Package Insert: Information for the User

Rasagilina Alter 1 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they 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.

Rasagilina Alter 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 Rasagilina Alter

• 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 Alter:

• 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 should wait at least 14 days after stopping treatment with Rasagilina Alter and starting treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor before starting to take Rasagilina Alter

• If you have any liver problems
• You should talk to your doctor about any suspicious changes in your skin. Treatment with Rasagilina Alter 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 Rasagilina Alter and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, ludomania, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts or feelings have been observed. Your doctor may need to adjust or interrupt your dose (see section 4).

Rasagilina Alter 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 Alter in children and adolescents is not appropriate. Therefore, Rasagilina is not recommended for minors under 18 years old.

Other medications and Rasagilina Alter

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-noradrenaline 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.

You should avoid using Rasagilina Alter with antidepressants containing fluoxetine or fluvoxamine.

If you are starting your treatment with Rasagilina Alter, you should wait at least 5 weeks since the interruption of treatment with fluoxetine.

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

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

Pregnancy, lactation, 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 Alter if you are pregnant, as the effects of Rasagilina Alter 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 Alter may affect your ability to perform these activities.

Rasagilina Alter may cause dizziness or drowsiness, as well as sudden sleep episodes.

This may increase if you take other medications to treat the symptoms of Parkinson's disease, if you take medications that can cause drowsiness, or if you consume alcohol during treatment with Rasagilina Alter. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Rasagilina Alter, do not drive or operate 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 Rasagilina Alter is 1 tablet of 1 mg taken by mouth, once a day. Rasagilina Alter may be taken with or without food.

If you take more Rasagilina Alter than you should

If you think you have taken more rasagilina tablets than you should, inform your doctor or pharmacist immediately. Bring the packaging of this medication with you to show to your doctor or pharmacist.

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

If you forget to take Rasagilina Alter

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

If you interrupt treatment with Rasagilina Alter

Do not stop treatment with this medication 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 doctorif 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 buying or excessive 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 doctorif 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:(may affect more than 1 in 10 people)

• Unintentional movements (dyskinesia).
• Headache.

Common:(may 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).
• Numbness and muscle weakness in the hand (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).
• Urgency to urinate.

Uncommon:(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 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttp://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 30°C.

Do not use this medication after the expiration date that appears on the packaging or blister 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 the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Rasagilina Alter Composition

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).
• The other components are: calcium phosphate dibasic dihydrate, cornstarch, pregelatinized cornstarch, anhydrous colloidal silica, talc, and stearic acid.

Appearance of the product and content of the packaging

Rasagilina Alter is presented in the form of round, flat, white tablets.

The tablets are presented in Poliamida/Aluminio/PVC-Aluminio blisters in packs of 30 tablets.

Marketing authorization holder and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: October 2023.

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