Segan

Package Leaflet: Information for the Patient

Segan, 5 mg, Tablets

Selegiline Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Segan and what is it used for

The active substance of Segan is selegiline. Selegiline inhibits the activity of monoamine oxidase type B enzyme, which is involved in the metabolism of dopamine in the central nervous system.
Segan is used in Parkinson's disease:

• as a single medicine in the early stages of Parkinson's disease, to delay the need for levodopa, Segan is used in Parkinson's disease or symptomatic parkinsonism:
• in combination with levodopa (with or without a decarboxylase inhibitor).

2. Important information before taking Segan

When not to take Segan:

• if you are allergic to selegiline or any of the other ingredients of this medicine (listed in section 6);
• if you have extrapyramidal syndromes not related to dopamine deficiency (Huntington's chorea, essential tremor);
• if you are taking a serotonin agonist (e.g. sumatriptan, naratriptan, zolmitriptan, rizatriptan);
• if you have active gastric or duodenal ulcer disease;
• if you have acute liver or kidney failure;
• if you have skin diseases of unknown origin (the medicine may stimulate the development of malignant melanoma);
• if you are taking pethidine or other opioids (strong painkillers: fentanyl, tramadol, methadone) or a cough suppressant: dextromethorphan, or tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, sertraline, paroxetine, citalopram, escitalopram) or serotonin and norepinephrine reuptake inhibitors (SNRIs) (venlafaxine), or sympathomimetic drugs, used e.g. in the treatment of asthma and to reduce nasal congestion (e.g. ephedrine, pseudoephedrine), monoamine oxidase inhibitors (e.g. linezolid).

Do not take Segan with buprenorphine (or buprenorphine/naloxone) without prior consultation with your doctor. Buprenorphine (or buprenorphine/naloxone) may interact with Segan and may cause the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, excitement, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C. If you experience such symptoms, contact your doctor.

Warnings and precautions

Before starting to take Segan, discuss it with your doctor.
Selegiline should not be used in combination with levodopaif:

• you have cardiovascular diseases (hypertension, severe angina pectoris, tachycardia, arrhythmias);
• you have psychoses with advanced dementia;
• you have prostatic hyperplasia with urinary retention;
• you have narrow-angle glaucoma;
• you have hyperthyroidism, thyrotoxicosis;
• you have a pheochromocytoma.

Be particularly cautious when taking Segan if you have:

• uncontrolled (unstable) hypertension;
• heart rhythm disorders;
• severe angina pectoris;
• mental illness (psychosis);
• a history of peptic ulcer disease, due to the possible exacerbation of these conditions during treatment;
• kidney or liver function disorders (your doctor will recommend a dose reduction);
• impulse control disorders, such as pathological gambling, increased libido, hypersexuality, uncontrolled appetite, shopping addiction - taking the medicine may exacerbate these behaviors;
• had surgery under general anesthesia and are taking MAO inhibitors, due to the risk of central nervous system depression;
• acute or chronic pain or other conditions treated with buprenorphine (or buprenorphine/naloxone). Taking buprenorphine (or buprenorphine/naloxone) with Segan may lead to serotonin syndrome, a life-threatening disease (see "Segan and other medicines").

Do not exceed the recommended daily dose of 10 mg, due to the risk of side effects, such as uncontrolled increase in blood pressure after consuming foods rich in tyramine (moldy cheeses, wine, beer, caviar).

Segan and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about the medicines you plan to take.
In particular, this applies to the use of:

• other medicines used in Parkinson's disease (levodopa, amantadine, anticholinergic medicines - such as trihexyphenidyl, biperiden, tropatepine, orphenadrine);
• tricyclic antidepressants (dibenzepine, desipramine, imipramine);
• selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) (fluoxetine, fluvoxamine, sertraline, paroxetine, venlafaxine);
• pethidine and other opioid painkillers (e.g. fentanyl, tramadol, methadone);
• dextromethorphan (cough suppressant)
• buspirone (medicine used in anxiety disorders);
• sympathomimetic medicines (e.g. ephedrine - used in nasal congestion);
• MAO inhibitors (e.g. moclobemide);
• oral contraceptives;
• dopamine, epinephrine or norepinephrine;
• cardiac glycosides;
• anticoagulant medicines;
• blood pressure regulating medicines;
• sedative and hypnotic medicines.

Do not take Segan with buprenorphine (or buprenorphine/naloxone) without prior consultation with your doctor. Buprenorphine (or buprenorphine/naloxone) may interact with Segan and may cause the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, excitement, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C. If you experience such symptoms, contact your doctor.

Segan with food, drink, and alcohol

Do not consume alcohol during treatment.

Pregnancy and breastfeeding

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

Driving and using machines

It cannot be excluded that the medicine may affect the ability to drive and use machines. Do not drive or use machines if you experience side effects that may affect your physical and mental ability (e.g. dizziness, hallucinations, disorientation).

Segan contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Segan

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor.
The recommended daily dose of Segan is 5 mg or 10 mg per day, given once - in the morning or in two doses - in the morning and at noon. During treatment, the dose can be reduced by half.
Taking selegiline in combination with levodopa allows the levodopa dose to be reduced by about 10 - 30% (as decided by the doctor).
Taking selegiline does not affect the dosage of other medicines used in Parkinson's disease.

Patients with kidney or liver function disorders

There are no data on the need to modify the dosage in patients with mild kidney or liver function disorders.

Overdose of Segan

In case of overdose, consult your doctor immediately.
Symptoms of overdose are: drowsiness, dizziness, fainting, irritability, increased activity, tremors, severe headaches, hallucinations, hypertension, hypotension, collapse, accelerated and irregular heart rate, chest pain, breathing disorders, fever, excessive sweating.

Missed dose of Segan

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose at the appropriate time. Do not take a double dose to make up for the missed dose.

Stopping Segan treatment

Do not stop treatment abruptly or change the dosage without consulting your doctor first.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Segan can cause side effects, although not everybody gets them.
The following side effects may occur when taking Segan.

Very common (occurring in more than 1 in 10 patients):

• oral mucosa inflammation

Common (occurring in less than 1 in 10 patients)

• sleep disorders, insomnia, hallucinations, confusion, depression
• movement disorders (e.g. dyskinesias, akinesia, bradykinesia), dizziness, headaches, balance disorders, tremors
• bradycardia (decreased heart rate)
• hypotension, hypertension
• nasal congestion, sore throat
• nausea, constipation, diarrhea, oral ulcers
• increased sweating
• joint pain, back pain, muscle cramps
• fatigue
• mild increase in liver enzyme activity in serum
• falls

Uncommon (occurring in less than 1 in 100 patients)

• pharyngitis
• decreased white blood cell and platelet count
• loss of appetite
• unusual dreams, excitement, anxiety, psychoses, mood changes
• mild, transient sleep disorders
• blurred vision
• supraventricular tachycardia, heart rhythm disorders, palpitations, angina pectoris
• decrease in blood pressure when changing body position from lying or sitting to standing, manifested by dizziness
• shortness of breath
• dry mouth
• transient increase in alanine aminotransferase (ALT) activity
• hair loss, skin rashes
• myopathy (muscle diseases, characterized by muscle weakness, stiffness, and cramps)
• chest pain, irritability, ankle edema

Rare (occurring in less than 1 in 1000 patients)

• anxiety, excitement
• postural hypotension (muscle weakness and relaxation, making it difficult to maintain a normal body posture and move)
• skin reactions
• urination disorders

Frequency not known (frequency cannot be estimated from the available data)

• hypersexuality*
• urinary retention

* In patients with Parkinson's disease treated with dopamine agonists or other dopaminergic medicines, impulse control disorders, such as pathological gambling, increased libido, hypersexuality, uncontrolled appetite, shopping addiction, and others, have been observed. They may be related to selegiline, but so far, very few cases have been reported.
Combination with levodopa
Since selegiline enhances the effect of levodopa, the side effects of levodopa may also be enhanced (anxiety, hyperkinetic disorders, abnormal movements, excitement, confusion, nausea, hallucinations, headaches, orthostatic hypotension, heart rhythm disorders, dizziness).
Side effects usually disappear after reducing the levodopa dose.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Segan

Keep the medicine out of the sight and reach of children.
Store in the original package at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the package after EXP.
The expiry date stated on the package after EXP means the last day of the stated month.
The inscription on the package after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Segan contains

• The active substance of Segan is selegiline hydrochloride. Each tablet contains 5 mg of selegiline hydrochloride.
• The other ingredients are: Ludipress (a mixture of lactose, povidone K30, and crospovidone), magnesium stearate.

What Segan looks like and contents of the pack

Segan is a white, round, biconvex tablet.
The package contains 60 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: