PLURIMEN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Plurimen 5 mg Tablets

Selegiline, hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

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

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

Contents of the Package Leaflet:

1. What is Plurimen and what is it used for
2. What you need to know before taking Plurimen
3. How to take Plurimen
4. Possible side effects
5. Storage of Plurimen
6. Package contents and additional information

1. What is Plurimen and what is it used for

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

Plurimen is indicated in:

• Treatment of idiopathic Parkinson's disease.
• It can be used as monotherapy in early stages of Parkinson's disease.
• It can also be used as an adjunct (auxiliary) to levodopa (with or without peripheral decarboxylase inhibitors).

2. What you need to know before taking Plurimen

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 duodenal or gastric ulcers.
• The combined therapy of 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 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 of Plurimen and fluoxetine should 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 Plurimen treatment and the start of fluoxetine treatment.
• 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 (pethidine) (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 for possible side 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 ulcers, your doctor will monitor you because selegiline may worsen these conditions.
• It should be used with caution in cases of severe liver or kidney disease.
• Cautions are recommended when taking selegiline in combination with substances that have activity in the central nervous system (see Use of Plurimen with other medications).
• The concomitant intake of selegiline and alcohol should be avoided.

Use of Plurimen with other medications

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

Plurimen should not be taken with the following medications:

• Nasal decongestants, hypertensives, psychostimulants.
• The following types of antidepressants: tricyclic, selective serotonin reuptake inhibitors (fluoxetine), serotonin and norepinephrine reuptake inhibitors (venlafaxine), as well as selective and non-selective MAO inhibitors. The simultaneous use of Plurimen and fluoxetine should 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 Plurimen treatment and the start of fluoxetine treatment.
• Opioid analgesics (pethidine and buprenorphine)
• MAO inhibitors of any type (including the antibiotic linezolid), as they 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 closely monitor you.
• CNS depressant medications (sedatives, hypnotics).
• Amantadine, anticholinergics, and levodopa or levodopa + peripheral decarboxylase inhibitors, as they may increase the number of side 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 high in tyramine such as aged cheeses and yeast-based products).

The concomitant intake of Plurimen and 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 medication.

Plurimen should 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

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

3. How to take Plurimen

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

As monotherapy in early 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 peripheral 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 with toxic doses of selegiline.

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

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

In case of overdose or accidental ingestion, consult the Toxicology 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 make up for forgotten doses.

If you stop taking Plurimen

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Common side effects (may affect up to 1 in 10 patients): dizziness, headache, abnormal movements, vertigo, nausea, bradycardia (decreased heart rate), and elevated liver enzyme levels in the blood, confusion, hallucinations.
• Uncommon side effects (may affect up to 1 in 100 patients): mild and transient sleep disorders, dry mouth, increased heart rate, and mood changes.
• Rare side 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).
• Side effects of unknown frequency: urinary retention, hypersexuality (increased libido), and impulse control disorders (e.g., compulsive shopping or repetitive mechanical movements).

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

These side effects can be reduced, in part, by decreasing the levodopa dose, which is possible under combined therapy with Plurimen.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Plurimen

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

Do not use this medication after the expiration date stated 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 disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

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 package contents

The Plurimen tablets are uncoated, round, convex, and white or almost white in color.

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

Plurimen is available in 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 last revision of this package leaflet: April 2021

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