Biosteron

Package Leaflet: Information for the Patient

Biosteron, 10 mg, tablets

Biosteron, 25 mg, tablets

(Dehydroepiandrosterone)

Read the 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 patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after a few weeks, contact your doctor.

Table of Contents of the Leaflet:

1.
What is Biosteron and what is it used for

• 2. Important information before taking Biosteron
• 3. How to take Biosteron
• 4. Possible side effects
• 5. How to store Biosteron
• 6. Package contents and other information

1. What is Biosteron and what is it used for

The active substance of Biosteron is dehydroepiandrosterone (DHEA), which is a steroid hormone produced in the adrenal glands and released into the blood.
In various tissues, DHEA is converted into active sex hormones: estrogens and androgens.
The highest concentrations of DHEA in serum occur during youth (2nd and 3rd decade of life), after which there is a slow decline, to about 10-20% in people aged 80.
A deficiency of DHEA may be the cause of unfavorable phenomena related to the aging process, such as:

• memory impairment, intellectual performance, concentration ability;
• depression and decreased well-being;
• psychological and physical complaints related to menopause in women and andropause in men;
• decreased muscle strength, excessive fatigue, chronic fatigue syndrome;
• decreased stress resistance;
• decreased libido and sexual performance;
• obesity, decreased tissue sensitivity to insulin, which can cause diabetes;
• atherosclerosis;
• sleep disorders;
• decreased immunity to viral and bacterial infections.

Supplementing DHEA deficiency may counteract the above-mentioned processes and phenomena, and ultimately improve the health and quality of life of aging individuals.

Indications for use

Biosteron is indicated for supplementing dehydroepiandrosterone (DHEA) deficiencies.

2. Important information before taking Biosteron

When not to take Biosteron:

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of Biosteron;
• if the patient has breast, ovarian, or other estrogen-dependent cancer;
• if the patient has prostate cancer or prostate hyperplasia;
• if the patient has severe liver failure;
• if the patient has severe kidney failure;
• during pregnancy and breastfeeding.

Warnings and precautions

• Patient under 40 years of age should discuss taking Biosteron with their doctor.
• If severe side effects occur, discontinue the medicine and consult a doctor.
• If side effects such as acne or skin oiliness occur, discontinue the medicine for 2-3 weeks. After this time, treatment can be continued with a lower dose than before, and it is recommended to consult a doctor. If side effects recur, the medicine should not be taken.

Biosteron is not indicated for use in children and adolescents.

Biosteron and other medicines

Taking Biosteron with hormone replacement therapy (HRT) may lead to increased estrogen levels and excess. Therefore, the medicine should not be taken by women receiving HRT.
Men treated with testosterone should not take Biosteron due to the possibility of enhanced effects.
DHEA may weaken the effect of certain medicines, such as:

• antiepileptic drugs (e.g., carbamazepine, valproic acid);
• psycholeptics (phenothiazine derivatives, diazepines, and oxazepines). It is not recommended to take Biosteron with these medicines due to the possibility of reduced efficacy.

In case of any doubts, consult a doctor or pharmacist .

Biosteron with food and drink

Biosteron should be taken with a meal to accelerate its absorption.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, consult a doctor or pharmacist before taking this medicine.
Biosteron is contraindicated during pregnancy and breastfeeding.
If a woman taking Biosteron becomes pregnant, she should discontinue the medicine and contact her doctor as soon as possible.

Driving and using machines

The effect of Biosteron on the ability to drive and use machines has not been studied.

Biosteron contains lactose

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

3. How to take Biosteron

Biosteron should be taken once a day, in the morning, in accordance with the natural rhythm of DHEA secretion. The medicine should be taken with a meal to facilitate its absorption.
The recommended initial single dose of DHEA for women is 5 mg, and for men, it is 10 mg. The initial dose of the medicine should be gradually increased (by 5 to 10 mg every 2 weeks).
The maximum recommended daily dose of DHEA for women is 25 mg, and for men, it is 50 mg.
The effect of the medicine is not immediate and occurs after several weeks of administration; therefore, Biosteron is intended for long-term use.
If higher doses than 25 mg per day for women and 50 mg per day for men (only with a doctor's prescription) are necessary, the DHEA concentration in serum should be regularly monitored, and medical examinations should be performed frequently.

Elderly patients

Elderly patients usually require higher doses of the medicine due to decreased DHEA production. However, taking higher doses than recommended should be discussed with a doctor.

Use in children and adolescents

Biosteron is not indicated for use in children and adolescents.

Overdose of Biosteron

There are no known cases of acute DHEA overdose in humans.
In case of taking a higher dose than recommended, consult a doctor or pharmacist immediately.

Missed dose of Biosteron

Biosteron is intended for long-term supplementation of DHEA deficiency, and missing a single dose does not significantly reduce the efficacy of the medicine.
Do not take a double dose to make up for a missed tablet.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist .

4. Possible side effects

Like all medicines, Biosteron can cause side effects, although not everybody gets them.
Properly used Biosteron is a safe medicine and very well tolerated. Side effects are rare, dose-dependent, and transient after discontinuation of therapy.
The likelihood of side effects is higher in women than in men.
The following side effects may occur during treatment with the medicine:
Very common(occurring in more than 1 in 10 patients):
increased sweating, skin oiliness, scalp itching, acne, or mild acne-like skin inflammation, and in women, moderate hirsutism.
Rare(occurring in more than 1 in 10,000 and less than 1 in 1,000 patients):
headache, anxiety, mood changes, breast enlargement and tenderness in men, menstrual disorders in women.
Very rare(occurring in less than 1 in 10,000 patients):
insomnia, mania, non-life-threatening heart rhythm disorders, resolving after discontinuation of DHEA and administration of appropriate medication (from the beta-adrenolytic group).
If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Biosteron

Store in a temperature below 25°C. Store in the original package to protect from moisture.
Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the given month.
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. Package contents and other information

What Biosteron contains

The active substance of the medicine is dehydroepiandrosterone (DHEA) in a quantity of 10 mg or 25 mg.
Biosteron tablets 10 mg and 25 mg contain: silicon dioxide, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

What Biosteron looks like and what the package contains

The tablets are white, round, biconvex with a smooth surface.
The 10 mg tablets have a dividing line on one side, allowing for the administration of half the dose, i.e., 5 mg.
The package of Biosteron tablets 10 mg consists of PVC/Aluminum blisters or a polyethylene container with a polyethylene cap, in a cardboard box.
The package of Biosteron tablets 25 mg consists of a polyethylene container with a polyethylene cap, in a cardboard box.
The package contains 60 tablets.

Marketing authorization holder and manufacturer:

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Tel. (022) 785 20 69
Fax: (022) 785 20 69 ext. 106
Date of the last update of the leaflet:2024-04-29