Prospect: Patient Information

RasagilinaViso Pharmaceutical1 mg tablets EFG

Rasagilina

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must 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 Viso Pharmaceutical and for what it is used

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

3.How to take Rasagilina Viso Pharmaceutical

4.Possible adverse effects

5.Storage of Rasagilina Viso Pharmaceutical

6.Contents of the package and additional information

Rasagilina Viso Farmacéutica 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 for Parkinson's disease).

Parkinson's disease causes a loss of cells in the brain that produce dopamine.Dopamine is a brain chemical involved in the control of movement.Rasagilina Viso Farmacéutica helps to increase and maintain dopamine levels in the brain.

Do not takeRasagilina Viso Farmacéutica

• If you areallergicto rasagilina or to any of the other components of this medication (listed in section 6)
• If you havesevere liver problems.

Do not take the following medications during your treatment with Rasagilina Viso Farmacéutica:

• Monamine oxidase inhibitors (MAO) (for the treatment of depression or Parkinson's disease, or for any other indication), including medications and natural products without a prescription, for example,St. John's Wort.
• Pethidine (a powerful analgesic).

You must wait at least 14 daysafter stopping treatment with Rasagilina Viso Farmacéutica to be able to start treatment with MAO inhibitors or pethidine.

Warnings and precautions

Consult your doctor before taking Rasagilina Viso Farmacéutica:

• If you have anyliver problems

You must speak with your doctor about any suspicious changes in your skin. Treatment with Rasagilina Viso Farmacéutica may possibly increase the risk of skin cancer.Inform your doctorif you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist theurge, the imperative need or the anxietyto perform certain harmful or detrimental activities for yourself or for others. This is known asimpulse control disorders. In patients taking RasagilinaViso Farmacéuticaor other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, ludopathy, excessive spending, impulsive behavior or an abnormally high sexual drive, or an increase in sexual thoughts or desires have been observed. Your doctor may need to adjust or discontinue your dose (see section 4).

Rasagilina Viso Farmacéutica 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). For more information, see the section “Driving and operating machines”.

Children and adolescents

The use of Rasagilina Viso Farmacéutica in children and adolescents is not relevant. Therefore, Rasagilina Viso Farmacéutica is not recommended for minors under 18 years old.

Other medications and Rasagilina Viso Farmacéutica

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

Consult your doctor before taking any of the following medications withRasagilina Viso Farmacéutica:

• 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 is recommended to avoid the use of RasagilinaViso Farmacéuticawith antidepressants containing fluoxetine or fluvoxamine.

If you are starting your treatment withRasagilina Viso Farmacéutica, you must wait at least 5 weeks after stopping treatment with fluoxetine.

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

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

Pregnancy, breastfeeding 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 must avoid taking RasagilinaViso Farmacéuticaif you are pregnant, as the effects of RasagilinaViso Farmacéuticaon 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 RasagilinaViso Farmacéuticamay affect your ability to perform these activities. RasagilinaViso Farmacéuticamay cause dizziness or drowsiness, as well as sudden episodes of sleep.

This may be exacerbated if you take other medications to treat the symptoms of Parkinson's disease, or if you take medications that may cause drowsiness, or if you consume alcohol while taking RasagilinaViso Farmacéutica. If you have experienced drowsiness and/or sudden episodes of sleep before, or while taking RasagilinaViso Farmacéutica, 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 RasagilinaViso Farmacéuticais a 1 mg tablet taken orally once a day.

RasagilinaViso Farmacéuticacan be taken with or without food.

If you take more RasagilinaViso Farmacéuticathan you should

If you think you have taken more RasagilinaViso Farmacéutica, inform your doctor or pharmacist immediately. Bring the packaging or bottle of RasagilinaViso Farmacéuticawith you to show to your doctor or pharmacist.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take RasagilinaViso Farmacéutica

Do not take a double dose to make up for the missed doses. Take the next scheduled dose normally when it is due.

If you interrupt treatment with RasagilinaViso Farmacéutica

Do not stop treatment with RasagilinaViso Farmacéuticawithout consulting your doctor first.

If you have any other questions about the use of this medication, consult 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 immediatelyif 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, gambling addiction, excessive purchases or spending, impulsive behavior, and an abnormally high or increased sexual desire (impulse control disorder) (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)

Get in touch with your doctorif you notice any suspicious changes in the 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 patients):

• Unintentional movements (dyskinesia)

Headache

Common(may affect up to 1 in 10 patients):

• Abdominal pain
• Falls
• Allergy
• Fever
• Common cold
• General feeling of being unwell
• Neck pain
• Chest pain (angina)
• Low blood pressure when standing, with symptoms such as dizziness/drowsiness (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal results in blood tests (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 problems (balance disorder)
• Depression
• Dizziness (vertigo)
• Prolonged muscle contractions (dystonia)
• Nasal discharge (rhinitis)
• Skin irritation (dermatitis)
• Rash
• Red eyes (conjunctivitis)
• Urgency to urinate

Uncommon(may affect up to 1 in 100 patients):

• 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 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 use this medication after the expiration date that appears on the box and the bottle or blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Only bottle

Shelf life once opened 2 months

Medicines should not be disposed of through drains or trash. Dispose of containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Content of RasagilinaViso Farmacéutica

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as rasagilina tartrate).
• The other components are microcrystalline cellulose, citric acid, pregelatinized cornstarch, anhydrous colloidal silica, stearic acid, talc

Appearance of RasagilinaViso Farmacéuticaand packaging contents

RasagilinaViso Farmacéuticais presented as flat, circular tablets of approximately 8 mm in diameter, white to off-white in color, with the number "771" engraved on one face, and a "G" on the other.

The tablets are presented in PVC/Aluminum/OPA-Aluminum blisters of 7, 10, 28, 30, 60, 100, and 112 tablets or in a white HDPE bottle, with and without a child-resistant cap, containing 30 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturerMarketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park, Croxley Green,

Hertfordshire, WD18 8YA

United Kingdom

Or

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143, 566 17 Vysoké Mýto,

Czech Republic

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Last review date of this leaflet:July 2021.

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