Segan

Package leaflet: Information for the patient

Segan, 5 mg, tablets
Selegilini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Segan is and what it is 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 Segan is and what it is used for

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

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

2. Important information before using Segan

When not to use Segan:

• if the patient is allergic to selegiline or any of the other ingredients of this medicine (listed in section 6);
• if the patient has extrapyramidal syndromes unrelated to dopamine deficiency (Huntington's chorea, essential tremor);
• if the patient is taking a serotonin agonist (e.g. sumatriptan, naratriptan, zolmitriptan, rizatriptan);
• if the patient has active peptic ulcer of the stomach or duodenum;
• if the patient has acute liver or kidney failure;
• if the patient has skin disorders of unknown origin (the medicine may stimulate the development of malignant melanoma);
• if the patient is taking meperidine or other opioids (strong painkillers: tramadol, fentanyl, methadone or the antitussive: dextromethorphan), tricyclic antidepressants, or medicines from the group of serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, sertraline, paroxetine, citalopram, escitalopram), or medicines from the group of serotonin and noradrenaline reuptake inhibitors (SNRIs) (venlafaxine), medicines classified as sympathomimetics used, for example, in the treatment of asthma and to reduce nasal mucosal swelling (e.g. ephedrine, pseudoephedrine), or monoamine oxidase inhibitors (e.g. linezolid).

Warnings and precautions

Before starting treatment with Segan, discuss this with your doctor.

Selegiline should not be used in combination with levodopa if the patient has:

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

Special caution is required when using Segan if the patient has:

• uncontrolled (unstable) hypertension;
• cardiac arrhythmias;
• severe angina pectoris;
• a psychiatric disorder (psychosis);
• a history of peptic ulcer disease, due to the risk of exacerbation during treatment;
• impaired kidney or liver function (your doctor may recommend a reduced dose);
• impulse control disorders, such as pathological gambling, increased libido, hypersexuality, compulsive eating, compulsive shopping – treatment with this medicine may worsen these behaviors;
• undergone surgery under general anesthesia while 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). Concurrent use of buprenorphine (or buprenorphine/naloxone) with Segan may lead to serotonin syndrome, a potentially life-threatening condition (see section "Segan with other medicines").

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

Segan with other medicines

Inform your doctor about all medicines currently used, recently used, or planned for use.

This particularly applies to the use of:

• other medicines used in Parkinson's disease (levodopa, amantadine, anticholinergic medicines – e.g. trihexyphenidyl, biperiden, tropatepine, orphenadrine);
• tricyclic antidepressants (dibenzepine, desipramine, imipramine);
• selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) (fluoxetine, fluvoxamine, sertraline, paroxetine, venlafaxine);
• meperidine and other opioid painkillers (e.g. fentanyl, tramadol, methadone);
• dextromethorphan (cough suppressant);
• buspirone (used for anxiety states);
• sympathomimetic medicines (e.g. ephedrine – used in nasal inflammatory conditions);
• MAO inhibitors (e.g. moclobemide);
• oral contraceptives;
• dopamine, epinephrine, or norepinephrine;
• cardiac glycosides;
• anticoagulants;
• medicines regulating blood pressure;
• sedatives and hypnotics.

Do not use Segan together with buprenorphine (or buprenorphine/naloxone) without prior consultation with your doctor. Buprenorphine (or buprenorphine/naloxone) may interact with Segan and may cause symptoms such as involuntary rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, contact your doctor immediately.

Segan, food, drink, and alcohol

Do not consume alcohol during treatment.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Selegiline should not be used during pregnancy or breastfeeding.

Driving and operating machinery

The effect of the medicine on the ability to drive and operate machinery cannot be excluded. Do not drive or operate machinery if adverse effects affecting psycho-motor performance occur (e.g. dizziness, hallucinations, disorientation).

Segan contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Segan

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor.
The recommended daily dose of Segan is 5 mg or 10 mg once daily – in the morning, or in two doses – in the morning and at noon. During treatment, the dose may be reduced by half.
The use of selegiline in combination with levodopa allows for a reduction in the administered levodopa dose by approximately 10–30% (as decided by the physician).
The use of selegiline does not affect the dosing of other medicines used in Parkinson's disease.

Patients with impaired kidney or liver function
There are no data regarding the need to modify the dosage in patients with mild impairment of kidney or liver function.

Use of a higher than recommended dose of Segan
In case of overdose, consult a physician immediately.
Symptoms of overdose include: drowsiness, dizziness, fainting, irritability, increased activity, tremor, severe headache, hallucinations, hypertension, hypotension, collapse, rapid and irregular heartbeat, chest pain, breathing difficulties, fever, and profuse sweating.

Missed dose of Segan
If a dose is missed, take it as soon as possible. However, 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 a missed dose.

Stopping treatment with Segan
Do not stop treatment suddenly or change the dosage without first consulting your doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with Segan.

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

• oral mucosal inflammation

Common (occurring in fewer than 1 in 10 patients):

• sleep disorders, insomnia, hallucinations, confusion, depression
• movement disorders (e.g. dyskinesia, akinesia, bradykinesia), dizziness, headache, balance disorders, tremor
• bradycardia (reduced heart rate)
• hypotension, hypertension
• nasal mucosal congestion, sore throat
• nausea, constipation, diarrhoea, oral ulceration
• increased sweating
• joint pain, back pain, muscle cramps
• fatigue
• slight increase in serum liver enzyme activity
• falls

Uncommon (occurring in fewer than 1 in 100 patients):

• pharyngitis
• decreased white blood cell and platelet count
• loss of appetite
• unusual dreams, restlessness, anxiety, psychosis, mood changes
• mild, transient sleep disturbances
• blurred vision
• supraventricular tachycardia, cardiac arrhythmia, palpitations, angina pectoris
• decrease in blood pressure upon changing position from lying or sitting to standing, manifesting as dizziness
• dyspnoea
• dry mouth
• transient increase in alanine aminotransferase (AlAT) activity
• hair loss, skin eruptions
• myopathy (muscle disorders presenting as muscle weakness, stiffness, and cramps)
• chest pain, irritability, ankle swelling

Rare (occurring in fewer than 1 in 1000 patients):

• restlessness, agitation
• reduced postural tone (muscle flaccidity and weakness impairing maintenance of normal posture and movement)
• skin reactions
• urinary 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, compulsive eating, compulsive shopping, and others have been observed. These may be related to selegiline, although very few cases have been reported to date.

Combination with levodopa
Since selegiline enhances the effect of levodopa, adverse effects of levodopa may also be intensified (restlessness, hyperkinetic disorders, abnormal movements, agitation, confusion, nausea, hallucinations, headache, orthostatic hypotension, cardiac arrhythmia, dizziness). These adverse effects usually subside after reducing the levodopa dose.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Segan

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

6. Contents of the package and other information

What Segan contains

• The active substance 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 pack contains 60 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01