RASAGILINE BLUEFISH 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Bluefish 1 mg Tablets EFG

rasagiline

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 symptoms are the same as yours.
• If you experience 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 Bluefish and what is it used for
2. What you need to know before you take Rasagiline Bluefish
3. How to take Rasagiline Bluefish
4. Possible side effects
5. Storage of Rasagiline Bluefish
6. Contents of the pack and further information

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

Rasagiline Bluefish contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. 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 Bluefish helps to increase and maintain dopamine levels in the brain.

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

Do not take Rasagiline Bluefish

• 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 Bluefish:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medicines and natural products without prescription, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You should wait at least 14 days after stopping treatment with Rasagiline Bluefish before starting treatment with MAOIs or pethidine.

Warnings and precautions

Talk to your doctor before starting Rasagiline Bluefish

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

Tell your doctor if you or your family/caregiver notice that you are presenting with unusual behaviors where you cannot resist the impulse, urge, or desire to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking Rasagiline Bluefish and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and 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 Bluefish 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 Bluefish in children and adolescents is not relevant. Therefore, Rasagiline Bluefish is not recommended for children under 18 years of age.

Other medicines and Rasagiline Bluefish

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 decongestants, and oral and anti-cough medicines containing ephedrine or pseudoephedrine.

Avoid using Rasagiline with antidepressants that contain fluoxetine or fluvoxamine.

If you are starting treatment with Rasagiline, 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 Bluefish 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 Bluefish if you are pregnant, as the effects of Rasagiline Bluefish on pregnancy and the fetus are unknown.

Driving and using machines

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

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 Bluefish. If you have experienced drowsiness and/or sudden episodes of sleep before or during treatment with Rasagiline Bluefish, do not drive or use machines (see section 2).

Rasagiline Bluefish contains sodium

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

3. How to take Rasagiline Bluefish

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

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

If you take more Rasagiline Bluefish than you should

If you think you have taken more tablets of Rasagiline Bluefish than you should, tell your doctor or pharmacist immediately. Take the pack or blister with you to show the doctor or pharmacist.

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

If you forget to take Rasagiline 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 Rasagiline Bluefish

Do not stop taking Rasagiline Bluefish without talking to 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.

Seek immediate medical attentionif you experience any of the following symptoms. You may need urgent medical treatment:

• If you experience unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and 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, restlessness, tremors, and sweating (serotonin syndrome).

Seek immediate medical attention if you notice any suspicious changes in your skin, as you may be at a higher risk of skin cancer (melanoma) with 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-like symptoms (influenza).
• General feeling of being unwell.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up 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.
• Muscle coordination problems (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (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 rash).

Frequency not known (cannot be estimated from the available data)

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

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 Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Bluefish

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 carton, bottle, or blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Rasagiline Bluefish

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

Appearance and packaging of the product

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

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

Package sizes of 30 and 100 tablets in bottles with a child-resistant screw cap contain a desiccant (silica gel). Do not swallow the desiccant used to keep the tablets dry.

Not all 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 Farmaceutica, S.A.

Rua Consiglieri Pedroso, no. 121-123

Queluz de Baixo, 22734-501 Barcarena

Portugal

You can request more information about this medicine from the local representative of the marketing authorization holder

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

This medicine is authorized in the following European Economic Area Member States with the following names:

Date of last revision of this leaflet:August 2021

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