Rasagiline Normon 1 mg tablets EFG

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rasagilina Normon 1 mg tablets 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Rasagilina Normon contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).

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

Dopamine is a chemical compound in the brain involved in the control of movement. Rasagilina Normon helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Normon

Do not take Rasagilina Normon

• If you are allergic to rasagiline or to 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 Rasagilina Normon:

• Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including over-the-counter medicines and herbal products, such as St. John's wort.
• Meperidine (a strong painkiller).

You must wait at least 14 days after stopping treatment with Rasagilina Normon before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions

Talk to your doctor before starting to take Rasagilina Normon:

• If you have any liver problems
• You should speak to your doctor about any suspicious changes in your skin. Treatment with Rasagilina Normon might possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors that you cannot resist the impulse, urge, or craving to carry out harmful or damaging activities to yourself or others. These are known as impulse control disorders. In patients taking Rasagilina Normon and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behavior, and abnormally high sex drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagilina Normon may cause drowsiness and may cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, see section "Driving and use of machines".

Children and adolescents

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

Other medicines and Rasagilina Normon

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

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

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used for infections
• The cough suppressant dextromethorphan
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.

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

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

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

Inform your doctor or pharmacist if you are using or plan to stop smoking. Smoking may reduce the amount of Rasagilina Normon in your blood.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and use of machines

Talk to your doctor before driving or operating machinery, as both Parkinson's disease and treatment with Rasagilina Normon may affect your ability to perform these activities. Rasagilina Normon may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.

This risk may increase if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking medicines that may cause drowsiness, or if you consume alcohol during treatment with Rasagilina Normon. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Rasagilina Normon, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Normon

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose of Rasagilina Normon is 1 tablet of 1 mg taken orally once daily. Rasagilina Normon may be taken with or without food.

If you take more Rasagilina Normon than you should

If you think you have taken more tablets of Rasagilina Normon than you should, inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

In any case, bring the Rasagilina Normon packaging with you to show to the doctor or pharmacist.

Symptoms reported after an overdose of Rasagilina Normon included slightly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagilina Normon

Do not take a double dose to make up for missed doses. Take the next dose as scheduled.

If you stop taking Rasagilina Normon

Do not stop treatment with Rasagilina Normon without first consulting your doctor.

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 everyone will experience them.

Contact your doctor immediately if you experience any of the following symptoms. You may need urgent medical treatment or care:

• If you have unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, or abnormally increased sex drive 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, restlessness, tremor, and sweating (serotonin syndrome).

Contact your doctor if 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.
• Allergy.
• Fever.
• Flu (influenza).
• General discomfort.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness or lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Changes in blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Difficulty with muscle coordination (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Runny nose (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 available data

• High blood pressure.
• Excessive sleepiness.
• Sudden sleep attacks.

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Normon

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Normon

• The active substance is Rasagilina.

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

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

Appearance of the product and contents of the pack

Rasagilina 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 the most recent review of this leaflet: October 2024

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