Biosteron, 25 mg, tablets
(Dehydroepiandrosteronum)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
– You must talk to a doctor if you do not feel better or if you feel worse after few weeks.

What is in this leaflet:
1. What Biosteron is and what it is used for
2. What you need to know before you take 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 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 transformed into active sexual hormones: oestrogens and androgens.
The highest serum concentrations of DHEA occur during adolescence (2nd and 3rd decade of life), followed by a slow decrease to approximately 10-20% in people aged 80.

DHEA deficiency may be a cause of unfavourable phenomena related to the ageing process, such as:
– weakening of memory, intellectual efficiency, ability to concentrate;
– mood deterioration and depression;
– mental and physical ailments, menopause-related in women and andropause-related in men;
– reduction of muscle strength, feeling of excessive fatigue, chronic fatigue syndrome;
– reduction of resistance to stress;
– decrease of sexual drive and reduction of sexual fitness;
– obesity, decreased sensitivity of tissues to insulin, which may cause diabetes mellitus;
– atherosclerosis;
– sleep disorders;
– decrease of the body’s immunity to viral and bacterial infections.

Supplementing DHEA deficiency can work against the above-mentioned processes and phenomena and, as a result, improve the health and quality of life of the ageing persons.

Indications for use
Biosteron is recommended for the supplementation of dehydroepiandrosterone (DHEA) deficiency.

2. What you need to know before you take Biosteron
Do not take Biosteron:
– if you are allergic (hypersensitive) to active substance or any of the other ingredients of Biosteron;
– if you have breast cancer, ovarian cancer or any other oestrogen-dependent cancer;
– if you have prostate enlargement and prostate cancer, breast cancer (in men);
– if you suffer from severe hepatic diseases;
– if you suffer from severe renal diseases;
– if you are pregnant and breast-feeding.

Warnings and precautions
– In you are under 40 years of age, talk to your doctor before you take Biosteron.
– If you experience serious side effects, stop taking this medicine and consult your doctor.
– If you experience side effects such as acne or oily skin, stop taking this medicine for 2-3 weeks. After this time, you can continue treatment at a lower dose than before, and it is advisable to consult your doctor. If the side effects reappear, do not take this medicine.

Biosteron is not recommended for use in children and adolescents.

Other medicines and Biosteron
The use of Biosteron in combination with hormone replacement therapy (HRT) can lead to increased concentrations and excess of oestrogens. Therefore, you should not take this medicine during HRT.

You should not take Biosteron if you are already treated with testosterone, as it may increase the effect.

DHEA may weaken the effects of some medicines, such as:
– anticonvulsants (e.g. carbamazepine, valproic acid);
– psycholeptics (phenothiazine, diazepines and oxazepines derivatives).
You should not use Biosteron with these drugs because of their potential to reduce efficacy.

If you have any further questions, consult your doctor or pharmacist.

Biosteron with food and drink
Biosteron should be taken with a meal to speed up its absorption.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Biosteron is contraindicated for use during pregnancy and breast-feeding.

If you are taking Biosteron and become pregnant, you should stop taking this medicine and immediately contact your doctor.

Driving and using machines
No studies have been performed on this medicine’s effect on the ability to drive vehicles and use machines.

Biosteron contains lactose
If you have been diagnosed to have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Biosteron

Biosteron should be taken once daily, in the morning, according to the natural rhythm of DHEA secretion. This medicine should be taken with a meal to ease absorption.

The recommended initial single daily dose of DHEA 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).
The maximum daily dose of DHEA recommended for women is 25 mg and 50 mg for men.

The effect of this medicine is not immediate and occurs after a several weeks of taking, therefore Biosteron is intended for long-term use.

If doses higher than 25 mg per day are required for women and 50 mg per day for men (only in consultation with a doctor), the blood DHEA level should be measured regularly and medical tests should be taken at appropriate intervals.

Elderly patients
Elderly patients usually require higher doses due to reduced DHEA production. However, you should talk to your doctor before you take doses higher than recommended.

Use in Children and adolescents
Biosteron is not recommended for use in children and adolescents.

If you take more Biosteron than you should
There are no known cases of acute DHEA overdose in human.
If you take more than the recommended dose, immediately consult your doctor or pharmacist.

If you forget to take Biosteron
Biosteron is used for long-term supplementation of DHEA deficiency and if you forget to take a single dose it will not cause an important reduce in the effectiveness of the drug.
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When properly used, Biosteron is a safe and very well tolerated. Side effects are rare, dependant on the dose of the medicine, and pass after its discontinuation.
Women are more likely to have side effects than men. The following side effects may occur while taking this medicine:

Very common (may affect more than 1 in 10 patients):
increase of sweating, seborrheic lesions of the face skin, itching of the scalp, acne of the facial skin or mild acne dermatitis, and in women moderately increased hypertrichosis (hirsutism).

Rare (may affect more than 1 in 10,000 and less than 1 in 1,000 patients):
headache, anxiety, mood changes, enlargement and tenderness of breast in men, menstrual disorders in women.

Very rare (may affect less than 1 in 10,000 patients):
insomnia, mania, non-life-threatening cardiac arrhythmias, disappearing after DHEA discontinuation and use of an appropriate medication (of the beta-adrenolytics group).

Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Adverse reactions can be reported to the marketing authorisation holder.

5. How to store Biosteron

Store below 25ºC. Keep in the original package in order to protect frommoisture.
Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Biosteron contains
The active substance is dehydroepiandrosterone (DHEA) at 25 mg.

The other ingredients, for Biosteron 25 mg tablets, are: anhydrous colloidal silica, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

What Biosteron looks like and contents of the pack
The tablets are white, round, biconvex, with a smooth surface on both sides.

The package of Biosteron 25 mg tablets consists of polyethylene container with a protective polyethylene cap, in a cardboard box.

One package contains 60 tablets.

Manufacturer: Lek-am. Poland