RIVASTIGMINA 1.5 mg HARD CAPSULES

2. What you need to know before you take Rivastigmine Kern Pharma hard capsules

Do not take Rivastigmine Kern Pharma hard capsules

• if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction that spreads beyond the patch size, 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 are in any of these situations, inform your doctor and do not take Rivastigmine.

Warnings and precautions

Consult your doctor before taking Rivastigmine Kern Pharma:

• if you have or have ever had an irregular or slow heart rate (pulse).
• 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.
• if you have or have ever had asthma or severe respiratory disease.
• if you have or have ever had kidney function impairment.
• if you have or have ever had liver function impairment.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as a feeling of nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

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 medicines and Rivastigmine

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

Rivastigmine should not be administered at the same time as other medicines with similar effects to those of Rivastigmine. Rivastigmine may interfere with anticholinergic 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 the two medicines together may 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 any anesthetic is administered, as rivastigmine may exaggerate the effects of some muscle relaxants during anesthesia.

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

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 medicine.

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 doctor will inform you if your illness allows you to drive or use machinery safely. Rivastigmine may cause dizziness and drowsiness, mainly at the start of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive or use machinery, or perform other tasks that require your attention.

3. How to take Rivastigmine Kern Pharma hard capsules

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist.

How to start treatment

Your doctor will tell you 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 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also check 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

• Tell your caregiver that you are taking rivastigmine.
• To benefit from your medicine, 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 liquid.
• Do not open or crush the capsule.

If you take more Rivastigmine Kern Pharma hard capsules than you should

Tell your doctor if you have accidentally taken a higher dose than indicated. You may need medical attention. 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 Kern Pharma hard capsules

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 forgotten doses.

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

4. Possible side effects

Like all medicines, Rivastigmine Kern Pharma hard capsules can cause side effects, although not everybody gets them.

You may have side effects more often when you start your treatment or when your dose is increased. Generally, side effects will disappear gradually as your body gets used to the medicine.

The frequencies of side effects are:

Very common: (affect more than 1 in 10 patients)

Common: (affect between 1 and 10 in 100 patients)

Uncommon: (affect between 1 and 10 in 1,000 patients)

Rare: (affect between 1 and 10 in 10,000 patients)

Very rare: (affect less than 1 in 10,000 patients)

Frequency not known: (cannot be estimated from the available data)

Patient's with dementia associated with Parkinson's disease experience some side effects more frequently, as well as additional side effects:

Other side effects observed in Rivastigmine transdermal patches and that may appear with the hard capsules:

If these symptoms occur, contact your doctor as you may need medical attention.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine Kern Pharma hard capsules

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules and packaging to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused capsules and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmine Kern Pharma hard capsules

• The active ingredient is rivastigmine hydrogen tartrate
• The other ingredients are: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, gelatin, sodium lauryl sulfate, titanium dioxide (E171), yellow iron oxide (E172), and purified water.

Each Rivastigmine Kern Pharma 1.5 mg hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg of rivastigmine.

Each Rivastigmine Kern Pharma 3.0 mg hard capsule contains rivastigmine hydrogen tartrate equivalent to 3.0 mg of rivastigmine.

Each Rivastigmine Kern Pharma 4.5 mg hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg of rivastigmine.

Each Rivastigmine Kern Pharma 6.0 mg hard capsule contains rivastigmine hydrogen tartrate equivalent to 6.0 mg of rivastigmine.

Appearance of the product and pack contents

• Rivastigmine Kern Pharma 1.5 mg hard capsules, contain a white to slightly yellowish powder in a capsule with a yellow cap and body, with a red print mark R 1.5 on the body.

• Rivastigmine Kern Pharma 3 mg hard capsules, contain a white to slightly yellowish powder in a capsule with an orange cap and body, with a red print mark R 3.0 on the body.
• Rivastigmine Kern Pharma 4.5 mg hard capsules, contain a white to slightly yellowish powder in a capsule with a red cap and body, with a white print mark R 4.5 on the body.
• Rivastigmine Kern Pharma 6 mg hard capsules, contain a white to slightly yellowish powder in a capsule with a red cap and orange body, with a red print mark R 6.0 on the body.

They are packaged in blisters and are available in three different presentations (28, 56, and 112 capsules).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in: December 2024

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