Finasteride Stada 5 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Finasterida Stada 5 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 or pharmacist.
- This medicine has been prescribed for you only, and you should 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Finasterida Stada is and what it is used for
- What you need to know before taking Finasterida Stada
- How to take Finasterida Stada
- Possible adverse effects
- How to store Finasterida Stada
- Contents of the pack and other information
1. What Finasteride Stada is and what it is used for
Finasteride is a 5-alpha reductase inhibitor that reduces prostate enlargement.
Your doctor has prescribed finasteride because you have a condition called benign prostatic hyperplasia. Your prostate, a gland located near the urinary bladder that produces the fluid in which sperm are transported, has increased in size and is making it difficult to pass urine.
Finasteride 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. Finasteride reduces the need for surgical intervention.
2. What you need to know before starting to take Finasteride Stada
Do not take Finasteride Stada
- If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or could be pregnant, Finasteride Stada is not indicated for use in women. Special caution is required in women who are or may be pregnant and who are likely to handle Finasteride Stada (see "Pregnancy, breastfeeding and fertility").
The condition for which finasteride is prescribed occurs only in men; therefore, women and children must not take it.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take finasteride.
Inform your doctor about any current or past medical conditions and any allergies you may have.
Finasteride is intended only for the treatment of benign prostatic hyperplasia in men. Women must not use finasteride if they are or could be pregnant, nor should they be exposed to finasteride by handling crushed or split tablets. If the active substance finasteride 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 substance finasteride, she must consult her doctor. Finasteride tablets are coated, which prevents contact with the active substance during normal handling, provided the tablets are not crushed or broken. If you have any doubts, ask your doctor.
Benign prostatic hyperplasia develops over a long period of time. Sometimes symptoms improve quickly, but you may need to take finasteride for at least six months to determine whether your symptoms improve. Even if you do not feel any improvement or change in symptoms, treatment with finasteride may reduce the risk of being unable to pass urine and thus the need for surgery. You should visit your doctor regularly for periodic check-ups and assessment of your progress.
Although benign prostatic hyperplasia is not cancer and does not cause cancer, both conditions may coexist. Only a doctor can evaluate symptoms and their possible causes.
Finasteride 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.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with 5 mg finasteride. If you experience any of these symptoms, consult your doctor as soon as possible.
Children and adolescents
Finasteride is not indicated for use in children.
Other medicines and Finasteride Stada
Finasteride does not usually interact with other medicines. However, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Finasteride Stada with food and drink
Take one finasteride tablet daily, with or without food.
Pregnancy, breastfeeding and fertility
Finasteride is for use in men only.
Finasteride is not indicated for use in women.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
Women who are or may be pregnant must not handle crushed or split finasteride tablets due to the potential for absorption of finasteride and the consequent potential risk to a male fetus. Finasteride tablets are coated, which prevents contact with the active substance during normal handling, provided the tablets are not split or crushed.
Driving and using machines
Finasteride is not expected to affect your ability to drive or operate machinery.
Finasteride Stada contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".
3. How to take Finasterida Stada
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose is one tablet daily (equivalent to 5 mg of finasteride).
The tablets may be taken either on an empty stomach or with food. The tablets should be swallowed whole and must not be split or crushed.
Although improvement may be observed in a short period, treatment for at least 6 months may be required to determine whether a satisfactory response has been achieved.
Your doctor will determine the duration of treatment with this medicine. Do not stop treatment prematurely, as symptoms may recur.
- Patients with hepatic impairment
There is no experience with the use of finasteride in patients with liver disorders (see also “Warnings and precautions”).
- Patients with renal impairment
Dose adjustment is not necessary. The use of finasteride in patients requiring hemodialysis has not yet been studied.
- Elderly patients
Dose adjustment is not necessary.
Consult your doctor or pharmacist if you think the effect of this medicine is too strong or too weak.
If you take more Finasterida Stada than you should
If you have taken more Finasterida Stada than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: (91) 562 04 20, stating the medicine and the amount taken.
If you forget to take Finasterida Stada
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 a missed dose.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
These are uncommon and do not occur in most cases. Adverse effects due to finasteride include:
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): ejaculation disorders, swelling and increased sensitivity in the breast, and breast enlargement.
Frequency not known (cannot be estimated from available data): testicular pain, persistent difficulty in achieving an erection that continued after stopping the medication; ejaculation problems that continued after stopping the medication, male infertility or poor semen quality.
You should immediately inform your doctor of any changes in breast tissue, such as lumps, pain, breast tissue growth, or nipple discharge, as these may be signs of a serious illness, such as breast cancer.
Additional tests
Common (may affect up to 1 in 10 patients): decreased volume of semen released during sexual activity. This reduction in semen volume does not appear to affect normal sexual function.
Psychiatric disorders
Common (may affect up to 1 in 10 patients): reduced sexual desire.
Frequency not known (cannot be estimated from available data): depression, reduced sexual desire that continued after stopping the medication, 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): skin rash.
Frequency not known: pruritus, urticaria
Immune system disorders
Frequency not known (cannot be estimated from available data): allergic-type reactions including swelling of the lips and face and itching.
Stop taking finasteride and inform your doctor immediately if you experience any symptoms of angioedema (frequency not known, cannot be estimated from available data), such as swelling of the face, lips, tongue, or throat; difficulty swallowing; lumps under the skin (hives), and breathing difficulties.
In some cases, these adverse effects disappeared even while the patient continued taking finasteride. When symptoms persisted, they usually resolved after stopping finasteride.
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 leaflet. You may also report them directly through 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 Finasteride Stada
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Finasteride Stada after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Finasterida Stada
The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other components (excipients) are:
Tablet core: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl starch (type A) (from potato), magnesium stearate (E470b).
Coating: hypromellose, microcrystalline cellulose, polyglycol 8 stearate.
Appearance of the product and contents of the pack
Finasterida Stada is presented in an aluminum calendar blister pack.
The tablets are white and round. Each pack contains 28 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
or
Siegfried Malta Ltd.
HHF070 Hal Far Industrial Estate
Hal Far BBG3000
Malta
or
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
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 Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es/