PROSPECTO: INFORMATION FOR THE USER

Rivastigmina Kern Pharma 1.5 mg hard capsules EFG

Rivastigmina Kern Pharma 3.0 mg hard capsules EFG

Rivastigmina Kern Pharma 4.5 mg hard capsules EFG

Rivastigmina Kern Pharma 6.0 mg hard capsules EFG

Read this prospectus carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Rivastigmina Kern Pharma hard capsules and what is it used for

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

3. How to take Rivastigmina Kern Pharma hard capsules

4. Possible adverse effects

5. Storage of Rivastigmina Kern Pharma hard capsules

6. Contents of the package and additional information

Rivastigmina belongs to a group of substances called cholinesterase inhibitors.

In patients with Alzheimer's disease or Parkinson's disease-associated dementia, certain nerve cells die in the brain, resulting in 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 Rivastigmina Kern Pharma hard capsules

• if you are allergic (hypersensitive) to rivastigmina or to any of the other ingredients ofthis 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 are in any of these situations, inform your doctor and do not take Rivastigmina.

Warnings and precautions

Consult your doctor before takingRivastigmina Kern Pharma:

• if you have or have had any irregular or slow heart rhythm.
• 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 nausea, vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are 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 Rivastigmina

Inform your doctor or pharmacist if you are using or have recently taken 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 (used to relieve muscle cramps or spasms, for the treatment of Parkinson's disease, or to prevent travel-related dizziness).

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.

If 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 bradycardia (slow heart rate) that may lead to dizziness or loss of consciousness.

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 with Rivastigmina.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmina may cause dizziness and somnolence, mainly at the beginning of treatment or when increasing the dose. If you feel dizzy or drowsy, do not drive, use machinery, or perform other tasks that require your attention.

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

Starting 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 the treatment.
• The highest dose you should take is 6.0 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.

Consult 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 Kern Pharma Hard Capsules Than You Should

Inform your doctor if you accidentally take a dose higher than indicated. You may require medical attention. Some people who have taken accidental higher doses have experienced dizziness (nausea), vomiting, diarrhea, high blood pressure, hallucinations. A slowing of heart rate and fainting may also occur.

If You Forget to Take Rivastigmina Kern Pharma Hard Capsules

If you forget your rivastigmina dose, 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 medicines, Rivastigmina Kern Pharma hard capsules may 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.Side effects usually 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 available data):

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

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

If you experience these symptoms, contact your doctor as they may require medical attention.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Rivastigmina Kern Pharma Hard Capsules Composition

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

Each Rivastigmina Kern Pharma 1.5 mg hard capsule contains the equivalent of 1.5 mg of rivastigmine as rivastigmine hydrogen tartrate.

Each Rivastigmina Kern Pharma 3.0 mg hard capsule contains the equivalent of 3.0 mg of rivastigmine as rivastigmine hydrogen tartrate.

Each Rivastigmina Kern Pharma 4.5 mg hard capsule contains the equivalent of 4.5 mg of rivastigmine as rivastigmine hydrogen tartrate.

Each Rivastigmina Kern Pharma 6.0 mg hard capsule contains the equivalent of 6.0 mg of rivastigmine as rivastigmine hydrogen tartrate.

Appearance of the product and contents of the pack

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

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

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

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Kern Pharma, S.L.

Venus,72- Pol. Ind.Colón II

08228 Terrassa -Barcelona

Spain

This leaflet has been approved in: December 2024

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