RIVASTIGMINE NORMON 2 mg/ml ORAL SOLUTION

2. What you need to know before taking Rivastigmine Normon

Do not take Rivastigmine Normon 2 mg/ml if:

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

Be cautious with Rivastigmine Normon:

• if you have or have had kidney or liver function disorders, irregular or slow heart rhythm, active stomach ulcers, asthma or severe respiratory disease, difficulty urinating or epileptic seizures (attacks or convulsions), your doctor may need to monitor you more closely while you are being treated.
• if you have not taken this medication for several days, do not take the next dose until you have spoken to 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 perform closer monitoring while you are being treated.

This medication is not recommended for use in children or adolescents (under 18 years of age).

Other medications and Rivastigmine Normon

In general, you can continue to use other medications. However, inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

In case you need to undergo surgery (operation) while taking this medication, inform your doctor before any anesthetic is administered, as this medication may enhance the effects of some muscle relaxants during anesthesia.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

Breastfeeding

Women being treated with this medication should not breastfeed their children.

Driving and using machines

Your illness may affect your ability to drive or use machinery, and you should not perform these activities unless your doctor indicates that it is safe to do so. Rivastigmine may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Rivastigmine Normon contains sodium benzoate (E-211) and sodium

This medication contains 0.90 mg of benzoic acid salt in each ml.

This medication contains less than 1 mmol of sodium (23mg) per ml; that is, it is essentially "sodium-free".

3. How to take Rivastigmine Normon

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Using the oral dosing syringe, extract the amount indicated by your doctor from the vial. Each dose of this medication can be taken directly from the syringe.

This medication should be taken twice a day with meals (in the morning and at night).

Your doctor will indicate what 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 that should be taken is 6 mg twice a day. If you have not taken this medication for several days, do not take the next dose until you have spoken to your doctor.

In order for this medication to have the desired effect, you must take it every day.

Inform your caregiver that you are taking this medication.

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

If you take more Rivastigmine 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 too high doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. It can also cause slower heart rate and fainting.

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

If you forget to take Rivastigmine Normon

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The tendency to notice side effects is more frequent when starting treatment or increasing the dose. The side effects will disappear gradually as your body gets used to the medication.

• Very common (affect more than 1 in 10 patients): dizziness, nausea, vomiting, diarrhea, and loss of appetite.
• Common (affect between 1 and 10 in 100 patients): heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, general malaise, weight loss, tremors, and nightmares.
• Uncommon (affect between 1 and 10 in 1,000 patients): depression, difficulty sleeping, changes in liver function, fainting or accidental falls.

• Rare (affect between 1 and 10 in 10,000 patients): chest pain, epileptic seizures (attacks or convulsions), skin rash, gastric and intestinal ulcers.
• Very rare (affect less 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 that can cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach), heart rhythm problems (fast or slow heart rate), high blood pressure, hallucinations, worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving).
• Frequency not known (cannot be estimated from available data): severe vomiting that can cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach), Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side).

Patients with dementia associated with Parkinson's disease experience some side effects more frequently, as well as additional side effects: tremors (very common), difficulty sleeping, anxiety, restlessness, worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving), abnormally slow or uncontrolled movements, slow heart rate, excessive saliva, and dehydration (common), irregular heart rate and loss of movement control (uncommon), Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side) (not known).

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

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

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 is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivastigmine 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 Rivastigmine Normon after the expiration date stated on the packaging after Exp. The expiration date is the last day of the month indicated. Use Rivastigmine Normon in the month following the first opening of the vial.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rivastigmine Normon

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

Appearance of the product and pack contents:

Rivastigmine Normon is a clear yellow solution. Each pack contains 1 vial of 120 ml.

Instructions for use:

1. Remove the oral dosing syringe and insert the syringe cannula into the vial stopper.
2. Extract the amount of Rivastigmine Normon indicated by your doctor from the vial.
3. Before removing the syringe containing the dose indicated by your doctor from the vial, eliminate large air bubbles with alternating movements of the plunger. The presence of a few small air bubbles is of no importance and does not affect the dose in any way.
4. Take Rivastigmine Normon directly from the syringe or mix it with a little water first. Stir and drink the mixture completely.
5. After use, clean the outside of the syringe with a clean cloth. Close the vial.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this package leaflet:January 2025

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