Introduction

Prospect: information for the user

Rivastigmina NORMON 4.5 mg hard capsules EFG

Read this prospect carefully before starting to take the medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

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

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

3.How to take Rivastigmina NORMON

4.Possible adverse effects

5.Storage of Rivastigmina NORMON

6.Contents of the package and additional information

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

Rivastigmina NORMON belongs to the group of substances known as cholinesterase inhibitors.

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

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

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

Before taking Rivastigmina NORMON, it is essential that you read the following information and discuss any questions with your doctor.

?Do not take Rivastigmina NORMON

if you are allergic (hypersensitive) to rivastigmina (the active ingredient in Rivastigmina NORMON) or to any of the other components of Rivastigmina NORMON listed in section 6 of this prospectus.

If you are in any of these situations, inform your doctor and do not take Rivastigmina.

?Be especially careful with Rivastigmina NORMON

if you have or have had any irregular or slow heart rhythm
if you have or have had any active stomach ulcer
if you have or have had any difficulty urinating
if you have or have had any seizures
if you have or have had any asthma or severe respiratory disease
if you have or have had any kidney function deterioration
if you have or have had any liver function deterioration
if you suffer from tremors
if you have a low body weight
if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea are prolonged.

If you are in any of these situations, your doctor may consider the need for closer monitoring while you are on treatment.

If you have not taken Rivastigmina NORMON for several days, do not take the next dose until you have consulted your doctor.

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

Use of Rivastigmina NORMON with other medications

Inform your doctor or pharmacist that you are using, have used, or may need to use any other medication, including those purchased without a prescription.

Rivastigmina NORMON should not be administered at the same time as other medications with similar effects. Rivastigmina NORMON may interact with anticholinergic medications (used to relieve muscle cramps or stomach spasms, for the treatment of Parkinson's disease, or to prevent travel sickness).

If you need to undergo surgery while taking Rivastigmina NORMON, inform your doctor before any anesthetic is administered, as Rivastigmina NORMON may exaggerate the effects of some muscle relaxants during anesthesia.

Pregnancy and breastfeeding

Inform your doctor if you become pregnant during treatment. It is preferable to avoid the use of Rivastigmina NORMON during pregnancy, unless it is clearly necessary.

You should not breastfeed your children during treatment with Rivastigmina NORMON.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

3. How to Take Rivastigmina NORMON

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to start treatment

Your doctor will tell you what dose of Rivastigmina NORMON you should take.

Normally, treatment starts with a low dose.
Your doctor will gradually increase the dose depending on how you respond to treatment.
The highest dose you should take is 6.0 mg twice a day.

Your doctor will regularly check if the medication is working for you. Your doctor will also monitor your weight while you are taking this medication.

If you have not taken Rivastigmina NORMON for several days, do not take the next dose until you have consulted your doctor.

Taking this medication
- Inform your caregiver that you are taking Rivastigmina NORMON.
- To benefit from your medication, take it every day.
- Take Rivastigmina NORMON twice a day (in the morning and at night), with meals.
- Swallow the capsule whole with liquid.
- Do not open or crush the capsule.

If you take moreRivastigmina NORMONthan you should

If you accidentally take more Rivastigmina NORMON than you should, inform your doctor. You may require medical attention. Some people who have taken accidentally higher doses have experienced dizziness (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. It may also cause a slowing of heart rate and fainting.

However, in case of overdose or accidental ingestion, go to a medical center or consult the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

If you forget to takeRivastigmina NORMON

If you forget your dose of Rivastigmina NORMON, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

4. Possible Adverse Effects

Like all medicines, Rivastigmina NORMON may cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Side effects usually disappear gradually as your body gets used to the medicine.

Frequencies are defined as:

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 dizziness (nauseas), vomiting, diarrhea

Common

Anxiety
Sweating
Headache
Heartburn
Weight loss
Stomach pain
Restlessness
Feeling tired or weak
General feeling of discomfort
Trembling or feeling confused
Nightmares

Uncommon

Depression
Difficulty sleeping
Blackouts or accidental falls
Changes in liver function

Rare

Chest pain
Rash, itching
Seizures (convulsions)
Ulcers in the stomach or intestine

Very rare

High blood pressure
Urinary tract infection
Seeing things that do not exist (hallucinations)
Problems with heart rhythm such as rapid or slow heart rate
Gastrointestinal bleeding: presents as blood in the stool or vomiting blood
Pancreatitis: symptoms include severe pain in the upper abdomen, often with dizziness (nauseas) or vomiting
Worsening of Parkinson's disease symptoms or development of similar symptoms, such as muscle stiffness, difficulty moving

Not known

Intense vomiting that may cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus)
Dehydration (loss of a large amount of fluid)
Hepatic disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
Aggression, feeling of restlessness
Irregular heart rhythm
Torticollis (condition that involves involuntary muscle contraction and abnormal inclination of the body and head to one side)

Patients with dementia or Parkinson's disease

These patients experience some side effects more frequently and also have some additional side effects:

Very common

Trembling

Common

Anxiety
Feeling of unease
Bradycardia
Difficulty sleeping
Excessive salivation and dehydration
Abnormally slow or uncontrolled movements
Worsening of Parkinson's disease symptoms or development of similar symptoms, such as muscle stiffness, difficulty moving.

Uncommon

Irregular heart rhythm and loss of movement control

Other side effects observed in rivastigmine transdermal patches and that may appear with hard capsules:

Common

Fever
Severe confusion

Not known

Torticollis (condition that involves involuntary muscle contraction and abnormal inclination of the body and head to one side)

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

5. Conservation of Rivastigmina NORMON

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment..

6. Contents of the packaging and additional information

Composition of Rivastigmina NORMON

- The active ingredient is rivastigmina hydrogentartrate. Each hard capsule of Rivastigmina NORMON 4.5 mg hard capsules contains 4.5 mg of rivastigmina.

- The other components are microcrystalline cellulose, hypromellose, magnesium stearate, and colloidal silica. The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the product and contents of the packaging

Rivastigmina NORMON 4.5 mg hard capsules are brown/brown hard capsules containing a white or almost white powder. They are presented in packs of 56 and 112 hard capsules.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Rivastigmina NORMON 1.5 mg hard capsules EFG.

Rivastigmina NORMON 3 mg hard capsules EFG.

Rivastigmina NORMON 6 mg hard capsules EFG.

Last review date of this leaflet January 2025

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