Rasagiline Bluefish 1 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Rasagilina Bluefish 1 mg tablets EFG

rasagiline

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

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

Rasagilina Bluefish contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It may 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 Bluefish helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Bluefish

Do not take Rasagilina Bluefish

• 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 Bluefish:

• 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 herbal products, e.g. St. John's wort.
• Meperidine (a strong painkiller).

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

Warnings and precautions

Talk to your doctor before starting Rasagilina Bluefish

• If you have any liver problems.
• You should speak to your doctor about any suspicious changes in your skin. Treatment with Rasagilina Bluefish might 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, urgent need, or craving to carry out certain harmful or damaging activities. These are known as impulse control disorders. In patients taking Rasagilina Bluefish and/or other medicines used to treat Parkinson's disease, such behaviours as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behaviour, and abnormally increased sex drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

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

Children and adolescents

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

Other medicines and Rasagilina Bluefish

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-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 Rasagilina together with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagilina, 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 Rasagilina.

Inform your doctor or pharmacist if you smoke or if you intend to stop smoking. Smoking may reduce the amount of Rasagilina Bluefish 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 Bluefish if you are pregnant, as the effects of Rasagilina Bluefish on pregnancy and the foetus are unknown.

Driving and use of machinery

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

This risk may increase if you take other medicines for the symptoms of Parkinson's disease, if you take medicines that may cause drowsiness, or if you consume alcohol during treatment with Rasagilina Bluefish. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with Rasagilina Bluefish, do not drive or operate machinery (see section 2).

Rasagilina Bluefish contains sodium

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

3. How to take Rasagilina Bluefish

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If you take more Rasagilina Bluefish than you should

If you think you have taken more tablets of Rasagilina Bluefish than you should, inform your doctor or pharmacist immediately. Take the pack/blister or bottle of Rasagilina Bluefish with you to show it to the doctor or pharmacist.

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

If you forget to take Rasagilina Bluefish

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

If you stop taking Rasagilina Bluefish

Do not stop taking Rasagilina Bluefish 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 will experience them.

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

• If you develop unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, 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 immediately 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 patients)

• Involuntary movements (dyskinesia).
• Headache.

Common (may affect up to 1 in 10 patients)

• Abdominal pain.
• Falls.
• Allergic reaction.
• Fever.
• Flu-like syndrome (influenza).
• General feeling of discomfort.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness/ 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.
• Redness of the eye (conjunctivitis).
• Urinary urgency.

Uncommon (may affect up to 1 in 100 patients)

• 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 onset.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for 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 Bluefish

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to 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 Bluefish

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The other components are: microcrystalline cellulose, corn starch, pregelatinized starch (from corn), talc, sodium fumarate.

Appearance of the product and contents of the pack

Rasagilina Bluefish tablets are presented as white or almost white, round, flat, bevelled tablets (6.5 mm).

Pack sizes of 7, 10, 28, 30, 60, 84, 98, 100, 112 tablets in blisters.

Pack sizes of 30 and 100 tablets in child-resistant screw-cap bottles contain a desiccant (silica gel). The desiccant used to keep the tablets dry must not be swallowed.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm

Sweden

Manufacturer

DELORBIS PHARMACEUTICALS LTD

17 Athinon Street, Ergates Industrial Area,

2643 Ergates

Lefkosia

Cyprus

Iberfar – Indústria Farmacêutica, S.A.

Rua Consiglieri Pedroso, no. 121-123

Queluz de Baixo, 22734-501 Barcarena

Portugal

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder

Bluefish Pharma S.L.U.,

P.O. Box 36007

2832094 Madrid, Branch 36

This medicinal product is authorized in the following European Economic Area Member States under the following names:

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Date of the last revision of this leaflet: August 2021

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/