Finasteride bluefish

Package leaflet: Information for the user

Finasteridum Bluefish, 5 mg, film-coated tablets
Finasteridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of the leaflet

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

1. What Finasteridum Bluefish is and what it is used for

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors.
These medicines work by reducing the size of an enlarged prostate gland in men.
Finasteridum Bluefish is used in the treatment and management of benign (i.e. non-cancerous) enlargement of the prostate gland (Benign Prostatic Hyperplasia, BPH). The medicine reduces the enlarged prostate, improves urine flow, relieves BPH-related symptoms, and reduces the risk of sudden inability to pass urine (called acute urinary retention) and the need for surgical intervention.

2. Important information before using Finasteridum Bluefish

When not to use Finasteridum Bluefish

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• since finasteride is intended for use only in men, women (see also section "Pregnancy and breastfeeding") and children should not take this medicine.

Warnings and precautions
Before starting treatment with Finasteridum Bluefish, discuss this with your doctor, pharmacist,
or nurse.

• If the patient has a large amount of residual urine remaining after urination and (or) significantly reduced urine flow. In such cases, the patient should be particularly monitored for urinary tract obstruction.
• If the patient has impaired liver function, finasteride blood concentrations may increase.
• If the patient's sexual partner is or may be pregnant, exposure to the patient's semen should be avoided, as it may contain small amounts of the medicine.
• If the patient is due to have a blood test to measure PSA levels (a test used to detect prostate cancer), the doctor should be informed, as finasteride may affect the blood concentration of the substance being analyzed (PSA).

If any of the above situations apply or have applied to the patient in the past, they should
be reported to the doctor.
The patient should promptly report to the doctor any changes in breast tissue, such as lumps, pain,
breast enlargement, or nipple discharge, which may be symptoms of serious conditions such as
breast cancer.
The patient should discuss any health problems, including allergies, with their doctor.
What should be known before using Finasteridum Bluefish?
Benign prostatic hyperplasia (BPH) develops over a long period. Some patients may experience early improvement in symptoms,
but for others, treatment with Finasteridum Bluefish may need to be continued for at least 6 months
before beneficial effects are observed.
Regardless of whether the patient notices improvement or changes in symptoms, treatment with
Finasteridum Bluefish may reduce the risk of acute urinary retention or the need for surgical
intervention. Regular follow-up with the doctor is recommended so that they can periodically
assess the direction of changes and the patient's clinical progress.
Although BPH is neither cancer nor does it lead to cancer, both conditions may occur
simultaneously. Only a doctor can evaluate symptoms and their possible causes.
Finasteride may affect a blood test called PSA. If a PSA test has been performed, the patient should
inform the doctor about taking finasteride.
What other precautions should be taken?
Finasteridum Bluefish is indicated only for the treatment of BPH in men.
Pregnant women or women who may become pregnant must not take Finasteridum Bluefish.
Tablets should not be crushed or broken. If the active ingredient of Finasteridum Bluefish is absorbed orally or through the skin by a pregnant woman and the fetus is male, it may cause malformation of the fetal genital organs. If a pregnant woman comes into contact with the active substance of Finasteridum Bluefish, she should consult a doctor.
Finasteridum Bluefish tablets are film-coated, which prevents contact with the active ingredient during
normal handling, provided the tablets are not broken or crushed.
If in doubt, contact your doctor.
Finasteridum Bluefish and other medicines
Finasteridum Bluefish generally does not interact with other medicines. No significant interactions with other medicines have been reported.
Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Finasteridum Bluefish with food and drink
Finasteridum Bluefish can be taken with or without food.
Pregnancy and breastfeeding
Finasteridum Bluefish is intended for use in men only. (See also section "What other precautions should be taken?").
If the patient's sexual partner is pregnant or may become pregnant, exposure to the patient's semen should be avoided (e.g. by using a condom), as it may contain trace amounts of the medicine, or treatment with finasteride should be discontinued. If a pregnant woman has had contact with finasteride, medical advice should be sought.
Driving and operating machinery
Finasteride is not expected to affect the ability to drive or operate machinery.
Finasteridum Bluefish contains lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.
Finasteridum Bluefish contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
Mood changes and depression
Mood changes such as depressed mood and depression, and rarely suicidal thoughts, have been observed in patients taking Finasteridum Bluefish. If any of these symptoms occur, the patient should seek immediate medical advice from their doctor.

3. How to use Finasteridum Bluefish

This medicine should always be taken as directed by the physician. In case of doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day (corresponding to 5 mg of finasteride), taken daily, with or without food. Follow your doctor's instructions.
The coated tablet must be swallowed whole and must not be split or crushed.
Although improvement may occur within a short period, treatment for at least 6 months may be necessary to assess whether an effective response to treatment has been achieved.
Your doctor will inform you how long you should continue taking Finasteridum Bluefish. Do not discontinue treatment prematurely, as symptoms may return.

Patients with hepatic impairment
There is no data on the use of Finasteridum Bluefish in patients with impaired liver function (see also section "Warnings and precautions").

Patients with renal impairment
Dosage adjustment is not required. Studies on the use of Finasteridum Bluefish in patients undergoing hemodialysis have not been conducted.

Elderly patients
Dosage adjustment is not required.

If you feel that the effect of Finasteridum Bluefish is too strong or too weak, consult your doctor or pharmacist.

Overdose of Finasteridum Bluefish
If a patient takes more Finasteridum Bluefish tablets than prescribed by the doctor, or if anyone else takes this medicine, contact the emergency department of the nearest hospital or contact a doctor immediately. Bring any remaining tablets or the empty packaging to help identify the medicine taken.

Missed dose of Finasteridum Bluefish
Finasteridum Bluefish should be taken as directed. If a dose of Finasteridum Bluefish is missed, the patient may take it as soon as they remember, unless it is almost time for the next dose. In that case, continue taking the medicine as directed by the physician. Do not take a double dose to make up for a missed dose. Take the next tablet according to the prescribed schedule.

Stopping Finasteridum Bluefish
Do not stop treatment unless advised by your doctor.
Remember that benign prostatic hyperplasia causes symptoms only after many years. Finasteridum Bluefish will be able to treat these symptoms and control your health condition only if taken for as long as directed by your doctor.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
They are not common and do not affect most men.
To assess adverse effects, the following terms are used to describe their frequency:
Very common: affects more than 1 in 10 people
Common: affects more than 1 in 100 but less than 1 in 10 people
Uncommon: affects less than 1 in 100 but more than 1 in 1,000 people
Rare: affects less than 1 in 1,000 but more than 1 in 10,000 people
Very rare: affects less than 1 in 10,000 people

The most common adverse effects are impotence (inability to achieve an erection) and reduced libido. Some men may experience changes or problems with ejaculation, such as a decrease in the amount of semen released during intercourse. This reduction in semen volume does not appear to interfere with normal sexual function. In some cases, these adverse effects resolved during treatment with Finasteridum Bluefish, but if symptoms persist, they usually resolve after discontinuation of treatment.

Some men may also experience breast swelling and/or tenderness. Some have also reported blood in the semen, male infertility and/or poor semen quality. Improvement in semen quality has been observed after discontinuation of treatment.

Immune system disorders
Unknown frequency: hypersensitivity reactions, including swelling of the lips, tongue, throat, and face

Psychiatric disorders
Common: decreased libido
Unknown frequency: decreased libido persisting after discontinuation of treatment, depression, anxiety, suicidal thoughts

Cardiac disorders
Unknown frequency: palpitations

Hepatobiliary disorders
Unknown frequency: increased liver enzyme activity

Skin and subcutaneous tissue disorders
Uncommon: rash
Unknown frequency: itching, urticaria

Reproductive system and breast disorders
Common: impotence
Uncommon: ejaculation disorders, breast tenderness, breast enlargement
Unknown frequency: testicular pain, sexual dysfunction (reduced libido, erectile and ejaculatory disorders)

Diagnostic investigations
Common: reduced ejaculate volume

Finasteride may affect laboratory PSA test results.

Any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, should be reported to a doctor immediately, as they may be signs of serious conditions such as breast cancer.

The use of Finasteridum Bluefish should be discontinued and immediate medical advice sought if any of the following symptoms occur (angioedema): swelling of the lips, face, tongue, or throat; difficulty swallowing; urticaria; or breathing difficulties.

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Finasteridum Bluefish

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicinal product.
Do not use this medicine after the expiry date stated on the packaging following "Expiry date" or "EXP". 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 no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Finasteridum Bluefish contains
The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other ingredients are:
Tablet core: lactose monohydrate (200 M), microcrystalline cellulose (PH 102), pregelatinized maize starch (1500), sodium docusate, sodium carboxymethyl starch (type A), magnesium stearate.
Coating Opadry Blue 03A80928: HPMC 2910/hypromellose 6cP, titanium dioxide (E 171), indigo carmine (E 132), aluminium lake, talc, yellow iron oxide (E 172).
What Finasteridum Bluefish looks like and contents of the pack
Film-coated tablet
Blue, round, biconvex film-coated tablet with the letter "H" embossed on one side and the number "37" on the other side.
Blister PVC/PE/PVDC/Aluminium in a cardboard box.
15, 28, 30, 50, 60, 90, 98 or 100 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden, tel. +46 8 51 91 16 00
Manufacturer
Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden
Pharmadox Healthcare Ltd., KW20A Corradino Industrial Estate, Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names: