Rasagiline Ababor 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rasagilina Ababor 1 mg tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rasagilina 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 dopamine-producing cells in the brain. Dopamine is a chemical substance in the brain involved in the control of movement. Rasagilina helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Ababor

Do not take Rasagilina Ababor:

• 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 Ababor:

• Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including prescription-free medicines and natural products, e.g. St. John's wort.
• Pethidine (a strong painkiller).

You must wait at least 14 days after stopping rasagiline treatment before starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

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

Inform your doctor if you or your family/carer notice that you are exhibiting unusual behaviours that you cannot resist the impulse, urge, or craving to perform certain activities that may be harmful to yourself or others. These are known as impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, such behaviours have been observed, including compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviour, and abnormally increased sexual urges or increased thoughts or feelings of sexuality. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline may cause drowsiness and 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 the section "Driving and use of machines".

Children and adolescents

The use of rasagiline in children and adolescents is not relevant. Therefore, rasagiline is not recommended for patients under 18 years of age.

Other medicines and Rasagilina Ababor

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

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

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

• The antibiotic ciprofloxacin, used to treat 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 this medicine together with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagilina Ababor, 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 rasagiline.

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

Pregnancy, breast-feeding and fertility

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

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

Driving and use of machines

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

This risk may be increased 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 rasagiline. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with rasagiline, do not drive or operate machinery (see section 2).

Rasagilina Ababor contains sodium

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

3. How to take Rasagilina Ababor

Follow exactly the instructions for use of this medicine 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 daily.

For oral use.

Rasagilina may be taken with or without food.

If you take more Rasagilina Ababor than you should

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

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 medicine and the amount ingested. Bring the rasagilina packaging with you to show to the doctor or pharmacist.

If you forget to take Rasagilina Ababor

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

If you stop taking Rasagilina Ababor

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• If you display unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behavior, abnormally increased sex drive, or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not real (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 adverse 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 or lightheadedness (orthostatic hypotension).
• Decreased 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.
• 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 eruption).

Frequency not known: cannot be estimated from available data

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Ababor

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

Do not use this medicine after the expiry date stated on the container or blister pack after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Ababor

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

Appearance of the medicine and contents of the pack

Rasagilina Ababor tablets are round, white or almost white tablets.

The tablets are presented in blister packs containing 28 and 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Ababor Pharmaceuticals, S. L
Chile, nº 4 – Building 1 – Office 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 the most recent revision of this leaflet: July 2023

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