Biosteron

Package Leaflet: Information for the Patient

Biosteron, 10 mg, tablets

Biosteron, 25 mg, tablets

(Dehydroepiandrosterone)

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 after a few weeks or the patient feels worse, they should contact their 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 associated with the aging process, such as:

• memory impairment, intellectual performance, concentration ability;
• worsening of well-being and depression;
• psychological and physical complaints related to menopause in women and andropause in men;
• reduced muscle strength, feeling of excessive fatigue, chronic fatigue syndrome;
• reduced stress resistance;
• decreased libido and reduced sexual potency;
• obesity, reduced tissue sensitivity to insulin, which can cause diabetes;
• atherosclerosis;
• sleep disorders;
• reduced 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 hypersensitive (allergic) 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 benign prostatic hyperplasia or prostate cancer;
• 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, the medicine should be discontinued and a doctor consulted.
• If side effects such as acne or skin oiliness occur, the medicine should be discontinued 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, a doctor or pharmacist should be consulted .

Biosteron with food and drink

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

Pregnancy and breastfeeding

During pregnancy, breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, a doctor or pharmacist should be consulted before taking this medicine.
Biosteron is contraindicated during pregnancy and breastfeeding.
If a woman taking Biosteron becomes pregnant, she should stop taking 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 the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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.
In case of the need to use doses higher than 25 mg per day in women and 50 mg per day in men (only with a doctor's prescription), the DHEA concentration in serum should be regularly determined, and medical examinations should be performed frequently.

Elderly patients

Elderly patients usually require higher doses of the medicine due to decreased DHEA production. However, the use of doses higher than recommended should be preceded by a consultation 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, a doctor or pharmacist should be consulted immediately.

Missed dose of Biosteron

Biosteron is intended for long-term supplementation of DHEA deficiency, and missing a single dose is not associated with a significant reduction in the efficacy of the medicine.
A double dose should not be taken to make up for a missed tablet.
In case of any further doubts related to the use of this medicine, a doctor or pharmacist should be consulted .

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.
During treatment with the medicine, the following side effects may occur:
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, moderately severe 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 any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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 can help 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.
The medicine should be stored in a place inaccessible and invisible to 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 containers. 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 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: colloidal anhydrous silica, 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 10 mg tablets consists of PVC/Aluminum blisters or a polyethylene container with a polyethylene cap, equipped with a safety device, in a cardboard box.
The package of Biosteron 25 mg tablets consists of a polyethylene container with a polyethylene cap, equipped with a safety device, 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 last update of the leaflet:2024-04-29