Leaflet: information for the user

Plurimen 5 mg Tablets

Selegiline hydrochloride

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

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

If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Plurimen has Selegiline hydrochloride as its active ingredient, which is a monoamine oxidase B (MAO B) inhibitor, intended for the treatment of Parkinson's Disease.

Plurimen is indicated for:

• The treatment of idiopathic Parkinson's disease.
• It may be used as monotherapy in the initial stages of Parkinson's Disease.
• It may also be used as an adjunct (auxiliary) to levodopa (with or without peripheral decarboxylase inhibitors).

Do not take Plurimen:

• If you are allergic to selegiline or any of the other components of this medication (listed in section 6).
• If you have a duodenal ulcer and/or gastric ulcer.
• Combined therapy of Plurimen and levodopa is contraindicated in: high blood pressure, hyperthyroidism, phaeochromocytoma (a type of tumor), narrow-angle glaucoma (alteration of the internal pressure of the eye), benign prostatic hyperplasia (prostate growth) with residual urine, tachycardia (increased heart rate), arrhythmias (irregular heart rhythm), severe angina pectoris, psychosis, and advanced dementia.
• Do not take Plurimen if you are taking antidepressants. The simultaneous use with fluoxetine will be avoided, as well as its administration during the 5 weeks following the last administration of fluoxetine (see Use of Plurimen with other medications).
• Do not take Plurimen if you are taking sympathomimetics (e.g. nasal decongestants), monoamine oxidase inhibitors (e.g. the antibiotic linezolid, or some types of antidepressants), or opioids (petidina) (see Use of Plurimen with other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Plurimen

• If you have been prescribed combined therapy of Plurimen and levodopa, your doctor will monitor you to control the possible adverse effects of levodopa, and adjust the medication doses if necessary.
• If you have variable blood pressure, irregular heart rhythm, severe angina pectoris, psychosis, or a history of peptic ulcer, your doctor will monitor you because selegiline may worsen these conditions.
• Use with caution in case of severe liver or kidney disease.
• Caution is recommended when taking selegiline in combination with substances with activity in the central nervous system (see Use of Plurimen with other medications).
• Concomitant ingestion of selegiline and alcohol should be avoided.

Use of Plurimen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Plurimen should not be taken with the following medications:

• Nasal decongestants, antihypertensives, psychostimulants.
• The following types of antidepressants: tricyclics, selective serotonin reuptake inhibitors (fluoxetine), serotonin and noradrenaline reuptake inhibitors (venlafaxine), as well as with non-selective and selective MAO inhibitors. The simultaneous use of Plurimen and fluoxetine will be avoided, as well as its administration during the 5 weeks following the last administration of fluoxetine. There will be a minimum of 2 weeks between the discontinuation of treatment with Plurimen and the start of treatment with fluoxetine.
• Opioid analgesics (petidina and buprenorphine)
• Any type of MAO inhibitor (including the antibiotic linezolid), as it may cause a severe increase or decrease in blood pressure.

Plurimen should be taken with caution if administered with the following medications:

• Oral contraceptives.
• Digitalis and/or anticoagulants. Your doctor will monitor you strictly.
• Central nervous system depressants (sedatives, hypnotics).
• Amantadine, anticholinergics, and levodopa or levodopa + peripheral carboxylase inhibitors, as they may cause a higher number of adverse effects.

Taking Plurimen with food, drinks, and alcohol

Unlike conventional MAO inhibitors or MAO-A inhibitors, Plurimen is an MAO B inhibitor and therefore does not require dietary restrictions (e.g. avoiding foods with high tyramine content such as aged cheeses and yeast-based products).

Concomitant ingestion of Plurimen and alcohol should be avoided.

Pregnancy and breastfeeding

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

Plurimen should not be taken in case of pregnancy or suspected pregnancy, nor during breastfeeding, as the effects of selegiline on the fetus or infant are unknown.

Driving and operating machinery

During treatment, your reaction time may be altered, so you should exercise extreme caution when driving vehicles or operating hazardous machinery.

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

As monotherapy in initial stages of Parkinson's Disease: 5-10 mg/day (1 or 2 tablets), either in a single dose or in 2 doses during the morning (breakfast and lunch).

As an adjunct (auxiliary) to levodopa (with or without decarboxylase inhibitors): 5-10 mg/day (1 or 2 tablets), either in a single dose or in 2 doses during the morning (breakfast and lunch). When administered with a levodopa regimen, the levodopa dose should be reduced (average reduction, 30%). The daily dose of Plurimen should not exceed 10 mg (2 tablets).

The tablets should be swallowed with a little water.

Use in children

The safety and efficacy of Plurimen in children have not been established.

If you take more Plurimen than you should

There is no clinical experience related to the ingestion of toxic doses of selegiline.

The symptoms of overdose may resemble those observed with non-selective MAO inhibitors (e.g. some types of antidepressants) (central and cardiovascular nervous system disorders). The symptoms of non-selective MAO inhibitor overdose may evolve over 24 hours, including agitation, tremor, alternating between low and high blood pressure, respiratory depression, severe muscle spasms, hyperpyrexia (fever above 40°C), coma, and seizures.

No specific antidote is known. Therefore, the treatment of overdose should be symptomatic.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Plurimen

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Plurimen

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

When administered alone (without being combined with other medications), selegiline has been detected:

• Frequent adverse effects (may affect up to 1 in 10 patients): dizziness, headache, abnormal movements, vertigo, nausea, bradycardia (decrease in heart rate) and elevated levels of liver enzymes in the blood, confusion, hallucinations.
• Rare adverse effects (may affect up to 1 in 100 patients): mild and transient sleep disturbances, dry mouth, increased heart rate and changes in mood.
• Rare adverse effects (may affect up to 1 in 1,000 patients): agitation, difficulty urinating, skin reactions, irregular heart rhythm and postural hypotension (drop in blood pressure when standing up).
• Adverse effects of unknown frequency: urinary retention, hypersexuality (increased libido) and impulse control disorder and compulsions (e.g. compulsive buying or repetitive or mechanical movements).

Under combined treatment with levodopa and Plurimen, the adverse effects of levodopa may increase (restlessness, involuntary or abnormal movements, agitation, confusion, hallucination, postural hypotension, cardiac arrhythmias).

These adverse effects may be reduced, in part, by reducing the dose of levodopa, which is possible under combined therapy with Plurimen.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the 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 Plurimen

The active ingredient is Selegiline hydrochloride. Each tablet contains 5 mg of Selegiline hydrochloride.

The other components are: mannitol, cornstarch, microcrystalline cellulose, povidone, magnesium stearate.

Appearance of the product and content of the container

Plurimen tablets are non-coated, round, convex, and white or almost white in color.

The tablets are presented in a round polyethylene container with a polyethylene closure system.

Plurimen is presented in 20 and 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ORION Corporation,

Orionitie, 1

Espoo (Finland)

Local Representative:

Orion Pharma S.L.

Avda. Alberto Alcocer 46B

28016 Madrid

Responsible for manufacturing:

ORION Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation

Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Last review date of this leaflet: April 2021

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