ALTINA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Altina 1 mg Tablets EFG

Rasagiline

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 Altina and what is it used for
2. What you need to know before taking Altina
3. How to take Altina
4. Possible side effects
5. Storage of Altina
6. Package Contents and Additional Information

1. What is Altina and what is it used for

Altina contains the active ingredient 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 Altina

Do not take Altina

• If you are allergic to rasagiline 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 Altina:

• 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 Altina and before starting treatment with MAOIs or pethidine.

Warnings and Precautions

Consult your doctor before starting to take Altina

• If you have any liver problems.
• You should discuss with your doctor any suspicious changes in your skin. Treatment with Altina 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 detrimental activities for yourself or others. These are called impulse control disorders. In patients taking Altina 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).

Altina 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 additional information, see the section "Driving and Using Machines".

Children and Adolescents

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

Other Medications and Altina

Inform your doctor or pharmacist if you are taking, have recently taken, 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, 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 medications and cough medicines that contain ephedrine or pseudoephedrine.

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

If you are starting treatment with Altina, 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 Altina.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of Altina 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 Altina if you are pregnant, as the effects of Altina 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 Altina may affect your ability to perform these activities. Altina 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 Altina. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Altina, do not drive or use machines (see section 2).

3. How to Take Altina

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Altina is 1 tablet of 1 mg taken by mouth, once a day.

Altina can be taken with or without food.

If you take more Altina than you should

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

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

If you forget to take Altina

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

If you stop taking Altina

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.

4. Possible Side Effects

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

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

• If you experience 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).

Contact your doctorif 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 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.
• Allergic reactions.
• 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 available data

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

Reporting 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 contribute to providing more information on the safety of this medication.

5. Storage of Altina

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 shown on the package or blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the pharmacy's SIGRE 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. Package Contents and Additional Information

Composition of Altina

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

Appearance of the Product and Package Contents

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

The tablets are presented in Poliamide/Aluminum/PVC-Aluminum blisters in packages 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/.