Selecom
Italy
Table of Contents
Package leaflet: Information for the patient
SELECOM 5 mg tablets
Selegiline hydrochloride
Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What SELECOM is and what it is used for
- What you need to know before taking SELECOM
- How to take SELECOM
- Possible side effects
- How to store SELECOM
- Contents of the pack and other information
1. What SELECOM is and what it is used for
SELECOM is a medicine that contains as its active substance a compound called selegiline.
SELECOM inhibits the action of an enzyme called monoamine oxidase (MAO) type B, thereby increasing the concentrations of a substance called dopamine.
SELECOM is indicated in adult patients for the treatment of Parkinson's disease (a disorder of the central nervous system characterized, for example, by tremor, muscle rigidity, slowness of movement, difficulty maintaining balance) and symptomatic parkinsonism (conditions with the same symptoms as Parkinson's disease but with a different cause).
SELECOM may be prescribed alone or in combination with other medicines used to treat Parkinson's disease.
2. What you need to know before taking SELECOM
Do not take SELECOM
-
if you are allergic to selegiline or to 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 depression and certain psychiatric disorders such as selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs, e.g. venlafaxine), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs);
o sympathomimetic medicines, a class of drugs that stimulate the nervous system;
o linezolid (an antibiotic);
o opioids such as meperidine, medicines used to treat pain;
(see section “Other medicines and SELECOM”). -
if you have a stomach or intestinal lesion (active gastric or duodenal ulcer).
Warnings and precautions
Talk to your doctor before taking SELECOM if:
- you have high blood pressure (hypertension),
- you have heart rhythm disorders (cardiac arrhythmia),
- you suffer from severe chest pain (severe angina pectoris),
- you have a mental disorder (psychosis),
- you have previously had a stomach lesion (peptic ulcer), as these conditions may worsen during treatment,
- you have severe liver or kidney disease (severe hepatic or renal dysfunction),
- you are scheduled for surgery under general anesthesia,
- you are taking substances or medicines acting on the central nervous system.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
There is no indication for the use of SELECOM in patients under 18 years of age.
Other medicines and SELECOM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Combinations contraindicated
- with sympathomimetics, a class of medicines that stimulate the nervous system;
- with meperidine (also known as pethidine), a medicine used to treat pain;
- with selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs, e.g. venlafaxine), medicines used to treat depression and certain psychiatric disorders;
- with fluoxetine, a medicine used to treat depression. Fluoxetine must not be used within 14 days after stopping selegiline therapy. Allow at least 5 weeks between discontinuation of fluoxetine and initiation of selegiline therapy;
- with tricyclic antidepressants (e.g. amitriptyline, imipramine, nortriptyline), medicines used to treat depression;
- with monoamine oxidase inhibitors (MAOIs), medicines used to treat depression or Parkinson's disease;
- linezolid, an antibiotic used to treat infections;
- medicines used to treat migraine attacks (e.g. sumatriptan, naratriptan, zolmitriptan, rizatriptan, lasmiditan).
Combinations not recommended
- with oral contraceptives (birth control pills);
- with digitalis, a medicine used to treat heart failure;
- with anticoagulants, medicines that slow or interrupt blood clotting.
Combinations requiring caution
- with levodopa (a medicine used to treat Parkinson's disease), as side effects of levodopa such as involuntary movements and/or agitation may increase.
In particular, inform 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 these may reduce 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 used to treat depression or Parkinson's disease), avoid consuming foods high in tyramine such as aged cheese and fermented products.
- avoid concomitant use of alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
SELECOM should not be used during pregnancy: therefore, your doctor will carefully evaluate any potential prescription of SELECOM.
Breastfeeding
It is not known whether selegiline is excreted in breast milk. Therefore, SELECOM must not be used during breastfeeding.
Fertility
Given the specific indications of the product, use of SELECOM in individuals of reproductive age is unlikely.
Driving and using machines
Since SELECOM may cause dizziness, do not drive or operate machinery if you experience this side effect during treatment.
SELECOM contains lactose
SELECOM contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him/her before taking this medicine.
3. How to take SELECOM
Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
If you take SELECOM as monotherapy
The recommended dose is 2 tablets daily, taken in the morning as a single dose or divided into two daily doses (morning and afternoon).
If you take SELECOM in combination with other medicines for Parkinson's disease
The initially recommended dose is 1–2 tablets daily, taken in the morning or divided into two daily doses (morning and afternoon).
The recommended dose in patients with reduced or lost ability to perform automatic movements (akinesia), abnormal and uncoordinated muscle movements (dyskinesias), or alternating phases of the disease ("on-off" phases) is 2 tablets daily.
There are no available data on dose adjustments in patients with kidney or liver problems (mild renal and/or hepatic insufficiency, renal or hepatic impairment).
If you take more SELECOM than you should
In case of accidental overdose of SELECOM, contact your doctor immediately or go to the nearest hospital.
You may experience increased blood pressure (hypertension).
If you forget to take SELECOM
Do not take a double dose to make up for the missed tablet.
If you stop taking SELECOM
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the instructions in this leaflet reduces the risk of 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 (cephalalgia),
- vertigo,
- reduced heart rate (bradycardia),
- nausea,
- slight increase in liver function test values shown in blood tests.
Uncommon (may affect up to 1 in 100 people)
- altered mood,
- sleep disorder (mild and temporary),
- increased heart rate (supraventricular tachycardia),
- dry mouth.
Rare (may affect up to 1 in 1,000 people)
- drop in blood pressure upon standing from a sitting position (postural hypotension),
- skin reaction.
Not known (frequency cannot be estimated from the available data)
- urinary retention,
- problems with impulse control and compulsive behaviors (such as compulsive shopping, gambling, eating, or sexual behavior).
If you are taking SELECOM and levodopa, the side effects of levodopa may be increased (restlessness, uncoordinated movements, abnormal movements, agitation, confusion, hallucinations, drop in blood pressure upon standing from a sitting position, heart rhythm disturbances).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 pack and other information
What SELECOM contains
- The active substance is selegiline hydrochloride (l-deprenyl) 5 mg.
- The other ingredients are: lactose (see section 2. SELECOM contains lactose), rice starch, talc, magnesium stearate, povidone.
Description of the appearance of SELECOM and contents of the pack
SELECOM is presented as white or almost white round tablets with a score line on one side.
The score line is not intended to divide the tablet into two equal doses.
SELECOM is available in a box containing 50 tablets of 5 mg.
Marketing Authorization Holder and Manufacturer
FULTON medicinali S.p.A., via Marconi 28/9 - Arese (MI).
Sales Licensee
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano – Italy
Manufacturer
FULTON medicinali S.p.A., via Marconi 28/9 - Arese (MI).