Novostella

Leaflet attached to the packaging: patient information

Novostella,10 mg, tablets
Prasterone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, you should contact your doctor.

Table of contents

• 1. What is Novostella and what is it 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 is Novostella and what is it used for

Novostella contains the active substance prasterone (dehydroepiandrosterone, DHEA), which belongs to the group of steroid hormones. Its amount in the body decreases with age. The highest concentration of prasterone in women occurs between 20 and 30 years of age, and after 30 years, it decreases gradually.

Indications for use

Novostella is indicated for the treatment of dehydroepiandrosterone (prasterone) deficiency in women with laboratory-confirmed prasterone deficiency.
Supporting effects of prasterone have been demonstrated in the following cases:

• menopause in women;
• excessive skin pigmentation, reduced skin thickness;
• reduced physical and mental fitness, especially in older people;
• depression, depressive states, sleep disorders, slowed thinking, and reduced mobility;
• decreased sexual activity;
• obesity;
• reduced tissue sensitivity to insulin;
• circulatory system disorders;
• immunological immunity impairment;
• primary and secondary adrenal cortex insufficiency.

2. Important information before taking Novostella

When not to take Novostella

• if you are allergic to prasterone or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver and/or kidney failure;
• if you have breast, ovarian, or other cancers;
• during pregnancy or breastfeeding;
• in children and adolescents;
• in women with normal prasterone levels.

Warnings and precautions

Before starting to take Novostella, you should discuss it with your doctor, who will order the necessary tests and decide on the need to use this medicine based on their results.
Women under 40 should not take this medicine.
If severe side effects occur, you should stop taking the medicine and contact your doctor.
Without consulting your doctor, you should not change or increase the dose of the medicine.
Taking higher doses than recommended for a longer period may cause:

• amenorrhea;
• infertility;
• reduced breast size;
• excessive hair growth on the body;
• masculinization (development of male characteristics in women);
• reduced immunity;
• increased aggression and restlessness;
• weight gain.

Treatment of menopausal symptoms in older women should be started after careful analysis of the benefits and potential risks associated with the use of the medicine, together with your doctor.
In the case of long-term use of the medicine in doses higher than 2 tablets (20 mg) per day, prasterone levels in the blood should be monitored, and medical examinations should be performed at regular intervals.
Novostella should not be used by athletes, as it belongs to the group of prohibited anabolic-androgenic agents.
Novostella should not be taken by women using hormone replacement therapy (HRT).
If side effects such as acne or skin oiliness occur, you should stop taking the medicine for 2-3 weeks. After this time, you can continue treatment using a lower dose than before, but it is recommended to consult a doctor. If side effects occur again, you should not take the medicine.

Children and adolescents

Novostella should not be used in children and adolescents.

Novostella and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you 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;
• antiepileptic medicines(used to treat epilepsy, such as carbamazepine, valproic acid), as Novostella may weaken their effect;
• psycholeptic medicines(used to treat mental disorders, such as phenothiazine derivatives, diazepines, and oxazepines), as Novostella may weaken their effect;
• calcium channel blockers(medicines used to treat cardiovascular diseases, such as nitrendipine, diltiazem), as they increase the concentration of dehydroepiandrosterone in the blood;
• oral hypoglycemic medicines(medicines used to treat diabetes, such as metformin), as they increase the concentration of dehydroepiandrosterone in the blood;
• glucocorticosteroids, as they strongly inhibit the production of dehydroepiandrosterone in the adrenal glands, which leads to a decrease in the hormone level in the blood;
• antipsychotic medicines(such as chlorpromazine, lithium salts), as Novostella may weaken their effect, which may cause a relapse of mental disorders;
• insulinproduced in the body and administered as a medicine, as it accelerates the elimination of DHEA from the body and reduces the hormone level in the blood.

If you are not sure whether you are taking any of the above medicines, you should ask your doctor.

Novostella with food and drink

The medicine should be taken during a meal to facilitate absorption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Novostella is contraindicated in women during pregnancy and breastfeeding.
If a woman taking Novostella becomes pregnant, she should stop taking the medicine immediately and contact her doctor as soon as possible.

Driving and using machines

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

The medicine contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Novostella

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose

The initial dose is 1 tablet (10 mg) once a day.
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 (by 1 tablet per day after 2 weeks) until the desired therapeutic effects are achieved. The smallest effective dose is recommended.
Dose changes, especially increases, always require consultation with a doctor.
A maximum of 2 tablets (20 mg) can be taken per day.
In the case of long-term use of doses higher than 2 tablets (20 mg) in women (only with a doctor's prescription), prasterone levels in the blood should be monitored at regular intervals, as ordered by the doctor.

Use in elderly patients (over 65 years)

Elderly patients usually require higher doses of the medicine due to decreased DHEA production. The use of higher doses should be consulted with a doctor.

Use in children and adolescents

Novostella should not be used in children and adolescents.

Method of administration

The medicine should be taken orally.
The medicine should be taken during a meal to facilitate absorption.
Dosing should be adjusted according to prasterone levels in the blood and the effectiveness of therapy.
Novostella is intended for long-term use; the effects of the medicine become visible after several weeks of use.

Taking a higher dose of Novostella than recommended

In case of taking a higher dose of the medicine than recommended, you should contact your doctor.

Missing a dose of Novostella

You should continue taking the medicine without increasing the next dose.
You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Novostella can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should stop taking the medicine and contact your doctor.

The following side effects may occur:

Rare(occurring in 1 to 10 patients out of 10,000):

• acne or mild acne-like skin inflammation;
• moderately severe excessive hair growth, mainly in women (hirsutism);
• seborrheic skin changes;
• scalp itching;
• increased sweating;
• male-pattern baldness;
• menstrual disorders;
• decreased voice tone;
• headache, restlessness, mood changes;
• 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 - high-density lipoproteinlevels).

Very rare(occurring in less than 1 patient 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 the medicine and using appropriate treatment (from the group of beta-adrenolytics);
• insomnia.

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 those not listed in this leaflet, you should contact your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
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 Novostella

The medicine should be stored 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 month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should 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 Novostella contains

• The active substance of the medicine is prasterone. 1 tablet contains 10 mg of prasterone.
• The other ingredients are: ludipress (lactose monohydrate, povidone, crospovidone), magnesium stearate.

What Novostella looks like and contents of the pack

The medicine is in the form of tablets.
The tablets are packaged in blisters and cardboard boxes. Each box contains 30 or 60 tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: