RASAGILINE SANDOZ FARMACEUTICA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Sandoz Pharmaceutical 1 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as 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 Sandoz Pharmaceutical and what is it used for
2. What you need to know before taking Rasagiline Sandoz Pharmaceutical
3. How to take Rasagiline Sandoz Pharmaceutical
4. Possible side effects
5. Storage of Rasagiline Sandoz Pharmaceutical
6. Package contents and additional information

1. What is Rasagiline Sandoz Pharmaceutical and what is it used for

Rasagiline Sandoz Pharmaceutical 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 Rasagiline Sandoz Pharmaceutical

Do not takeRasagiline Sandoz Pharmaceutical:

• 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 rasagiline:

• 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 and before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor before starting to take Rasagiline Sandoz Pharmaceutical:

• if you have liver problems,
• you should discuss any suspicious changes in your skin with your doctor, as treatment with rasagiline may possibly increase the risk of skin cancer,
• if you are taking medications containing buprenorphine. The use of these medications with rasagiline may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Rasagiline Sandoz Pharmaceutical").

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

Rasagiline 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 Sandoz Pharmaceutical in children and adolescents is not relevant. Therefore, rasagiline is not recommended for individuals under 18 years of age.

Other medications and Rasagiline Sandoz Pharmaceutical

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 or may take 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,
• medications containing buprenorphine for treating severe pain. These medications may interact with rasagiline and cause serotonin syndrome, with symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Consult your doctor if you experience such symptoms.

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

If you are starting treatment with rasagiline, 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.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking can decrease the amount of rasagiline 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 before using this medication.

You should avoid taking rasagiline if you are pregnant, as the effects of rasagiline on pregnancy and the fetus are unknown.

Driving and using machines

Seek medical advice before driving or using machines, as both Parkinson's disease and treatment with rasagiline can affect your ability to perform these activities. Rasagiline 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 can cause drowsiness, or if you consume alcohol during treatment with rasagiline. If you have experienced drowsiness and/or sudden episodes of sleep before or during treatment with rasagiline, do not drive or use machines (see section 2).

Rasagiline Sandoz Pharmaceutical contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Rasagiline Sandoz Pharmaceutical

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 is 1 tablet of 1 mg taken orally once a day.

Rasagiline can be taken with or without food.

If you take more Rasagiline Sandoz Pharmaceutical 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/blisters of rasagiline with you to show the doctor or pharmacist.

If you have taken more Rasagiline Sandoz Pharmaceutical than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Bring the package of Rasagiline Sandoz Pharmaceutical with you to show the doctor or pharmacist.

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

If you forget to take Rasagiline Sandoz Pharmaceutical

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 Sandoz Pharmaceutical

Do not stop taking rasagiline 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 immediately if you notice any of the following symptoms. You may need urgent medical advice or treatment:

• if you develop unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally high sexual desire or increased sexual thoughts and feelings (impulse control disorders) (see section 2),
• if you see or hear things that are not there (hallucinations),
• any combination of hallucinations, fever, agitation, tremors, and sweating (serotonin syndrome),
• if you notice suspicious changes in your skin, as the risk of skin cancer (melanoma) may increase 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-like symptoms (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,
• vivid dreams,
• difficulty with muscle coordination (balance disorder),
• depression,
• dizziness (vertigo),
• prolonged muscle contractions (dystonia),
• runny nose (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 onset of 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rasagiline Sandoz Pharmaceutical

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. 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 Rasagiline Sandoz Pharmaceutical

• The active ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The other components are microcrystalline cellulose, cornstarch, pregelatinized starch (from corn), talc, and sodium stearyl fumarate.

Appearance of the product and package contents

Rasagiline Sandoz Pharmaceutical tablets are white to off-white, round, flat, and beveled (6.5 mm).

The tablets are available in blister packs of 10, 28, 30, 98, 100, or 112 tablets and in packages with a child-resistant screw cap containing a desiccant (silica gel) of 30 and 100 tablets. The desiccant is used to keep the tablets dry and should not be swallowed.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Delorbis Pharmaceuticals Ltd.

17, Athinon Street, Ergates Industrial Area,

2643 Ergates, Lefkosia

Cyprus

or

Iberfar, Indústria Farmacêutica, S.A.

• Consiglieri Pedroso, nº 121-123,

Queluz de Baixo

2734-501 Barcarena

Portugal

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben,

Germany

Date of the last revision of this package leaflet:June 2024

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