Novostella

Patient Information Leaflet

Novostella, 10 mg, tablets
Prasteronum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised.

• Keep this leaflet so that you can read it again if necessary.
• 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 if you feel worse, contact your doctor.

Table of Contents

1. What Novostella is and what it is used for
2. Important information before taking Novostella
3. How to take Novostella
4. Possible side effects
5. How to store Novostella
6. Contents of the pack and other information

1. What Novostella is and what it is used for

Novostella contains the active substance prasterone (dehydroepiandrosterone, DHEA), which belongs to the group of steroid hormones. Its levels in the body decrease with aging. In women, the highest concentrations of prasterone occur between the ages of 20 and 30, after which levels gradually decline.
Indications
Novostella is indicated for the treatment of dehydroepiandrosterone (prasterone) deficiency in women with laboratory-confirmed prasterone deficiency.
Supportive effects of prasterone have been demonstrated in the following conditions:

• menopause in women;
• excessive skin pigmentation, reduced epidermal thickness;
• decreased physical and mental performance, particularly in elderly individuals;
• low mood, depressive states, sleep disturbances, slowed thinking, and reduced mobility;
• decreased sexual activity;
• obesity;
• reduced tissue sensitivity to insulin;
• circulatory system disorders;
• weakened immunological immunity;
• primary and secondary adrenal cortical insufficiency.

2. Important information before taking Novostella

When not to take Novostella

• if the patient has hypersensitivity to prasterone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe hepatic and/or renal insufficiency;
• if the patient has breast cancer, ovarian cancer, or other tumors;
• during pregnancy or breastfeeding;
• in children and adolescents;
• in women with normal prasterone levels.

Warnings and precautions
Before starting treatment with Novostella, discuss this with your doctor, who will arrange
for necessary tests and decide whether the use of this medicine is required.
Women under the age of 40 should not use this medicine.
If severe adverse reactions occur, discontinue the medicine and contact your doctor.
Without consulting a doctor, the patient should not change the dose, and especially should not increase it.
When Novostella is used at higher than recommended doses for a prolonged period, the following may occur:

• absence of menstruation;
• infertility;
• reduction of mammary glands;
• excessive body hair growth;
• masculinization (development of male characteristics in women);
• decreased immunity;
• increased aggression and hyperactivity;
• weight gain.

Treatment of menopausal symptoms in older women should be initiated only after a thorough evaluation with a doctor weighing the benefits against potential risks associated with the use of the medicine.
When Novostella is used long-term at doses exceeding 2 tablets (20 mg) per day, blood prasterone levels should be monitored and regular medical examinations should be performed at appropriate intervals.
Novostella should not be used by athletes, as it belongs to the group of prohibited anabolic-androgenic substances.
Novostella should not be taken by women undergoing hormone replacement therapy (HRT).
If adverse effects such as acne or oily skin occur, the medicine should be discontinued 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 adverse effects recur, the medicine should not be used.

Children and adolescents
Novostella should not be used in children and adolescents.

Novostella and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The patient should inform the doctor if she is 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;
• antiepileptic drugs (used in epilepsy treatment, e.g. carbamazepine, valproic acid), because Novostella may reduce their effectiveness;
• psycholeptics (used in the treatment of psychiatric disorders, e.g. phenothiazine derivatives, diazepines, and oxazepines), because Novostella may reduce their effectiveness;
• calcium channel antagonists (medicines used in cardiovascular diseases, e.g. nitrendipine, diltiazem), as they increase dehydroepiandrosterone (DHEA) levels in blood serum;
• oral hypoglycemic agents (medicines used in diabetes, e.g. metformin), as they increase dehydroepiandrosterone (DHEA) levels in blood serum;
• glucocorticosteroids, as they strongly inhibit dehydroepiandrosterone production in the adrenal glands, leading to decreased hormone levels in blood;
• antipsychotic drugs (e.g. chlorpromazine, lithium salts), because Novostella may reduce their effectiveness, potentially causing a relapse of psychiatric disorders;
• insulin, whether produced endogenously or administered as a medicine, because it accelerates DHEA elimination from the body and lowers hormone levels in blood.

If the patient is unsure whether she is taking any of the above-mentioned medicines, she should
consult her physician.

Novostella with food and drink
The medicine should be taken during a meal to facilitate absorption.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Novostella is contraindicated in women during pregnancy and breastfeeding.
If a woman taking Novostella becomes pregnant, she should immediately discontinue the medicine and contact her doctor as soon as possible.

Driving and operating machinery
There is no data available on the effect of this medicine on the ability to drive or operate machinery.

The medicine contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should
consult her doctor before taking this medicine.

3. How to take Novostella

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
The initial dose is 1 tablet (10 mg) once daily.
The medicine should be taken in the morning, in accordance with the natural rhythm of DHEA hormone secretion.
The initial dose should be gradually increased (after 2 weeks by 1 tablet per day) until the desired therapeutic effects are achieved. It is recommended to use the lowest effective dose.
Any change in dose, especially an increase, must always be discussed with a doctor.
The maximum dose is 2 tablets (20 mg) per day.
In the case of long-term use of doses exceeding 2 tablets (20 mg) in women (only under medical prescription), serum hormone concentration should be monitored at appropriate intervals as directed by the doctor.
Use in elderly patients (over 65 years of age)
Elderly patients usually require higher doses of the medicine due to decreased DHEA production. The use of higher doses should be discussed with a doctor.
Use in children and adolescents
Novostella must not be used in children and adolescents.
Method of administration
The medicine should be taken orally.
It should be taken with food to facilitate absorption.
Dosage should be adjusted according to serum dehydroepiandrosterone concentration and therapeutic response.
Novostella is intended for long-term use; therapeutic effects become apparent after several weeks of treatment.
If you take more Novostella than you should
If you take more than the recommended dose, contact your doctor immediately.
If you miss a dose of Novostella
Continue taking the medicine as before, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
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 everyone experiences them.
If any of the symptoms listed below occur, discontinue use of the medicine
and contact your doctor.
The following adverse reactions may occur:
Rare (occur in 1 to 10 of 10,000 patients):

• facial acne or mild acneiform skin inflammation;
• moderately increased excessive hair growth, mainly in women (hirsutism);
• seborrheic skin changes of the face;
• scalp itching;
• increased sweating;
• male-pattern vertex baldness;
• menstrual disturbances;
• lowering of voice pitch;
• headache, anxiety, mood changes;
• nausea, vomiting, increased appetite;
• edema due to water and salt retention in the body;
• hypercalcemia (increased calcium levels in blood);
• unfavorable changes in blood lipid composition (e.g. decreased HDL - high-density lipoprotein).

Very rare (occur in less than 1 of 10,000 patients):

• hepatitis;
• enlargement of the liver (hepatomegaly);
• mania (psychiatric disorder characterized by elevated or irritable mood);
• non-life-threatening cardiac arrhythmias, resolving after discontinuation of the medicine and treatment with appropriate medication (from the beta-blocker group);
• insomnia.

The medicine, when used at recommended doses, is generally well tolerated.
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 symptoms occur, including any adverse symptoms not listed
in this leaflet, consult your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Novostella

Keep this medicine out of sight and reach of children.
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.
Store below 25 °C.
Medicines must 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 Novostella contains

• The active substance is prasterone. Each tablet contains 10 mg of prasterone.
• The other ingredients are: Ludipress (monohydrate lactose, povidone, crospovidone), magnesium stearate.

What Novostella looks like and contents of the pack
Novostella is a tablet.
The tablets are packed in blisters and cardboard boxes. Each box contains 30 or 60 tablets.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów