Package Insert: Information for the User

Rivastigmina Normon 2 mg/ml Oral Solution

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others who have the same symptoms, as it may harm them.

• Inform your doctor or pharmacist if you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert.

Rivastigmina belongs to a group of substances called cholinesterase inhibitors.

Rivastigmina is used for the treatment of memory disorders in patients with Alzheimer's disease.

Rivastigmina is used for the treatment of dementia in patients with Parkinson's disease.

Do not take RivastigminaNormon2mg/mlif:

• if you are allergic to rivastigmina or any of the other components of this medication.
• if you have severe liver problems.

?Be especially careful with RivastigminaNormon:

• if you have or have had any time kidney or liver function abnormalities, irregular or slow heart rhythm, active stomach ulcer, asthma or severe respiratory disease, difficulty urinating or seizures, 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 with your doctor.
• if you experience gastrointestinal reactions such as nausea and vomiting.
• if you have a low body weight.
• if you are experiencing tremors.

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.

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

?Other medications and Rivastigmina 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, even those obtained without a prescription.

If you need to undergo surgery (operation) while taking this medication, inform your doctor before any anesthetic is administered, as this medication may exaggerate 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 cramps or stomach spasms, to treat Parkinson's disease or to prevent motion sickness).

?Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

It is preferable to avoid the use of 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 operating machinery

Your condition may affect your ability to drive or operate machinery and you should not engage in these activities unless your doctor tells you it is safe to do so. Rivastigmina may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

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

This medication contains 0.90 mg of sodium benzoate in each ml.

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

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

Using the syringe, extract the amount of medication indicated by your doctor from the bottle. 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 how much rivastigmina you should take, starting with a low dose and gradually increasing it depending on how you respond to the treatment. The maximum dose you should take 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 with your doctor.

To achieve the desired effect, you must take this medication 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 is exerting the desired effects. Your doctor will monitor your weight while you are taking this medication.

? If you take more Rivastigmina Normon than you should

Inform your doctor if you have accidentally taken a dose higher 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 may also cause slower heart rate and dizziness.

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

? If you forgot to take Rivastigmina Normon

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medicationmay 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. Side effects will likely disappear gradually as your body becomes accustomed to the medication.

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

-Common (affects between 1 and 10 per 100 patients): heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, general discomfort, weight loss, tremors, and nightmares.

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

-Rare (affects between 1 and 10 per 10,000 patients): chest pain, epileptic seizures (attacks or convulsions), skin rash (skin eruption), gastric and intestinal ulcers.

-Very rare (affects fewer than 1 in 10,000 patients): gastrointestinal bleeding (blood in stool or vomit), urinary tract infection, pancreatitis (severe pain in the upper abdomen, often accompanied by nausea and vomiting), severe vomiting that may cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach), cardiac 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).

-Unknown frequency (cannot be estimated from available data): severe vomiting that may cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach),Pisa syndrome (condition characterized by involuntary muscle contraction and abnormal inclination of the body and head to one side).

Patients with dementia associated with Parkinson's disease experience some side effects more frequently and 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 rhythm, and poor motor control (uncommon), Pisa syndrome (condition characterized by involuntary muscle contraction and abnormal inclination of the body and head to one side) (unknown).

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated. Use Rivastigmina Normon in the month following the first opening of the bottle.

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

Composition of Rivastigmina N ormon

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

Appearance of the product and contents of the packaging:

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

Instructions for use:

1. Extract the oral dosing syringe and insert the cannula of the syringe into the stopper opening.
2. Extract from the bottle the amount of Rivastigmina Normon indicated by the doctor.
3. Before removing the syringe containing the dose indicated by the doctor from the bottle, eliminate large bubbles with alternating movements of the plunger. The presence of some small bubbles is of no importance and does not affect the dose in any way.
4. Take Rivastigmina Normon directly from the syringe or mixed first with a little water. Stir and drink the mixture completely.
5. After using it, clean the exterior of the syringe with a clean cloth. Close the bottle.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

Date of the last review of this prospectus: January 2025

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