Finasteride
Hyplafin contains the active substance finasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors. Its action is to reduce the size of the prostate gland in men.
Hyplafin is used to treat and control benign (non-cancerous) prostatic hyperplasia.
Before taking Hyplafin, discuss with your doctor or pharmacist:
You should immediately inform your doctor about any changes in breast tissue, such as: lumps, pain, enlargement of breasts or fluid discharge from the nipples, as they may be symptoms of a serious disease such as breast cancer.
If your partner is pregnant or may become pregnant, you should avoid exposing your partner to contact with your semen, as it may contain a small amount of the medicine (see section "Pregnancy, breastfeeding and fertility").
If you are going to have a blood test called the "PSA test", you should first inform your doctor or nurse, as finasteride may change the test results.
In patients taking Hyplafin, mood changes, such as depressive mood and depression, and less frequently suicidal thoughts, have been reported. If you experience any of these symptoms, you should immediately consult your doctor for further medical advice.
Hyplafin can usually be taken with other medicines. You should consult your doctor before taking any other medicine.
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Hyplafin can be taken with or without food.
Hyplafin is intended for use only in men.
If your sexual partner is pregnant or may become pregnant, you should avoid exposing your partner to contact with your semen, which may contain small amounts of the medicine.
broken Hyplafin tablets.If finasteride is absorbed through the skin or ingested by a pregnant woman carrying a male fetus, the child may be born with deformed external genitalia. The tablets have a coating that protects against contact with finasteride, provided that the tablets are not crushed or broken.
In men treated with finasteride, infertility and poor semen quality have been reported. In some of these cases, other risk factors may have affected fertility. After discontinuation of finasteride, normalization or improvement of semen quality has been reported.
There is no evidence that Hyplafin affects the ability to drive and use machines.
If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which means that the medicine is essentially "sodium-free".
This medicine should always be taken exactly as advised by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet per day.
The tablet should be swallowed whole and not crushed or broken.
Hyplafin can be taken with or without food.
Immediately contact your doctor or go to the nearest hospital for advice.
Do not take a double dose to make up for a forgotten tablet. Take the next tablet as advised.
Although improvement in condition is often noticeable after a short period of treatment, the treatment should be continued for at least 6 months. Do not change the dose or stop taking the medicine without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Hyplafin and immediately contact your doctor if you experience any of the following symptoms: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing. These symptoms may be signs of an allergic reaction, including angioedema, which have been reported with an unknown frequency (frequency cannot be estimated from the available data).
Common (may affect up to 1 in 10 people)
Impotence, decreased libido, decreased semen volume (amount of semen).
Uncommon (may affect up to 1 in 100 people)
Breast tenderness, skin rash, breast enlargement, difficulty achieving ejaculation (semen discharge).
Frequency not known (frequency cannot be estimated from the available data)
Depression, testicular pain, blood in semen, impotence even after stopping Hyplafin, ejaculation disorders persisting after treatment, decreased libido persisting after treatment, infertility in men and (or) poor semen quality (improvement in semen quality has been reported after discontinuation of the medicine), itching, hives (blisters), irregular, intense heartbeat, increased liver enzyme activity, anxiety.
You should immediately inform your doctor if you experience any changes in breast tissue, such as: lumps, pain, enlargement of breasts or fluid discharge from the nipples, as they may be symptoms of a serious disease, such as breast cancer.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 representative of the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.
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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Hyplafin is a blue, round, biconvex tablet with the marking "F5".
The diameter of the tablet is 7 mm.
Blisters contain 10, 20, 30, 60, 100 tablets.
Not all pack sizes may be marketed.
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria
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
Bulgaria/Czech Republic/Poland
Hyplafin
Slovakia
Androfin 5 mg
Sweden
Finaset
Hungary
Redupros 5 mg filmtabletta
To obtain more detailed information on this medicine, please contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
phone: +48 12 262 32 36
e-mail: krakow@pluspharma.eu
Date of last revision of the leaflet: May 2024
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