Adaster

Package Leaflet: Information for the User

ADASTER, 5 mg, Film-Coated Tablets

Finasteride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is ADASTER and What is it Used For
• 2. Important Information Before Taking ADASTER
• 3. How to Take ADASTER
• 4. Possible Side Effects
• 5. How to Store ADASTER
• 6. Contents of the Package and Other Information

1. What is ADASTER and What is it Used For

ADASTER belongs to a group of medications called 5-alpha-reductase inhibitors.
This medication binds to an enzyme called 5-alpha-reductase, thereby inhibiting the production of a substance involved in the enlargement of the prostate gland. As a result of this inhibition, further enlargement of the prostate is prevented. With long-term use, in most cases, an enlarged prostate becomes smaller.
This medication is intended for use only in men.

Why was ADASTER Prescribed by Your Doctor?

Finasteride is a specific enzyme inhibitor used in the treatment of men with benign prostatic hyperplasia (BPH). ADASTER reduces the size of an enlarged prostate and alleviates urinary symptoms. This medication reduces the risk of sudden inability to urinate (acute urinary retention) and the need for surgery.

2. Important Information Before Taking ADASTER

When Not to Take ADASTER

• in women (since this medication is intended for men).
• in children. The condition for which ADASTER is prescribed occurs only in men. Women who are pregnant or may become pregnant should not handle broken or crushed tablets (see "Pregnancy, Breast-feeding, and Fertility").

Warnings and Precautions

Before starting treatment with ADASTER, discuss it with your doctor or pharmacist.

Breast Cancer
During treatment with finasteride, cases of breast cancer have been reported. If you notice any of the symptoms described in section 4, you should immediately inform your doctor.
Effect on Prostate-Specific Antigen (PSA)
This medication may affect the results of a blood test called PSA measurement. This test is used to detect prostate cancer. If you are having your PSA level measured, you should inform your doctor that you are taking this medication, as it may lower your PSA level.
Effect on Fertility
Infertility has been reported in men who have taken finasteride for a long time and have also been exposed to other factors that may affect fertility. After stopping finasteride, an improvement or return to normal sperm quality has been observed. No long-term studies have been conducted on the effect of finasteride on male fertility.
Mood Changes and Depression
Patients taking ADASTER have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If you experience any of these symptoms, you should immediately consult your doctor for further medical advice.

Children

This medication should not be used in children. There is no data on the efficacy and safety of finasteride in children.

Other Medications and ADASTER

You should inform your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
ADASTER usually does not affect the action of other medications.

ADASTER with Food, Drink, and Alcohol

ADASTER can be taken with or without food.

Pregnancy, Breast-feeding, and Fertility

ADASTER is intended for the treatment of benign prostatic hyperplasia in men only. For information on fertility in men, see "Effect on Fertility" above.
Women who are pregnant or may become pregnant should not handle broken or crushed ADASTER tablets.
If finasteride is absorbed through the skin or taken orally by a pregnant woman, the child may be born with genital organ malformation.
The tablets are film-coated, which prevents contact with finasteride, as long as the tablets are not broken or crushed.
If your sexual partner is or may become pregnant, it is recommended that you limit your partner's exposure to your semen (e.g., by using a condom) or stop taking ADASTER.
If you have any questions, consult your doctor or pharmacist.

Driving and Operating Machines

There is no data indicating that ADASTER affects the ability to drive or operate machines.

ADASTER Contains Lactose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medication.

ADASTER Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take ADASTER

This medication should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Dosage

The recommended dose is one ADASTER 5 mg tablet per day (equivalent to 5 mg of finasteride).
The film-coated tablets should be taken with or without food.
The film-coated tablets should be swallowed whole and not divided or crushed.

Your Doctor May Prescribe ADASTER with Another Medication, Doxazosin, to Help Control BPH.

Adults

Remember that it took years for the prostate to become large enough to cause symptoms.
ADASTER works against these symptoms and affects the condition only when taken for a long time.
Although rapid improvement may be noticeable, treatment for at least 6 months may be necessary to assess whether a beneficial response to treatment has been achieved.
Your doctor will inform you how long you should take ADASTER 5 mg. Do not stop treatment prematurely, as symptoms may recur.
Your doctor should regularly monitor the treatment results.

Patients with Liver Function Disorders

There is no data on the use of ADASTER 5 mg in patients with liver function disorders.

Patients with Kidney Function Disorders

No dose adjustment is necessary (see "Dosage" and "Adults"). No studies have been conducted on the use of ADASTER 5 mg in patients undergoing hemodialysis.

Patients of Advanced Age

No dose adjustment is necessary (see "Dosage" and "Adults").
If you think that the effect of ADASTER 5 mg is too strong or too weak, consult your doctor or pharmacist.

Overdose of ADASTER

If you have taken more than the recommended dose of ADASTER or if a child has accidentally taken the medication, immediately inform your doctor or pharmacist.

Missed Dose of ADASTER

If you miss a dose of ADASTER, take it as soon as possible, unless it is almost time for your next dose. In this case, continue treatment as prescribed by your doctor.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, ADASTER can cause side effects, although not everybody gets them. The following side effects may occur with this medication:

Allergic Reactions

If You Have an Allergic Reaction to ADASTER, Stop Taking the Medication and Immediately

Consult Your Doctor. Symptoms May Include(frequency not known, i.e., cannot be estimated from the available data) :

• skin rash, itching, or lumps under the skin (hives)
• swelling of the lips, tongue, throat, and face.

Side Effects May Occur with the Following Frequency:
Common(may affect up to 1 in 10 people):

• erectile dysfunction (impotence)
• decreased libido
• ejaculation disorders, e.g., decreased semen volume during ejaculation. The decrease in semen volume appears to have no effect on sexual function. The above side effects may resolve during continued treatment with ADASTER. If they do not, they usually resolve after stopping ADASTER.

Uncommon(may affect up to 1 in 100 people):

• breast tenderness and/or breast enlargement
• rash
• ejaculation disorders (ejaculation).

Unknown(frequency cannot be estimated from the available data):

• palpitations (feeling of a strong heartbeat)
• liver function disorders, detected in blood tests
• testicular pain
• blood in semen
• depression, decreased libido that persists after stopping the medication
• erectile dysfunction that persists after stopping the treatment
• male infertility and/or poor semen quality. Cases of reduced fertility have been reported in men who have taken finasteride for a long time and have also been exposed to other risk factors that may affect fertility. After stopping finasteride, sperm quality has been observed to normalize or improve.
• anxiety
• suicidal thoughts.

You should immediately inform your doctor about any changes in breast tissue, such as lumps, pain, enlargement, or discharge, as these may be symptoms of a serious disease, such as breast cancer.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store ADASTER

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after EXP:. The expiration date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medication if you notice signs of deterioration.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What ADASTER Contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride,
• Other ingredients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), maize starch, sodium lauryl sulfate, magnesium stearate, hydroxypropylcellulose, hypromellose 6 cP, titanium dioxide (E171), talc, indigo carmine (E132), yellow iron oxide (E172).

What ADASTER Looks Like and Contents of the Package

Film-Coated Tablet
Blue, round, biconvex film-coated tablets with a beveled edge, with the letter E embossed on one side and the numbers 61 on the other.
ADASTER 5 mg is available in PVC/PE/PVDC/Aluminum blisters in a cardboard box.
The package contains 10, 14, 15, 20, 28, 30, 45, 50, 60, 90, 98, 100, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Importer

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Cyprus
Finasteride Aurobindo 5 mg film-coated tablets
Germany
Finasteride Aurobindo 5 mg film-coated tablets
Denmark
Finasteride Aurobindo 5 mg film-coated tablets
France
FINASTERIDE ARROW LAB 5 mg, film-coated tablets
Ireland
Fintrid 5 mg film-coated tablets
Netherlands
Finasteride Aurobindo 5 mg, film-coated tablets
Poland
ADASTER 5 mg
Sweden
Finasteride Aurobindo 5 mg, film-coated tablets

Date of Last Revision of the Package Leaflet: 06.2025