FINASTERIDE STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Finasteride Stada 5 mg Film-Coated Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Finasteride Stada and what is it used for

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

Your doctor has prescribed finasteride because you are suffering from a condition called benign prostatic hyperplasia. 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.

Finasteride decreases the size of the enlarged prostate and relieves urinary symptoms: the need to urinate frequently, pain when urinating, weak stream of urine, feeling that the bladder is not completely empty. Finasteride reduces the need for surgical intervention.

2. What you need to know before you take Finasteride Stada

Do not take Finasteride Stada

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or may be pregnant, Finasteride Stada is not indicated for use in women. Special care is required in women who are or may be pregnant and are likely to handle Finasteride Stada (see "Pregnancy, breast-feeding and fertility").

The disorder for which finasteride is prescribed only occurs in men, so women and children should not take it.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start taking finasteride.

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

Finasteride is intended only for the treatment of benign prostatic hyperplasia in males. Women should not use finasteride when they are or may be pregnant, nor should they be exposed to finasteride by handling crushed or broken tablets. If the active ingredient finasteride 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 finasteride, she should consult a doctor. The tablets of finasteride 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.

Benign prostatic hyperplasia develops over a long period of time. Sometimes the symptoms improve quickly, but you may need to take finasteride 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 finasteride may reduce the risk of not being able to urinate and therefore the need for surgery. You should see your doctor regularly so that he can perform periodic check-ups and assess your progress.

Although benign prostatic hyperplasia 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.

Finasteride 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 finasteride.

Mood changes and depression

Mood changes, such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with finasteride 5 mg. If you experience any of these symptoms, talk to your doctor as soon as possible.

Children and adolescents

Finasteride is not indicated in children.

Other medicines and Finasteride Stada

Finasteride does not usually interact with other medicines. However, tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Taking Finasteride Stada with food and drinks

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

Pregnancy, breast-feeding and fertility

Finasteride is for use in males only.

Finasteride is not indicated in women.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women or women who may be pregnant should not handlecrushed or broken finasteride tablets, due to the possible absorption of finasteride and the potential risk to the male fetus. The tablets of finasteride have a coating that prevents contact with the active ingredient when handled normally, provided that the tablets are not crushed or broken.

Driving and using machines

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

Finasteride Stada contains lactose and sodium

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

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

3. How to take Finasteride Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual dose is one tablet a day (equivalent to 5 mg of finasteride).

The tablets can be taken with or without food. The tablets should be swallowed whole and not divided or crushed.

Although an improvement can be seen in a short period of time, it may be necessary to take finasteride for at least 6 months to determine if a satisfactory response has been obtained.

Your doctor will tell you how long to take this medicine. Do not stop taking it before then, as your symptoms may come back.

• Patients withliverimpairment

There is no experience with the use of finasteride in patients with liver disorders (see also "Warnings and precautions").

• Patients withrenalimpairment

No dose adjustment is necessary. The use of finasteride has not been studied in patients who require hemodialysis.

• Elderly patients

No dose adjustment is necessary.

Ask your doctor or pharmacist if you think the effect of this medicine is too strong or too weak.

If you take more Finasteride Stada than you should

If you have taken more Finasteride Stada than you should, talk to a doctor, pharmacist or call the Toxicology Information Service, telephone: (91) 562 04 20, stating the medicine and the amount taken.

If you forget to take Finasteride Stada

If you forget to take a dose, do not take a double dose to make up for the forgotten dose. Just take the next dose as usual.

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. The side effects due to finasteride include:

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): ejaculation disorders, swelling and increased sensitivity of the breast and breast enlargement.

Frequency not known (cannot be estimated from the available data): testicular pain, persistent difficulty in having 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 enlargement or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

Investigations

Common(may affect up to 1 in 10 patients): decreased semen volume. This decrease in semen volume does not seem to affect normal sexual function.

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 heart rate.

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: pruritus, urticaria

Immune system disorders

Frequency not known (cannot be estimated from the available data): allergic reactions including swelling of the lips and face and itching.

Stop taking finasteride and inform your doctor immediately if you experience any of the symptoms of angioedema (frequency not known, cannot be estimated from the available data) such as swelling of your face, lips, tongue or throat; difficulty swallowing; lumps under the skin (hives) and difficulty breathing.

In some cases, these side effects disappeared despite the patient continuing to take finasteride. When the symptoms persisted, they usually disappeared after stopping finasteride.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: http://www.notificaram.es. By reporting side 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 is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Stada

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

The other ingredients (excipients) are:

Core of the tablet: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate (E470b).

Coating: hypromellose, microcrystalline cellulose, macrogol 8 stearate.

Appearance of the product and pack contents

Finasteride Stada is presented in a calendar blister pack of aluminum.

The tablets are white and round. Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

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 last revision of this package leaflet:September 2025

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/