Biosteron

Package leaflet: Information for the user

Biosteron, 10 mg, tablets
Biosteron, 25 mg, tablets
Dehydroepiandrosterone

Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, you should contact your doctor.

Leaflet contents:

1. What Biosteron is and what it is used for

2. Important information before taking Biosteron

3. How to take Biosteron

4. Possible side effects

5. How to store Biosteron

6. Contents of the pack and other information

1. What Biosteron is and what it is used for
The active substance in Biosteron is dehydroepiandrosterone (DHEA), a steroid hormone produced in the adrenal glands and released into the bloodstream.
In various tissues, DHEA is converted into sex hormones: estrogens in women and androgens in men.
Its levels in the body decrease with aging. The highest concentration occurs between the ages of 20 and
30, and after age 30, levels gradually decline.

Supportive effects of DHEA have also been observed in other disorders and conditions:

• menopause in women;
• andropause in men;
• excessive skin pigmentation, reduced epidermal thickness;
• decline in physical and mental performance, especially in elderly individuals;
• mood deterioration, depressive states, sleep disturbances, and reduced psychomotor drive;
• reduced muscle strength;
• decreased sexual activity;
• obesity;
• reduced tissue sensitivity to insulin;
• circulatory system disorders;
• weakened immunity;
• primary and secondary adrenal cortex insufficiency.

Indications for use
Biosteron is indicated for the treatment of dehydroepiandrosterone (DHEA) deficiency in women and men with laboratory-confirmed DHEA deficiency.

2. Important information before taking Biosteron

When not to use Biosteron:

• if you are allergic to dehydroepiandrosterone or to any of the other ingredients of this medicine (listed in section 6);
• if you are a woman with breast cancer, ovarian cancer, or any other estrogen-dependent tumor;
• if you are a man with benign prostatic hyperplasia or prostate cancer, or with breast cancer;
• if you have severe liver failure;
• if you have severe renal failure;
• during pregnancy and breastfeeding;
• in children and adolescents;
• in individuals with normal DHEA levels.

Warnings and precautions
Before starting Biosteron, you should discuss it with your doctor, who will order necessary tests and decide whether treatment with this medicine is appropriate.

• Individuals under the age of 40 should not take Biosteron.
• Biosteron should not be taken by women undergoing hormone replacement therapy (HRT) or by men receiving testosterone treatment.
• The decision to use Biosteron for symptoms related to andropause or menopause must be made solely by a physician after a thorough assessment of benefits and potential risks, including appropriate dosage and duration of treatment.
• Patients taking Biosteron require regular medical monitoring, including evaluation of various clinical and biochemical parameters such as: psychological state (vitality, well-being, potency), body weight, fat tissue distribution, muscle tissue status, levels of certain hormones, serum acid phosphatase (PSA) levels in men, prostate status, bone status, blood pressure values, and biochemical tests (complete blood count, hematocrit, glucose, sodium, potassium, calcium, phosphorus, liver enzyme activity, and lipid profile).
• Without consulting a doctor, patients should not change, and especially not increase, the dose of the medicine.
• If severe adverse reactions occur, discontinue the medicine and contact your doctor.
• In cases of long-term use at doses exceeding 25 mg per day in women and 50 mg per day in men, blood DHEA levels should be monitored and regular medical check-ups should be performed frequently.
• In women, prolonged use of higher doses may lead to: absence of menstruation, infertility, reduced breast tissue, excessive body hair growth, masculinization (development of male characteristics in women), reduced immunity, increased aggression and hyperactivity, weight gain, lowered voice pitch, and male-pattern temporal baldness.
• Biosteron should not be used by athletes, as it belongs to the group of prohibited anabolic-androgenic substances.
• If adverse reactions such as acne or oily skin occur, discontinue Biosteron for 2–3 weeks. After this period, treatment may be continued at a lower dose than previously used, preferably after consulting a doctor. If adverse reactions recur, the medicine should not be taken.

Children and adolescents
Biosteron must not be used in children and adolescents.
Biosteron and other medicines
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Patients should inform their doctor if they are taking any of the following medicines:

• anticoagulants (used to reduce blood clotting, e.g. heparin, warfarin);
• medicines used in hormone replacement therapy (HRT), as this may lead to increased estrogen secretion;
• medicines containing androgens (male sex hormones), such as testosterone and testosterone derivatives, as androgenic effects may be intensified;
• antiepileptic drugs (used in epilepsy treatment, e.g. carbamazepine, valproic acid), as Biosteron may reduce their effectiveness;
• psycholeptics (used in psychiatry, e.g. phenothiazine derivatives, diazepines, oxazepines), as Biosteron may reduce their effectiveness;
• calcium antagonists (medicines used in cardiovascular diseases, e.g. nitrendipine, diltiazem);
• oral hypoglycemic agents (medicines used in diabetes, e.g. metformin), which increase serum dehydroepiandrosterone levels;
• glucocorticosteroids, which strongly inhibit dehydroepiandrosterone production in the adrenal glands, leading to reduced blood hormone levels;
• antipsychotics (e.g. chlorpromazine, lithium salts), as Biosteron may reduce their effectiveness, potentially causing relapse of psychiatric disorders;
• insulin, whether naturally produced or administered as a medicine, accelerates DHEA elimination from the body and lowers blood hormone levels.

If you have any doubts, please consult your doctor or pharmacist.
Biosteron with food and drink
Biosteron should be taken with food to enhance its absorption.
Pregnancy and breastfeeding
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 operating machinery
There is no data available on the effects of Biosteron on the ability to drive or operate machinery.
Biosteron contains lactose
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Biosteron contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Biosteron

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Starting treatment with Biosteron should be discussed with your doctor, who will order the necessary tests and decide whether this medicine is required based on their results.
Biosteron should be taken once daily in the morning, in accordance with the natural rhythm of DHEA secretion. The medicine should be taken with food to facilitate its absorption. Patients using Biosteron require regular monitoring by a physician, during which various clinical and biochemical parameters will be assessed (see section 2, Warnings and precautions).

Recommended dose
The recommended initial daily dose of Biosteron is 5 mg for women and 10 mg for men.
The initial dose should be gradually increased (by 5 to 10 mg every 2 weeks) until the desired therapeutic effects are achieved. It is recommended to use the lowest effective dose.
Any dose adjustment, especially dose increase, must always be discussed with a doctor.
The maximum recommended daily dose of DHEA is 25 mg for women and 50 mg for men.
The doctor will adjust the dose according to the patient's sex, serum DHEA concentration, and treatment efficacy.
If higher doses than 25 mg in women and 50 mg in men are required (only under medical supervision), serum DHEA concentration and other tests ordered by the doctor should be monitored at appropriate intervals.
The effect of the medicine is not immediate and appears after several weeks of use; therefore, Biosteron is intended for long-term use.

Use in elderly patients
Elderly patients usually require higher doses of the medicine due to decreased DHEA production. Use of doses higher than recommended should be discussed with a doctor.

Use in children and adolescents
Biosteron should not be used in children and adolescents.

Taking more than the recommended dose of Biosteron
If more than the recommended dose has been taken, contact your doctor.

Missed dose of Biosteron
Biosteron is intended for long-term DHEA deficiency supplementation, and missing a single dose does not significantly reduce the medicine's effectiveness.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Biosteron
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The medicine is generally well tolerated when used at recommended doses.
Adverse effects are rare, depend on the dose and duration of treatment, and resolve after discontinuation of therapy.
The likelihood of adverse effects is higher in women than in men. The risk increases when the medicine is used at doses higher than recommended and for prolonged periods.

The following adverse effects may occur during treatment:

Rare (may occur in less than 1 in 1,000 people):
increased libido, seborrheic skin changes of the face, scalp itching, facial acne or mild acneiform dermatitis, and moderate excessive hair growth, mainly in women (hirsutism), headache, anxiety, mood changes, breast enlargement and tenderness in men, menstrual disturbances in women, male-pattern temporal balding, nausea, vomiting, increased appetite, oedema due to water and salt retention, hypercalcaemia (increased blood calcium levels), unfavourable changes in blood lipid composition (e.g. decreased HDL concentration), voice lowering.

Very rare (may occur in less than 1 in 10,000 people):
hepatitis, liver enlargement (hepatomegaly), mania (psychiatric disorder characterized by elevated or irritable mood), non-life-threatening cardiac arrhythmias, which resolve after discontinuation of Biosteron and administration of appropriate medication (beta-blockers).

If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If any adverse effects occur, including those not mentioned in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Biosteron

Keep the medicine out of sight and reach of children.
Store below 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of 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 Biosteron contains

• The active substance is dehydroepiandrosterone (DHEA). Each tablet contains 10 mg or 25 mg of DHEA.
• The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

What Biosteron looks like and contents of the pack
Biosteron tablets are white, round, biconvex, with a smooth surface.
The 10 mg tablets have a score line on one side, allowing division into two equal 5 mg doses.
The packaging for Biosteron 10 mg tablets consists of PVC/Aluminum blisters or a polyethylene container with a polyethylene cap equipped with a safety closure, in a cardboard box.
The packaging for Biosteron 25 mg tablets consists of a polyethylene container with a polyethylene cap equipped with a safety closure, in a cardboard box.
The pack contains 60 tablets.

Marketing Authorisation Holder and Manufacturer:
LEK-AM Pharmaceutical Company Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Tel. (022) 785 20 69