Prospect: information for the user

Finasterida Qualigen5mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist or nurse.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this prospect.See section 4.

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

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

3. How to take Finasterida Qualigen

4. Possible adverse effects

5. Storage of Finasterida Qualigen

6. Contents of the pack and additional informationl

Finasterida Qualigen is a 5-alpha reductase inhibitor that reduces the enlargement of the prostate.

Your doctor has prescribed Finasterida Qualigen because you suffer 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.

Finasterida Qualigen reduces the size of the enlarged prostate and alleviates urinary symptoms: frequent need to urinate, painful urination, weak urine stream, sensation that the bladder has not been fully emptied. Finasterida Qualigen reduces the need for surgical intervention.

Do not take Finasterida Qualigen

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

This condition for which Finasterida Qualigen is prescribed only occurs in men, so women and children should not take it.

Warnings and precautions

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

Inform your doctor of your current and past medical problems and any allergies you may have. Finasterida Qualigen is only intended for the treatment of BPH in males. Women should not use Finasterida Qualigen when pregnant or could be pregnant, nor should they be exposed to Finasterida Qualigen when handling crushed or broken tablets. If the active ingredient of Finasterida Qualigen is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, the fetus may be born with abnormalities in its sexual organs. If the pregnant woman has come into contact with the active ingredient of Finasterida Qualigen, she should consult her doctor. Finasterida Qualigen tablets are coated, which will prevent contact with the active ingredient during normal handling, as long as 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 prolonged period of time. Sometimes symptoms improve right away, but you may need to take Finasterida Qualigen for at least six months to see if your symptoms improve. Even if you do not feel any improvement or change in symptoms, Finasterida Qualigen therapy 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 to assess your progress.

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

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

Mood changes and depression

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

Children and adolescents

Finasterida Qualigen is not indicated for children.

Other medications and Finasterida Qualigen

Finasterida Qualigen usually does not interact with other medications.

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Finasterida Qualigen and food, beverages, and alcohol

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

Pregnancy, breastfeeding, and fertility

Finasterida Qualigen is for exclusive use in males. Finasterida Qualigen is not indicated for women.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Finasterida Qualigen should not affect your ability to drive or operate machinery.

Finasterida Qualigen contains sodium and Sunset Yellow FCF

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

This medication may cause allergic reactions because it contains Sunset Yellow FCF. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Finasterida Qualigen is an oral medication. Take one Finasterida Qualigen tablet per day, with or without food.

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

Your doctor may prescribe Finasterida Qualigen along with another medication, called doxazosina, to help you better control your BPH.

If you estimate that the action of Finasterida Qualigen is too strong or too weak, inform your doctor or pharmacist.

If you take more Finasterida Qualigen than you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: (91) 562 04 20. Additionally, you must inform your doctor immediately.

If you forgot to take Finasterida Qualigen

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

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Finasterida Qualigen may cause side effects, although not everyone will experience them.

These are rare and do not occur in most cases. Among the side effects due to Finasterida Qualigen are:

Immune system disorders

Unknown frequency (cannot be estimated from available data): allergic reactions including swelling of the lips and face.

Mental health disorders

Frequent (may affect up to 1 in 10 patients): reduced libido.

Unknown frequency (cannot be estimated from available data): depression, anxiety.

Cardiac disorders

Unknown frequency (cannot be estimated from available data): irregular heart rate.

Hepatobiliary disorders

Unknown frequency (cannot be estimated from available data): elevated liver enzymes.

Skin and subcutaneous tissue disorders

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

Unknown frequency:itching, urticaria.

Reproductive and mammary disorders

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

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

Unknown frequency:testicular pain, inability to achieve an erection that continued after discontinuing the medication; male infertility or poor semen quality. Improved semen quality has been reported after discontinuing the medication.

Additional diagnostic tests

Frequent (may affect up to 1 in 10 patients):decreased semen volume during sexual intercourse. This decrease in semen volume does not appear to affect 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 disease, such as breast cancer.

In some cases, these side effects disappeared despite the patient continuing to take Finasterida Qualigen. When symptoms persisted, they generally disappeared after discontinuing Finasterida Qualigen.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use Finasterida Qualigen if visible signs of deterioration are observed.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Finasterida Qualigen

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

The other components (excipients) are:

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

Coating:Hydroxypropyl methylcellulose (E-464), titanium dioxide (E171), talc, propylene glycol (E-1520), aluminium lake carmine (E-132), quinoline yellow (E-104), and sunset yellow FCF (E-110).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer

Kleva, S.A.

Parnithos Ave, 189

Acharnai, Attiki 13671

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

Last review date of this leaflet: July 2018.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/