RASAGILINE ALTER 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Alter 1 mg Tablets EFG

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

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

Contents of the Package Leaflet

1. What is Rasagiline Alter and what is it used for
2. What you need to know before taking Rasagiline Alter
3. How to take Rasagiline Alter
4. Possible side effects
5. Storage of Rasagiline Alter
6. Contents of the pack and further information

1. What is Rasagiline Alter and what is it used for

Rasagiline Alter contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medication used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a brain chemical involved in movement control. Rasagiline helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagiline Alter

Do not take Rasagiline Alter

• If you are allergic to rasagiline or any of the other ingredients of this medication (listed in section 6).
• If you have severe liver problems.

Do not take the following medications while taking Rasagiline Alter:

• Monoamine oxidase inhibitors (MAOIs) (e.g., for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medications and natural products, e.g., St. John's Wort.
• Pethidine (a potent analgesic).

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

Warnings and Precautions

Consult your doctor before starting to take Rasagiline Alter

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

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

Rasagiline 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 using machines".

Children and Adolescents

The use of Rasagiline Alter in children and adolescents is not appropriate. Therefore, Rasagiline is not recommended for individuals under 18 years of age.

Other Medications and Rasagiline Alter

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

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

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine 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 oral and anti-cough medications containing ephedrine or pseudoephedrine.

The use of Rasagiline Alter with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline Alter, 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 Alter.

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

Pregnancy, Breastfeeding, and Fertility

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

You should avoid taking Rasagiline Alter if you are pregnant, as the effects of Rasagiline Alter 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 Alter may affect your ability to perform these activities.

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

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

3. How to Take Rasagiline Alter

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

The recommended dose of Rasagiline Alter is 1 tablet of 1 mg taken orally, once a day. Rasagiline Alter can be taken with or without food.

If you take more Rasagiline Alter than you should

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

Do not take a double dose to make up for forgotten doses. Take the next dose normally, when it is due.

If you stop taking Rasagiline Alter

Do not stop treatment with this medication without consulting your doctor first.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

If you exhibit unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulse or increased 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, 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 medication (see section 2).

Other side effects

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

• Involuntary movements (dyskinesia).
• Headache.

Common:(may affect up to 1 in 10 people)

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up with symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal blood test results (leukopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination difficulties (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

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 the available data

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

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rasagiline Alter

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date stated on the package or blister after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Rasagiline Alter

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients are: calcium phosphate dibasic dihydrate, corn starch, pregelatinized starch (from corn), colloidal anhydrous silica, talc, and stearic acid.

Appearance of the Product and Contents of the Pack

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

The tablets are presented in Polyamide/Aluminum/PVC-Aluminum blisters in packs of 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last revision of this package leaflet: October 2023.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.