RASAGILINE KRKA 1 mg TABLETS

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

Do not take Rasagiline Krka

• 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:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicinal products e.g. St. John's Wort.
• Pethidine (a strong pain killer).

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

Warnings and precautions

Consult your doctor before starting Rasagiline Krka.

• If you have any liver problems.
• You should discuss with your doctor any suspicious changes in your skin. Treatment with Rasagiline Krka may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/carer notice that you are developing unusual behaviours where you cannot resist the impulse, urge or temptation to perform certain activities harmful to yourself or others. These are called impulse control disorders. In patients taking Rasagiline Krka and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sex drive or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline Krka may cause you to feel dizzy or fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you need more information, see the section “Driving and using machines”.

Children and adolescents

The use of Rasagiline Krka in children and adolescents is not relevant. Therefore, Rasagiline Krka is not recommended for use in minors under 18 years.

Other medicines and Rasagiline Krka

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 and 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 cough and cold medicines containing ephedrine or pseudoephedrine.

The use of Rasagiline Krka with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with Rasagiline Krka, 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 Krka.

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

Taking Rasagiline Krka with food, drinks and alcohol

Rasagiline Krka can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should avoid taking Rasagiline Krka if you are pregnant, as the effects of Rasagiline Krka 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 Krka may affect your ability to perform these activities. Rasagiline Krka may cause you to feel dizzy or fall asleep suddenly.

This may increase if you take other medicines for treating the symptoms of Parkinson's disease, if you take medicines that may cause you to feel sleepy, or if you drink alcohol during treatment with Rasagiline Krka. If you have experienced excessive daytime sleepiness or sudden sleep episodes before or during treatment with Rasagiline Krka, do not drive or use machines (see section 2).

3. How to take Rasagiline Krka

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

If you take more Rasagiline Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. Bring the package/blisters of rasagiline to show to your doctor or pharmacist.

The symptoms reported after an overdose of Rasagiline Krka were mildly euphoric mood (mild mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagiline Krka

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 Krka

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Get medical help immediately if you:

• Experience unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sex drive or increased sexual thoughts and feelings (impulse control disorders) (see section 2).
• See or hear things that are not there (hallucinations).
• Experience any combination of hallucinations, fever, agitation, tremor, and sweating (serotonin syndrome).

Tell your doctor if you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with this medicine (see section 2).

Other side effects

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

• Involuntary movements (dyskinesia).
• Headache.

Common side effects (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/spinning (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 side effects (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 sleepiness.
• Sudden sleep episodes.

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

5. Storage of Rasagiline Krka

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 after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Store in the original package to protect from moisture.

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 other information

What Rasagiline Krka contains

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

Appearance and packaging

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

Rasagiline Krka is available in packs containing:

• 14, 15, 28, 30, and 112 tablets in blisters, in a carton.
• 14 x 1, 15 x 1, 28 x 1, 30 x 1, and 112 x 1 tablets in single-dose precut blisters,
• 14 x 1, 15 x 1, 28 x 1, 30 x 1, and 112 x 1 tablets in single-dose precut blisters with the names of the days (calendarized).

Not all pack sizes may be marketed.

Marketing authorisation 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

You can ask for the information on this medicine in the local language of any of the countries listed below:

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

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:May 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/