Rivastigmine Kern Pharma 2 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmine Kern Pharma 2 mg/ml oral solution EFG

Rivastigmine (hydrogen tartrate)

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Rivastigmine Kern Pharma 2 mg/ml oral solution is and what it is used for
2. Before you take Rivastigmine Kern Pharma 2 mg/ml oral solution
3. How to take Rivastigmine Kern Pharma 2 mg/ml oral solution
4. Possible side effects
5. How to store Rivastigmine Kern Pharma 2 mg/ml oral solution
6. Further information

1. What Rivastigmina Kern Pharma 2 mg/ml oral solution is and what it is used for

Rivastigmine belongs to a group of substances known as cholinesterase inhibitors.

Rivastigmine is used to treat memory disorders in patients with Alzheimer's disease.

Rivastigmine is used to treat dementia in patients with Parkinson's disease.

2. Before taking Rivastigmina Kern Pharma 2 mg/ml oral solution

Before taking Rivastigmina Kern Pharma 2 mg/ml oral solution, it is important that you read the following information and discuss any questions with your doctor.

Do not take Rivastigmina Kern Pharma 2 mg/ml oral solution

• if you are allergic (hypersensitive) to rivastigmine or to any of the other components of Rivastigmina Kern Pharma 2 mg/ml oral solution,
• if you have severe liver problems.

Take special care with Rivastigmina Kern Pharma 2 mg/ml oral solution

• if you have or have ever had kidney or liver function impairment, irregular or slow heart rate, active stomach ulcer, asthma or a serious respiratory disease, difficulty urinating, or epileptic seizures (fits or convulsions), your doctor may need to monitor you more closely during treatment,
• if you experience gastrointestinal reactions such as nausea and vomiting,
• if you have low body weight,
• if you suffer from tremors.

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

The use of Rivastigmina Kern Pharma 2 mg/ml oral solution is not recommended in children or adolescents (under 18 years of age).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

If you need to undergo surgery while taking rivastigmine, inform your doctor before any anaesthetic is administered, as rivastigmine may exaggerate the effects of certain muscle relaxants used during anaesthesia.

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

Pregnancy and breastfeeding

Pregnancy:

If you are pregnant, think you may be pregnant, or become pregnant during treatment, you must inform your doctor before taking this medicine. It is preferable to avoid using this medicine during pregnancy unless strictly necessary.

Breastfeeding:

Breastfeeding is not recommended for women receiving rivastigmine treatment.

Driving and using machines

Your medical condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor has advised you that it is safe to do so. Rivastigmina Kern Pharma 2 mg/ml oral solution may cause dizziness and drowsiness, particularly at the start 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 Kern Pharma 2 mg/ml oral solution

Follow exactly the administration instructions for Rivastigmina Kern Pharma 2 mg/ml oral solution provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

For accurate dosing, the packaging contains an oral syringe with graduations. Using this syringe, draw the prescribed amount of rivastigmine from the bottle.

Insert the syringe into the perforated stopper, invert the bottle, pull the plunger until the liquid reaches the mg mark, return the bottle to its upright position, and remove the syringe.

The syringe should be cleaned and dried after each use.

Each dose of rivastigmine can be taken directly from the syringe.

Rivastigmine must be taken twice daily with meals (in the morning and at night).

Your doctor will determine the dose of rivastigmine you should take, starting treatment with a low dose and gradually increasing it depending on your response to treatment. The maximum dose to be taken is 6 mg twice daily. If you have not taken rivastigmine for several days, do not take the next dose until you have spoken with your doctor. To ensure your medicine produces the desired effect, you must take it every day.

Inform your caregiver that you are taking rivastigmine.

This medicine should only be prescribed by a specialist, and your doctor must periodically evaluate whether it is producing the desired effects. Your doctor will monitor your weight while you are taking this medicine.

If you take more Rivastigmina Kern Pharma 2 mg/ml oral solution than you should

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

If you forget to take Rivastigmina Kern Pharma 2 mg/ml oral solution

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 a missed dose.

4. Possible adverse effects

Like all medicines, Rivastigmina Kern Pharma 2 mg/ml oral solution can cause adverse effects, although not everyone experiences them.

The likelihood of experiencing adverse effects is higher when starting treatment or increasing the dose. These adverse effects will likely diminish gradually as your body adjusts to the medicine.

The frequencies of adverse effects are:

Very common adverse effects (affect more than 1 in 10 patients): dizziness, nausea, vomiting, diarrhoea, and loss of appetite.

Common adverse effects (affect between 1 and 10 in 100 patients): heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, malaise, weight loss, nightmares, and tremor.

Uncommon: (affect between 1 and 10 in 1,000 patients): patients have reported depression, difficulty sleeping, changes in liver function, fainting, or accidental falls.

Rare (affect between 1 and 10 in 10,000 patients): patients have experienced chest pain, epileptic seizures (fits or convulsions), skin rash, gastric and intestinal ulcers.

Very rare (affect fewer than 1 in 10,000 patients): patients have experienced gastrointestinal haemorrhage (blood in stools or vomit), urinary tract infection, pancreatitis (severe upper abdominal pain, often accompanied by nausea and vomiting), heart rhythm problems (fast or slow heartbeat), high blood pressure, hallucinations, worsening of Parkinson’s disease or development of similar symptoms (muscle rigidity, difficulty performing movements).

Frequency not known (cannot be estimated from available data): Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side), severe vomiting which may lead to oesophageal rupture (part of the digestive tube connecting the mouth to the stomach).

Patients with dementia associated with Parkinson’s disease may experience some adverse effects more frequently, as well as additional adverse effects: tremor (very common), difficulty sleeping, anxiety, restlessness, worsening of Parkinson’s disease or development of similar symptoms (muscle rigidity, difficulty performing movements), abnormally slow or uncontrolled movements, slow heartbeat, excessive salivation, and dehydration (common), irregular heartbeat and impaired movement control (uncommon), Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side, frequency not known).

If any of these symptoms occur, contact your doctor, as medical attention may be required.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can 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 Kern Pharma 2 mg/ml oral solution

Keep out of the reach and sight of children.

Do not use Rivastigmina Kern Pharma 2 mg/ml oral solution after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

No special storage conditions are required. Use Rivastigmina Kern Pharma 2 mg/ml oral solution within one month after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Additional information

Composition of Rivastigmine Kern Pharma 2 mg/ml oral solution

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine base.
• The other components are sodium benzoate (E-211), quinoline yellow water-soluble dye (E-104), and purified water.

Appearance of the product and contents of the container

Rivastigmine Kern Pharma 2 mg/ml oral solution is a yellow, clear solution (2.0 mg/ml rivastigmine base) supplied in 120 ml amber glass bottles with child-resistant closure. An oral dosing syringe is included with the oral solution.

Marketing Authorization Holder

Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain

Manufacturer

Industria Química y Farmacéutica Vir, S.A
C/ Laguna 66-68-70, Pol.Industrial Urtinsa II
Alcorcón, Madrid

This leaflet was last approved in: December 2024

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