Label: information for the user

PROSCAR 5 mg film-coated tablets

finasteride

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this label. See section 4.

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

Your doctor has prescribed Proscar 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.

Proscar reduces the size of the enlarged prostate and alleviates urinary symptoms: frequent need to urinate, pain while urinating, weak urine stream, sensation that the bladder has not been completely emptied.Proscar reduces the need for surgical intervention.

Do not take Proscar

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

This condition for which Proscar 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 Proscar.

Inform your doctor of your current and past medical conditions and any allergies you may have.

Proscar is only intended for the treatment of BPH in men. Women should not use Proscar when pregnant or could be pregnant, nor should they be exposed to Proscar by handling crushed or broken tablets. If the active ingredient of Proscar 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 Proscar, she should consult her doctor. Proscar 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 Proscar for at least six months to see if your symptoms improve. Even if you do not feel any improvement or change in symptoms, Proscar therapy may reduce the risk of not being able to urinate and therefore the need for surgery. You should visit your doctor regularly for periodic check-ups and to evaluate 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 your symptoms and their possible causes.

Proscar 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 Proscar.

Mood changes and depression

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

Children and adolescents

Proscar is not indicated for children.

Taking Proscar with other medications

Proscar usually does not interact with other medications.

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

Taking Proscar with food, drinks, and alcohol

Take one Proscar tablet a day, with or without food.

Pregnancy, breastfeeding, and fertility

Proscar is for exclusive use in men.

Proscar is not indicated for women.

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

Driving and operating machinery

Proscar should not affect your ability to drive or operate machinery.

Proscar contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Proscar contains sodium

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

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

Remember to take your medication.

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

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

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

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

If you take more Proscar than you should

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

If you forgot to take Proscar

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, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These are rare and do not appear in most cases. Among the side effects due to Proscar are:

Immune system disorders

Unknown frequency (cannot be estimated from available data): allergic reactions such as swelling of the lips, tongue, throat, and face.

Mental health disorders

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

Unknown frequency (cannot be estimated from available data): depression, decreased libido that continued after discontinuing the medication, anxiety, suicidal thoughts.

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.

Dermatological and subcutaneous tissue disorders

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

Unknown frequency (cannot be estimated from available data):itching, urticaria.

Reproductive and mammary disorders

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

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

Unknown frequency (cannot be estimated from available data):testicular pain, blood in semen, inability to achieve an erection that continued after discontinuing the medication; ejaculation problems that continued after discontinuing the medication, male infertility or poor semen quality. Semen quality improvement has been reported after discontinuing the medication.

Complementary examinations

Frequent (can affect up to 1in 10patients):decreased semen volume during sexual intercourse. This decrease in semen volume does not appear to alter normal sexual function.

You should immediately inform your doctor of any changes in breast tissue, such as lumps, pain, swelling, 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 Proscar. When symptoms persisted, they generally disappeared after discontinuing Proscar.

Stop taking Proscar and contact your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat; difficulty swallowing; hoarseness and difficulty breathing.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging.

Keep the container perfectly closed to protect it from light and moisture.

Store below 86°F (30°C).

Do not use this medication after the expiration date that appears on the container 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 containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Proscar

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

• The other components (excipients) are:

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

Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E171), talc, aluminum lake carmine (E132), and purified water.

Appearance of the product and contents of the packaging

Proscar is presented in a 28-tablet pack, in an aluminum-PVC calendar blister.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone:915911279

Responsible manufacturer:

Organon Heist bv

Industriepark30

2220Heist-op-den-Berg

Belgium

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Last review date of this leaflet:July2024.

The 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/)