Rivastigmine Kern Pharma 1.5 mg hard capsules EFG

Spain
Brand name Rivastigmine Kern Pharma 1.5 mg hard capsules EFG
Form capsules, hard
Active substance / Dosage
RIVASTIGMINE TARTRATE · 2,4 mg
Prescription type Hospital Diagnosis
ATC code
N06D N06DA N06DA03
Registration number 75562
Manufacturer Kern Pharma S.L.
Rivastigmine Kern Pharma 1.5 mg hard capsules EFG capsules, hard

Table of Contents

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rivastigmine Kern Pharma 1.5 mg hard capsules EFG

Rivastigmine Kern Pharma 3.0 mg hard capsules EFG

Rivastigmine Kern Pharma 4.5 mg hard capsules EFG

Rivastigmine Kern Pharma 6.0 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. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

  1. What Rivastigmine Kern Pharma hard capsules are and what they are used for
  2. What you need to know before taking Rivastigmine Kern Pharma hard capsules
  3. How to take Rivastigmine Kern Pharma hard capsules
  4. Possible side effects
  5. How to store Rivastigmine Kern Pharma hard capsules
  6. Contents of the pack and other information

1. What Rivastigmina Kern Pharma hard capsules are and what they are used for

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 blocking 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 taking Rivastigmina Kern Pharma hard capsules

Do not take Rivastigmina Kern Pharma hard capsules

  • if you are allergic (hypersensitive) 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 Rivastigmina.

Warnings and precautions

Talk to your doctor before taking Rivastigmina 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 a serious respiratory disease.
  • if you have or have ever had (impaired) kidney function.
  • if you have or have ever had (impaired) 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 could 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 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

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

Other medicines and Rivastigmina

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 effects similar 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 motion sickness).

Rivastigmine should not be taken 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 receiving any anesthetic, as rivastigmine may intensify the effects of certain muscle relaxants used during anesthesia.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 Rivastigmina must be weighed against the potential adverse effects on the fetus. Rivastigmina should not be used during pregnancy unless clearly necessary.

Breastfeeding should not be undertaken during treatment with Rivastigmina.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmina may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or sleepy, do not drive or use machinery or perform any other tasks requiring your full attention.

3. How to take Rivastigmina Kern Pharma hard capsules

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist.

Starting treatment

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

  • Treatment is usually started at a low dose.
  • Your doctor will gradually increase your dose depending on how you respond to treatment.
  • The highest dose you will take is 6.0 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 a day (in the morning and in the evening), 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 have accidentally taken more than the prescribed dose. You may require medical attention. Some people who have accidentally taken higher doses have experienced dizziness (nausea), vomiting, diarrhoea, 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 miss a dose of rivastigmine, wait and take the next dose at the usual time. Do not take a double dose to make up for missed 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, Rivastigmine Kern Pharma hard capsules may produce 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 becomes accustomed to the medicine.

The frequencies of adverse effects are:

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

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

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

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

Very rare: (affects fewer than 1 in 10,000 patients)

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

Very common

  • Dizziness
  • Loss of appetite
  • Stomach problems such as nausea, vomiting, diarrhea

Common

  • Anxiety
  • Sweating
  • Headache
  • Heartburn
  • Weight loss
  • Stomach pain
  • Feeling restless
  • Feeling tired or weak
  • General malaise
  • Tremor or confusion
  • Decreased appetite

Nightmares

Uncommon

  • Depression
  • Sleep difficulties
  • Changes in liver function
  • Fainting or accidental falls

Rare

  • Chest pain
  • Seizures (convulsions)
  • Skin rash, itching
  • Ulcers in the stomach or intestine

Very rare

  • High blood pressure
  • Urinary tract infection
  • Seeing things that are not real (hallucinations)
  • Heart rhythm problems such as fast or slow heartbeat
  • Gastrointestinal bleeding (seen as blood in stools or vomit)
  • Inflammation of the pancreas (symptoms include severe upper abdominal pain, often with nausea or vomiting)
  • Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving

Frequency not known

  • Severe vomiting which may cause tearing of part of the digestive tract connecting mouth to stomach (esophagus)
  • 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, restlessness
  • Irregular heartbeat
  • Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

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

Very common

  • tremor
  • fainting
  • accidental falls

Common

  • anxiety
  • restlessness
  • slow and fast heart rate
  • difficulty sleeping
  • excessive saliva and dehydration
  • abnormally slow or uncontrolled movements
  • worsening of Parkinson's disease signs or development of similar symptoms – such as muscle rigidity, difficulty performing movements, and muscle weakness

Uncommon

  • irregular heartbeat and impaired movement control.

Unknown

  • 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 the hard capsules:

Frequent

  • fever
  • severe confusion
  • urinary incontinence (inability to properly control urination)

Uncommon

  • hyperactivity (high level of activity, restlessness)

Frequency not known

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

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

If these symptoms occur, contact your doctor as you may require medical assistance.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, 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 stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Kern Pharma hard capsules

  • The active substance 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 rivastigmine hydrogen tartrate equivalent to 1.5 mg of rivastigmine.

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

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

Each Rivastigmina 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

  • Rivastigmina Kern Pharma 1.5 mg hard capsules contain a whitish to slightly yellow powder in a capsule with yellow cap and body, with a red imprint "R 1.5" on the body.

  • Rivastigmina Kern Pharma 3.0 mg hard capsules contain a whitish to slightly yellow powder in a capsule with orange cap and body, with a red imprint "R 3.0" on the body.

  • Rivastigmina Kern Pharma 4.5 mg hard capsules contain a whitish to slightly yellow powder in a capsule with red cap and body, with a white imprint "R 4.5" on the body.

  • Rivastigmina Kern Pharma 6.0 mg hard capsules contain a whitish to slightly yellow powder in a capsule with red cap and orange body, with a red imprint "R 6.0" on the body.

It is packaged in blister packs and available in three different pack sizes (28, 56 and 112 capsules).

Only certain pack sizes may be commercially available.

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”