FINASTERIDE QUALIGEN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride Qualigen5mg film-coated tablets EFG

Read this leaflet carefully before you start 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 or pharmacist or nurse.
• 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, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Finasteride Qualigen and what is it used for

Finasteride Qualigen is a 5-alpha reductase inhibitor that reduces the size of an enlarged prostate.

Your doctor has prescribed Finasteride Qualigen because you are suffering from a condition called benign prostatic hyperplasia (BPH). Your prostate, a gland located near the urinary bladder that produces a fluid in which sperm are transported, has increased in size and makes it difficult to urinate.

Finasteride Qualigen decreases the size of the enlarged prostate and relieves urinary symptoms: frequent need to urinate, pain while urinating, weak stream of urine, feeling that the bladder is not completely empty. Finasteride Qualigen reduces the need for surgical intervention.

2. What you need to know before you take Finasteride Qualigen

Do not take Finasteride Qualigen

If you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).

The disorder for which Finasteride Qualigen is prescribed only occurs in men, so women and children should not take it.

Warnings and precautions

Consult your doctor or pharmacist or nurse before taking Finasteride Qualigen.

Tell your doctor about your current and past medical problems and any allergies you suffer from. Finasteride Qualigen is only intended for the treatment of BPH in men. Women should not use Finasteride Qualigen when they are or may be pregnant, nor should they be exposed to Finasteride Qualigen by handling crushed or broken tablets. If the active ingredient of Finasteride Qualigen is absorbed after oral use or through the skin by a woman who is pregnant with a male fetus, the fetus may be born with abnormalities of the genital organs. If a pregnant woman comes into contact with the active ingredient of Finasteride Qualigen, she should consult a doctor. The tablets of Finasteride Qualigen are film-coated and this will prevent contact with the active ingredient during normal handling, provided that the tablets are not crushed or broken. If you have any doubts, ask your doctor.

If your sexual partner is or may be pregnant, you should avoid exposing her to your semen as it may contain minimal amounts of the drug.

BPH develops over a long period of time. Sometimes the symptoms improve quickly, but you may need to take Finasteride Qualigen for at least six months to see if your symptoms improve. Even if you do not feel any improvement or change in symptoms, therapy with Finasteride Qualigen may reduce the risk of not being able to urinate and therefore the need for surgery. You should see your doctor regularly for periodic check-ups and to assess your progress.

Although BPH is not cancer and does not cause cancer, both conditions can exist at the same time. Only a doctor can evaluate the symptoms and their possible causes.

Finasteride Qualigen may decrease the levels of prostate-specific antigen (PSA, a substance in the body that increases when the prostate grows and may cause obstruction). If you have had a PSA test, tell your doctor that you are taking Finasteride Qualigen.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Qualigen. If you experience any of these symptoms, consult your doctor as soon as possible.

Children and adolescents

Finasteride Qualigen is not indicated in children.

Other medicines and Finasteride Qualigen

Finasteride Qualigen does not usually interact with other medicines.

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Taking Finasteride Qualigen with food and drinks and alcohol

Take one Finasteride Qualigen tablet a day, with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride Qualigen is for use in men only. Finasteride Qualigen is not indicated in women.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Finasteride Qualigen is unlikely to affect your ability to drive or use machines.

Finasteride Qualigen contains sodium and orange yellow S

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

This medicine may cause allergic reactions because it contains orange yellow S. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Finasteride Qualigen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Finasteride Qualigen is a medicine that is taken orally. Take one Finasteride Qualigen tablet a day, with or without food.

Remember that your prostate took many years to grow enough to cause symptoms. Finasteride Qualigen will only be able to treat your symptoms and control the disease if you continue to take it long-term.

Your doctor may prescribe Finasteride Qualigen along with another medicine, called doxazosin, to help you better control your BPH.

If you think the effect of Finasteride Qualigen is too strong or too weak, tell your doctor or pharmacist.

If you take more Finasteride Qualigen than you should

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: (91) 562 04 20. You should also inform your doctor immediately.

If you forget to take Finasteride Qualigen

If you forget to take a dose, do not take an extra dose; just take the next tablet as usual.

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, Finasteride Qualigen can cause side effects, although not everybody gets them.

These are uncommon and do not occur in most cases. The side effects due to Finasteride Qualigen include:

Immune system disorders

Frequency not known (cannot be estimated from the available data): allergic reactions including swelling of the lips and face.

Psychiatric disorders

Common (may affect up to 1 in 10 patients): decreased libido.

Frequency not known (cannot be estimated from the available data): depression, anxiety.

Cardiac disorders

Frequency not known (cannot be estimated from the available data): irregular heart rate.

Hepatobiliary disorders

Frequency not known (cannot be estimated from the available data): elevated liver enzymes.

Skin and subcutaneous tissue disorders

Uncommon (may affect up to 1 in 100 patients): skin rash

Frequency not known (cannot be estimated from the available data): itching, urticaria.

Reproductive system and breast disorders

Common (may affect up to 1 in 10 patients): impotence (inability to have an erection).

Uncommon (may affect up to 1 in 100 patients): breast tenderness and enlargement, and problems with ejaculation.

Frequency not known (cannot be estimated from the available data): testicular pain, inability to have an erection that continued after stopping the medication; male infertility or poor semen quality. An improvement in semen quality has been reported after stopping the medication.

Investigations

Common (may affect up to 1 in 10 patients): decrease in the amount of semen released during sex. This decrease in semen amount does not seem to affect normal sexual function.

You should immediately inform your doctor of any change in breast tissue, such as lumps, pain, enlargement, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

In some cases, these side effects disappeared even though the patient continued to take Finasteride Qualigen. When the symptoms persisted, they usually disappeared after stopping Finasteride Qualigen.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Qualigen

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Finasteride Qualigen if you notice visible signs of deterioration.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Finasteride Qualigen

The active substance is finasteride. Each tablet contains 5 mg of finasteride.

The other ingredients (excipients) are:

Core of the tablet: microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate, yellow iron oxide (E172), sodium docusate, magnesium stearate, and purified water.

Coating: hypromellose (E-464), titanium dioxide (E171), talc, propylene glycol (E-1520), aluminum lake carmine indigo (E-132), quinoline yellow (E-104), orange yellow S (E-110).

Appearance of the product and pack contents

Finasteride Qualigen 5 mg film-coated tablets are presented in the form of film-coated tablets. The tablets are light blue, round, biconvex, and scored on one side.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Kleva, S.A.

Parnithos Ave, 189

Acharnai, Attiki 13671

Greece

Pharmathen, S.A.

Dervenakion, 6

Pallini 15351

Attiki

Greece

Pharmathen International, S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Famar, S.A.

7, Anthoussa Ave.

15344 Anthoussa

Greece

Date of last revision of this leaflet: July 2018.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/