Rasagiline Sandoz Farmaceutica 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rasagilina Sandoz Farmacéutica 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.

  • If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Rasagilina Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Rasagilina Sandoz Farmacéutica
3. How to take Rasagilina Sandoz Farmacéutica
4. Possible adverse effects
5. How to store Rasagilina Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Rasagilina Sandoz Farmacéutica is and what it is used for

Rasagilina Sandoz Farmacéutica contains the active substance rasagilina and is indicated for the treatment in adults of Parkinson's disease. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of dopamine-producing cells in the brain.

Dopamine is a chemical substance in the brain involved in the control of movement. Rasagilina helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Sandoz Farmacéutica

Do not take Rasagilina Sandoz Farmacéutica:

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

Do not take the following medicines while taking rasagiline:

• monoamine oxidase inhibitors (MAO inhibitors) (e.g., for the treatment of depression or Parkinson's disease, or for other indications), including non-prescription medicines and herbal products, e.g., St. John's Wort,
• meperidine (a strong painkiller).

You must wait at least 14 days after stopping rasagiline before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions

Talk to your doctor before taking Rasagilina Sandoz Farmacéutica:

• if you have any liver problems,
• you should speak to your doctor about any suspicious changes in your skin. Treatment with rasagiline may possibly increase the risk of skin cancer,
• if you are taking medicines containing buprenorphine. Using these medicines together with rasagiline may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Rasagilina Sandoz Farmacéutica").

Inform your doctor if you or your family/caregiver notice any unusual behaviors in which you cannot resist the impulse, urge, or craving to carry out harmful or damaging activities to yourself or others. These are known as impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally increased sex drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline may cause drowsiness and cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, see the section “Driving and use of machines”.

Children and adolescents

The use of Rasagilina Sandoz Farmacéutica in children and adolescents is not relevant. Therefore, rasagiline is not recommended for patients under 18 years of age.

Other medicines and Rasagilina Sandoz Farmacéutica

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor especially if you are taking or might take any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants),
• the antibiotic ciprofloxacin used to treat infections,
• the cough medicine dextromethorphan,
• sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine,
• medicines containing buprenorphine for the treatment of severe pain. These medicines may interact with rasagiline and cause a condition called serotonin syndrome, with symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, overactive reflexes, increased muscle tone, and body temperature above 38°C. Consult your doctor if you experience such symptoms.

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

If you are starting treatment with rasagiline, you must wait at least 5 weeks after stopping treatment with fluoxetine.

If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with rasagiline.

Inform your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may reduce the amount of rasagiline in your blood.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

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

Driving and use of machines

Seek medical advice before driving or operating machinery, as both Parkinson's disease and treatment with rasagiline may affect your ability to perform these activities. Rasagiline may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.

This risk may increase if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking medicines that may cause drowsiness, or if you consume alcohol during treatment with rasagiline. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with rasagiline, do not drive or operate machinery (see section 2).

Rasagilina Sandoz Farmacéutica contains sodium

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

3. How to take Rasagilina Sandoz Farmacéutica

Follow exactly the instructions for use of this medicine provided 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 daily.

Rasagilina may be taken with or without food.

If you take more Rasagilina Sandoz Farmacéutica than you should

If you think you have taken more rasagilina tablets than you should, inform your doctor or pharmacist immediately. Take the rasagilina pack/blister with you to show to the doctor or pharmacist.

If you have taken more Rasagilina Sandoz Farmacéutica than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. Take the Rasagilina Sandoz Farmacéutica packaging with you to show to the doctor or pharmacist.

Symptoms reported following an overdose of rasagilina include slightly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagilina Sandoz Farmacéutica

Do not take a double dose to make up for forgotten doses. Take the next dose as scheduled.

If you stop taking Rasagilina Sandoz Farmacéutica

Do not stop taking rasagilina without first consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviours, or abnormally increased sex drive or increased sexual thoughts (impulse control disorders) (see section 2),
• if you see or hear things that are not there (hallucinations),
• any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome),
• if you notice suspicious changes in the skin, as there may be an increased risk of cancer (melanoma) with the use of this medicine (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-like syndrome (influenza),
• general malaise,
• neck pain,
• chest pain (angina pectoris),
• low blood pressure upon standing, with symptoms such as dizziness or lightheadedness (orthostatic hypotension),
• decreased appetite,
• constipation,
• dry mouth,
• nausea and vomiting,
• flatulence,
• changes in blood test results (leucopenia),
• joint pain (arthralgia),
• musculoskeletal pain,
• joint swelling (arthritis),
• numbness and muscle weakness in the hand (carpal tunnel syndrome),
• weight loss,
• strange 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 available data)

• high blood pressure
• excessive sleepiness
• sudden onset of sleep

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Sandoz Farmacéutica

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, tablet container, or blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Sandoz Farmacéutica

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

Appearance of the product and contents of the pack

Rasagilina Sandoz Farmacéutica tablets are white to off-white, round, flat, bevelled tablets (6.5 mm).

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

Only certain pack 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 most recent revision of this package leaflet: June 2024

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