Package Insert: Information for the User

Altina 1 mg Tablets EFG

Rasagilina

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.

Altina 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 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:

• 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.
• Pethidine (a potent analgesic).

You should wait at least 14 days after stopping treatment with Altina and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Consult your doctor before starting to take Altina

• If you have any liver problems.
• You should talk to your doctor about any suspicious changes in your skin.The 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 harmful activities for yourself or for 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, 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).

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 more information, see the section "Driving and operating machines".

Children and adolescents

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

Other medications and Altina

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 should be avoided to use Altina together with antidepressants containing fluoxetine or fluvoxamine.

If you are starting your treatment with Altina, 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 Altina.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of Altina 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 Altina if you are pregnant, as the effects of Altina 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 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 the symptoms of Parkinson's disease, 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 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 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 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 (mild mania), very high blood pressure, and serotonin syndrome (see section 4).

section 4).

If you forget to take Altina

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 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.

Like all medicines, this medicine can 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

thoughts, excessive spending or purchases, 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 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 (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).
• 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 eruption).

Frequency not known: cannot be estimated from available data

- High blood pressure.

- Excessive sleepiness.

- 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 86°F (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 containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Altina

• 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 (from corn), anhydrous colloidal silica, talc, and stearic acid.

Appearance of the product and content of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last review of this leaflet: October 2023.

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