Rivastigmine Normon 2 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmine Normon 2 mg/ml oral solution EFG

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 should not be given to others, even if they have the same symptoms, as it may harm them.

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

Leaflet contents:

1. What Rivastigmine Normon is and what it is used for
2. What you need to know before taking Rivastigmine Normon
3. How to take Rivastigmine Normon
4. Possible side effects
5. How to store Rivastigmine Normon
6. Contents of the pack and other information

1. What Rivastigmina Normon is and what it is used for

Rivastigmina belongs to a group of substances called cholinesterase inhibitors.

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

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

2. What you need to know before starting to take Rivastigmina Normon

Do not take Rivastigmina Normon 2 mg/ml if:

• you are allergic to rivastigmine or to any of the other ingredients of this medicine.
• you have severe liver problems.

? Take special care with Rivastigmina Normon:

• 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 have not taken this medicine for several days, do not take the next dose until you have spoken with your doctor.
• 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 while you are on treatment.

The use of this medicine is not recommended in children and adolescents (under 18 years of age).

?Other medicines and Rivastigmina Normon

In general, you can continue using other medicines. However, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

If you need to undergo surgery while taking this medicine, inform your doctor before being given any anaesthetic, as this medicine may intensify the effects of certain muscle relaxants used during anaesthesia.

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

? Pregnancy and breast-feeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

It is preferable to avoid using this medicine during pregnancy unless clearly necessary. Inform your doctor if you become pregnant during treatment.

Breast-feeding

Women being treated with this medicine should not breast-feed their children.

? Driving and use of 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. Rivastigmine may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, do not drive or operate machinery.

? Rivastigmina Normon contains sodium benzoate (E-211) and sodium

This medicine contains 0.90 mg of benzoic acid salt per ml.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially “sodium-free”.

3. How to take Rivastigmina Normon

Follow exactly the instructions for use of this medicine given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Using the syringe, draw up the amount of this medicine prescribed by your doctor from the vial. Each dose of this medicine can be taken directly from the syringe.

This medicine should 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 how you respond to treatment. The maximum dose to be taken is 6 mg twice a day. If you have not taken this medicine for several days, do not take the next dose until you have spoken with your doctor.

To achieve the desired effect, you must take this medicine every day.

Inform your caregiver that you are taking this medicine.

This medicine must only be prescribed by a specialist, and your doctor should 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 Normon than you should

Inform your doctor if you have accidentally taken a higher dose than indicated. You may require medical attention. Some people who have accidentally taken excessively high doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. It may also cause slower heart rate and fainting.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

? If you forget to take Rivastigmina Normon

Do not take a double dose to make up for missed doses.

If you forget to take your dose of Rivastigmina Normon, wait and take the next dose at the usual time. If you have missed several doses, you should consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Common (affects between 1 and 10 in 100 patients): heartburn, stomach pain, headache, restlessness, confusion, weakness, fatigue, sweating, malaise, weight loss, tremor, and nightmares.

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

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

• Very rare (affects fewer than 1 in 10,000 patients): gastrointestinal bleeding (blood in stools or vomit), urinary tract infection, pancreatitis (severe pain in the upper abdomen, often accompanied by nausea and vomiting), severe vomiting which may lead to oesophageal rupture (part of the digestive tract connecting the mouth to the stomach), 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): severe vomiting which may lead to oesophageal rupture (part of the digestive tract connecting the mouth to the stomach), 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 certain adverse effects more frequently, as well as additional adverse effects: tremor (very common), difficulty sleeping, anxiety, agitation, 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 motor 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 effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Normon

Keep out of sight and reach of children.

No special storage conditions are required. Do not refrigerate or freeze.

Keep in an upright position.

Do not use Rivastigmina Normon after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated. Use Rivastigmina Normon within the month following the first opening of the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Normon

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

Appearance of the product and contents of the pack:

Rivastigmina Normon is a yellow, transparent solution. Each pack contains 1 bottle of 120 ml.

Instructions for use:

1. Remove the oral dosing syringe and insert the syringe cannula into the stopper's opening.
2. Draw from the bottle the amount of Rivastigmina Normon indicated by the physician.
3. Before removing the syringe containing the prescribed dose from the bottle, remove large air bubbles by moving the plunger back and forth. The presence of a few small bubbles is unimportant and does not affect the dose in any way.
4. Take Rivastigmina Normon directly from the syringe or first mix it with a small amount of water. Stir and drink the entire mixture.
5. After use, clean the outside of the syringe with a clean cloth. Close the bottle.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: January 2025

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