Prospect: information for the user

Rasagilina Sandoz Pharmaceutical 1 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

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

-This medicine has been prescribed only for you, and you should not give it to other people 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 prospect. See section 4.

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

2. What you need to know before starting to take Rasagilina Sandoz Pharmaceutical

3. How to take Rasagilina Sandoz Pharmaceutical

4. Possible adverse effects

5. Storage of Rasagilina Sandoz Pharmaceutical

6. Contents of the package and additional information

Rasagilina Sandoz Pharmaceutical contains the active ingredient rasagilina and is indicated for the treatment in adults of Parkinson's disease. It can be used with or without levodopa (another medication used for the treatment of 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 takeRasagilina Sandoz Pharmaceutical:

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

Do not takethe following medications while taking rasagilina:

• monoamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without a doctor's prescription, e.g. St. John's Wort,
• petidina (strong analgesic).

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

Warnings and precautions

Consult your doctor before starting to take Rasagilina Sandoz Pharmaceutical:

• if you have any liver problems,
• you should talk to your doctor about any suspicious changes in your skin. Treatment with rasagilina may possibly increase the risk of skin cancer,
• if you are taking medications containing buprenorphine. The use of these medications with rasagilina may produce the serotonin syndrome, a potentially fatal disease (see "Other medications and Rasagilina Sandoz Pharmaceutical").

Inform your doctor if you or your family/caregiver notice that you are experiencing unusual behaviors in which you cannot resist the urge, the imperative 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 rasagilina 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 discontinue your dose (see section4).

Rasagilina 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 Rasagilina Sandoz Pharmaceutical in children and adolescents is not relevant. Therefore, rasagilina is not recommended for minors under 18 years old.

Other medications and Rasagilina Sandoz Pharmaceutical

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

Inform your doctor especiallyif you are taking or may take 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 medications for cataracts containing ephedrine or pseudoephedrine,
• medications containing buprenorphine for intense pain. These medications may interact with rasagilina and experience the so-called serotonin syndrome with symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Consult your doctor when you experience such symptoms.

It is recommended to avoid using this medication with antidepressants containing fluoxetine or fluvoxamine.

If you are starting your treatment with rasagilina, 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 rasagilina.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

You should avoid taking rasagilina if you are pregnant, as the effects of rasagilina 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 rasagilina may affect your ability to perform these activities. Rasagilina may cause dizziness or drowsiness, as well as sudden episodes of sleep.

This may increase if you take other medications for Parkinson's disease symptoms, if you take medications that may cause drowsiness, or if you consume alcohol during treatment with rasagilina. If you have experienced drowsiness and/or sudden episodes of sleep before or during treatment with rasagilina, do not drive or operate machines (see section2).

Rasagilina Sandoz Pharmaceutical contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; thisis, essentially “sodium-free”.

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

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

Rasagilina can be taken with or without food.

If you take more Rasagilina Sandoz Pharmaceutical than you should

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

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

The symptoms reported after a rasagilina overdose were mildly euphoric mood (mild form of mania), very high blood pressure and serotonin syndrome (see section4).

If you forgot to take Rasagilina Sandoz Pharmaceutical

Do not take a double dose to compensate for the missed doses.Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Sandoz Pharmaceutical

Do not stop taking rasagilina 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 may cause side effects, although not everyone will experience them.

Get in touch with your doctor immediately if you notice any of the following symptoms. You may need advice or urgent medical treatment:

• if you develop unusual behaviors such as compulsions, obsessive thoughts, addictive games, excessive spending or purchases, impulsive behaviors, 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 are not there (hallucinations),
• any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome),
• if you observe suspicious changes in the skin because 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,
• general discomfort,
• neck pain,
• chest pain (angina pectoris),
• 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,
• inflammation of the joints (arthritis),
• numbness and muscle weakness of the hand (carpal tunnel syndrome),
• weight loss,
• strange dreams,
• difficulty with muscle coordination (balance disorder),
• depression,
• dizziness (vertigo),
• prolonged muscle contractions (dystonia),
• nasal discharge (rhinitis),
• skin irritation (dermatitis),
• eruption,
• conjunctivitis (red eye),
• urinary urgency.

Rare(may affect up to 1 in 100 people)

• stroke (cerebrovascular accident),
• heart attack (myocardial infarction),
• vesiculobullous rash.

Frequency not known(cannot be estimated through available data)

• high blood pressure
• excessive somnolence
• sudden onset of 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 Vigilance of Medicines for Human Use: https://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 use this medication after the expiration date that appears on the box, blister pack or tablet container 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 drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Rasagilina Sandoz Pharmaceutical

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as rasagilina tartrate).
• The other componentsare microcrystalline cellulose, cornstarch, pregelatinized cornstarch, talc, and stearic acid and sodium fumarate.

Appearance of the product and contents of the packaging

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

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Delorbis Pharmaceuticals Ltd.

17, Athinon Street, Ergates Industrial Area,

2643 Ergates, Lefkosia

Cyprus

or

Iberfar, Industrial Farmacêutica, S.A.

R. Consiglieri Pedroso, nº 121-123,

Queluz de Baixo

2734-501 Barcarena

Portugal

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben,

Germany

Last review date of thisleaflet:June 2024

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