Package Leaflet: Information for the User

Rasagilina Normon 1 mg Tablets EFG

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

• Keep this leaflet, as 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

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

Do not take Rasagilina Normon

• If you are allergic to rasagilina or any of the other components of this medication (listed in section 6)
• If you have severe liver problems

Do not take the following medications while taking Rasagilina Normon:

• Monamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without a prescription, e.g. St. John's Wort.
• Petidina (a potent analgesic).

You should wait at least 14 days after stopping treatment with Rasagilina Normon and starting treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor before starting to takeRasagilina Normon.

- If you have any liver problems

- You should speak with your doctor about any suspicious changes in your skin. Treatment with Rasagilina Normon may possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, the urgent need or the anxiety to perform certain harmful or detrimental activities for yourself or for others. These are known as impulse control disorders. In patients taking Rasagilina Normon and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, ludomania, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts or feelings have been observed. Your doctor may need to adjust or discontinue your dose (see section 4).

Rasagilina Normon maycause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medications (used to treat Parkinson's disease). If you want more information, see the section “Driving and operating machines”.

Children and adolescents

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

Other medications and Rasagilina Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor especially if you are taking any of the following medications:

- Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, or tetracyclic antidepressants).

- The antibiotic ciprofloxacino used against infections

- The antitussive dextrometorfano

- Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing efedrina or pseudoefedrina.

Avoid using Rasagilina Normon with antidepressants containing fluoxetina or fluvoxamina.

If you are starting your treatment with Rasagilina Normon, you should wait at least 5 weeks since the interruption of treatment with fluoxetina.

If you are starting your treatment with fluoxetina or fluvoxamina, you should wait at least 14 days since the interruption of treatment with Rasagilina Normon.

Inform your doctor or pharmacist if you are quitting or plan to quit smoking. Smoking may decrease the amount of Rasagilina Normon in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 operating machines

Consult your doctor before driving or operating machines, 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 sleep episodes.

This may increase if you take other medications for Parkinson's disease symptoms, if you take medications 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 machines (see section 2).

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

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

If you take more Rasagilina Normon than you should

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

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

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

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

If you forgot to take Rasagilina Normon

Do not take a double dose to compensate for the missed doses. Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Normon

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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, for example, compulsions, obsessive thoughts, compulsive gambling, excessive purchases or spending, impulsive behavior, and an abnormally high sex drive or an increase in 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, tremors, 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.

- Allergy.

- Fever.

- Flu (influenza).

- General malaise.

- Neck pain.

- Chest pain (angina pectoris).

- Low blood pressure when standing with symptoms such as dizziness/vertigo (orthostatic hypotension).

- Decreased appetite.

- Constipation.

- Dry mouth.

- Nausea and vomiting.

- Flatulence.

- Alteration of blood test results (leucopenia).

- Joint pain (arthralgia).

- Musculoskeletal pain.

- Inflammation of the joints (arthritis).

- Numbness and muscle weakness of the hand (carpal tunnel syndrome).

- Weight loss.

- Abnormal dreams.

- Difficulty with muscle coordination (balance disorder).

- Depression.

- Dizziness (vertigo).

- Prolonged muscle contractions (dystonia).

- Nasal discharge (rhinitis).

- Skin irritation (dermatitis).

- Rash.

- Redness of the eyes (conjunctivitis).

- Urinary urgency.

Rare(may affect up to 1 in 100 people):

- Stroke (cerebrovascular accident).

- Heart attack (myocardial infarction).

- Vesiculobullous rash (vesiculobullous eruption).

Frequency not known: cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Rasagilina CompositionNorman

- The active ingredient isRasagilina.

Cada comprimido contains 1 mg of rasagilina (as tartrate).

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

Product appearance and packaging contents

The RasagilinaNormantablets are white or almost white, round, flat, and uncoated.

Cada envase contains 30 tablets.

Marketing authorization holder and manufacturer responsible

Laboratorios Norman, S.A.

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

Last review date of this leaflet:october2024

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