Proscar 5 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
PROSCAR 5 mg film-coated tablets
finasteride
Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Proscar is and what it is used for
- What you need to know before taking Proscar
- How to take Proscar
- Possible side effects
- How to store Proscar
- Contents of the pack and other information
1. What Proscar is and what it is used for
Proscar is a 5-alpha reductase inhibitor that reduces prostate enlargement.
Your doctor has prescribed Proscar 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.
Proscar reduces the size of the enlarged prostate and relieves urinary symptoms: the need to urinate frequently, pain during urination, weak urine stream, and the sensation that the bladder has not emptied completely. Proscar reduces the need for surgical intervention.
2. What you need to know before taking Proscar
Do not take Proscar
- If you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
The condition for which Proscar is prescribed occurs only in men, so it must not be taken by women or children.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you start taking Proscar.
Inform your doctor about any current or past medical conditions and any allergies you may have.
Proscar is intended only for the treatment of BPH in men. Women must not use Proscar if they are or could be pregnant, and they should not be exposed to Proscar by handling crushed or broken tablets. If the active ingredient in Proscar 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 been exposed to the active ingredient in Proscar, she should consult her doctor. Proscar tablets are 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 trace amounts of the drug.
BPH develops over a long period of time. Sometimes symptoms improve quickly, but you may need to take Proscar for at least six months to determine whether your symptoms improve. Even if you do not feel improvement or a change in symptoms, treatment with Proscar 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 progress.
Although BPH is not cancer and does not cause cancer, both conditions can occur simultaneously. Only a doctor can evaluate symptoms and their possible causes.
Proscar may reduce 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 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 use in children.
Taking Proscar with other medicines
Proscar generally does not interact with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Proscar with food, drinks, and alcohol
Take one Proscar tablet daily, with or without food.
Pregnancy, breastfeeding, and fertility
Proscar is for use in men only.
Proscar 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
Proscar is unlikely to affect your ability to drive or operate machinery.
Proscar contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Proscar contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Proscar
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Proscar is a medicine taken by mouth. Take one Proscar tablet daily, with or without food.
Please remember that it took many years for your prostate to grow large enough to cause your symptoms. Proscar will only be able to treat your symptoms and control the disease if you continue taking 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, contact the Toxicology Information Service. Telephone: (91) 562 04 20. In addition, you must inform your doctor immediately.
If you forget to take Proscar
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, this medicine can cause adverse effects, although not everyone experiences them.
These are uncommon and do not occur in most cases. Adverse effects associated with Proscar include:
Immune system disorders
Frequency not known (cannot be estimated from available data): allergic-type reactions such as swelling of the lips, tongue, throat, 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, decreased sexual desire that continued after stopping treatment, anxiety, suicidal thoughts.
Cardiac disorders
Frequency not known (cannot be estimated from available data): irregular heartbeat.
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, hives.
Reproductive system 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 breasts, and problems with ejaculation.
Frequency not known (cannot be estimated from available data): testicular pain, blood in semen, inability to achieve an erection that continued after stopping treatment; problems with ejaculation that continued after stopping treatment; male infertility or poor semen quality. Improvement in semen quality has been reported after discontinuation of treatment.
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 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 condition, such as breast cancer.
In some cases, these side effects resolved even while the patient continued taking Proscar. When symptoms persisted, they usually resolved 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; or breathing difficulties.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 packaging.
Keep the container tightly closed to protect it from light and moisture.
Store below 30°C.
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 should 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 containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Proscar
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The active substance is finasteride. Each tablet contains 5 mg of finasteride.
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The other components (excipients) are:
Tablet core: lactose monohydrate, pregelatinized corn starch, sodium starch glycolate from potato, yellow iron oxide (E172), sodium docusate, purified water, microcrystalline cellulose and magnesium stearate.
Coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E171), talc, indigo carmine aluminum lake (E132) and purified water.
Appearance of the product and contents of the pack
Proscar is available in a pack of 28 tablets, in an aluminum-PVC calendar blister pack.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Date of the most recent review of this leaflet: July 2024.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)