HYPLAFIN 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Hyplafin
3. 5 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Hyplafin and what is it used for
5. Important information before taking Hyplafin
   1. When not to take Hyplafin
   2. Warnings and precautions
   3. Mood changes and depression
   4. Hyplafin with other medicines
   5. Hyplafin with food and drink
   6. Pregnancy, breastfeeding and fertility
   7. Women who are pregnant or may become pregnant should not handle crushed or
   8. Driving and using machines
   9. Hyplafin contains lactose and sodium
6. How to take Hyplafin
   1. Overdose of Hyplafin
   2. Missed dose of Hyplafin
   3. Stopping treatment with Hyplafin
7. Possible side effects
   1. Reporting side effects
8. How to store Hyplafin
9. Contents of the pack and other information
   1. What Hyplafin contains
   2. What Hyplafin looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Hyplafin

5 mg, film-coated tablets

Finasteride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Hyplafin and what is it used for
• 2. Important information 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 is Hyplafin and what is it used for

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.

2. Important information before taking Hyplafin

When not to take Hyplafin

• if you are 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 taking Hyplafin, discuss with your doctor or pharmacist:

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

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.

Mood changes and depression

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 with other medicines

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 with food and drink

Hyplafin can be taken with or without food.

Pregnancy, breastfeeding and fertility

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.

Women who are pregnant or may become pregnant should not handle crushed or

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.

Driving and using machines

There is no evidence that Hyplafin affects the ability to drive and use machines.

Hyplafin contains lactose and sodium

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".

3. How to take Hyplafin

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.

Overdose of Hyplafin

Immediately contact your doctor or go to the nearest hospital for advice.

Missed dose of Hyplafin

Do not take a double dose to make up for a forgotten tablet. Take the next tablet as advised.

Stopping treatment with Hyplafin

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.

4. Possible side effects

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.

Reporting side effects

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.

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 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.

6. Contents of the pack and other information

What Hyplafin contains

• The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
• The other ingredients of the tablet core are: lactose monohydrate, microcrystalline cellulose, maize starch, lauryl macrogolglycerides, sodium carboxymethylcellulose (type A), magnesium stearate. The tablet coating contains: hypromellose, macrogol 6000, titanium dioxide (E 171), indigo carmine (E 132), lak.

What Hyplafin looks like and contents of the pack

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.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

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: [email protected]
Date of last revision of the leaflet: May 2024