PROSCAR 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

PROSCAR 5 mg film-coated tablets

finasteride

Read all of 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 signs of illness are the same as yours.
• If you get 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 pack

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

1. What is Proscar and what is it used for

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

Your doctor has prescribed Proscar 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.

Proscar 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. Proscar reduces the need for surgical intervention.

2. What you need to know before you take Proscar

Do not take Proscar

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

The disorder for which Proscar 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 starting to take Proscar.

Tell your doctor about your current and past medical problems and any allergies you suffer from.

Proscar is only intended for the treatment of BPH in men. Women should not use Proscar when they are or may 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 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 Proscar, she should consult her doctor. The tablets of Proscar 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 soon, 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, therapy with Proscar 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.

Proscar may decrease the levels of 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 in children.

Taking Proscar with other medicines

Proscar is not expected to interact with other medicines.

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

Taking Proscar with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Proscar is for use in men only.

Proscar 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

Proscar is unlikely to affect your ability to drive or use machines.

Proscar contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Proscar contains sodium

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

3. How to take Proscar

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.

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

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

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

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

If you take more Proscar than you should

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

If you forget to take Proscar

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 other questions about the use of this medicine, ask your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Immune system disorders

Frequency not known (cannot be estimated from the available data): allergic reactions such as swelling of the lips, tongue, throat, 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, decreased libido that continued after stopping the medication, anxiety, suicidal thoughts.

Cardiac disorders

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

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, blood in the semen, impotence that continued after stopping the medication; problems with ejaculation that continued after stopping the medication, male infertility or poor semen quality. 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 sexual intercourse. This decrease in the amount of semen 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 despite the patient continuing to take Proscar. When the symptoms persisted, they usually disappeared after stopping 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; hives and difficulty breathing.

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 http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Proscar

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

Store in the original package.

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

Do not store above 30°C.

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

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 Proscar

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

• The other ingredients (excipients) are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, 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 indigo (E132), and purified water.

Appearance and packaging of the product

Proscar is available in packs of 28 tablets, in a calendar blister pack of aluminum-PVC.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Date of last revision of this leaflet:July 2024.

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/)