Prospect: Information for the user

Rasagilina Ababor 1 mgtablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Rasagilina Ababor

3.How to take Rasagilina Ababor

4.Possible adverse effects

5.Storage of Rasagilina Ababor

6.Contents of the package and additional information

Rasagilina Ababor is indicated for the treatment of Parkinson's disease. 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 helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina Ababor:

• if you are allergic to rasagilina 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 Rasagilina Ababor:

- Inhibitors of monoamine oxidase (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medicines and natural products without a prescription, e.g. St. John's Wort.

- Petidina (potent analgesic).

You should wait at least 14 days after stopping treatment with rasagilina to start treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

- If you have any liver problems.

- If you must speak with your doctor about any suspicious changes in your skin. Treatment with rasagilina may possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are presenting unusual behaviors in which you cannot resist the urge, the imperative need or the anxiety to perform certain harmful or harmful activities for yourself or for others. These are called impulse control disorders. In patients taking rasagilina and/or other medicines 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 interrupt your dose (see section 4).

Rasagilina 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 operating machines”.

Children and adolescents

The use of rasagilina in children and adolescents is not relevant. Therefore, rasagilina is not recommended for minors under 18 years.

Other medicines and Rasagilina Ababor

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

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

- Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline 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 medicines containing efedrina or pseudoefedrina.

Avoid using this medicine with antidepressants containing fluoxetina or fluvoxamina.

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

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

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of rasagilina 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 medicine.

Avoid taking rasagilina if you are pregnant, as the effects of rasagilina 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 may affect your ability to perform these activities. Rasagilina may cause dizziness or drowsiness, as well as sudden sleep episodes.

This may increase if you take other medicines to treat Parkinson's disease symptoms, if you take medicines that may cause drowsiness, or if you consume alcohol during rasagilina treatment. If you have experienced drowsiness and/or sudden sleep episodes before or during rasagilina treatment, do not drive or operate machines (see section 2)..

Rasagilina Ababor contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

The recommended dose of Rasagilina Ababor is 1 tablet of 1 mg, once a day.

Oral route.

Rasagilina can be taken with or without food.

If you take more Rasagilina Ababor than you should

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

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.Bring the rasagilina packaging with you to show to your doctor or pharmacist.

If you forgot to take Rasagilina Ababor

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

If you interrupt treatment with Rasagilina Ababor

Do not stop treatment with rasagilina 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 can 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 behavior, excessive spending or purchases, 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):

-Uncontrollable 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).

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

-Decreased appetite.

-Constipation.

-Dry mouth.

-Nausea and vomiting.

-Flatulence.

-Alteration of blood test results (leucopenia).

-Joint pain (arthralgia).

-Musculoskeletal pain.

-Joint inflammation (arthritis).

-Hand numbness and weakness (carpal tunnel syndrome).

-Weight loss.

-Abnormal dreams.

-Muscle coordination disorder (balance disorder).

-Depression.

-Dizziness (vertigo).

-Prolonged muscle contractions (dystonia).

-Nasal discharge (rhinitis).

-Skin irritation (dermatitis).

-Rash.

-Redness of the eyes (conjunctivitis).

-Urgency to urinate.

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

-Stroke (cerebrovascular accident).

-Heart attack (myocardial infarction).

-Blistering 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 national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: 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 use this medication after the expiration date that appears on the packaging or blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Rasagilina Ababor

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as hemitartrate).
• The other components are trehalose dihydrate, pregelatinized cornstarch, colloidal anhydrous silica

citric acid, talc, stearic acid, microcrystalline cellulose, and sodium croscarmellose.

Appearance of the product and contents of the packaging

Rasagilina Ababor tablets are presented in the form of round, white or almost white tablets.

The tablets are presented in blister packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Ababor Pharmaceuticals, S. L

C) Chile, nº 4 – Edificio 1 – Office 1- Las Matas

Las Rozas (28290) Madrid

Responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Industrial Estate URTINSA II

28923 Alcorcón (Madrid)

Spain

or

J. Uriach and Company S.A

Avda camí Reial 51-57, Palau-Solitá I Plegamans

08184 Barcelona

Spain

Last review date of this leaflet:july 2023

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