Femistelin

Package leaflet: Information for the patient

Femistelin, 10 mg, tablets
(Dehydroepiandrosterone)

Please read all of this leaflet carefully before taking the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as prescribed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, you should contact your doctor.

Contents of the leaflet:

1. What Femistelin is and what it is used for

2. Important information before taking Femistelin

3. How to take Femistelin

4. Possible side effects

5. How to store Femistelin

6. 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, after which it gradually declines.

Indications
Femistelin is indicated for the treatment of dehydroepiandrosterone deficiency in women with laboratory-confirmed DHEA deficiency.
Supportive effects of DHEA have also been demonstrated in other disorders and conditions:

• menopause in women;
• excessive skin pigmentation, reduced epidermal thickness;
• decreased 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 cortex insufficiency.

2. Important information before taking Femistelin

When not to take 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 suffer from severe liver failure;
• if you suffer from severe kidney failure;
• during pregnancy and breastfeeding;
• in individuals with normal DHEA levels;
• Femistelin should not be used in children and adolescents.

Warnings and precautions
Before starting Femistelin, discuss with your doctor, who will order necessary tests and decide whether treatment with this medicine is required.

• Women under the age of 40 should not take Femistelin.
• Femistelin should not be taken by women undergoing hormone replacement therapy (HRT).
• The decision to use Femistelin for menopausal symptoms must be made solely by a doctor after a thorough assessment of benefits and potential risks, and with recommendations regarding appropriate dosage and duration of treatment.
• Women taking Femistelin require regular medical monitoring, including assessment of various clinical and biochemical parameters such as: mental state (vitality, well-being, potency), body weight, fat distribution, muscle tissue condition, levels of certain hormones, bone status, blood pressure values, and biochemical tests (morphology, hematocrit, glucose, sodium, potassium, calcium, phosphorus concentrations, liver enzyme activity, and lipid profile).
• Without consulting your doctor, you should not change, and especially not increase, the dose of the medicine.
• If severe side effects occur, discontinue the medicine and contact your doctor.
• In women using long-term treatment with doses exceeding 25 mg per day, blood DHEA levels should be monitored and regular medical examinations should be performed frequently.
• Long-term use of higher doses may lead to: absence of menstruation, infertility, reduced breast tissue, excessive body hair growth, virilization (development of male characteristics in women), reduced immunity, increased aggression and hyperexcitability, weight gain, lowered voice pitch, and male-pattern hair loss.
• Femistelin should not be used by athletes, as it belongs to the group of prohibited anabolic-androgenic substances.
• If side effects 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 doctor is recommended. If side effects recur, the medicine should not be taken.

Children and adolescents
Femistelin should not be used in children and adolescents.
Femistelin with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
You should inform your doctor if you 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;
• anticonvulsants (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) increase serum dehydroepiandrosterone concentration;
• glucocorticosteroids 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 relapse of psychiatric disorders;
• insulin, whether endogenous or administered as a medicine, accelerates DHEA elimination from the body and lowers blood hormone levels.

If in doubt, 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 becomes pregnant while taking Femistelin, she should discontinue the medicine and contact her doctor immediately.
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 taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Starting treatment with Femistelin should be discussed with a 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 medical monitoring, during which the physician will assess numerous clinical and biochemical parameters (see section 2, Warnings and precautions).

Recommended dose
The recommended initial daily dose of Femistelin in women is 5 mg. The medicine should be taken in the morning, in line with the natural rhythm of DHEA hormone secretion.
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, and especially dose escalation, must always be discussed with a doctor.
The maximum recommended daily dose of DHEA for women is 25 mg.
The doctor will adjust the dose according to serum DHEA concentration and treatment efficacy. If doses higher than 25 mg are required in women (only under a doctor's prescription), serum hormone concentration and other tests ordered by the physician should be monitored at appropriate intervals.
The therapeutic 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.

Accidental overdose of Femistelin
If an overdose is taken, consult a doctor immediately.

Missed dose of Femistelin
Femistelin is intended for long-term supplementation of DHEA deficiency, 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.

Discontinuation of 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.
Femistelin is generally well tolerated when used at recommended doses.
Adverse effects occur rarely and depend on the dose, duration of use, 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 higher than recommended doses and for prolonged periods.

The following adverse effects may occur during treatment:

Rare (occur in 1 to 10 out of 10,000 people):
increased libido, seborrheic facial skin changes, scalp itching, acne of the face or mild acneiform dermatitis, moderate hirsutism (excessive hair growth), headache, anxiety, mood changes, menstrual disturbances, male-pattern temporal baldness, nausea, vomiting, increased appetite, fluid retention-related edema, hypercalcemia (increased blood calcium levels), unfavorable changes in blood lipid composition (e.g., decreased HDL levels), voice lowering.

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

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: +48 22 49-21-301,
Fax: +48 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 the 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 packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Femistelin contains

• The active substance is dehydroepiandrosterone (DHEA). One tablet contains 10 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 tablets have a score line on one side, allowing division into two equal doses of 5 mg.
The packaging consists of a polyethylene container with a polyethylene cap equipped with a tamper-evident seal, placed in a cardboard box.
The pack contains 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym