Leaflet: information for the user

Rivastigmina Stadafarma 1.5 mg hard capsules EFG

Rivastigmina Stadafarma 3 mg hard capsules EFG

Rivastigmina Stadafarma 4.5 mg hard capsules EFG

Rivastigmina Stadafarma 6 mg hard capsules EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The active ingredient of RivastigminaStadafarmais rivastigmina.

Rivastigminabelongs to the group of substances known as cholinesterase inhibitors. In patients with Alzheimer's disease or Parkinson's disease-associated dementia, certain nerve cells die in the brain, causing low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmina acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmina allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmina is used for the treatment of adult patients with mild to moderately severe Alzheimer's disease, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.

Do not take RivastigminaStadafarma:

• If you are allergic to rivastigmina or to any of the other components of this medication (listed in section 6).
• If you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you find yourself in any of these situations, inform your doctor and do not take rivastigmina.

Warnings and precautions

Consult your doctor before starting to take Rivastigmina Stadafarma:

• If you have or have had any irregular or slow heart rhythm, prolonged QTc, family history of prolonged QTc, torsade de pointes, or if you have low blood levels of potassium or magnesium.
• If you have or have had any active stomach ulcer.
• If you have or have had any difficulty urinating.
• If you have or have had any seizures.
• If you have or have had any severe respiratory disease.
• If you have or have had any kidney function deterioration.
• If you have or have had any liver function deterioration.
• If you suffer from tremors.
• If you have a low body weight.
• If you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are on treatment.

If you have not taken rivastigmina for more than three days, do not take the next dose until you have consulted your doctor.

Children and adolescents

Rivastigmina should not be used in the pediatric population for the treatment of Alzheimer's disease.

Other medications and RivastigminaStadafarma

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

Rivastigmina should not be administered at the same time as other medications with similar effects to rivastigmina. Rivastigmina may interfere with anticholinergic medications (medications used to relieve muscle cramps or spasms, for the treatment of Parkinson's disease, or to prevent motion sickness).

Rivastigmina should not be administered at the same time as metoclopramide (a medication used to relieve or prevent nausea and vomiting). Taking the two medications together may cause problems such as stiffness in the limbs and hand tremors.

In the event that you need to undergo surgery while taking rivastigmina, inform your doctor before any anesthetic is administered, as rivastigmina may exacerbate the effects of some muscle relaxants during anesthesia.

Care should be taken when rivastigmina is used with beta-blockers (medications such as atenolol used to treat hypertension, angina, and other cardiovascular conditions). Taking the two medications together may cause complications such as a decrease in heart rate (bradycardia) that may lead to fainting or loss of consciousness.

Care should be taken when rivastigmina is used with other medications that may affect heart rhythm or the heart's electrical system (prolonged QT).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication

If you are pregnant, it is necessary to evaluate the benefits of using rivastigmina against the possible adverse effects on the fetus. Rivastigmina should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during treatment withrivastigmina.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so.

Rivastigmina may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse again.

How to start treatment

Your doctor will tell you what dose of rivastigmina you should take.

• Normally, treatment starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to treatment.
• The highest dose you should take is 6 mg twice a day.

Your doctor will regularly check if the medication is working for you. Your doctor will also monitor your weight while you are taking this medication.

If you have not taken rivastigmina for more than three days, do not take the next dose until you have consulted your doctor.

Taking this medication

• Inform your caregiver that you are taking rivastigmina.
• To benefit from your medication, take it every day.
• Take rivastigmina twice a day (in the morning and at night), with meals.
• Swallow the capsule whole with liquid.
• Do not open or crush the capsule.

If you take more Rivastigmina Stadafarma than you should

If you accidentally take more rivastigmina than you should, inform your doctor. You may require medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Some people who have taken accidentally higher doses have experienced dizziness (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to take Rivastigmina Stadafarma

If you forget your dose of rivastigmina, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

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

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Generally, side effects will slowly disappear as your body gets used to the medication.

Frequencies are defined as:

• Very common (may affect more than 1 in 10 people).
• Common (may affect up to 1 in 10 people).
• Uncommon (may affect up to 1 in 100 people).
• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• Frequency not known (cannot be estimated from available data).

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

• Dizziness.
• Loss of appetite.
• Stomach problems, such as dizziness (nausea), vomiting, diarrhea.

Common(may affect up to 1 in 10 people).

• Anxiety.
• Sweating.
• Headache.
• Heartburn.
• Weight loss.
• Abdominal pain.
• Restlessness.
• Feeling tired or weak.
• General feeling of discomfort.
• Trembling or feeling confused.
• Decreased appetite.
• Nightmares.

Uncommon(may affect up to 1 in 100 people).

• Depression.
• Difficulty sleeping.
• Blackouts or accidental falls.
• Changes in liver function.

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

• Chest pain.
• Cutaneous rash, itching.
• Seizures (convulsions).
• Ulcers 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 do not exist (hallucinations).
• Problems with heart rhythm, such as rapid or slow heart rate.
• Gastrointestinal bleeding - presents as blood in the stool or vomiting blood.
• Pancreatitis - symptoms include severe pain in the upper abdomen, often with dizziness (nausea) or vomiting.
• Worsening of Parkinson's disease symptoms or development of similar symptoms - such as muscle stiffness, difficulty moving, and muscle weakness.

Not known(cannot be estimated from available data).

• Intense vomiting that may cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus).
• Dehydration (loss of a large amount of fluid).
• Hepatic disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, fatigue, and loss of appetite).
• Aggression, feeling of restlessness.
• Irregular heart rhythm.
• Pisa syndrome (condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side).

Patients with dementia or Parkinson's disease

These patients experience some side effects more frequently and also have some additional side effects:

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

• Trembling.
• Blackouts.
• Accidental falls.

Common(may affect up to 1 in 10 people).

• Anxiety.
• Feeling of unease.
• Irregular heart rhythm.
• Difficulty sleeping.
• Excessive saliva and dehydration.
• Abnormally slow or uncontrolled movements.
• Worsening of Parkinson's disease symptoms or development of similar symptoms - such as muscle stiffness, difficulty moving, and muscle weakness.

Uncommon(may affect up to 1 in 100 people).

• Irregular heart rhythm and loss of motor control.

Not known(cannot be estimated from available data).

• Pisa syndrome (condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side).

Other side effects observed with rivastigmine transdermal patches and that may appear with hard capsules:

Common(may affect up to 1 in 10 people).

• Fever.
• Severe confusion.
• Urinary incontinence (inability to stop urinating properly).

Uncommon(may affect up to 1 in 100 people).

• Hypervigilance (high level of activity, restlessness).

Not known(cannot be estimated from available data).

• Allergic reaction where the patch was applied, such as blisters or skin inflammation.

If you experience any of these side effects, contact your doctor as they may require medical attention.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Rivastigmina Stadafarma

• The active ingredient is rivastigmine hydrogen tartrate.
• Rivastigmina Stadafarma 1.5 mg: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg of rivastigmina.
• Rivastigmina Stadafarma 3 mg: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg of rivastigmina.
• Rivastigmina Stadafarma 4.5 mg: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg of rivastigmina.
• Rivastigmina Stadafarma 6 mg: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg of rivastigmina.

• The other components (excipients) are:

Powder: Microcrystalline cellulose, hypromellose, magnesium stearate, anhydrous colloidal silica, and purified water.

Capsule: Red iron oxide (E-172), titanium dioxide (E-171), and gelatin.

Rivastigmina Stadafarma 3 mg, 4.5 mg, and 6 mg capsules also contain yellow iron oxide (E172).

Appearance of the product and contents of the package

Rivastigmina Stadafarma 1.5 mg are hard capsules of a deep pink color that contain a white to slightly yellowish powder.

Rivastigmina Stadafarma 3 mg are hard capsules of an orange color that contain a white to slightly yellowish powder.

Rivastigmina Stadafarma 4.5 mg are hard capsules of a caramel color that contain a white to slightly yellowish powder.

Rivastigmina Stadafarma 6 mg are hard capsules with an orange cap and a deep pink body that contain a white to slightly yellowish powder.

It is packaged in blisters and is available in three different presentations: 28, 56, and 112 capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A. (MEDINSA)

c/ Solana, 26.

28850 Torrejón de Ardoz (Madrid)

Spain

or

Laboratori Fundació Dau

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

Last review date of this leaflet : January 2025.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/