Rivastigmine Normon 4,5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmina NORMON 4.5 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet.

Leaflet contents:

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

2. What you need to know before taking Rivastigmina NORMON

3. How to take Rivastigmina NORMON

4. Possible side effects

5. How to store Rivastigmina NORMON

6. Contents of the pack and other information

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

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

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

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

2. What you need to know before starting Rivastigmina NORMON

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

? Do not take Rivastigmina NORMON

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

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

? Take special care with Rivastigmina 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 a serious respiratory disease
• if you have or have ever had (impairment) of kidney function
• if you have or have ever had (impairment) of liver function
• if you suffer from tremors
• if you have low body weight
• if you experience gastrointestinal reactions such as feeling dizzy (nausea), vomiting, and diarrhea. You could become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

If you are in any of these situations, your doctor may consider it necessary to carry out 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.

The use of Rivastigmina NORMON is not recommended in children or adolescents (under 18 years of age).

• Use of Rivastigmina NORMON with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

If you need to undergo surgery while taking Rivastigmina NORMON, inform your doctor before you are given any anesthetic, as Rivastigmina NORMON may exaggerate the effects of certain 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 clearly necessary.

You must not breastfeed while being treated with Rivastigmina NORMON.

Consult your doctor or pharmacist before using any medicine.

• Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Rivastigmina NORMON may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. 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 medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Starting treatment

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

• Treatment is usually started at a low dose.
• Your doctor will gradually increase your dose depending on how you respond to treatment.
• The highest dose you will take is 6.0 mg twice daily.

Your doctor will regularly monitor whether the medicine is working for you. Your doctor will also monitor your weight while you are taking this medicine.

If you have not taken Rivastigmina 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 Rivastigmina NORMON.
  • To benefit from your medicine, 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 more Rivastigmina NORMON than you should

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

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

• If you forget to take Rivastigmina NORMON

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

4. Possible adverse effects

Like all medicines, Rivastigmine NORMON can produce adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will gradually disappear as your body gets used to the medicine.

Frequencies are defined as follows:

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 nausea, vomiting, diarrhoea

Common

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• Feeling generally unwell
• Tremor or confusion
• Nightmares

Uncommon

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

Rare

• Chest pain
• Skin rash, itching
• Epileptic seizures (convulsions)
• Ulcers in the stomach or intestine

Very rare

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm problems such as fast or slow heartbeat
• Gastrointestinal bleeding: manifested as blood in stools or in vomit
• Inflammation of the pancreas: signs include severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms, such as muscle rigidity, difficulty performing movements

Frequency not known

• Severe vomiting which may cause a tear in the part of the digestive tract connecting the mouth to the stomach (oesophagus)

• Dehydration (loss of large amounts of fluid)

• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite)

• Aggressiveness, feeling of restlessness

• Irregular heartbeat

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

• Patients with dementia or Parkinson's disease

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

Very common

• Tremor

Common

• Anxiety
• Restlessness
• Slow heart rate
• Difficulty sleeping
• Excessive salivation and dehydration
• Abnormally slow movements or movements that cannot be controlled
• Worsening of Parkinson's disease symptoms or development of similar symptoms, such as muscle rigidity, difficulty performing movements

Uncommon

• Irregular heartbeat and poor movement control

Frequency not known

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

Other adverse effects observed with rivastigmine transdermal patches and which may also occur with hard capsules:

Common

• Fever
• Severe confusion

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. 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 Rivastigmina NORMON 4.5 mg hard capsule contains 4.5 mg of rivastigmine.
• The other components are microcrystalline cellulose, hypromellose, magnesium stearate and colloidal silicon dioxide. The gelatin capsule shell consists 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 pack

Rivastigmina NORMON 4.5 mg hard capsules are brown/brown hard capsules containing 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

Rivastigmina NORMON 1.5 mg hard capsules EFG.

Rivastigmina NORMON 3 mg hard capsules EFG.

Rivastigmina NORMON 6 mg hard capsules EFG.

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

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