Plurimen 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plurimen 5 mg Tablets

Selegiline hydrochloride

Read the entire 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, 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Plurimen is and what it is used for

Plurimen contains the active substance Selegiline hydrochloride, which is an inhibitor of monoamine oxidase B (MAO B), 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 early stages of Parkinson's disease.
• It may also be used as an adjunct (auxiliary) to levodopa (with or without peripheral decarboxylase inhibitors).

2. What you need to know before starting to take Plurimen

Do not take Plurimen:

• If you are allergic to selegiline or to any of the other components of this medicine (listed in section 6).
• If you have duodenal ulcer and/or gastric ulcer.
• Combination therapy with Plurimen and levodopa is contraindicated in: arterial hypertension (high blood pressure), hyperthyroidism (thyroid gland disorder), pheochromocytoma (a type of tumor), narrow-angle glaucoma (eye pressure disorder), prostatic adenoma (prostate enlargement) with residual urine, tachycardia (increased heart rate), arrhythmias (irregular heartbeat), severe angina pectoris, psychosis, and advanced dementia.
• Do not take Plurimen if you are taking antidepressants. Concomitant use with fluoxetine must be avoided, as well as administration within the 5 weeks following the last dose of fluoxetine (see Use of Plurimen with other medicines).
• Do not take Plurimen if you are taking sympathomimetics (e.g. nasal decongestants), monoamine oxidase inhibitors (e.g. the antibiotic linezolid, or certain types of antidepressants), or opioids (meperidine) (see Use of Plurimen with other medicines).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Plurimen

• If you have been prescribed combination therapy with Plurimen and levodopa, your doctor will monitor you for possible adverse effects of levodopa and adjust your medication dosage 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 closely, as 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 that have activity on the central nervous system (see Use of Plurimen with other medicines).
• Concomitant intake of selegiline and alcohol should be avoided.

Other medicines and Plurimen

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

Plurimen must not be taken together with the following medicines:

• Nasal decongestants, hypertensive agents, psychostimulants.
• The following types of antidepressants: tricyclics, selective serotonin reuptake inhibitors (fluoxetine), serotonin and noradrenaline reuptake inhibitors (venlafaxine), as well as selective and non-selective MAO-inhibiting antidepressants. Concomitant use of Plurimen and fluoxetine must be avoided, as well as administration within 5 weeks after the last dose of fluoxetine. A minimum interval of 2 weeks should be maintained between discontinuation of Plurimen and initiation of fluoxetine treatment.
• Opioid analgesics (meperidine and buprenorphine).
• MAO inhibitors of any type (including the antibiotic linezolid), as they may cause severe increase or decrease in blood pressure.
• Medicines used to treat migraine attacks (e.g. sumatriptan, naratriptan, zolmitriptan, rizatriptan, lasmiditan).

Plurimen should be taken with caution if administered together with the following medicines:

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

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 high in tyramine such as aged cheeses and yeast-based products).

The intake of Plurimen with alcohol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Plurimen must not be taken during pregnancy or suspected pregnancy, nor during breastfeeding, as it is unknown whether selegiline passes into breast milk.

Driving and using machines

Your reaction ability may be impaired during treatment; therefore, extreme caution should be exercised when driving vehicles or operating dangerous machinery.

3. How to take Plurimen

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

As monotherapy in early stages of Parkinson's Disease: 5–10 mg/day (1 or 2 tablets), either as a single dose or in two 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 as a single dose or in two 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 10 mg (2 tablets) must not be exceeded.

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 regarding the ingestion of toxic doses of selegiline.

Symptoms of overdose may resemble those observed with non-selective MAO inhibitors (e.g. certain types of antidepressants) (central nervous and cardiovascular system disorders). Symptoms of overdose due to non-selective MAO inhibitors may progress over 24 hours and include agitation, tremor, alternating low and high blood pressure, respiratory depression, severe muscle spasms, hyperpyrexia (fever above 40°C), coma, and convulsions.

There is no known specific antidote. Therefore, treatment of overdose should be symptomatic.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Plurimen

Do not take a double dose to make up for missed doses.

If you stop taking Plurimen

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When selegiline is administered alone (without being combined with other medicines), the following have been observed:

• Common adverse effects (may affect up to 1 in 10 patients): dizziness, headache, abnormal movements, vertigo, nausea, bradycardia (decreased heart rate), elevated liver enzyme levels in the blood, confusion, hallucinations.
• Uncommon adverse effects (may affect up to 1 in 100 patients): mild and transient sleep disorders, dry mouth, increased heart rate, and mood changes.
• Rare adverse effects (may affect up to 1 in 1,000 patients): agitation, difficulty urinating, skin reactions, irregular heartbeat, and postural hypotension (drop in blood pressure upon standing).
• Adverse effects of unknown frequency: urinary retention and problems controlling impulses and compulsive behaviors (such as compulsive shopping, gambling, binge eating, compulsive sexual behavior, or repetitive or mechanical movements).

When levodopa is used in combination with Plurimen, the adverse effects of levodopa may increase (restlessness, involuntary or abnormal movements, agitation, confusion, hallucinations, postural hypotension, cardiac arrhythmias).

These adverse effects may be partially reduced by decreasing the dose of levodopa, which is possible under combination therapy with Plurimen.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Plurimen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plurimen

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

• The other components are: mannitol, corn starch, microcrystalline cellulose, povidone, magnesium stearate.

Appearance of the product and contents of the pack

Plurimen tablets are uncoated, round, convex, white or almost white.

The tablets are supplied in a white round polyethylene bottle with a polyethylene closure cap.

Plurimen is available in packs containing 20 and 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

ORION Corporation,

Orionintie, 1

Espoo (Finland)

Local Representative:

Orion Pharma S.L.

Avda. Alberto Alcocer 46B

28016 Madrid

Manufacturer:

ORION Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

ORION Corporation

Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Date of the most recent review of this leaflet: February 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)