Femistelin

Package Leaflet: Information for the Patient

Femistelin, 10 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 this package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

Table of Contents of the Package Leaflet:

1.
What is Femistelin and what is it 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 is Femistelin and what is it used for

The active substance of Femistelin 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 sex hormones: estrogens in women and androgens in men.
Its amount in the body decreases during aging. The highest concentration occurs between 20 and 30 years of age, and after 30 years, it gradually decreases.

Indications for Use

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

• menopause in women;
• excessive skin pigmentation, decreased skin thickness;
• decreased physical and mental performance, especially in the elderly;
• depression, depressive states, sleep disorders, slowed thinking, and decreased psychomotor drive;
• decreased sexual activity;
• obesity;
• decreased tissue sensitivity to insulin;
• circulatory system disorders;
• immune system weakness;
• primary and secondary adrenal cortex insufficiency.

2. Important Information Before Taking Femistelin

When Not to Take Femistelin:

• if the patient is allergic to dehydroepiandrosterone or any other component of this medicine (listed in section 6);
• if the patient has breast cancer, ovarian cancer, or other estrogen-dependent tumors;
• if the patient has severe liver failure;
• if the patient has severe kidney failure;
• during pregnancy and breastfeeding;
• in individuals with normal DHEA levels;
• Femistelin should not be taken by children and adolescents.

Warnings and Precautions

Before starting to take Femistelin, discuss with your doctor, who will order the necessary tests and decide on the need to take this medicine based on the results.

• Women under 40 years of age should not take Femistelin.
• Femistelin should not be taken by women using hormone replacement therapy (HRT).
• The decision to use Femistelin in the treatment of menopausal symptoms is made exclusively by a doctor after a thorough analysis of the benefits and potential risks associated with treatment and with the recommendation to follow the recommended doses and duration of treatment.
• In patients taking Femistelin, it is necessary to monitor therapy by a doctor, during which many clinical and biochemical parameters will be checked, such as: mental state (vitality, well-being, potency), body weight, fat distribution, muscle tissue condition, levels of certain hormones, bone condition, blood pressure values, biochemical tests (morphology, hematocrit, glucose levels, sodium, potassium, calcium, phosphorus, liver enzyme activity, and lipid profile).
• Without consulting a doctor, patients should not change, especially increase, the dose of the medicine.
• If severe side effects occur, the medicine should be discontinued and a doctor consulted.
• In the case of long-term use of the medicine in doses higher than 25 mg per day in women, it is necessary to determine the DHEA level in the blood and perform medical examinations as ordered by the doctor.
• In the case of using the medicine in higher doses for a longer period, the following may occur: amenorrhea, infertility, decreased breast size, excessive hair growth on the body, masculinization (development of male characteristics in women), decreased immunity, excessive aggression and hyperactivity, weight gain, decreased voice tone, androgenetic alopecia.
• Femistelin should not be taken by athletes, as it belongs to the group of prohibited anabolic-androgenic agents.
• 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 using a lower dose than before, and it is recommended to consult a doctor. If side effects recur, the medicine should not be taken.

Children and Adolescents

Femistelin should not be taken by children and adolescents.

Femistelin and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Patients should inform their doctor if they are taking any of the following medicines:

• anticoagulant medicines(used to reduce blood clotting, such as heparin, warfarin);
• hormone replacement therapy (HRT) medicines, as this may lead to increased estrogen secretion;
• androgen medicines(male sex hormones), such as testosterone and its derivatives, as androgenic effects may be enhanced;
• antiepileptic medicines(used to treat epilepsy, such as carbamazepine, valproic acid), as Femistelin may weaken their effect;
• psycholeptic medicines(used in psychiatry, such as phenothiazine derivatives, diazepines, and oxazepines), as Femistelin may weaken their effect;
• calcium channel blockers(medicines used to treat cardiovascular diseases, such as nitrendipine, diltiazem);
• oral hypoglycemic medicines(medicines used to treat diabetes, such as metformin) increase the level of dehydroepiandrosterone in the blood;
• glucocorticosteroidsstrongly inhibit the production of dehydroepiandrosterone in the adrenal glands, which leads to a decrease in the level of this hormone in the blood;
• antipsychotic medicines(such as chlorpromazine, lithium salts), as Femistelin may weaken their effect, which can lead to a relapse of mental disorders;
• insulinproduced in the body and administered as a medicine accelerates the elimination of DHEA from the body and decreases the level of the hormone in the blood.

In case of any doubts, consult a doctor or pharmacist.

Femistelin with Food and Drink

Femistelin should be taken with food to accelerate its absorption.

Pregnancy and Breastfeeding

Femistelin is contraindicated during pregnancy and breastfeeding.
If a woman taking Femistelin becomes pregnant, she should stop taking the medicine and contact her doctor as soon as possible.

Driving and Operating Machines

There is no data on the effect of Femistelin on the ability to drive and operate machines.

Femistelin Contains Lactose

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.

3. How to Take Femistelin

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Starting to take Femistelin should be discussed with a doctor, who will order the necessary tests and decide on the need to take this medicine based on the results.
Femistelin should be taken once a day, in the morning, in accordance with the natural rhythm of DHEA secretion. The medicine should be taken with food to facilitate its absorption. In patients taking Femistelin, it is necessary to monitor therapy by a doctor, during which many clinical and biochemical parameters will be checked (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 accordance with the natural rhythm of DHEA secretion.
The initial dose of the medicine should be gradually increased (by 5 to 10 mg every 2 weeks) until the desired therapeutic effects are achieved. The smallest effective dose should be used.
Changing the dose, especially increasing the dose, always requires consultation with a doctor.
The maximum recommended daily dose of DHEA for women is 25 mg.
The doctor will adjust the dose based on the DHEA level in the blood and the effectiveness of the treatment. If it is necessary to take doses higher than 25 mg in women (only with a doctor's prescription), it is necessary to regularly perform the prescribed tests to determine the hormone level in the blood and other tests prescribed by the doctor.
The effect of the medicine is not immediate and occurs after several weeks of taking it, so 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. Taking doses higher than recommended should be discussed with a doctor.

Use in Children and Adolescents

Femistelin should not be taken by children and adolescents.

Taking a Higher Than Recommended Dose of Femistelin

In case of taking a higher dose than recommended, contact a doctor.

Missing a Dose of Femistelin

Femistelin is used for long-term supplementation 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 Treatment

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Femistelin can cause side effects, although not everybody gets them.
Femistelin, when taken in the recommended doses, is generally well-tolerated.
Side effects are rare, depend on the dose and duration of treatment, and disappear after stopping therapy. The likelihood of side effects is higher in women than in men. It increases when the medicine is taken in doses higher than recommended and for a longer period.
The following side effects may occur during treatment with Femistelin:
Rare(occurring in 1 to 10 people out of 10,000):
increased sweating, skin changes on the face, itching of the scalp, acne on the face or mild acne-like skin inflammation, moderately severe excessive hair growth (hirsutism), headache, anxiety, mood changes, menstrual disorders, androgenetic alopecia, nausea, vomiting, increased appetite, edema caused by water and salt retention in the body, hypercalcemia (elevated calcium levels in the blood), unfavorable changes in blood lipid composition (e.g., decreased HDL levels), decreased voice tone.
Very Rare(occurring in less than 1 person out of 10,000):
hepatitis, liver enlargement (hepatomegaly), mania (psychiatric disorders characterized by elevated or irritable mood), non-life-threatening heart rhythm disorders, which disappear after stopping Femistelin and taking appropriate medication (from the group of beta-adrenolytics).
If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 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 will help gather more information on the safety of the medicine.

5. How to Store Femistelin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Femistelin Contains

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

What Femistelin Looks Like and What the Pack Contains

The tablets are white, round, and biconvex with a smooth surface.
The tablets have a score line on one side, allowing them to be divided into two equal doses of 5 mg each.
The packaging is a polyethylene container with a polyethylene cap, which has a safety feature, in a cardboard box.
The packaging contains 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: 22 785 20 69

Date of Last Revision of the Package Leaflet: