Adaster

Package leaflet: Information for the user

ADASTER, 5 mg, film-coated tablets
Finasteride
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What ADASTER is and what it is 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 pack and other information

1. What ADASTER is and what it is used for

ADASTER belongs to a group of medicines called 5α-reductase inhibitors.
This medicine binds to an enzyme known as 5-alpha-reductase, thereby inhibiting the formation 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 the enlarged prostate becomes smaller.
This medicine is intended for use in men only.
Why has your doctor prescribed ADASTER?
Finasteride is a specific enzyme inhibitor used in the treatment of men with benign prostatic hyperplasia (BPH). ADASTER reduces the enlarged prostate and relieves urinary symptoms. It also reduces the risk of acute urinary retention and the need for surgical intervention.

2. Important information before using ADASTER

When not to use ADASTER

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• in women (as this medicine is intended for men only).
• in children. The condition for which ADASTER has been prescribed occurs only in men. Women who are pregnant or may become pregnant must not handle crushed or broken tablets (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting treatment with ADASTER, discuss this with your doctor or pharmacist.

• if the patient has a large amount of residual urine and/or significantly reduced urine flow. In such cases, the patient should be closely monitored for urinary tract obstruction.
• if the patient's sexual partner is or may be pregnant, exposure to the partner should be avoided from contact with the patient's semen, which may contain a small amount of the medicine and could disrupt normal development of the child's sex organs.
• if the patient has impaired liver function.

Breast cancer
Cases of breast cancer have been reported during finasteride treatment. If the patient notices any of the symptoms described in section 4, he should immediately inform his doctor.

Effect on prostate-specific antigen (PSA)
This medicine may affect the results of a blood test known as PSA measurement. This test is used to detect prostate cancer. If the patient is undergoing PSA testing, he should inform his doctor about taking this medicine, as it reduces PSA levels.

Effect on fertility
Infertility has been reported in men who have used finasteride for a long time and who have also been exposed to other factors that may impair fertility. After discontinuation of finasteride, improvement or return to normal of semen quality has been observed. Long-term studies on the effect of finasteride on male fertility have not been conducted.

Mood changes and depression
In patients taking ADASTER, mood changes such as depressive mood and depression, and rarely suicidal thoughts, have been reported. If any of these symptoms occur, the patient should immediately seek medical advice from a doctor.

Children
This medicine must not be used in children. There is no data indicating the efficacy and safety of finasteride use in children.

Other medicines and ADASTER
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

ADASTER usually does not affect the action of other medicines.

ADASTER with food, drink and alcohol
ADASTER may be taken regardless of meals.

Pregnancy, breastfeeding and fertility
ADASTER is intended solely for the treatment of benign prostatic hyperplasia in men. For effects on male fertility, see "Effect on fertility" above.

Women who are pregnant or who may become pregnant must not handle crushed or broken ADASTER tablets.

If finasteride is absorbed through the skin or taken orally by a woman expecting a male child, the baby may be born with malformations of the genital organs.

The tablets are film-coated, which prevents contact with finasteride as long as the tablets are not broken or crushed.

If the patient's sexual partner is or may become pregnant, it is recommended that the patient limit the partner's exposure to semen (e.g. by using a condom) or discontinue treatment with ADASTER.

If you have any questions, consult your doctor or pharmacist.

Driving and operating machinery
There is no data indicating that ADASTER affects the ability to drive vehicles or operate machinery.

ADASTER contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

ADASTER contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use ADASTER

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Dosage
The recommended dose of ADASTER is one 5 mg tablet per day (corresponding to 5 mg
of finasteride).
The coated tablets should be swallowed whole and must not be divided or crushed.
The tablets may be taken either on an empty stomach or with food.
Your doctor may prescribe ADASTER together with another medicine, doxazosin, to help control BPH.
Adults
Keep in mind that it took years for the prostate to become so enlarged as to cause these symptoms.
ADASTER works against these symptoms and affects the condition only when used over a long period.
Although improvement may be seen quickly, treatment for at least 6 months may be necessary
to determine whether a beneficial response to treatment has been achieved.
Your doctor will inform you how long you should continue taking ADASTER 5 mg. Do not discontinue
treatment prematurely, as symptoms may recur.
Your doctor should regularly monitor the treatment outcomes.
Patients with hepatic function impairment
There are no data on the use of ADASTER 5 mg in patients with hepatic function impairment.
Patients with renal function impairment
Dosage adjustment is not required (see sections “Dosage” and “Adults”). Studies on the use of
ADASTER 5 mg in patients undergoing hemodialysis have not been conducted.
Elderly patients
Dosage adjustment is not necessary (see sections “Dosage” and “Adults”).
Consult your doctor or pharmacist if the patient feels that the effect of ADASTER 5 mg is too strong or too weak.
Overdose of ADASTER
In case of an overdose of ADASTER or if the medicine has been accidentally ingested by a child,
contact your doctor or pharmacist immediately.
Missed dose of ADASTER
If a dose of ADASTER is missed, take it as soon as possible, unless it is almost time for the next dose.
In that case, continue treatment according to your doctor’s instructions.
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.
The following adverse reactions may occur with the use of this medicinal product:
Allergic reactions
If a patient has an allergic reaction to the medicine, they should stop taking the medicine and immediately
contact a doctor. Symptoms may include (frequency is unknown, i.e. cannot be estimated based on available data):

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

Adverse reactions may occur with the following frequencies:
Common (may occur in up to 1 in 10 people):

• erectile dysfunction (impotence)
• decreased sexual desire
• ejaculation problems, e.g. reduced semen volume during ejaculation. Reduced semen volume does not appear to affect sexual performance. The above adverse reactions may resolve during continued treatment with ADASTER. If not, they usually resolve after discontinuation of ADASTER.

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

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

Unknown (frequency cannot be estimated from available data):

• palpitations (feeling of a rapidly or strongly beating heart)
• liver function abnormalities detected in blood tests
• testicular pain
• blood in semen
• depression, decreased sexual desire that persists after discontinuation of the medicine
• erectile dysfunction that persists after completion of treatment
• male infertility and/or poor semen quality. Cases of impaired fertility have been reported in men who have been taking finasteride for a long time and who also had other risk factors that may impair fertility. After discontinuation of finasteride, semen quality normalized or improved.
• anxiety
• suicidal thoughts.

Any changes in breast tissue, such as lumps, pain, enlargement or nipple discharge, should be reported to a doctor immediately, as they may be symptoms of a serious illness, such as breast cancer.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or nurse. 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
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 ADASTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP:. The expiry date refers to the last day of the specified month.
No special storage conditions are required.
Do not use this medicine if signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What ADASTER contains

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

What ADASTER looks like and contents of the pack
Film-coated tablet
Blue, round, biconvex film-coated tablets with bevelled edges, marked with the letter E on one side and the number 61 on the other.
ADASTER 5 mg is available in PVC/PE/PVDC/Aluminium blisters packed in cardboard boxes.
Pack sizes contain 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 Authorisation 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 authorised in the European Economic Area under the following names:
Cyprus Finasterid Aurobindo 5 mg επικαλυμμένο με λεπτό υμένιο δισκία
Germany Finasterid Aurobindo 5 mg Filmtabletten
Denmark Finasterid Aurobindo 5 mg filmovertrukne tabletter
France FINASTERIDE ARROW LAB 5 mg, comprimé pelliculé
Ireland Fintrid 5 mg film-coated tablets
Netherlands Finasteride Aurobindo 5 mg, filmomhulde tabletten
Poland ADASTER 5 mg
Sweden Finasterid Aurobindo 5 mg filmdragerade tabletter