Dhea Aflofarm

1. What is DHEA Aflofarm and what is it used for

Dehydroepiandrosterone, the active substance of DHEA Aflofarm, is a hormone produced in the adrenal glands and released into the blood. Production is highest at around 25 years of age and then gradually decreases with age (to 20% of the maximum value at around 70 years of age). In organs and tissues, dehydroepiandrosterone is converted into sex hormones: androgens in men and estrogens in women.

Indications for use

DHEA Aflofarm is used to supplement dehydroepiandrosterone (DHEA) deficiencies in men and women with laboratory-confirmed deficiency of this hormone. Supplementing deficiencies may have a beneficial effect on some diseases and symptoms related to the aging process.

2. Important information before taking DHEA Aflofarm

When not to take DHEA Aflofarm:

• if the patient is allergic to dehydroepiandrosterone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has breast cancer, ovarian cancer, or other estrogen-dependent tumors (whose growth depends on female sex hormones);
• if the patient has severe liver or kidney failure;
• if the patient has prostate enlargement and/or prostate cancer;
• if the patient has breast cancer;
• if the patient has tumors;
• in women during pregnancy and breastfeeding;
• in children and adolescents. Consult a doctor, even if the above warnings apply to past situations.

Warnings and precautions

Before starting to take DHEA Aflofarm, discuss it with your doctor or pharmacist.

The following people should not take this medicine:

• people under 40 years of age;
• athletes who engage in competitive sports, as DHEA is a banned anabolic-androgenic substance;
• patients undergoing hormonal treatment, e.g. women undergoing hormone replacement therapy (HRT) or men undergoing testosterone treatment (see section: Using other medicines).

The decision to use DHEA Aflofarm 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 recommended doses and duration of treatment.

Without consulting a doctor, patients should not change, and in particular, increase the dose of the medicine.

In patients taking DHEA Aflofarm, 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, 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).

In the case of taking the medicine in higher than recommended doses for a longer period, the following may occur in women:

• absence of menstruation;
• infertility;
• reduction of breast tissue;
• masculinization (development of male characteristics in women);
• decreased immunity;
• excessive aggression and hyperactivity;
• weight gain;
• deepening of the voice;
• male-pattern baldness;
• excessive hair growth on the body.

Children and adolescents

Do not use the medicine in children and adolescents.

DHEA Aflofarm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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)medicines, as this may lead to increased estrogen secretion;
• androgen medicines(male sex hormones) such as testosterone and its derivatives, as this may increase androgenic effects;
• antiepileptic medicines(used to treat epilepsy, such as carbamazepine, valproic acid), as DHEA Aflofarm may weaken their effect;
• psycholeptic medicines(used in psychiatry, such as phenothiazine derivatives, diazepines, and oxazepines), as DHEA Aflofarm 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 DHEA Aflofarm may weaken their effect, which may cause a relapse of mental disorders;
• insulinproduced in the body and administered as a medicine accelerates the removal of DHEA from the body and lowers the level of the hormone in the blood.

Using DHEA Aflofarm with food and drink

Take the medicine with a meal.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Do not use the medicine in women during pregnancy and breastfeeding.

Driving and using machines

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

DHEA Aflofarm contains sorbitol and sodium

Sorbitol

The medicine contains 25 mg of sorbitol in each tablet.

Sodium

The medicine contains 1.87 mg of sodium in each tablet, which is less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take DHEA Aflofarm

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

In case of doubt, consult a doctor or pharmacist.

Starting to take DHEA Aflofarm should be discussed with a doctor, who will order the necessary tests and decide on the need to use this medicine based on their results.

Recommended dose

1 tablet (25 mg) once a day.

Take the medicine in the morning, in accordance with the natural rhythm of DHEA hormone secretion.

In patients taking DHEA Aflofarm, 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).

The maximum daily dose for women is 25 mg (1 tablet once a day), and for men, it is 50 mg (2 tablets per day).

The doctor will adjust the dose depending on the patient's sex, DHEA level in the blood, and the effectiveness of the treatment.

In the case of needing to take higher doses than 1 tablet (25 mg) for women and 2 tablets (50 mg) for men (only with a doctor's prescription), it is necessary to frequently perform the tests ordered by the doctor to determine the level of the hormone in the blood and other tests ordered by the doctor.

Elderly patients

In elderly patients, there is a greater deficiency of DHEA than in younger patients.

In this group of patients, the doctor will adjust the daily dose of the medicine accordingly.

Method of administration

Take the medicine orally with a meal.

The medicine is intended for long-term use, and its effects occur after several weeks of taking the medicine.

Taking a higher dose of DHEA Aflofarm than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor.

Missing a dose of DHEA Aflofarm

Continue taking the medicine without increasing the next dose.

Do not take a double dose to make up for a missed dose.

Stopping DHEA Aflofarm treatment

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

4. Possible side effects

Like all medicines, DHEA Aflofarm can cause side effects, although not everybody gets them.

The following side effects may occur:

Rarely(occurring in 1 to 10 people out of 10,000):

• excessive hair growth of male type in women (hirsutism);
• acne, skin itching, increased sweating;
• seborrhea of the skin and hair;
• intensification of hair loss on the head;
• unfavorable changes in blood lipid composition (e.g. decrease in HDL levels);
• menstrual disorders.

In women, side effects are the result of the androgenic effect of hormone metabolites. These effects occur rarely, usually in women taking high doses of DHEA, approximately 50-200 mg/day, for a longer period.

The medicine is generally well-tolerated when used in recommended doses.

The likelihood of side effects may increase when the medicine is used in higher doses than recommended and for a longer period.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,

Al. Jerozolimskie 181C

PL-02 222 Warsaw

Tel.: + 48 22 49 21 301

Fax: + 48 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 allow for the collection of more information on the safety of the medicine.

5. How to store DHEA Aflofarm

Keep the medicine out of the sight and reach of children.

Store in a temperature below 25°C.

Do not use this medicine after the expiry date stated on the blister and carton.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What DHEA Aflofarm contains

• The active substance of the medicine is prasterone (dehydroepiandrosterone).
• 1 tablet contains 25 mg of prasterone.
• The other ingredients are: calcium hydrogen phosphate dihydrate, sorbitol, stearic acid, sodium croscarmellose, hypromellose, macrogol 600, maltodextrin.

What DHEA Aflofarm looks like and contents of the pack

Tablets in PVC/PVDC/Aluminum blisters in a cardboard box.

The box contains 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

tel. (42) 22-53-100

Manufacturer:

Zakłady Farmaceutyczne COLFARM S.A.

ul. Wojska Polskiego 3

• 39 - 300 Mielec

Date of last revision of the leaflet: