RIVASTIGMINA 6 mg Hard Capsules

2. What you need to know before taking Rivastigmine Stadafarma

Do not take Rivastigmine Stadafarma:

If you are in any of these situations, inform your doctor and do not take rivastigmine.

Warnings and Precautions

Consult your doctor before starting to take Rivastigmine Stadafarma:

If you are in any of these situations, your doctor may consider it necessary to monitor you more closely while you are being treated.

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

Other Medications and Rivastigmine Stadafarma

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

Rivastigmine should not be administered at the same time as other medications with similar effects to those of rivastigmine. Rivastigmine may interfere with anticholinergic medications (medications 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 medication used to relieve or prevent nausea and vomiting). Taking the two medications together can cause problems such as stiffness in the limbs and hand tremors.

In case you need to undergo surgery while taking rivastigmine, inform your doctor before you are given any anesthetic, as rivastigmine may exaggerate the effects of some muscle relaxants during anesthesia.

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

Cautions should be taken when using rivastigmine with other medications that can affect heart rate or the heart's electrical system (QT prolongation).

Pregnancy, Breastfeeding, and Fertility

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

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

You should not breastfeed during treatment with rivastigmine.

Driving and Using Machines

Your illness may affect your ability to drive or use machines, and you should not engage in these activities unless your doctor indicates that it is safe to do so.

Rivastigmine may cause dizziness and drowsiness, mainly at the start of treatment or when the dose is increased. If you experience these effects, you should not drive or use machines.

3. How to Take Rivastigmine Stadafarma

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor, pharmacist, or nurse again.

How to start treatment

Your doctor will indicate what dose of rivastigmine 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 check your weight while you are taking this medication.

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 medication

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

If you take more Rivastigmine Stadafarma than you should

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

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

If you forget to take Rivastigmine Stadafarma

If you forget your dose of rivastigmine, 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

You may have side effects more frequently when starting your 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.
• Lack of appetite.
• Stomach problems, such as nausea, vomiting, diarrhea.

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

• Anxiety.
• Sweating.
• Headache.
• Heartburn.
• Weight loss.
• Stomach pain.
• Feeling of agitation.
• Feeling of fatigue or weakness.
• Feeling of general discomfort.
• Tremors or feeling of confusion.
• 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.
• 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).
• Heart rhythm problems, such as fast or slow heart rate.
• Gastrointestinal bleeding - manifested as blood in the stool or when vomiting.
• Pancreatitis - signs include severe pain in the upper abdomen, often with nausea or vomiting.
• Worsening of Parkinson's disease symptoms or development of similar symptoms - such as muscle stiffness, difficulty moving.

Not Known (cannot be estimated from available data).

• Severe vomiting that can cause a tear in the tube that connects the mouth to the stomach (esophagus).
• Dehydration (loss of a large amount of fluid).
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite).
• Aggression, feeling of restlessness.
• Irregular heart rhythm.
• Pisa syndrome (a 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).

• Tremors.
• Fainting.
• Accidental falls.

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

• Anxiety.
• Feeling of restlessness.
• Fast or slow heart rate.
• Difficulty sleeping.
• Excessive saliva and dehydration.
• Abnormally slow movements or movements that cannot be controlled.
• 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 heartbeat and loss of movement control.

Not Known (cannot be estimated from available data).

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

Other Side Effects Observed in 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 properly control urine).

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 patch application site, such as blisters or skin inflammation.

If you experience any of these side effects, contact your doctor, as you may need 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivastigmine Stadafarma

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging and blister pack, after EXP. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Rivastigmine Stadafarma

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

• 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.

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

Appearance of the Product and Package Contents

Rivastigmine Stadafarma 1.5 mg are hard capsules of a garnet color that contain a white to slightly yellowish powder.

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

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

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

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

Not all 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)

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

Date of the Last Revision of this Package Leaflet:January 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/