Finasteride Qualigen 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Finasteride Qualigen 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Finasteride Qualigen is a 5-alpha reductase inhibitor that reduces prostate enlargement.

Your doctor has prescribed Finasteride Qualigen because you have 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 is making it difficult to pass urine.

Finasteride Qualigen reduces the size of the enlarged prostate and relieves urinary symptoms: the need to urinate frequently, pain when urinating, weak urine stream, and the sensation that the bladder has not emptied completely. Finasteride Qualigen reduces the need for surgical intervention.

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

Do not take Finasteride Qualigen

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

The condition for which Finasteride Qualigen is prescribed occurs only in men, so it must not be taken by women or children.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Finasteride Qualigen.

Inform your doctor about any current or past medical conditions and any allergies you may have. Finasteride Qualigen is intended only for the treatment of benign prostatic hyperplasia (BPH) in men. Women must not use Finasteride Qualigen if they are or could be pregnant, nor should they be exposed to Finasteride Qualigen by handling crushed or split tablets. If the active ingredient in Finasteride Qualigen is absorbed orally 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 has come into contact with the active ingredient in Finasteride Qualigen, she should consult her doctor. Finasteride Qualigen tablets are film-coated, which prevents contact with the active ingredient during normal handling, provided the tablets are not crushed or broken. If you have any doubts, ask your doctor.

If your sexual partner is or could 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 symptoms improve quickly, but you may need to take Finasteride Qualigen for at least six months to determine whether your symptoms improve. Even if you do not feel improvement or changes in symptoms, treatment with Finasteride Qualigen may reduce the risk of being unable to urinate and therefore the need for surgery. You should visit your doctor regularly for periodic check-ups and evaluation of your condition.

Although BPH is neither cancer nor does it cause cancer, both conditions can coexist. Only a doctor can evaluate symptoms and their possible causes.

Finasteride Qualigen may decrease levels of prostate-specific antigen (PSA—a substance in the body that increases when the prostate enlarges 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 for use in children.

Other medicines and Finasteride Qualigen

Finasteride Qualigen is not usually associated with interactions with other medicines.

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

Taking Finasteride Qualigen with food and drink and alcohol

Take one Finasteride Qualigen tablet daily, with or without food.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Finasteride Qualigen is unlikely to affect your ability to drive or operate machinery.

Finasteride Qualigen contains sodium and sunset yellow FCF (E110)

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

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Finasteride Qualigen

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

Remember to take your medicine.

Finasteride Qualigen is a medicine taken by mouth. Take one Finasteride Qualigen tablet daily, with or without food.

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

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

If you think that 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, contact the Toxicology Information Service. Telephone: (91) 562 04 20. Additionally, you must inform your doctor immediately.

If you forget to take Finasteride Qualigen

If you forget to take a dose, do not take a double dose; simply take the next tablet as usual.

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

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

4. Possible adverse effects

Like all medicines, Finasteride Qualigen may produce adverse effects, although not everyone experiences them.

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

Immune system disorders

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

Psychiatric disorders

Common (may affect up to 1 in 10 patients): reduced sexual desire.

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

Cardiac disorders

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

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

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

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

Reproductive and breast disorders

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

Uncommon (may affect up to 1 in 100 patients): swelling and increased sensitivity in the breast, and problems with ejaculation.

Frequency not known (cannot be estimated from available data): testicular pain, persistent inability to achieve an erection after discontinuation of the medication; male infertility or poor semen quality. Improvement in semen quality has been reported after discontinuation of the medication.

Investigations

Common (may affect up to 1 in 10 patients): decreased volume of semen ejaculated during sexual activity. This reduction in semen volume does not appear to interfere with normal sexual function.

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

In some cases, these side effects resolved even while the patient continued taking Finasteride Qualigen. When symptoms persisted, they usually resolved after stopping Finasteride Qualigen.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 any visible signs of deterioration.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Finasterida Qualigen

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

The other components (excipients) are:

Tablet core: microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate from potato, yellow iron oxide (E172), docusate sodium, magnesium stearate, and purified water.

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

Appearance of the product and contents of the pack

Finasterida Qualigen 5 mg tablets are film-coated tablets. The tablets are light blue, round, biconvex, and scored on one side.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Kleva Pharmaceuticals, S.A.

Parnithos Ave, 189

Acharnai, Attiki 13675

Greece

Pharmathen, S.A.

Dervenakion, 6

Pallini 15351

Attiki

Greece

Pharmathen Internacional, S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Famar, S.A.

7, Anthoussa Ave.

15344 Anthoussa

Greece

Date of the most recent review of this leaflet: September 2025.

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