Rasagiline Krka 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rasagilina Krka 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Rasagilina Krka contains the active substance rasagilina 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 dopamine-producing cells in the brain.

Dopamine is a chemical compound in the brain involved in the control of movement. Rasagilina Krka helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Krka

Do not take Rasagilina Krka

• 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 rasagiline:

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

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

Warnings and precautions

Talk to your doctor before starting to take Rasagilina Krka.

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

Inform your doctor if you or your family/caregiver notice that you are displaying unusual behaviours that you cannot resist the impulse, urge, or craving to carry out harmful or damaging activities. These are known as impulse control disorders. In patients taking Rasagilina Krka and/or other medicines used to treat Parkinson's disease, such behaviours as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behaviour, and abnormally increased sexual drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagilina Krka may cause drowsiness and make you fall asleep suddenly during everyday 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 Rasagilina Krka in children and adolescents is not relevant. Therefore, Rasagilina Krka is not recommended for patients under 18 years of age.

Other medicines and Rasagilina Krka

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 for 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 Krka together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with Rasagilina Krka, 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 Rasagilina Krka.

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

Taking Rasagilina Krka with food, drinks and alcohol

Rasagilina Krka may be taken with or without food.

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 Krka if you are pregnant, as the effects of Rasagilina Krka 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 Rasagilina Krka may affect your ability to perform these activities. Rasagilina Krka may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.

This risk may increase 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 Rasagilina Krka. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with Rasagilina Krka, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Krka

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

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

If you take more Rasagilina Krka than you should

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 pack or blister pack with you to show to the doctor or pharmacist.

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

If you forget to take Rasagilina Krka

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

If you stop taking Rasagilina Krka

Do not stop treatment with Rasagilina Krka without first consulting your doctor.

If you have any further questions about 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 everyone gets them.

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

• If you have unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, abnormally high sex drive, or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not there (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 side effects

Very common side effects (may affect more than 1 in 10 people):

• Involuntary movements (dyskinesia).
• Headache.

Common side effects (may affect up to 1 in 10 people):

• Abdominal pain.
• Falls.
• Allergic reaction.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness or lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal blood test results (leukopenia).
• 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 side effects (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 available data

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Krka

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

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of medicines and their packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Krka

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline hemitartrate).
  • The other components (excipients) are: microcrystalline cellulose (E460), pregelatinized corn starch (type 1500), colloidal anhydrous silica (E551), talc (E553b), and stearic acid.

Nature of the product and contents of the pack

White or almost white, round, slightly biconvex tablets, 7 mm in diameter, with bevelled edges and visible dark specks.

Rasagilina Krka is available in packs containing:

• 14, 15, 28, 30 and 112 tablets in blister packs, in a box.
• 14 × 1, 15 × 1, 28 × 1, 30 × 1 and 112 × 1 tablets in pre-cut single-dose blisters.
• 14 × 1, 15 × 1, 28 × 1, 30 × 1 and 112 × 1 tablets in pre-cut single-dose blisters with day names (calendarized).

Not all pack sizes may be marketed.

Marketing Authorization Holder

Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last review of this leaflet: May 2021

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