HYPLAFIN

Patient Information Leaflet

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

• 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 them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Hyplafin is and what it is used for

Hyplafin contains the active substance finasteride, which belongs to a group of medicines called
5-α-reductase inhibitors. It works by reducing the size of the prostate gland in men.
Hyplafin is used in the treatment and management of benign (non-cancerous) prostate enlargement.

2. Important information before using Hyplafin

When not to use Hyplafin

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• in women and children (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting to take Hyplafin, discuss this with your doctor or pharmacist:

• if the patient has impaired liver function
• if the patient has problems with complete emptying of the urinary bladder or significantly weakened urine flow through the urethra. Patients with such symptoms should be thoroughly examined by a doctor before starting Hyplafin to exclude other causes of urinary tract obstruction.

Inform your doctor immediately about any changes in breast tissue, such as: lumps, pain, breast enlargement or fluid discharge from the nipples, as these may be symptoms of a serious disease such as breast cancer.
If the patient's partner is pregnant or potentially could become pregnant, it is recommended to limit the partner's exposure to the patient's semen, as it may contain a small amount of the medicine (see section "Pregnancy, breastfeeding and fertility").
If the patient is due to have a blood test called a "PSA" test, he should first inform the doctor or nurse, because finasteride may affect the test results.

Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Hyplafin. If any of these symptoms occur, seek immediate medical advice from a doctor.

Hyplafin and other medicines
Hyplafin can generally be taken with other medicines. Consult your doctor before taking any other medicine during treatment.
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.

Hyplafin with food and drink
Hyplafin may be taken with or without food.

Pregnancy, breastfeeding and fertility
Hyplafin is intended for use in men only.
If the patient's sexual partner is pregnant or could become pregnant, the patient should avoid exposing the partner to semen, which may contain small amounts of the medicine.
Pregnant women or women who could become pregnant should not handle crushed or broken Hyplafin tablets. If finasteride is absorbed through the skin or swallowed by a pregnant woman expecting a male child, the baby may be born with malformed external genital organs. The tablets have a coating that protects against contact with finasteride, provided the tablets are not broken or crushed.

Infertility and poor semen quality have been reported in men treated with finasteride.
In some of these cases, men had other risk factors that could have affected fertility. After discontinuation of finasteride, normalization or improvement of semen quality has been reported.

Driving and operating machinery
There are no data indicating that Hyplafin affects the ability to drive or operate machinery.

Hyplafin contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Hyplafin

This medicine should always be used as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The recommended dose is 1 tablet per day.
The tablet should be swallowed whole and must not be broken or crushed.
Hyplafin may be taken with or without food.
Taking more Hyplafin than recommended
Seek immediate medical advice from a doctor or go to the nearest hospital.
Missing a dose of Hyplafin
Do not take a double dose to make up for the missed tablet. Take the next tablet as scheduled.
Stopping Hyplafin treatment
Although improvement is often noticeable after a short period of use, treatment should be continued for at least 6 months. Do not change the dose or stop using this medicine without consulting your doctor.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Hyplafin should be discontinued and medical advice should be sought immediately if any of the following symptoms occur: swelling of the face, tongue or throat, difficulty swallowing, urticaria (hives), and breathing difficulties. These symptoms may be signs of a hypersensitivity reaction, including angioedema, the frequency of which is reported as unknown (frequency cannot be estimated from the available data).

Common (may occur in up to 1 in 10 people)
Inability to achieve erection, reduced sexual desire, decreased ejaculate volume (amount of semen).

Uncommon (may occur in up to 1 in 100 people)
Breast tenderness, skin rash, breast enlargement, difficulty in achieving ejaculation (semen discharge).

Frequency not known (frequency cannot be estimated from the available data)
Depression, testicular pain, blood in semen, inability to achieve erection even after discontinuation of Hyplafin, persistent ejaculation disorders after stopping treatment, persistent reduction in sexual desire after stopping treatment, male infertility and/or poor semen quality (improvement in semen quality has been reported after stopping the drug), itching, urticaria (blisters), irregular and rapid heartbeat, increased liver enzyme activity, anxiety, suicidal thoughts.

A doctor should be informed immediately if any changes in the breasts occur, such as lumps, pain, breast enlargement, or fluid discharge from the nipples, as these may be symptoms of a serious illness, such as breast cancer.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, they should be reported to a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the representative of the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hyplafin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Hyplafin contains

• The active substance is finasteride. One coated tablet contains 5 mg of finasteride.
• The other ingredients of the tablet core are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, glyceryl laurate macrogol, sodium carboxymethyl starch (type A), magnesium stearate. The tablet coating contains: hypromellose, polyethylene glycol 6000, titanium dioxide (E 171), indigo carmine (E 132), lacquer.

What Hyplafin looks like and contents of the pack
Hyplafin is a blue, round, biconvex coated tablet marked with "F5".
The tablet diameter is 7 mm.
Blisters contain 10, 20, 30, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer/Importer
Genericon Pharma Gesellschaft m.b.H.
Hafnerstraße 211
8054 Graz
Austria
Actavis Group PTC ehf
Dalshraun 1
220 Hafnarfjörður
Iceland
G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria/Czech Republic/Poland Hyplafin
Slovakia Androfin 5 mg
Sweden Finaset
Hungary Redupros 5 mg filmtabletta

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
Tel.: +48 12 262 32 36
E-mail: [email protected]