Package leaflet: Information for the patient

Femistelin, 10 mg, tablets
Femistelin, 25 mg, tablets
(Dehydroepiandrosterone)

Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents of the leaflet:

What Femistelin is and what it is used for
Important information before taking Femistelin
How to take Femistelin
Possible side effects
How to store Femistelin
Contents of the pack and other information

1. What Femistelin is and what it is used for
The active substance in Femistelin 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.
The amount of DHEA in the body decreases with aging. The highest concentration occurs between the ages of 20 and 30, and after age 30 it gradually declines.

Indications
Femistelin is indicated for the treatment of dehydroepiandrosterone deficiency in men and women with laboratory-confirmed DHEA deficiency.
Supportive effects of DHEA have also been demonstrated 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, slowed thinking, and reduced psychomotor drive;
decreased sexual activity;
obesity;
reduced tissue sensitivity to insulin;
circulatory system disorders;
weakened immunity;
primary and secondary adrenal insufficiency.

2. Important information before taking Femistelin

When not to use Femistelin:

if you are allergic to dehydroepiandrosterone or to any of the other ingredients of this medicine (listed in section 6);
if you have breast cancer, ovarian cancer, or any other estrogen-dependent tumor;
if you have benign prostatic hyperplasia or prostate cancer, or 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 Femistelin, discuss with your doctor, who will order necessary tests and decide whether treatment with this medicine is required.

Individuals under the age of 40 should not take Femistelin.
Femistelin should not be taken by women undergoing hormone replacement therapy (HRT) or by men receiving testosterone treatment.
The decision to use Femistelin for symptoms related to andropause or menopause must be made solely by a physician after a thorough assessment of benefits and potential risks, and with recommendations regarding appropriate dosing and duration of treatment.
Patients taking Femistelin require medical monitoring, during which various clinical and biochemical parameters will be evaluated, including: psychological status (vitality, well-being, potency), body weight, fat distribution, muscle tissue condition, concentrations of certain hormones, acid phosphatase levels (PSA), prostate status, bone condition, arterial blood pressure, and biochemical tests (morphology, hematocrit, glucose, sodium, potassium, calcium, phosphorus, liver enzyme activity, and lipid profile).
Patients should not change, and especially not increase, the dose of the medicine without consulting a physician.
If severe adverse reactions occur, discontinue the medicine and contact your doctor.
In cases of long-term use at doses exceeding 25 mg daily in women and 50 mg daily in men, blood DHEA levels should be monitored, and regular medical examinations should be performed frequently.
With prolonged use of higher doses, the following may occur: amenorrhea, infertility, reduction of mammary glands, excessive body hair growth, masculinization (development of male characteristics in women), reduced immunity, excessive aggression and hyperexcitability, weight gain, lowered voice tone, male-pattern temporal baldness.
Femistelin 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 the medicine for 2–3 weeks. After this period, treatment may be continued at a lower dose than previously used, but consultation with a physician is recommended. If adverse reactions recur, the medicine should not be taken.

Children and adolescents
Femistelin must not be used in children and adolescents.
Femistelin and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
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 Femistelin may reduce their effectiveness;
psycholeptics (used in psychiatry, e.g., phenothiazine derivatives, diazepines, and oxazepines), as Femistelin 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 concentration;
glucocorticosteroids, which strongly inhibit dehydroepiandrosterone production in the adrenal glands, leading to reduced blood hormone levels;
antipsychotics (e.g., chlorpromazine, lithium salts), as Femistelin may reduce their effectiveness, potentially causing recurrence of psychiatric disorders;
insulin, both endogenous and administered as a medicine, accelerates DHEA elimination from the body and lowers blood hormone levels.

If you have any doubts, consult your doctor or pharmacist.
Femistelin with food and drink
Femistelin should be taken with food to enhance its absorption.
Pregnancy and breastfeeding
Femistelin is contraindicated during pregnancy and breastfeeding.
If a woman taking Femistelin 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 effect of Femistelin on the ability to drive or operate machinery.
Femistelin contains lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Femistelin

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Starting treatment with Femistelin should be discussed with your doctor, who will order the necessary tests and decide whether this medicine is required based on their results.
Femistelin 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 Femistelin 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 Femistelin 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, particularly dose escalation, 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 doses higher than 25 mg in women or 50 mg in men are required (only by prescription), serum hormone concentration and other tests ordered by the doctor should be performed at appropriate intervals.

The effect of the medicine is not immediate and becomes apparent after several weeks of treatment; therefore, Femistelin 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
Femistelin should not be used in children and adolescents.

If you take more Femistelin than recommended
If you take more than the recommended dose, contact your doctor immediately.

If you miss a dose of Femistelin
Femistelin is intended for long-term replacement of DHEA deficiency, and missing a single dose does not significantly reduce the effectiveness of the medicine.
Do not take a double dose to make up for a missed tablet.

Stopping Femistelin
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 experiences them.
The medicine is generally well tolerated when used at the 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 with this medicine:

Rare (occur in 1 to 10 people in 10,000):
increased libido, seborrheic skin changes of the face, scalp itching, acne of the face or mild acneiform dermatitis, and moderate excessive hair growth, mainly in women (hirsutism), headache, anxiety, mood changes, enlargement and tenderness of the breasts in men, menstrual disturbances in women, male-pattern temporal baldness, nausea, vomiting, increased appetite, oedema due to water and salt retention in the body, hypercalcaemia (increased calcium levels in the blood), unfavourable changes in blood lipid composition (e.g. decreased HDL concentration), voice deepening.

Very rare (occur in less than 1 person in 10,000):
hepatitis, enlargement of the liver (hepatomegaly), mania (psychiatric disturbances characterized by elevated or irritable mood), non-life-threatening cardiac arrhythmias, which resolve after discontinuation of Femistelin and administration of appropriate medication (from the beta-blocker group).

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

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 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 Femistelin

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Femistelin contains

The active substance is dehydroepiandrosterone (DHEA). One 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 Femistelin looks like and contents of the pack
The 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 consists of a polyethylene container with a polyethylene cap equipped with a safety closure, placed in a cardboard box.
The pack contains 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym
Tel. (022) 785 20 69
Fax: (022) 785 20 69 ext. 106