RASAGILINE NORMON 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Normon 1 mg tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Rasagiline Normon and what is it used for
2. What you need to know before taking Rasagiline Normon
3. How to take Rasagiline Normon
4. Possible side effects
5. Storage of Rasagiline Normon
6. Contents of the pack and further information

1. What is Rasagiline Normon and what is it used for

Rasagiline Normon contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of cells that produce dopamine in the brain.

Dopamine is a brain chemical involved in controlling movement. Rasagiline Normon helps to increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagiline Normon

Do not take Rasagiline Normon

• If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6)
• If you have severe liver problems

Do not take the following medicines while taking Rasagiline Normon:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You should wait at least 14 days after stopping treatment with Rasagiline Normon before starting treatment with MAOIs or pethidine.

Warnings and precautions

Talk to your doctor before starting Rasagiline Normon.

• If you have any liver problems
• You should discuss any suspicious changes in your skin with your doctor. Treatment with Rasagiline Normon may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/caregiver notice that you are presenting unusual behaviors where you cannot resist the impulse, urge, or desire to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking Rasagiline Normon and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline Normon may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you want more information, see the section "Driving and using machines".

Children and adolescents

The use of Rasagiline Normon in children and adolescents is not appropriate. Therefore, Rasagiline Normon is not recommended for people under 18 years of age.

Other medicines and Rasagiline Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor especially if you are taking any of the following medicines:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used against infections
• The cough suppressant dextromethorphan
• Sympathomimetics such as those found in eye drops, nasal decongestants, and oral and anti-cough medicines that contain ephedrine or pseudoephedrine.

The use of Rasagiline Normon with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline Normon, you should wait at least 5 weeks after stopping treatment with fluoxetine.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping treatment with Rasagiline Normon.

Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may decrease the amount of Rasagiline Normon in your blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should avoid taking Rasagiline Normon if you are pregnant, as the effects of Rasagiline Normon on pregnancy and the fetus are unknown.

Driving and using machines

Talk to your doctor before driving or using machines, as both Parkinson's disease and treatment with Rasagiline Normon can affect your ability to perform these activities. Rasagiline Normon may cause dizziness or drowsiness, as well as sudden episodes of sleep.

This may increase if you take other medicines for Parkinson's disease symptoms, if you take medicines that can cause drowsiness, or if you consume alcohol during treatment with Rasagiline Normon. If you have experienced drowsiness and/or sudden episodes of sleep before or during treatment with Rasagiline Normon, do not drive or use machines (see section 2).

3. How to take Rasagiline Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Rasagiline Normon is 1 tablet of 1 mg taken by mouth, once a day. Rasagiline Normon can be taken with or without food.

If you take more Rasagiline Normon than you should

If you think you have taken more Rasagiline Normon tablets than you should, tell your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

In any case, take the Rasagiline Normon package with you to show it to your doctor or pharmacist.

The symptoms reported after an overdose of Rasagiline Normon were mildly euphoric mood (mild mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagiline Normon

Do not take a double dose to make up for forgotten doses. Take the next normal dose when it is due.

If you stop taking Rasagiline Normon

Do not stop taking Rasagiline Normon without consulting your doctor first.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediatelyif you experience any of the following symptoms. You may need treatment or urgent medical attention:

• If you experience unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).

• Any combination of hallucinations, fever, agitation, tremor, and sweating (serotonin syndrome).

Contact your doctorif you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).

Other side effects

Very common (may affect more than 1 in 10 people)

• Involuntary movements (dyskinesia).
• Headache.

Common (may affect up to 1 in 10 people)

• Abdominal pain.
• Falls.
• Allergic reactions.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up with symptoms such as dizziness/lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal blood test results (leukopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination difficulties (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Blistering rash (vesiculobullous rash).

Frequency not known: cannot be estimated from the available data

• High blood pressure.
• Excessive drowsiness.
• Sudden sleep.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Normon

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rasagiline Normon

• The active substance is rasagiline.

Each tablet contains 1 mg of rasagiline (as tartrate).

• The other ingredients are: mannitol (E 421), corn starch, pregelatinized corn starch, colloidal anhydrous silica, stearic acid, and talc.

Appearance of the product and pack contents

Rasagiline Normon tablets are white or almost white, round, flat, and unmarked.

Each pack contains 30 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this package leaflet:October 2024

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