RAGLYSA 1 mg TABLETS

2. What you need to know before you take Raglysa

Do not take Raglysa

• 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 painkiller).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Raglysa:

• If you have any liver problems.
• You should discuss with your doctor any suspicious changes in your skin. Treatment with Raglysa 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 Raglysa 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 sexual drive or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Raglysa may cause you to feel dizzy or sleepy, or to suddenly fall asleep during the day, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you would like more information, see the section “Driving and using machines”.

Children and adolescents

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

Other medicines and Raglysa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Inform 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 and oral decongestants, and cough and cold medicines containing ephedrine or pseudoephedrine.

The use of rasagiline with antidepressants containing fluoxetine or fluvoxamine should be avoided. 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 Raglysa in your blood.

Taking Raglysa with food and drink

Rasagiline 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 for advice before taking this medicine.

You should avoid taking Raglysa if you are pregnant, as the effects of Raglysa 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 Raglysa may affect your ability to perform these activities. Raglysa may cause you to feel dizzy or sleepy, or to suddenly fall asleep during the day. This could increase if you take other medicines for treating Parkinson's disease symptoms, if you take medicines that may cause you to feel sleepy, or if you drink alcohol during treatment with Raglysa. If you have experienced excessive daytime sleepiness and/or sudden sleep episodes before or during treatment with Raglysa, do not drive or use machines (see section 2).

3. How to take Raglysa

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

If you take more Raglysa than you should

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

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

If you forget to take Raglysa

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

If you stop taking Raglysa

Do not stop taking Raglysa without consulting 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.

Contact your doctor immediatelyif you experience any of the following symptoms. You may need urgent medical treatment:

• If you experience unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive 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, agitation, tremor, and sweating (serotonin syndrome).
• Contact your doctorif 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 (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 via the Spanish Medicines Surveillance System for human use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Raglysa

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

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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 Raglysa 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), anhydrous colloidal silica (E551), talc (E553b), and stearic acid.

Appearance and packaging

This medicine is presented as white to almost white, round, 7 mm diameter, slightly biconvex tablets, with bevelled edges and possible darker spots visible.

The tablets are available in boxes of 30 tablets in blisters.

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

or

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L.

C/ Anabel Segura, 10,

28108 Alcobendas, Madrid

Spain

Date of last revision of this leaflet: June 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/