Leaflet: Information for the user

Rasagilina Krka 1 mg tablets EFG

Read this 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. Do not give it to others, even if they have the same symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Rasagilina Krka

3.How to take Rasagilina Krka

4.Possible side effects

5.Storage of Rasagilina Krka

6.Contents of the pack and additional information

Rasagilina Krka contains the active ingredient rasagilina and is indicated for the treatment of Parkinson's disease in adults. It may be used with or without Levodopa (another medication used to treat Parkinson's disease).

With Parkinson's disease, there is a loss of cells that produce dopamine in the brain.

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

Do not take Rasagilina Krka

-If you are allergic to rasagilina or any of the other components of this medication (listed in section 6).

-If you have severe liver problems.

Do not take the following medications while taking rasagilina:

-Monamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for other indications) including medications and natural products without prescription e.g. St. John's Wort.

-Petidina (strong analgesic).

You should wait at least 14 days after stopping treatment with rasagilina and starting treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor before starting to takeRasagilina Krka.

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

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors that you cannot resist, an overwhelming urge or need to perform certain activities that are harmful or detrimental to yourself or others. These are known as impulse control disorders. In patients taking Rasagilina Krka and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, pathological gambling, excessive spending, impulsive behavior, and an abnormally high or increased sexual drive or thoughts have been observed. Your doctor may need to adjust or discontinue your dose (see section 4).

Rasagilina Krka may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medications (used to treat Parkinson's disease). If you want more information, see the section “Driving and operating machines”.

Children and adolescents

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

Other medications and Rasagilina Krka

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to take any other medication.

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

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

-The antibiotic ciprofloxacin used against infections.

-The antitussive dextromethorphan.

-Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing ephedrine or pseudoephedrine.

Avoid using Rasagilina Krka with antidepressants containing fluoxetine or fluvoxamine. If you are starting your treatment with Rasagilina Krka, wait at least 5 weeks since the interruption of treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, wait at least 14 days since the interruption of treatment with Rasagilina Krka.

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

Taking Rasagilina Krka with food, drinks, and alcohol

Rasagilina Krka can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should avoid taking Rasagilina Krka if you are pregnant, as the effects of Rasagilina Krka on pregnancy and the fetus are unknown.

Driving and operating machines

Consult your doctor before driving or operating machines, 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 sleep.

This may increase if you take other medications for Parkinson's disease symptoms, if you take medications that can cause drowsiness, or if you consume alcohol during treatment with Rasagilina Krka. If you have experienced drowsiness and/or sudden episodes of sleep before or during treatment with Rasagilina Krka, do not drive or operate machines (see section 2).

Follow exactly the administration instructions for this medication as indicated 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 by mouth, once a day. Rasagilina Krka can be taken with or without food.

If you take more Rasagilina Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.Bringthe box/ blisterof rasagilina withyou to show it to your doctor or pharmacist.

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

If you forgot to take Rasagilina Krka

Do not take a double dose to compensate for the missed doses. Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Krka

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you experience any of the following symptoms. You may need treatment or urgent medical attention:

• If you experience unusual behaviors such as, for example, compulsions, obsessive thoughts, compulsive gambling, excessive purchases or spending, impulsive behavior, and an abnormally high sex drive or an increase in 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, tremors, and sweating (serotonin syndrome).

Contact your doctor if you observe 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 (affect more than 1 in 10 people):

• Uncontrolled movements (dyskinesia).
• Headache.

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

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu (influenza).
• General discomfort.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing with symptoms such as dizziness/dizziness (orthostatic hypotension).

• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Alteration of blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Hand numbness and weakness (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination difficulty (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urgent urination.

Uncommon side effects (affect up to 1 in 100 people):

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Wart-like rash (vesiculobullous rash).

Frequency not known: cannot be estimated from available data

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for human use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the Pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Rasagilina Krka

-The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as rasagilina hemitartrate)

• The other components (excipients) are: microcrystalline cellulose (E460), pregelatinized maize starch (type 1500), anhydrous colloidal silica (E551), talc (E553b) and stearic acid.

Appearance of the product and contents of the pack

White or off-white, round, slightly biconvex tablets, 7 mm in diameter, with bevelled edges and dark spots that may be visible.

Rasagilina Krka is available in packs containing:

- 14, 15, 28, 30 and 112 tablets in blisters, in a box.

- 14x1, 15x1, 28x1, 30x1 and 112x1 tablets in pre-cut single-dose blisters,

- 14x1, 15x1, 28x1, 30x1 and 112x1 tablets in pre-cut single-dose blisters with the names of the days (calendarized).

It may not be marketed in all pack sizes.

Marketing authorisation holder

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

Responsible for manufacturing

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

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

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

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 with the following names:

Last review date of this leaflet:May 2021

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