Stimen

Package Leaflet: Information for the Patient

Stymen,10 mg, tablets
Prasteronum

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents:

• 1. What is Stymen and what is it used for
• 2. Important information before taking Stymen
• 3. How to take Stymen
• 4. Possible side effects
• 5. How to store Stymen
• 6. Package contents and other information

1. What is Stymen and what is it used for

Stymen contains the active substance prasterone (dehydroepiandrosterone, DHEA), which belongs to the group of steroid hormones. Its amount in the body decreases with age. The highest concentration of DHEA occurs in men between 20 and 30 years of age, and after 30 years, it decreases gradually. Administration of DHEA may have a beneficial effect on, among other things, erection, libido, well-being, immune system, and musculoskeletal system.
Supporting effects of DHEA have been demonstrated in the following cases:

• andropause in men;
• reduced physical and mental fitness, especially in older people;
• mood disorders, depressive states, sleep disorders, decreased drive;
• erectile dysfunction and decreased sexual activity;
• obesity;
• decreased tissue sensitivity to insulin;
• circulatory disorders;
• decreased immune resistance;
• primary and secondary adrenal insufficiency.

Indications for Use

Stymen is indicated for the treatment of dehydroepiandrosterone (DHEA) deficiency in men with laboratory-confirmed DHEA deficiency.

2. Important Information Before Taking Stymen

When Not to Take Stymen

• in children.

Warnings and Precautions

Starting to take Stymen should be discussed with a doctor, who will order the necessary tests and decide on the need to use this medicine based on their results.
Patients under 40 years of age should not use this medicine.
Without consulting a doctor, the patient should not change, in particular, increase the dose of the medicine.
Treatment of andropause symptoms in older people should be undertaken after a thorough analysis of the benefits and potential risks associated with the use of the medicine, together with a doctor.
In the case of long-term use of the medicine in doses higher than 5 tablets (50 mg) per day, the concentration of DHEA hormone in the blood should be determined and medical examinations should be performed at appropriate intervals.
Stymen is intended for long-term use; the effects of the medicine are visible after several weeks of use.
Stymen should not be used by athletes, as it belongs to the group of prohibited anabolic-androgenic agents.

Children

This medicine should not be used in children.

Stymen and Other Medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any medicines that the patient plans to take.
The patient should inform the doctor if they are taking any of the following medicines:

• anticoagulant medicines (used to reduce blood clotting, such as heparin, warfarin);
• medicines containing androgens (male sex hormones) such as testosterone and testosterone derivatives, as androgenic effects may be enhanced;
• antiepileptic medicines (used to treat epilepsy, such as carbamazepine, valproic acid);
• psycholeptic medicines (used to treat mental disorders, such as phenothiazine derivatives, diazepines, and oxazepines), as Stymen may weaken their effect.

If the patient is unsure whether they are taking any of the above medicines, they should ask their attending doctor.

Stymen with Food and Drink

The medicine should be taken during a meal to facilitate absorption.

Pregnancy, Breastfeeding

The medicine is intended for men.
It should not be used in pregnant or breastfeeding women.

Driving and Operating Machinery

There is no data on the effect on the ability to drive and operate machinery.

The Medicine Contains Lactose

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

3. How to Take Stymen

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.

Recommended Dose

The initial dose is 1 tablet once a day.
The medicine should be taken in the morning, in accordance with the natural rhythm of DHEA secretion.
The initial dose should be gradually increased (every 2 weeks by 1 tablet per day) until the desired therapeutic effects are achieved.
A maximum of 5 tablets (50 mg) can be taken per day.

Method of Administration

The medicine should be taken orally.
The medicine should be taken during a meal to facilitate absorption.
Stymen is intended for long-term use; the effects of the medicine are visible after several weeks of use.
Dosing should be adjusted according to the DHEA concentration in serum and the effectiveness of the action.

Taking a Higher Than Recommended Dose of Stymen

In case of taking a higher dose than recommended, a doctor should be consulted.

Missing a Dose of Stymen

The patient should continue taking the medicine without increasing the next dose.
A double dose should not be taken to make up for a missed dose.

Stopping Stymen

In case of any further doubts about the use of the medicine, a doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The Following Side Effects May Occur:

Rarely(occurring in 1 to 10 people out of 10,000):

• acne;
• excessive hair growth;
• seborrheic skin changes;
• male pattern baldness;
• prostate enlargement;
• low voice;
• nausea, vomiting, increased appetite;
• edema caused by water and salt retention in the body;
• hypercalcemia (elevated calcium levels in the blood).

Very Rarely(occurring in less than 1 person out of 10,000):

• hepatitis;
• liver enlargement (hepatomegaly);
• mania (psychiatric disorders characterized by elevated or irritable mood).

The medicine is generally well-tolerated when used in recommended doses.
The likelihood of side effects may increase when the medicine is used in higher doses than recommended and for a longer period.
In case of any of the above side effects, the medicine should be discontinued and a doctor consulted.

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in the leaflet, a doctor or pharmacist should be consulted.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
{current address, phone number, and fax of the aforementioned Department}
e-mail: [email protected].
Reporting side effects can help gather more information on the safety of the medicine.

5. How to Store Stymen

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the specified month.
Blister markings:
Lot: batch number
EXP: expiry date.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package Contents and Other Information

What Stymen Contains

• The active substance of the medicine is prasterone. 1 film-coated tablet contains 10 mg of prasterone.
• The other ingredients are: ludipress (lactose monohydrate, povidone, crospovidone), magnesium stearate.

What Stymen Looks Like and Contents of the Package

The medicine is in the form of tablets.
The tablets are packaged in blisters and cardboard boxes. The box contains 30 or 60 tablets.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
To obtain more detailed information, the marketing authorization holder should be contacted.
Date of Last Update of the Leaflet:22.06.2020