PROMETAX 1.5 mg Hard capsule

Зміст інструкції

1. Prometax 1.5 mg hard capsules, 3.0 mg hard capsules, 4.5 mg hard capsules, 6.0 mg hard capsules
   1. What is Prometax and what is it used for
   2. What you need to know before taking Prometax
   3. How to take Prometax
   4. Possible side effects
   5. How to store Prometax
   6. Contents of the pack and other information
2. Prometax 2 mg/ml oral solution
   1. What is Prometax and what is it used for
   2. What you need to know before taking Prometax
   3. How to take Prometax
   4. Possible side effects
   5. How to store Prometax
   6. Contents of the pack and other information
3. Prometax 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch, 13.3 mg/24 hour transdermal patch
   1. What is Prometax and what is it 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. Package Contents and Other Information

Prometax 1.5 mg hard capsules, 3.0 mg hard capsules, 4.5 mg hard capsules, 6.0 mg hard capsules

rivastigmine

Read this leaflet carefully before you start taking this medicine becauseit contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Prometax and what is it used for

Prometax contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia or dementia associated with Parkinson's disease, some brain cells
die, leading to low levels of 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, Prometax increases the levels of
acetylcholine in the brain, improving the symptoms of Alzheimer's disease or dementia associated
with Parkinson's disease.
Prometax is used for the treatment of adult patients with Alzheimer's dementia of mild to
moderate severity, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behavior. The hard capsules and oral solution are also
used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Prometax

Do not take Prometax

• if you are allergic to rivastigmine (the active ingredient of Prometax) or to any of the other ingredients of this medicine (listed in section 6).
• if when using the patch you have had a skin reaction that extended beyond the area where the patch was applied, if you have had a local reaction more intense (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours of removing the patch. If this is your case, tell your doctor and do not take Prometax.

Warnings and precautions
Talk to your doctor before taking Prometax:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolonged QT interval, family history of prolonged QT interval, torsade de pointes, or have a low level of potassium or magnesium in the blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you are underweight.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhea. If vomiting and diarrhea are persistent you may become dehydrated (excessive loss of fluids). If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy with this medicine.

If you have not taken Prometax for more than three days, consult your doctor before resuming treatment.

Children and adolescents
There is no indication for a specific use of Prometax in the pediatric population in the
treatment of Alzheimer's disease.

Other medicines and Prometax
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Prometax should not be administered together with other medicines that have similar effects. Prometax
may interfere with anticholinergic medicines (medicines used to relieve cramps or spasms in the
stomach, for the treatment of Parkinson's disease or to prevent travel sickness).
Prometax should not be administered simultaneously with metoclopramide (a medicine used
to relieve or prevent nausea and vomiting). Taking the two medicines together may cause disorders
such as rigidity of the limbs and tremor in the hands.
If you are going to have surgery and are taking Prometax, tell your doctor before
being subjected to anesthesia, as Prometax may increase the effects of some muscle relaxants
during anesthesia.
Caution is recommended when Prometax is taken together with beta-blockers (medicines such as
atenolol, used for the treatment of hypertension, angina and other heart diseases). Taking
the two medicines together may cause disorders such as slowing of the heartbeat (bradycardia) which
may lead to fainting or loss of consciousness.
Caution is recommended when Prometax is taken together with other medicines that may
affect the heart rhythm or the electrical system of the heart (prolongation of the QT interval).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Prometax must be weighed against the
possible effects on the unborn child. Prometax should not be used during pregnancy unless strictly
necessary.
You should not breastfeed during treatment with Prometax.

Driving and operating machinery
Your doctor will tell you if your illness allows you to drive and operate machinery safely. Prometax may cause dizziness and drowsiness, especially at the beginning of treatment or when
the dose is increased. If you feel dizzy or sleepy, do not drive, do not use machinery and do not perform
any other activity that requires vigilance.

3. How to take Prometax

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.

How to start treatment
Your doctor will tell you which dose of Prometax to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working. Your doctor will also monitor your
weight while you are taking this medicine. If you have not taken Prometax for more than three days,
consult your doctor before resuming treatment.

Taking the medicine

• Inform the person who is taking care of you that you are being treated with Prometax.
• To benefit from the treatment, take the medicine every day.
• Take Prometax twice a day, in the morning and evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or break the capsules.

If you take more Prometax than you should
If you accidentally take more Prometax than you should, inform your doctor. You may need
medical care. Some people who have accidentally taken an excessive amount of Prometax have
experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. Slowing of the
heartbeat and fainting can also occur.

If you forget to take Prometax
If you discover that you have forgotten to take your dose of Prometax, wait and take the next dose
at the scheduled time. Do not take a double dose to make up for a missed dose. If you have any
doubts about using 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.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as the
body gets used to the medicine.

Very common(may affect more than 1 in 10 people)

• Feeling dizzy
• Loss of appetite
• Stomach discomfort such as feeling nauseous, vomiting, diarrhoea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremors or feeling confused
• Loss of appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression
• Sleep disturbances
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• Convulsions (seizures)
• Ulcer in the stomach or intestine

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as a fast or slow heartbeat
• Bleeding from the intestine - this manifests with the presence of blood in the stool or vomit
• Inflammation of the pancreas - this manifests with severe pain in the upper part of the stomach, often accompanied by feeling nauseous or vomiting
• The signs of Parkinson's disease worsen or symptoms similar to it develop - such as muscle stiffness, difficulty performing movements

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

• Severe vomiting that can lead to rupture of the tract connecting the mouth to the stomach (esophagus)
• Dehydration (excessive fluid loss)
• Liver disorders (yellowing of the skin and the white of the eye, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Patients with dementia and Parkinson's disease
These patients more frequently experience some side effects. They also experience some
additional side effects:

Very common(may affect more than 1 in 10 people)

• Tremors
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Fast and slow heartbeat
• Sleep disturbances
• Excessive salivation and dehydration
• Unusual slowing down of movements or movements that cannot be controlled
• The signs of Parkinson's disease worsen or symptoms similar to it develop - such as muscle stiffness, difficulty performing movements and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

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

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Other side effects observed with Prometax transdermal patches and that may occur
with the capsules:
Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to adequately retain urine)

Uncommon(may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

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

• Allergic reactions at the patch application site, such as blisters or skin inflammation If you experience any of these symptoms, contact your doctor as you may need medical assistance.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Prometax

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is reported on the pack after Exp.. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prometax contains

• The active ingredient is rivastigmine hydrogen tartrate.
• The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, precipitated silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and shellac.

Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine.
Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.

Description of the appearance of Prometax and contents of the pack

• Prometax 1.5 mg hard capsules, containing a nearly white to slightly yellow powder, have a yellow head and a yellow body, with red lettering “ENA 713 1.5 mg” on the body.
• Prometax 3.0 mg hard capsules, containing a nearly white to slightly yellow powder, have an orange head and an orange body, with red lettering “ENA 713 3 mg” on the body.
• Prometax 4.5 mg hard capsules, containing a nearly white to slightly yellow powder, have a red head and a red body, with white lettering “ENA 713 4.5 mg” on the body.
• Prometax 6.0 mg hard capsules, containing a nearly white to slightly yellow powder, have a red head and an orange body, with red lettering “ENA 713 6 mg” on the body. Prometax hard capsules are packaged in blisters available in three different packs (28, 56 or 112 capsules), but not all pack sizes may be marketed.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, Ελλάδα,

España, France, Hrvatska, Ireland, Ísland, Italia, Κύπρος, Latvija, Lietuva,
Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska,
Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige
Almirall, S.A.
Tel: +34 93 291 30 00

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu/

Prometax 2 mg/ml oral solution

rivastigmine

Read this leaflet carefully before you start to take this medicine becauseit contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Prometax and what is it used for

Prometax contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia or dementia associated with Parkinson's disease, some brain cells
die, leading to low levels of 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, Prometax increases the levels of
acetylcholine in the brain, improving the symptoms of Alzheimer's disease or dementia associated
with Parkinson's disease.
Prometax is used for the treatment of adult patients with Alzheimer's dementia of mild to
moderate severity, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behaviour. The hard capsules and oral solution are also
used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Prometax

Do not take Prometax

• if you are allergic to rivastigmine (the active ingredient of Prometax) or to any of the other ingredients of this medicine (listed in section 6).
• if when using the patch you have had a skin reaction that spread beyond the area where the patch was applied, if you have had a local reaction more intense (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours of removing the patch. If this is the case, tell your doctor and do not take Prometax.

Warnings and precautions
Talk to your doctor before taking Prometax:

• if you have or have ever had a heart condition such as irregular or slow heartbeat,

prolongation of the QT interval, family history of prolonged QT interval,
torsades de pointes, or have a low level of potassium or magnesium in the blood.

• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you weigh little.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive fluid loss). If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy with this medicine.

If you have not taken Prometax for more than three days, consult your doctor before resuming treatment.

Children and adolescents
There is no indication for specific use of Prometax in the pediatric population in the
treatment of Alzheimer's disease.

Other medicines and Prometax
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Prometax must not be administered together with other medicines that have similar effects. Prometax
may interfere with anticholinergic medicines (medicines used to relieve cramps or spasms in the
stomach, for the treatment of Parkinson's disease or to prevent travel sickness).
Prometax must not be administered simultaneously with metoclopramide (a medicine used
to relieve or prevent nausea and vomiting). Taking the two medicines together may cause disorders
such as rigidity of the limbs and tremors in the hands.
If you are to undergo surgery and are taking Prometax, tell your doctor before
being subjected to anesthesia, as Prometax may increase the effects of some muscle relaxants
during anesthesia.
Caution is recommended when Prometax is taken together with beta-blockers (medicines such as
atenolol, used for the treatment of hypertension, angina and other heart diseases). Taking
the two medicines together may cause disorders such as slowing of the heartbeat (bradycardia) which
can lead to fainting or loss of consciousness.
Caution is recommended when Prometax is taken together with other medicines that may
affect the heart rhythm or the electrical system of the heart (prolongation of the QT interval).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Prometax must be weighed against the
possible effects on the unborn child. Prometax should not be used during pregnancy unless strictly
necessary.
Do not breastfeed during treatment with Prometax.

Driving and using machines
Your doctor will tell you if your condition allows you to drive and use machines safely. Prometax may cause dizziness and drowsiness, especially at the beginning of treatment or when
increasing the dose. If you feel dizzy or sleepy, do not drive, do not use machines and do not perform
any other activity that requires vigilance.

Prometax contains sodium benzoate (E211) and sodium
One of the inactive ingredients of Prometax oral solution is sodium benzoate (E211). Benzoic
acid is weakly irritating to the skin, eyes and mucous membranes. This medicine contains 3 mg of
sodium benzoate (E211) per 3 ml of oral solution
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially‘sodium-free’.

3. How to take Prometax

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.

How to start treatment
Your doctor will tell you which dose of Prometax to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working. Your doctor will also monitor your weight while you are taking this medicine.
If you have not taken Prometax for more than three days, consult your doctor before resuming treatment.

Taking the medicine

• Inform the person who is caring for you that you are being treated with Prometax.
• To benefit from the treatment, take the medicine every day.
• Take Prometax twice a day, in the morning and in the evening, with food.

How to use this medicine

• 1. Preparation of the vial and syringe

• Remove the syringe from the protective tube.
• To open the vial, press and rotate the safety cap.

• 2. Inserting the syringe into the vial

• Push the syringe nozzle into the hole of the white seal.

• 3. Filling the syringe

• Pull the plunger up to reach the mark corresponding to the dose prescribed by your doctor.

• 4. Removing bubbles

• Push and pull the plunger several times to eliminate any large bubbles.
• Some small bubbles are not a cause for concern and do not affect the correct dosage in any way.
• Verify that the dose is still correct.
• Then remove the syringe from the vial.
• 5. Taking the medicine

• Drink the medicine directly from the syringe.
• It is also possible to mix the medicine in a glass with a little water. Mix and drink the entire mixture.

• 6. After using the syringe

• Wipe the outside of the syringe with a clean paper towel.
• Then put the syringe back in the protective tube.
• Replace the safety cap on the vial to close it.

If you take more Prometax than you should
If you accidentally take more Prometax than you should, inform your doctor. You may need medical
care. Some people who have accidentally taken an excessive amount of Prometax have
experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. Slowing of the heartbeat and fainting can also
occur.

If you forget to take Prometax
If you discover that you have forgotten to take your dose of Prometax, wait and take the next dose
at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any questions about using 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.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as the
body gets used to the medicine.

Very common(may affect more than 1 in 10 people)

• Feeling dizzy
• Loss of appetite
• Stomach discomfort such as feeling nauseous, vomiting, diarrhoea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• General feeling of discomfort
• Tremors or feeling confused
• Loss of appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression
• Sleep disturbances
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• Convulsions (seizures)
• Stomach or intestinal ulcer

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as a fast or slow heartbeat
• Bleeding from the intestine - manifested by the presence of blood in the stool or vomit
• Inflammation of the pancreas - manifested by severe pain in the upper part of the stomach, often accompanied by nausea or vomiting
• The signs of Parkinson's disease worsen or symptoms similar to those develop - such as muscle stiffness, difficulty performing movements

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

• Severe vomiting that can lead to rupture of the tract connecting the mouth to the stomach (esophagus)
• Dehydration (excessive fluid loss)
• Liver disorders (yellowing of the skin and the white of the eye, abnormal

coloration of the urine dark, or unexplained nausea, vomiting, fatigue and loss of appetite)

• Aggression, feeling restless
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Patients with dementia and Parkinson's disease
These patients more frequently experience some side effects. They also report some
additional side effects:

Very common(may affect more than 1 in 10 people)

• Tremors
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Fast and slow heartbeat
• Sleep disturbances
• Excessive salivation and dehydration
• Unusual slowing of movements or movements that cannot be controlled
• The signs of Parkinson's disease worsen or symptoms similar to those develop - such as muscle stiffness, difficulty performing movements and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

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

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Other side effects observed with Prometax transdermal patches and that may occur
with the oral solution:
Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to adequately retain urine)

Uncommon(may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

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

• Allergic reactions at the patch application site, such as blisters or skin inflammation If any of these symptoms occur, contact your doctor as you may need medical attention.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Prometax

• 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 pack after Exp. The expiry date refers to the last day of that month.
• Do not store above 30°C. Do not refrigerate or freeze.
• Store in an upright position.
• Use Prometax oral solution within 1 month of opening the bottle.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prometax contains

• The active ingredient is rivastigmine hydrogen tartrate. Each ml contains an amount of rivastigmine hydrogen tartrate corresponding to 2.0 mg of rivastigmine base.
• The other ingredients are sodium benzoate (E211), citric acid, sodium citrate, quinoline yellow colourant (E104) and purified water.

Description of the appearance of Prometax and contents of the pack
Prometax oral solution is available in an amber glass bottle with a safety cap, seal, dropper
and self-aligning piston, containing 50 ml or 120 ml of a yellow, clear solution. The
oral solution is packaged with an oral dosing syringe contained in a plastic tube.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, Ελλάδα,

España, France, Hrvatska, Ireland, Ísland, Italia, Κύπρος, Latvija, Lietuva,
Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska,
Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige
Almirall, S.A.
Tél/Tel/Teл./Tlf./Τηλ/Sími/Tel./Tlf/Puh: +34 93 291 30 00

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/

Prometax 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch, 13.3 mg/24 hour transdermal patch

rivastigmine

Read this leaflet carefully before you start using this medicine becauseit contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Prometax is and what it is used for
• 2. What you need to know before you use 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 is Prometax and what is it used for

Prometax contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia, some brain cells die, leading to low levels of
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, Prometax increases the levels of acetylcholine in the
brain, improving the symptoms of Alzheimer's disease.
Prometax is used for the treatment of adult patients with Alzheimer's dementia of mild to
moderate severity, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behavior.

2. What you need to know before using Prometax

Do not use Prometax

• if you are allergic to rivastigmine (the active ingredient of Prometax) or to any of the other ingredients of this medicine (listed in section 6).
• if you have already had an allergic reaction to similar types of medicines (carbamate derivatives).
• if when using the patch you had a skin reaction that spread beyond the area where the patch was applied, if you had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours of removing the patch. If this is the case, inform your doctor and do not apply Prometax transdermal patches.

Warnings and precautions
Talk to your doctor before using Prometax:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolonged QTc interval, a family history of prolonged QTc interval, torsades de pointes, or have a low level of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever had asthma or severe respiratory disorders.
• if you suffer from tremors.
• if you have a low body weight.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive fluid loss).
• if you have impaired liver function. If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy with this medicine.

If you have not applied a patch for more than three days, consult your doctor before applying the next one.

Children and adolescents
There is no indication for specific use of Prometax in the pediatric population in the treatment of Alzheimer's disease.

Other medicines and Prometax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Prometax must not be administered together with other medicines that have similar effects. Prometax can interfere with anticholinergic medicines (medicines used to relieve cramps or spasms in the stomach, for the treatment of Parkinson's disease or to prevent travel sickness).
Prometax patch must not be administered simultaneously with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together can cause disorders such as stiffness of the limbs and tremors in the hands.
If you are to undergo surgery and are being treated with Prometax, inform your doctor before being given anesthesia, as Prometax may increase the effects of some muscle relaxants during anesthesia.
Caution is recommended when Prometax patch is taken together with beta-blockers (medicines such as atenolol, used to treat hypertension, angina and other heart diseases). Taking the two medicines together can cause disorders such as slowing of the heartbeat (bradycardia) which can lead to fainting or loss of consciousness.
Caution is recommended when Prometax is taken together with other medicines that can affect heart rhythm or the heart's electrical system (prolongation of the QT interval).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Prometax must be weighed against the possible effects on the unborn child. Prometax should not be used during pregnancy unless strictly necessary.
You should not breastfeed during treatment with Prometax transdermal patches.

Driving and using machines
Your doctor will tell you if your condition allows you to drive and use machines safely. Prometax transdermal patches can cause fainting or severe confusion. If you feel faint or confused, do not drive, use machines and do not perform any other activity that requires vigilance.

3. How to use Prometax

Use Prometax transdermal patches always exactly as your doctor has instructed. If you have any doubts
consult your doctor, pharmacist or nurse.

IMPORTANT:

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

How to start treatment
Your doctor will tell you which Prometax transdermal patch is most suitable for you.

• Treatment usually starts with Prometax 4.6 mg/24 hours.
• The normal recommended daily dose is Prometax 9.5 mg/24 hours. If well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 hours.
• Apply only one Prometax patch at a time and replace the patch with a new one every 24 hours. During treatment, your doctor may vary the dose to adjust it to your individual needs.

If you have not applied a patch for more than three days, do not apply the next one before consulting
your doctor. You can resume treatment with the transdermal patches at the same dose if the therapy has not
been interrupted for more than 3 days; alternatively, your doctor will start the treatment again
with Prometax 4.6 mg/24 hours.
Prometax can be used at the same time as taking food, drinks and alcohol.

Where to apply Prometax transdermal patch

• Before applying a patch, make sure that the skin is clean, dry and hair-free, free of dust, oils, moisturizers or lotions that may prevent the patch from adhering correctly to the skin, which must be without cuts, rashes and/or irritations.
• Carefully remove any patch before applying a new one.Having more patches on the skin could expose it to an excessive amount of medicine which could be potentially dangerous.
• Apply ONLY ONEpatch per day on ONLY ONEof the possible locations highlighted in the figures below:
• upper left arm orupper right arm
• upper left chest orupper right chest (avoid the breast)
• upper left back orupper right back
• lower left back orlower right back

Every 24 hours remove the previous patch before placing
ONE new one on ONE of the following possible locations.

When changing the patch, you must remove the patch from the previous day before applying a
new one each time in a different location (for example, on the right side of the body one day and on the
left side the next day, on the upper part of the body one day and on the lower part the next
day). Do not apply a new patch to the same point a second time before 14 days have elapsed.

How to apply Prometax transdermal patch
Prometax patches are thin, opaque, plastic material that adheres to the skin. Each patch is
sealed in a sachet that protects it until it is used. Do not open the sachet or
remove the patch until just before application.
Carefully remove any patch already present before applying
a new one.
For patients starting treatment for the first time and for
patients resuming treatment with Prometax after
an interruption, please refer to the instructions below
next to the second image.

Each patch is sealed in its 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 film covers the adhesive side of the patch.
Peel off one side of the protective film and do not touch the
adhesive part of the patch with your fingers.

Place the adhesive side of the patch on the upper
or lower back, on the upper arm or
on the chest, then remove the second side of the protective film.

Press the patch firmly with the palm of your hand
for at least 30 seconds, making sure that the edges
adhere well
If it helps, you can write on the patch, for example, the day
of the week with a thin ballpoint pen.
The patch must be worn continuously, until it is time to replace it with a new one. If you wish, by applying a new patch you can try different points, to find those that are more
comfortable for you and where clothes do not rub against the patch.

How to remove Prometax transdermal patch
Gently lift a corner of the patch to remove it slowly from the skin. If
adhesive residue remains on the skin, moisten the area thoroughly but gently with
lukewarm water and a mild soap, or use baby oil to remove it. Alcohol
or other solvents (for removing nail polish or other types) should not be used.
After removing the patch, wash your hands with water and soap. If it comes into contact with the eyes or if
the eyes become red after handling the patch, rinse immediately with plenty of water
and consult a doctor if the symptoms do not subside.

Can you apply Prometax transdermal patch while bathing, swimming, or sunbathing?

• Bathing, swimming or showering should not interfere with the patch. Make sure the patch does not detach during these activities.
• Do not expose the patch to external sources of heat (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch comes off
If a patch comes off, apply a new one for the rest of the day, then replace the patch the
next day at the usual time.

When and for how long to apply Prometax transdermal patch

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

If you use more Prometax than you should
If you accidentally apply more than one patch, remove all patches from the skin and inform the doctor that you
have accidentally applied more than one patch. You may need medical attention. Some people who have accidentally taken an excessive amount of Prometax have experienced nausea,
vomiting, diarrhea, high blood pressure and hallucinations. Slowing of the heartbeat and fainting can also occur.

If you forget to use Prometax
If you realize you have forgotten to apply a patch, apply one immediately. You can
apply the next patch the next day at the scheduled time. Do not apply two patches to
make up for the forgotten one.

If you stop treatment with Prometax
If you stop treatment with the patch, inform your doctor or pharmacist.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prometax transdermal patches can cause side effects, although not everyone will experience them.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as the
body gets used to the medicine.

Remove the patch and inform your doctor immediately if you notice that any of the following
side effects becomes severe:
Common(may affect up to 1 in 10 people)

• Loss of appetite
• Feeling dizzy
• Feeling agitated or drowsy
• Urinary incontinence (inability to adequately control urination)

Uncommon(may affect up to 1 in 100 people)

• Heartbeat disturbances such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive fluid loss)
• Hyperactivity (high level of activity, restlessness)
• Aggression

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

• Falls

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

• Stiffness in the arms or legs
• Tremors in the hands

Not known(frequency cannot be estimated based on available data)

• Allergic reactions at the patch application site, such as blisters or inflamed skin
• Symptoms of Parkinson's disease worsen - such as tremor, rigidity and shuffling gait
• Inflammation of the pancreas - manifests with severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Convulsions (seizures)
• Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• Changes in test values indicating how your liver is working
• Feeling restless
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contraction with

abnormal flexion of the body and head to one side)
Remove the patch and inform your doctor immediately if you notice the onset of any of the
side effects described above.

Other side effects observed with Prometax capsules or oral solution and that may
occur with the patch:
Common(may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Feeling restless
• General feeling of discomfort
• Tremors or confusion
• Increased sweating

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat (e.g., fast heartbeat)
• Sleep disturbances
• Accidental falls

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

• Convulsions (seizures)
• Ulcer in the intestine
• Chest pain - this may be caused by cardiac spasm

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

• High blood pressure
• Inflammation of the pancreas - manifests with severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Bleeding from the intestine - manifests with the presence of blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• In some people who have had severe vomiting, rupture of the tract connecting the mouth to the stomach (esophagus) has occurred

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Prometax

• 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 package and on the sachet after Scad./EXP. The expiry date refers to the last day of that month.
• Do not store at a temperature above 25°C.
• Store the transdermal patch in the sachet until the time of use.
• Do not use the patch if it is damaged or if it shows signs of tampering.
• After removing a patch, fold it in half with the adhesive sides inwards and press them together. Put the used patch back in its original sachet and dispose of it in a way that children cannot touch it. Do not touch your eyes with your fingers and wash your hands with water and soap after removing the patch. Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Prometax Contains

• The active ingredient is rivastigmine.
• Prometax 4.6 mg/24 hours transdermal patches: Each 5 cm patch releases 4.6 mg of rivastigmine in 24 hours and contains 9 mg of rivastigmine.
• Prometax 9.5 mg/24 hours transdermal patches: Each 10 cm patch releases 9.5 mg of rivastigmine in 24 hours and contains 18 mg of rivastigmine.
• Prometax 13.3 mg/24 hours transdermal patches: Each 15 cm patch releases 13.3 mg of rivastigmine in 24 hours and contains 27 mg of rivastigmine.
• The other ingredients are lacquered polyester terephthalate film, alpha-tocopherol, poly(butyl methacrylate, methyl methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film, coated with fluoropolymer.

Description of the Appearance of Prometax and Package Contents
Each transdermal patch is thin and consists of three layers. The outer layer is beige and is
marked with one of the following inscriptions:

• “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 transdermal patch is sealed in a sachet. The patches are available in packs containing
7 or 30 sachets and in multiple packs containing 60 or 90 sachets. Not all 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, Ελλάδα,

España, France, Hrvatska, Ireland, Ísland, Italia, Κύπρος, Latvija, Lietuva,
Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska,
Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige
Almirall, S.A.
Tel: +34 93 291 30 00

Other Sources of Information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION(S)
Scientific conclusions
In light of the assessment of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for rivastigmine, the PRAC’s scientific
conclusions are as follows:
Based on literature data suggesting a causal association between rivastigmine and
pleurototonia, with reports of positive response to withdrawal (dechallenge) and/or
reintroduction (rechallenge), including a dose-response relationship in some cases and in view of a
potential class effect, it is recommended to amend the product information of medicinal products
containing rivastigmine to include the adverse reaction "pleurototonia", also known as Pisa syndrome.
Having examined the PRAC recommendation, the Committee for Medicinal Products for Human Use
(CHMP) agrees with the overall conclusions and the justification of the recommendation.

Justification for the variation of the marketing authorisation(s)
Based on the scientific conclusions on rivastigmine, the CHMP considers that the benefit/risk
balance of the medicinal product(s) containing rivastigmine remains unchanged, save for the proposed
changes to the product information.
The CHMP recommends the variation of the marketing authorisation(s).