Package leaflet: information for the patient

DHEA Aflofarm, 25 mg, coated tablets
Prasteronum
Please read this leaflet carefully before taking this medicine because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician 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 condition does not improve or worsens, contact your doctor.

Table of contents

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

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

Dehydroepiandrosterone, the active substance in DHEA Aflofarm, is a hormone produced in the
adrenal glands and released into the bloodstream. Its production peaks around the age of 25 and then
gradually declines with age (to about 20% of maximum levels by around age 70). In organs and tissues,
dehydroepiandrosterone is converted into sex hormones: androgens in men and estrogens in women.
Indications
DHEA Aflofarm is indicated for supplementation in cases of dehydroepiandrosterone (DHEA) deficiency
confirmed by laboratory testing in men and women. Replenishing DHEA deficiency may beneficially affect
certain conditions and symptoms associated with the aging process.

2. Important information before taking DHEA Aflofarm
When not to take DHEA Aflofarm:

if you are allergic to dehydroepiandrosterone or any of the other ingredients of this medicine (listed in section 6);
if you have breast cancer, ovarian cancer, or other estrogen-dependent tumors (tumors whose growth depends on female sex hormones);
if you have severe liver and/or kidney insufficiency;
if you have benign prostatic hyperplasia and/or prostate cancer;
if you have breast cancer;
if you have any malignant tumors;
in women during pregnancy and breastfeeding;
in children and adolescents.
Contact your doctor even if the above warnings refer to conditions you had in the past.

Warnings and precautions
Before starting treatment with DHEA Aflofarm, discuss it with your doctor or pharmacist.
The medicine should not be used by:

individuals under 40 years of age;
athletes engaged in competitive sports, as DHEA belongs to the group of prohibited anabolic-androgenic substances;
patients undergoing hormonal therapy, e.g. women receiving hormone replacement therapy (HRT) or men undergoing testosterone treatment (see section: Concomitant use of other medicines).

The decision to use DHEA Aflofarm for treating symptoms associated with andropause and menopause must be made exclusively by a physician after a thorough assessment of benefits and potential risks of treatment, and following recommendations regarding appropriate dosage and duration of therapy.
Patients should not change the dose, and especially should not increase it, without consulting their doctor.
Patients using DHEA Aflofarm require regular medical monitoring during which the physician will assess various clinical and biochemical parameters, such as:
mental state (vitality, well-being, potency), body weight, fat tissue distribution, muscle tissue condition, concentrations of certain hormones, acid phosphatase levels (PSA), prostate condition, bone status, arterial blood pressure, and biochemical tests (morphology, hematocrit, glucose, sodium, potassium, calcium, phosphorus levels, liver enzyme activity, and lipid profile).

When DHEA Aflofarm is used at higher than recommended doses for prolonged periods, women may experience:

absence of menstruation;
infertility;
reduction of breast tissue;
masculinization (development of male characteristics in women);
decreased immunity;
excessive aggression and hyperactivity;
increased body weight;
lowering of voice pitch;
male-pattern hair loss;
excessive body hair growth.

Children and adolescents
Do not use this medicine in children and adolescents.

DHEA Aflofarm 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;
androgen-containing medicines (male sex hormones) such as testosterone and testosterone derivatives, as this may intensify androgenic effects;
antiepileptic drugs (used in epilepsy treatment, e.g. carbamazepine, valproic acid), as DHEA Aflofarm may reduce their effectiveness;
psycholeptics (used in psychiatry, e.g. phenothiazine derivatives, diazepines, oxazepines), as DHEA Aflofarm may reduce their effectiveness;
calcium channel blockers (used in cardiovascular diseases, e.g. nitrendipine, diltiazem);
oral hypoglycemic agents (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 levels of this hormone;
antipsychotics (e.g. chlorpromazine, lithium salts), as DHEA Aflofarm may reduce their effectiveness, potentially causing relapse of psychiatric disorders;
insulin, both endogenous and administered as a medicine, accelerates DHEA elimination from the body and lowers blood hormone levels.

Taking DHEA Aflofarm with food and drink
Take the medicine during a meal.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine must not be used in women during pregnancy and breastfeeding.

Driving and operating machinery
There is no data available on the effects of DHEA Aflofarm on the ability to drive or operate machinery.

DHEA Aflofarm contains sorbitol and sodium
Sorbitol
The medicine contains 25 mg of sorbitol per tablet.
Sodium
The medicine contains 1.87 mg of sodium per tablet, less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take DHEA Aflofarm

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Starting treatment with DHEA Aflofarm should be discussed with your doctor, who will order the necessary tests and decide whether this medicine is required based on their results.
Recommended dose
1 tablet (25 mg) once daily.
The medicine should be taken in the morning, in accordance with the natural rhythm of DHEA hormone secretion.
Patients taking DHEA Aflofarm require regular monitoring by a physician, during which various clinical and biochemical parameters will be assessed. (See section 2, Warnings and precautions).
The maximum daily dose for women is 25 mg (1 tablet once daily), and for men 50 mg (2 tablets daily).
The doctor will adjust the dose according to sex, serum DHEA concentration, and treatment efficacy.
If doses higher than 1 tablet (25 mg) in women and 2 tablets (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.
Elderly patients
Elderly patients typically have a greater DHEA deficiency compared to younger individuals.
In this patient group, the doctor will appropriately adjust the daily dose of the medicine.
Method of administration
The medicine should be taken orally during a meal.
This medicine is intended for long-term use; therapeutic effects become apparent after several weeks of treatment.
If you take more DHEA Aflofarm than you should
In case of overdose, contact your doctor immediately.
If you miss a dose of DHEA Aflofarm
Continue taking the medicine as before, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Stopping DHEA Aflofarm
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur:
Rare (occur in 1 to 10 people per 10,000):

excessive male-pattern hair growth in women (hirsutism);
acne, skin itching, increased sweating;
increased oiliness of the skin and hair;
increased hair loss on the head;
unfavorable changes in blood lipid composition (e.g., decreased HDL concentration);
menstrual disorders.

Adverse reactions in women are due to the androgenic effect of hormone metabolites. These reactions
are rare and usually occur in women taking high doses of DHEA, approximately 50–200 mg/day,
over a prolonged period of time.
The medicine is generally well tolerated when used at recommended doses.
The likelihood of adverse reactions may increase when the medicine is used at doses higher than
recommended and for prolonged periods.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor or pharmacist.
Adverse reactions 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store DHEA Aflofarm

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What DHEA Aflofarm contains

The active substance is prasterone (dehydroepiandrosterone).
One tablet contains 25 mg of prasterone.
Other ingredients are: calcium hydrogen phosphate dihydrate, sorbitol, stearic acid, sodium croscarmellose, hypromellose, polyethylene glycol 600, maltodextrin.

What DHEA Aflofarm looks like and contents of the pack
Tablets in blisters made of PVC/PVDC/Aluminum foil, packed in a cardboard box.
Each box contains 30 or 60 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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