Selgres

Package Leaflet: Information for the Patient

Selgres, 5 mg, Coated Tablets

Selegiline Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Selgres and What is it Used For
• 2. Important Information Before Taking Selgres
• 3. How to Take Selgres
• 4. Possible Side Effects
• 5. How to Store Selgres
• 6. Contents of the Package and Other Information

1. What is Selgres and What is it Used For

Selgres belongs to a group of medications called selective monoamine oxidase type B inhibitors.
It selectively reduces the activity of one of the enzymes found in the brain (monoamine oxidase type B), which is responsible for breaking down dopamine. As a result of the medication's action, the amount and duration of action of dopamine in the brain increase, and thus the action of medications containing levodopa used in the treatment of Parkinson's disease is also enhanced (this allows for a reduction in levodopa doses by about 30% on average).
Selgres is used in the treatment of Parkinson's disease and symptomatic parkinsonism - in the early stage as a single medication, in later stages in combination with levodopa or levodopa and carbidopa.

2. Important Information Before Taking Selgres

When Not to Take Selgres

• if you are allergic to the active substance or any of the other ingredients of this medication (listed in section 6).
• in combination with: selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine), serotonin and noradrenaline reuptake inhibitors (SNRIs) (venlafaxine), tricyclic antidepressants, sympathomimetics, monoamine oxidase inhibitors (e.g., linezolid), and opioids (pethidine). See section "Selgres and Other Medications".
• if you have an active duodenal or gastric ulcer.

If selegiline is prescribed with levodopa, the contraindications for levodopa should be taken into account.

Warnings and Precautions

• Caution should be exercised when standing up from a lying or sitting position, as this may cause hypotension (to reduce the risk of hypotension, stand up slowly);
• Selegiline enhances the action of levodopa, so the side effects of levodopa may be more pronounced, especially in patients taking high doses of levodopa. In these patients, treatment will be carried out under close medical supervision. Adding selegiline to levodopa treatment may cause involuntary movements and/or agitation. These side effects disappear after reducing the dose of levodopa (concomitant use with selegiline allows for a reduction in levodopa doses to about 30%);
• If selegiline is used in a dose higher than recommended (10 mg), it may lose its selective MAO-B inhibitor properties and thus increase the risk of hypertension;
• Particular caution should be exercised when using Selgres in patients with unstable hypertension, cardiac arrhythmias, severe angina pectoris, psychosis, or a history of peptic ulcers, as these conditions may worsen during treatment;
• Caution should be exercised in patients taking MAO inhibitors, including selegiline, during general anesthesia for surgical procedures, as selegiline may enhance the action of medications used for general anesthesia on the central nervous system. Transient respiratory failure and circulatory failure, hypotension, and coma have been reported.
• Cautious use is recommended when taking selegiline with other substances and medications that act on the central nervous system.
• Concomitant consumption of alcohol should be avoided.

Selgres and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as medications you plan to take, including those available without a prescription.
Sympathomimetics
Due to the risk of hypertension, concomitant administration of selegiline and sympathomimetics is contraindicated.
Narcotic Pain Medications
Concomitant administration of selegiline and pethidine is contraindicated.
Selegiline should not be used concomitantly with narcotic pain medications (including pethidine and meperidine), due to the risk of hypotension or arterial hypertension, respiratory disorders, coma, seizures, very high fever, vascular collapse, and even death.
Selective Serotonin Reuptake Inhibitors and Serotonin and Noradrenaline Reuptake Inhibitors
Concomitant administration of selegiline and SSRIs (e.g., fluoxetine) or SNRIs (venlafaxine) is contraindicated due to the risk of confusion, mild manic states, hallucinations, and manic episodes, agitation, hyperreflexia, incoordination, tremors, seizures, including clonic muscle seizures, ataxia, excessive sweating, diarrhea, fever, and hypertension.
Treatment with selegiline can be started no earlier than 5 weeks after discontinuation of fluoxetine, and treatment with fluoxetine can be started no earlier than 14 days after discontinuation of selegiline.
Tricyclic Antidepressants
Concomitant use of selegiline and tricyclic antidepressants (e.g., amitriptyline and imipramine) is contraindicated. In patients taking tricyclic antidepressants and selegiline concomitantly, rare cases of severe toxic effects on the central nervous system (serotonin syndrome) have been reported, sometimes associated with hypertension, hypotension, and excessive sweating.
Tricyclic antidepressants can be used no earlier than 14 days after discontinuation of selegiline.
MAO Inhibitors
Concomitant administration of selegiline and MAO inhibitors may cause disorders of the central nervous system and circulatory system.
Concomitant use of selegiline and non-selective monoamine oxidase inhibitors may cause significant arterial hypotension.
Oral Contraceptives
Concomitant administration of selegiline and oral contraceptives should be avoided.
Concomitant administration of medications containing digitalis and/or anticoagulants should be carried out under medical supervision.

Selgres with Food and Drink

So far, it has not been found that taking large amounts of food containing tyramine (e.g., long-ripened cheeses, beans, yeast, smoked and pickled meat, poultry, and fish, salami-type sausages, overripe fruit, wine, and beer) during treatment with selegiline at recommended doses causes an increase in blood pressure (this means that selegiline does not cause the so-called "cheese effect"). Therefore, no dietary restrictions are required.
However, in the case of concomitant use of selegiline and moclobemide, dietary restrictions are recommended (e.g., avoiding foods with high tyramine content, such as ripened cheeses and yeast products) due to the risk of the so-called "cheese effect", which involves a sudden increase in blood pressure.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Selgres should not be used during pregnancy and breastfeeding.

Driving and Operating Machines

Since selegiline may cause dizziness, do not drive or operate machines if you experience this side effect during treatment.

Selgres Contains Lactose Monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medication.

Selgres Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Selgres

This medication should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Typically, the recommended dose of Selgres is:
Adults:
Orally, usually in a daily dose of 10 mg taken once (in the morning) or in 2 divided doses (5 mg in the morning and 5 mg in the early afternoon).
Do not take doses higher than 10 mg per day.
Concomitant use of selegiline and levodopa or selegiline and levodopa with carbidopa allows for a reduction in levodopa doses by about 30% (up to 50%).
Use in Children and Adolescents:
Selgres should not be used in children and adolescents.
Elderly Patients:
No dose adjustment is necessary.
Patients with Liver or Kidney Impairment:
There is no data on dose adjustment in patients with mild liver or kidney impairment.
The medication should be used with caution in patients with moderate and severe liver or kidney impairment.

Overdose of Selgres

Overdose does not have a specific clinical picture. Symptoms of overdose may resemble those observed with non-selective MAO inhibitors (disorders of the central nervous system and circulatory system).
Symptoms of overdose may develop within 24 hours and include: agitation, tremors, alternating low and high blood pressure, respiratory disorders or respiratory failure, severe muscle cramps, very high fever, coma, and seizures.
There is no specific antidote, and treatment should be symptomatic.
In case of overdose, contact your doctor immediately.
Treatment in case of overdose includes:

• removal of selegiline from the gastrointestinal tract (induction of vomiting, gastric lavage, administration of activated charcoal),
• monitoring of the patient's condition (mainly cardiovascular),
• symptomatic treatment.

Missing a Dose of Selgres

If you miss a dose, take it as soon as possible. However, if it is close to the time of the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Selgres

Stopping treatment with Selgres may lead to worsening of the disease for which it is being used. If you have any doubts about taking the medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Selgres can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• dizziness, headache
• slow heart rate (bradycardia)
• nausea
• mild increase in liver enzyme activity

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

• mood changes
• mild transient sleep disorders
• rapid heart rate (supraventricular tachycardia)
• dry mouth

Rare (may affect up to 1 in 1,000 people):

• orthostatic hypotension
• skin reactions

Unknown (frequency cannot be estimated from the available data):

• excessive sexual desire (hypersexuality)
• urinary retention

In combination with levodopa
Since selegiline enhances the action of levodopa, the side effects of levodopa (anxiety, hyperkinesia, abnormal movements, agitation, confusion, hallucinations, orthostatic hypotension, cardiac arrhythmias) may be more pronounced during combination therapy (usually levodopa should be administered with a peripheral decarboxylase inhibitor). Combination therapy with selegiline may allow for further reduction in levodopa dose (up to 30%).

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Selgres

Store in a temperature below 25°C. Store in the original package.
Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the label.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Selgres Contains

The active substance of the medication is selegiline hydrochloride.
The other ingredients of the medication are: lactose monohydrate, cornstarch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.
Coating ingredients: colloidal silicon dioxide, hypromellose, sodium docuzate, titanium dioxide (E 171), yellow iron oxide (E 172), hydroxypropylcellulose, macrogol 400, macrogol 6000, talc.

What Selgres Looks Like and Contents of the Package

Selgres is a coated tablet.
It is packaged in Al/PCV film blisters in a cardboard box.
The package contains 50 coated tablets (2 blisters of 25 tablets each).

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

Date of Last Revision of the Package Leaflet: