Rivastigmine Stadafarma 4.5 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivastigmine Stadafarma 1.5 mg hard capsules EFG

Rivastigmine Stadafarma 3 mg hard capsules EFG

Rivastigmine Stadafarma 4.5 mg hard capsules EFG

Rivastigmine Stadafarma 6 mg hard capsules EFG

Read the entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Rivastigmina Stadafarma is and what it is used for

The active substance in Rivastigmina Stadafarma is rivastigmine.

Rivastigmine belongs to a group of substances known as cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, certain nerve cells in the brain die, resulting in 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, rivastigmine increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmine 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 behavior. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before starting Rivastigmina Stadafarma

Do not take Rivastigmina Stadafarma:

• if you are allergic to rivastigmine or to any of the other ingredients of this medicine (listed in section 6).
• if you have 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 you are in any of these situations, inform your doctor and do not take rivastigmine.

Warnings and precautions

Talk to your doctor before starting Rivastigmina Stadafarma:

• if you have or have ever had an irregular or slow heart rate (pulse), QTc prolongation, a family history of QTc prolongation, torsade de pointes, or 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 in urination.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a severe respiratory disease.
• if you have or have ever had (impairment) of kidney function.
• if you have or have ever had (impairment) of liver function.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

If you are in any of these situations, your doctor may consider it necessary to carry out closer monitoring during treatment.

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

Children and adolescents

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

Other medicines and Rivastigmina Stadafarma

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

Rivastigmine should not be administered at the same time as other medicines with similar effects to rivastigmine. Rivastigmine may interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent travel sickness).

Rivastigmine should 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 taking rivastigmine, inform your doctor before you are given any anesthetic, as rivastigmine may intensify the effects of certain muscle relaxants used during anesthesia.

Caution is required when using rivastigmine together with beta-blockers (medicines such as atenolol used to treat high blood pressure, 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 required when using rivastigmine 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 rivastigmine must be weighed against the potential adverse effects on the fetus. Rivastigmine should not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with rivastigmine.

Driving and using machines

Your condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor has advised you that it is safe to do so.

Rivastigmine may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

3. How to take Rivastigmina Stadafarma

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse again.

How to start treatment

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

• Treatment is usually started at a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose you will take is 6 mg twice daily.

Your doctor will regularly monitor whether the medicine is working for you. Your doctor will also monitor your weight while you are taking this medicine.

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

Taking this medicine

• Inform your caregiver that you are taking rivastigmine.
• To benefit from your medicine, take it every day.
• Take rivastigmine twice daily (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 rivastigmine than you should, inform your doctor. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Some people who have accidentally taken higher doses have experienced dizziness (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.

If you forget to take Rivastigmina Stadafarma

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

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

4. Possible adverse effects

Like all medicines, this medicine can 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 will gradually disappear as your body gets used to the medicine.

Frequencies are defined as follows:

• 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 feeling sick (nausea), vomiting, diarrhoea.

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

• Anxiety.
• Sweating.
• Headache.
• Indigestion.
• Weight loss.
• Stomach pain.
• Feeling restless.
• Feeling tired or weak.
• Feeling generally unwell.
• Tremor or feeling confused.
• Decreased appetite.
• Nightmares.

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

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

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

• Chest pain.
• Skin rash, itching.
• Epileptic seizures (convulsions).
• Ulcers in your 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).
• Problems with your heart rhythm, such as fast or slow heartbeat.
• Gastrointestinal bleeding –表现为 blood in stools or vomiting blood.
• Inflammation of the pancreas – signs include severe pain in the upper stomach, often with feeling sick (nausea) or vomiting.
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in moving.

Frequency not known (cannot be estimated from available data).

• Severe vomiting which may cause a tear in part of the digestive tube connecting your mouth to your stomach (oesophagus).
• Dehydration (loss of large amounts of fluid).
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite).
• Aggression, feeling restless.
• Irregular heartbeat.
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side).

Patients with dementia or Parkinson's disease

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

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

• Tremor.
• Fainting.
• Accidental falls.

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

• Anxiety.
• Restlessness.
• Slow and fast heart rate.
• Difficulty sleeping.
• Excessive salivation and dehydration.
• Abnormally slow movements or uncontrollable movements.
• Worsening of signs of Parkinson's disease or development of Parkinson-like symptoms—such as muscle rigidity, difficulty performing movements, and muscle weakness.

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

• Irregular heartbeat and impaired movement control.

Not known (cannot be estimated from available data):

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal sideways tilting of the body and head).

Other adverse effects observed with rivastigmine transdermal patches and which may also occur with hard capsules:

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

• Fever.
• Severe confusion.
• Urinary incontinence (inability to properly control urination).

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

• Hyperactivity (high level of activity, restlessness).

Not known (cannot be estimated from available data):

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

If you experience any of these adverse effects, contact your doctor, as medical attention may be required.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Stadafarma

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and blister, after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Stadafarma

• The active substance is rivastigmine hydrogen tartrate.

• Rivastigmina Stadafarma 1.5 mg: each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg of rivastigmine.

• Rivastigmina Stadafarma 3 mg: each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg of rivastigmine.

• Rivastigmina Stadafarma 4.5 mg: each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg of rivastigmine.

• Rivastigmina Stadafarma 6 mg: each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg of rivastigmine.

• The other components (excipients) are:

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

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

Rivastigmina Stadafarma 3 mg, 4.5 mg, and 6 mg capsules additionally contain iron oxide yellow (E-172).

Appearance of the product and contents of the pack

Rivastigmina Stadafarma 1.5 mg are dark red hard capsules containing a white to slightly yellowish powder.

Rivastigmina Stadafarma 3 mg are orange hard capsules containing a white to slightly yellowish powder.

Rivastigmina Stadafarma 4.5 mg are caramel-colored hard capsules containing a white to slightly yellowish powder.

Rivastigmina Stadafarma 6 mg are hard capsules with an orange cap and dark red body containing a white to slightly yellowish powder.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Medicamentos Internacionales, S.A. (MEDINSA)
Calle Solana, 26
28850 Torrejón de Ardoz (Madrid)
Spain

or

Laboratori Fundació Dau
Calle C 12-14
Polígono Industrial de la Zona Franca
08040 Barcelona
Spain

Date of the most recent review of this leaflet: January 2025

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