Femistelin

Package Leaflet: Information for the Patient

Femistelin, 10 mg, tablets

Femistelin, 25 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 for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their 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 with age. The highest concentration occurs between 20 and 30 years of age, and after 30 years, it decreases gradually.

• The highest concentration occurs between 20 and 30 years of age, and after 30 years, it decreases gradually.

Indications for Use

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

• menopause in women;
• andropause in men;
• excessive skin pigmentation, reduced skin thickness;
• decreased physical and mental fitness, especially in the elderly;
• mood deterioration, 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 has an allergy 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 prostate cancer or breast cancer;
• if the patient has severe liver failure;
• if the patient has severe kidney failure;
• during pregnancy and breastfeeding;
• in children and adolescents;
• in individuals with normal DHEA levels.

Warnings and Precautions

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

• Individuals under 40 years of age should not take Femistelin.
• Femistelin should not be taken by women using hormone replacement therapy (HRT) or by men undergoing testosterone treatment.
• The decision to use Femistelin in the treatment of andropause and menopause symptoms is made by the doctor after a thorough analysis of the benefits and potential risks associated with treatment and with the recommendation to follow the appropriate 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 in the patient, such as: mental state (vitality, well-being, potency), body weight, fat distribution, muscle tissue condition, levels of certain hormones, prostate-specific antigen (PSA) levels, prostate condition, bone condition, blood pressure values, biochemical tests (morphology, hematocrit, glucose levels, sodium, potassium, calcium, phosphorus, liver enzyme activity, and lipid profile).
• Patients should not change or increase the dose of the medicine without consulting their doctor.
• If severe side effects occur, the medicine should be discontinued, and the doctor should be consulted.
• In the case of long-term use of the medicine in doses higher than 25 mg per day in women and 50 mg per day in men, DHEA levels in the blood should be determined, and medical examinations should be performed as directed by the doctor.
• In the case of taking the medicine in higher doses for a longer period, the following may occur: amenorrhea, infertility, reduced 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, male-pattern baldness.
• Femistelin should not be used 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 with 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 used in children and adolescents.

Femistelin and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Patient 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), as this may lead to increased estrogen secretion;
• androgenic 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), which increase dehydroepiandrosterone levels 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 reduces the hormone level in the blood.

In case of any doubts, the patient should consult their doctor or pharmacist.

Femistelin with Food and Drink

Femistelin should be taken with a meal to enhance 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 Using Machines

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

Femistelin Contains Lactose

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

3. How to Take Femistelin

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their 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 a meal 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 in the patient (see section 2, Warnings and Precautions).

Recommended Dose

The recommended initial daily dose of Femistelin for women is 5 mg, and for men, it is 10 mg.
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 it, always requires consultation with a doctor.
The maximum recommended daily dose of DHEA for women is 25 mg, and for men, it is 50 mg.
The doctor will adjust the dose based on the patient's sex, DHEA levels in the blood, and the effectiveness of the treatment.
In the case of the need to use doses higher than 25 mg in women and 50 mg in men (only with a doctor's prescription), the doctor should regularly determine the hormone level in the blood and perform other tests as directed 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. The use of doses higher than recommended should be consulted with a doctor.

Use in Children and Adolescents

Femistelin should not be used in children and adolescents.

Taking a Higher Than Recommended Dose of Femistelin

In case of taking a higher than recommended dose of the medicine, the patient should contact their 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.
A double dose should not be taken to make up for a missed tablet.

Stopping Femistelin Treatment

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Femistelin can cause side effects, although not everybody gets them.
The medicine is generally well-tolerated when taken in the recommended doses.
Side effects are rare, depend on the dose and duration of treatment, and are reversible after discontinuation of 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, and moderately severe excessive hair growth, mainly in women (hirsutism), headache, anxiety, mood changes, breast enlargement and tenderness in men, menstrual disorders in women, male-pattern baldness, 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 resolve after discontinuation of Femistelin and administration of appropriate medication (from the beta-adrenolytic group).
If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
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 expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 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, and biconvex with a smooth surface.
The 10 mg tablets have a score line on one side, allowing them to be divided into two equal doses of 5 mg each.
The packaging consists of 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: (022) 785 20 69
Fax: (022) 785 20 69 ext. 106

Date of Last Revision of the Package Leaflet: