SELECOM 5 mg Tablet

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1. SELECOM 5 mg tablets

SELECOM 5 mg tablets

Selegiline hydrochloride
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

SELECOM is a medicine that contains a substance called selegiline as its active ingredient.
SELECOM blocks the action of an enzyme called monoamine oxidase (MAO) type B, thus causing
an increase in the concentrations of a substance called dopamine.
SELECOM is indicated in adult patients for the treatment of Parkinson's disease (a disease of the
central nervous system that manifests, for example, with tremor, muscle rigidity,
slowing of movements, difficulty maintaining balance) and symptomatic parkinsonism
(diseases with the same symptoms as Parkinson's disease but with a different cause).
SELECOM can be prescribed alone or in combination with other medicines used for the
treatment of Parkinson's disease.

• 2. What you need to know before you take SELECOM

Do not take SELECOM

• if you are allergic to selegiline or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe movement disorders not due to dopamine deficiency (e.g., essential tremor, Huntington's disease);
• if you are taking: o medicines for the treatment of depression and some psychiatric illnesses such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs, e.g., venlafaxine), tricyclic antidepressants, monoamine oxidase inhibitors (MAO);
  o sympathomimetic medicines, a class of medicines that stimulate the nervous system;
  o linezolid (antibiotic);
  o opioids such as pethidine, medicines for treating pain;
  (see section “Other medicines and SELECOM”).

serotonin-norepinephrine reuptake inhibitors (SNRIs, for example venlafaxine), tricyclic antidepressants, monoamine oxidase inhibitors (MAO);
or sympathomimetic medicines, a class of medicines that stimulate the nervous system;
or linezolid (antibiotic);
or opioids such as pethidine, medicines for treating pain;
(see section “Other medicines and SELECOM”).

• if you suffer from a lesion of the stomach or intestine (active gastric or duodenal ulcer).

Warnings and precautions
Talk to your doctor before taking SELECOM if:

• you suffer from high blood pressure (hypertension),
• you suffer from heart rhythm disturbances (cardiac arrhythmia),
• you suffer from severe chest pain (severe angina pectoris),
• you suffer from a mental disorder (psychosis),
• you have suffered from a stomach lesion (peptic ulcer), as a worsening of these conditions may occur during treatment,
• you suffer from a severe liver or kidney disease (severe hepatic or renal dysfunction),
• you are to undergo a general anesthetic operation,
• you are taking substances or medicines that are active at the central nervous system level.

For athletes: the use of the drug without therapeutic need constitutes doping and
may still result in positive doping tests.
Children and adolescents
There is no indication for specific use of SELECOM in patients under the age of 18.
Other medicines and SELECOM
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Contraindicated associations

• with sympathomimetics ,a class of medicines that stimulate the nervous system;
• with pethidine (also known as meperidine), a medicine used to treat pain;
• with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs, e.g., venlafaxine) ,medicines used to treat depression and some psychiatric illnesses;
• with fluoxetine, a medicine used to treat depression. The latter should not be used for 14 days before stopping selegiline therapy. Allow at least 5 weeks to pass between stopping fluoxetine and starting selegiline therapy;
• with tricyclic antidepressants (e.g., amitriptyline, imipramine, nortriptyline), medicines used to treat depression;
• with monoamine oxidase inhibitors (MAO), medicines used to treat depression or Parkinson's disease;
• linezolid, an antibiotic for treating infections.

Associations not recommended

• with oral contraceptives (the pill);
• with digitalis, a medicine used to treat a weak heart;
• with anticoagulants, medicines that can slow down or stop the blood clotting process.

Associations that require caution

• with levodopa (a medicine used to treat Parkinson's disease), as the side effects of levodopa such as involuntary movements and/or agitation may increase.

In particular, tell your doctor if you are taking:

• reserpine, a medicine used to treat mental disorders,
• papaverine, a medicine used to treat pain,
• vitamin B6 (pyridoxine), as they decrease the effects of levodopa;

SELECOM with food, drinks and alcohol

• if you are taking SELEGILINE and non-selective MAO inhibitors or selective MAO-A inhibitors (medicines for treating depression or Parkinson's disease), avoid eating foods containing high amounts of tyramine such as aged cheese and fermented products.
• avoid concomitant use of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
SELECOM should not be used during pregnancy: therefore, your doctor will carefully assess any
prescription of SELECOM.
Breastfeeding
It is not known whether selegiline is present in breast milk. Therefore, SELECOM should not
be used during breastfeeding.
Fertility
Given the specific indications of the product, the use of SELECOM in patients of childbearing potential is unlikely.
Driving and using machines
As SELECOM can cause dizziness, do not drive or use machines if you experience this
side effect during treatment.
SELECOM contains lactose
SELECOM contains lactose (milk sugar). If you have been diagnosed with intolerance to
some sugars (e.g. lactose), contact your doctor before taking this medicine.

• 3. How to take SELECOM

Take this medicine exactly as your doctor has told you. If you have any doubts
ask your doctor or pharmacist.
If you take SELECOM as single therapy
The recommended dose is 2 tablets a day in the morning in a single dose or divided
into 2 daily doses morning and afternoon.
If you take SELECOM in combination with other medicines for the treatment of Parkinson's disease
The initially recommended dose is 1 – 2 tablets a day in the morning or divided into 2
daily doses morning and afternoon.
The recommended dose in patients who experience a reduction or loss of the ability to
perform automatic movements (akinesia) or an abnormal and uncoordinated movement of
muscles (dyskinesias) and alternating phases of the disease (“on-off”) is 2 tablets a day.
There are no data available on dose adjustments in patients with kidney or liver problems (mild
renal and/or hepatic insufficiency, renal impairment, hepatic impairment).
If you take more SELECOM than you should
In case of accidental ingestion / intake of an excessive dose of SELECOM contact
immediately your doctor or go to the nearest hospital.
You may experience an increase in blood pressure (hypertension).
If you forget to take SELECOM
Do not take a double dose to make up for a missed tablet.
If you stop taking SELECOM
If you have any questions about using this medicine, ask your doctor or pharmacist.

• 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone
gets them.
side effects. The frequency of the side effects listed below is defined according to the
following convention:
Common (may affect up to 1 in 10 people)

• insomnia,
• dizziness
• headache,
• vertigo,
• decreased heart rate (bradycardia),
• nausea,
• slight increase, shown with blood tests, in the values indicating liver function.

Uncommon (may affect up to 1 in 100)

• altered mood,
• sleep disturbance (mild and temporary),
• increased heart rate (supraventricular tachycardia),
• dry mouth.

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

• lowering of blood pressure when going from sitting to standing (postural hypotension),
• skin reaction.

Not known (frequency cannot be estimated from available data)

• increased sexual desire (hypersexuality),
• urinary retention.

If you take SELECOM and levodopa, the side effects of levodopa may be increased
(restlessness, uncoordinated movements, abnormal movements, agitation, confusion, hallucination, lowering of blood pressure when going from sitting to standing,
heart rhythm disturbances).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety
of this medicine.

• 5. How to store SELECOM

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

• 6. Contents of the pack and other information

What SELECOM contains

• The active ingredient is selegiline hydrochloride (l-deprenil) 5 mg.
• The other ingredients are: lactose (see section 2. SELECOM contains lactose), rice starch, talc, magnesium stearate, povidone.

Description of SELECOM and contents of the pack
SELECOM is available as round, white or almost white tablets with a fracture line
on one side.
The fracture line is not functional for dividing the tablet into two equal doses.
SELECOM is available in blister packs of 50 tablets of 5 mg.
Marketing authorisation holder and manufacturer
FULTON medicinali S.p.A., via Marconi 28/9 - Arese (MI).
Manufacturer
FULTON medicinali S.p.A., via Marconi 28/9 - Arese (MI).