RIVASTIGMINE NORMON 4.5 mg HARD CAPSULES

2. What you need to know before you take Rivastigmine NORMON

Before taking Rivastigmine NORMON, it is important that you read the following information and discuss any doubts with your doctor.

? Do not take Rivastigmine NORMON

• if you are allergic (hypersensitive) to rivastigmine (the active ingredient of Rivastigmine NORMON) or to any of the other ingredients of Rivastigmine NORMON listed in section 6 of this leaflet.

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

? Take special care with Rivastigmine NORMON

• if you have or have ever had an irregular or slow heart rate (pulse)
• if you have or have ever had an active stomach ulcer
• if you have or have ever had difficulty urinating
• if you have or have ever had seizures
• if you have or have ever had asthma or severe respiratory disease
• if you have or have ever had kidney function impairment
• if you have or have ever had liver function impairment
• if you suffer from tremors
• if you have low body weight
• if you have gastrointestinal reactions such as a feeling of dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in any of these situations, your doctor may consider it necessary to monitor you more closely while you are taking this medicine.

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

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

• Using Rivastigmine NORMON with other medicines

Tell your doctor or pharmacist that you are using, have used, or may need to use any other medicine, including those obtained without a prescription.

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

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

• Pregnancy and breastfeeding

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

You should not breastfeed your child while taking Rivastigmine NORMON.

Consult your doctor or pharmacist before using any medicine.

• Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Rivastigmine NORMON may cause dizziness and drowsiness, mainly at the start of treatment or when the dose is increased. If you experience these effects, do not drive or use machines.

3. How to take Rivastigmine NORMON

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• How to start treatment

Your doctor will tell you what dose of Rivastigmine NORMON to 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 medicine is working for you. Your doctor will also check your weight while you are taking this medicine.

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

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

• If you take more Rivastigmine NORMON than you should

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

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

• If you forget to take Rivastigmine NORMON

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

4. Possible side effects

Like all medicines, Rivastigmine NORMON can cause side effects, although not everybody gets them.

You may have side effects more often when you start your treatment or when your dose is increased. Generally, side effects will slowly disappear as your body gets used to the medicine.

Frequencies are defined as:

Very common (affect more than 1 in 10 patients)

Common (affect between 1 and 10 in 100 patients)

Uncommon (affect between 1 and 10 in 1,000 patients)

Rare (affect between 1 and 10 in 10,000 patients)

Very rare (affect less than 1 in 10,000 patients)

Frequency not known (cannot be estimated from the available data)

Very common

• Feeling of dizziness
• Lack of appetite
• Stomach problems such as a feeling of dizziness (nausea), vomiting, diarrhea

Common

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling of restlessness
• Feeling of tiredness or weakness
• Feeling of general discomfort
• Tremor or feeling of confusion
• Nightmares

Uncommon

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

Rare

• Chest pain
• Skin rash, itching
• Seizures (convulsions)
• Ulcers in your stomach or intestine

Very rare

• High blood pressure
• Urinary tract infection
• Seeing things that do not exist (hallucinations)
• Heart rate problems such as fast or slow heart rate
• Gastrointestinal bleeding: it manifests as blood in the stool or when vomiting
• Pancreatitis: the signs include severe pain in the upper part of the stomach, often with a feeling of dizziness (nausea) or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms, such as muscle stiffness, difficulty moving

Not known

• Severe vomiting that can cause a tear in the digestive tube that connects your mouth to your stomach (esophagus)
• Dehydration (loss of a large amount of fluid)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling of restlessness
• Irregular heart rate
• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting 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

• Tremor

Common

• Anxiety
• Feeling of restlessness
• Slow heart rate
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow movements or movements that you cannot control
• Worsening of Parkinson's disease symptoms or development of similar symptoms, such as muscle stiffness, difficulty moving.

Uncommon

• Irregular heartbeat and loss of movement control

Not known

• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side)

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

Common

• Fever
• Severe confusion

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Rivastigmine NORMON

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

Composition of Rivastigmine NORMON

• The active substance is rivastigmine hydrogen tartrate. Each Rivastigmine NORMON 4.5 mg hard capsule contains 4.5 mg of rivastigmine.
• The other ingredients 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 pack contents

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

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Rivastigmine NORMON 1.5 mg hard capsules EFG.

Rivastigmine NORMON 3 mg hard capsules EFG.

Rivastigmine NORMON 6 mg hard capsules EFG.

Date of last revision of this leaflet May 2025

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