it with a new one every 24 hours.

If you use more Prometax than you should

If you accidentally applied more than one patch, remove all patches from the skin and inform your doctor. You may require medical attention. Some people who have accidentally taken excessive oral doses of Prometax have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. Slowed heart rate and fainting may also occur.

If you forget to use Prometax

If you realize you have forgotten to apply a patch, do so immediately. The next day, apply the following patch at your usual time. Do not apply two patches to make up for the missed one.

If you stop using Prometax

Inform your doctor or pharmacist if you discontinue using the patches.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Prometax transdermal patches may cause adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects gradually disappear as your body becomes accustomed to the medicine.

If you notice any of the following adverse effects, which may be serious, remove the patch and contact your doctor immediately.

Frequent (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling of restlessness
• Urinary incontinence (inability to properly control urination)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as nausea, vomiting, diarrhea
• Heartburn
• Stomach pain
• Rash
• Allergic reaction at the application site, such as blisters or skin swelling
• Feeling of tiredness or weakness
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heartbeat
• Stomach ulcer
• Dehydration (loss of large amounts of fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggressiveness

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

• Falls

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

• Stiffness in arms or legs and hand tremors

Not known (cannot be estimated from available data)

• Worsening of signs of Parkinson's disease – such as tremor, stiffness, and difficulty moving
• Pancreatitis (inflammation of the pancreas) – signs include upper abdominal pain, frequently accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Epileptic seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function tests
• Feeling of restlessness
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
• Seeing things that are not there (hallucinations)
• Tremor
• Drowsiness
• Skin rash, itching
• Redness of the skin
• Blisters

If you notice any of the adverse effects listed above, remove the patch and contact your doctor immediately.

Other adverse effects reported with Prometax capsules or oral solution that may also occur with the patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Feeling of restlessness
• Feeling of general discomfort
• Tremor
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat (e.g., fast heartbeat)
• Difficulty sleeping
• Accidental falls

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

• Epileptic seizures (convulsions)
• Intestinal ulcer
• Chest pain – probably caused by spasm in the heart

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

• High blood pressure
• Pancreatitis – signs include severe upper abdominal pain frequently with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stools or vomit
• Seeing things that are not there (hallucinations)
• Some people who have experienced severe vomiting have developed a tear in part of the digestive tract connecting the mouth to the stomach (esophagus)

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prometax

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the carton and on the sachet after CAD/EXP. The expiry date refers to the last day of the month indicated.

• Do not store above 25°C.

• Keep the transdermal patch inside the sachet until use.

• Do not use any patch if it appears damaged or shows signs of tampering.

• After removing a patch, fold it in half with the adhesive side inwards and press together. When disposing of the patch, place it back into the original sachet and ensure it is kept out of the reach of children. After removing the patch, avoid touching the eyes and wash your hands thoroughly with water and soap. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Package contents and other information

Composition of Prometax

• The active substance is rivastigmine.

• Prometax 4.6 mg/24 h transdermal patch: Each patch delivers 4.6 mg of rivastigmine over 24 hours, measures 5 cm² and contains 9 mg of rivastigmine.

• Prometax 9.5 mg/24 h transdermal patch: Each patch delivers 9.5 mg of rivastigmine over 24 hours, measures 10 cm² and contains 18 mg of rivastigmine.

• Prometax 13.3 mg/24 h transdermal patch: Each patch delivers 13.3 mg of rivastigmine over 24 hours, measures 15 cm² and contains 27 mg of rivastigmine.

• The other components are lacquered polyethylene terephthalate film, alpha tocopherol, poly(butyl methacrylate, methyl methacrylate), acrylic copolymer, silicone oil, dimethicone, fluoropolymer-coated polyester film.

Description of the product and contents of the pack

Thin transdermal patch composed of three layers. The outer layer is beige and marked with:

• «Prometax», «4.6 mg/24 h» and «AMCX».
• «Prometax», «9.5 mg/24 h» and «BHDI».
• «Prometax», «13.3 mg/24 h» and «CNFU».

Each sachet contains one transdermal patch. The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Manufacturer

LTS Lohmann Therapie – Systeme AG

Lohmannstrasse 2

56626 Andernach

Germany

More information about this medicine is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Almirall, S.A.

Tél/Tel/Te?./Tlf./Τηλ/Sími/Tel./Tlf/Puh: +34 93 306 42 00

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu