RASAGILINE ABABOR 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Ababor 1 mgtablets 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Rasagiline Ababor is indicated for the treatment of Parkinson's disease. 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 cells that produce dopamine in the brain. Dopamine is a brain chemical involved in controlling movement. Rasagiline helps to increase and maintain dopamine levels in the brain.

2. What you need to know before you take Rasagiline Ababor

Do not take Rasagiline Ababor:

• 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 Ababor:

• 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 before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine

• If you have any liver problems.
• You should talk to your doctor if you notice any suspicious changes in your skin. Treatment with rasagiline may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviors where you cannot resist the impulse, urge or desire to perform certain activities that could be harmful to you or others. These are called impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and an 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 may cause drowsiness and make you suddenly fall asleep during 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 in children and adolescents is not relevant. Therefore, rasagiline is not recommended for children under 18 years of age.

Other medicines and Rasagiline Ababor

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 and oral decongestants, and cough and cold medicines containing ephedrine or pseudoephedrine.

Concomitant use of this medicine with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline Ababor, 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.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

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

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

Rasagiline Ababor contains sodium

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

3. How to take Rasagiline Ababor

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

Oral use.

Rasagiline can be taken with or without food.

If you take more Rasagiline Ababor than you should

Symptoms reported after an overdose of rasagiline were a mildly euphoric mood (a mild form of 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the rasagiline packaging with you to show the doctor or pharmacist.

If you forget to take Rasagiline Ababor

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking Rasagiline Ababor

Do not stop treatment with rasagiline without consulting your doctor first.

If you have any further questions on 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 urgent medical treatment:

• If you develop unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and an abnormally high sexual impulse or increased sexual thoughts and feelings (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).

Consult 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).

(orthostatic hypotension)

• Loss of appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal 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.
• Muscle coordination problems (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

Rare (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 sleepiness.

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 leaflet. You can also report side effects directly via the national reporting system listed in the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Ababor

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

Do not use this medicine after the expiry date which is stated on the packaging or blister after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Rasagiline Ababor

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as hemitartrate).
• The other ingredients are trehalose dihydrate, pregelatinized corn starch, anhydrous colloidal silica, citric acid, talc, stearic acid, microcrystalline cellulose, and sodium croscarmellose.

Appearance and packaging of the product

Rasagiline Ababor tablets are presented as round, white or almost white tablets.

The tablets are presented in blister packs of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ababor Pharmaceuticals, S.L.

• Chile, nº 4 – Edificio 1 – Oficina 1- Las Matas

Las Rozas (28290) Madrid

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

• Uriach y Compañía S.A.

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

08184 Barcelona

Spain

Date of last revision of this leaflet:July 2023

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