Package Insert: Information for the User

Raglysa 1 mg Tablets EFG

rasagilina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Raglysa 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 helps to increase and maintain dopamine levels in the brain.

Do not take Raglysa

• 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 another indication) including medications and natural products without prescription, e.g. St. John's Wort.
• Petidina (strong analgesic).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Raglysa:

• If you have any liver problems.
• You must speak with your doctor about any suspicious changes in your skin. Treatment with Raglysa may possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are presenting unusual behaviors in which you cannot resist the impulse, the urgent need or the anxiety to perform certain harmful or harmful activities for yourself or for others. These are called impulse control disorders. In patients taking Raglysa and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, ludopathy, excessive spending, impulsive behavior, and an abnormally high sexual impulse or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or interrupt your dose (see section 4).

Raglysa 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 using machines".

Children and adolescents

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

Other medications and Raglysa

Inform your doctor or pharmacist if you are taking, have taken recently or 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.

It is recommended to avoid the use of rasagilina with antidepressants containing fluoxetine or fluvoxamine. If you are starting your treatment with rasagilina, you must wait at least 5 weeks since the interruption of treatment with fluoxetine.

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

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

Taking Raglysa with food and drinks

Rasagilina 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 before using this medication.

You must 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 dizziness or drowsiness, as well as sudden sleep episodes. This may increase if you take other medications to treat Parkinson's disease symptoms, if you take medications that may cause drowsiness, or if you consume alcohol during treatment with Raglysa. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Raglysa, do not drive or use machines (see section 2).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring with you the box/blister of rasagilina to show it to your doctor or pharmacist.

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

If you forgot to take Raglysa

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

If you interrupt treatment with Raglysa

Do not stop treatment with Raglysa 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 may 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 the 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).

Unknown frequency (cannot be estimated from available data):

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for human use:https://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 store at a temperature above 86°F (30°C).

Store in the original packaging to protect it from moisture.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the Pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Raglysa

• The active principle is rasagilina. Each tablet contains 1 mg of rasagilina (as hemitartrate of rasagilina).

• The other components 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 packaging

This medicine is presented in the form of white to almost white, round, 7 mm in diameter, slightly biconvex tablets with bisected edges and possible darker points visible.

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

Holder of the marketing authorization

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

or

TAD Pharma GmbH

Heinz-Lohmann – Straße 5

2742 Cuxhaven

Germany

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

KRKA Farmacéutica, S.L.

C/ Anabel Segura, 10,

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet: June 2021

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