Leaflet: information for the patient

Finasteride Stada 5 mg film-coated tablets EFG

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

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

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

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

3. How to take Finasteride Stada

4. Possible side effects

5. Storage of Finasteride Stada

6. Contents of the pack and additional information

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

Your doctor has prescribed finasterida because you suffer 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 expel urine.

Finasterida 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. Finasterida reduces the need for surgical intervention.

Do not take Finasterida Stada

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are pregnant or could be pregnant, Finasterida Stada is not indicated for use inwomen. Special care is required in women who are or may be pregnant and who are likely to handle Finasterida Stada (see “Pregnancy, lactation, and fertility”).

The condition for which finasteride 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 finasteride.

Inform your doctor of your current and past medical problems and any allergies you suffer.

Finasteride is only intended 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 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 finasteride, she should consult her doctor. Finasteride tablets are coated and this 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.

Benign prostatic hyperplasia develops over a prolonged period of time. Sometimes symptoms improve immediately, but you may need to take finasteride for at least six months to see if your symptoms improve. Although you may not feel any improvement or change in symptoms, finasteride therapy 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 to evaluate your progress.

Although benign prostatic hyperplasia is not cancer and does not cause cancer, the two conditions can exist at the same time. Only a doctor can evaluate your symptoms and their possible causes.

Finasteride 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 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, consult your doctor as soon as possible.

Children and adolescents

Finasteride is not indicated in children.

Other medications and Finasterida Stada

Finasteride usually does not interact with other medications. However, inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

Taking Finasterida Stada with food and drinks

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

Pregnancy, lactation, and fertility

Finasteride is for exclusive use in males.

Finasterideis notindicated in women.

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

Women who are or may be pregnantshould not handlecrushed or broken finasteride tablets, due to the possible absorption of finasteride and the potential risk to the male fetus. Finasteride tablets have a coating that prevents contact with the active ingredient when handled normally, as long as the tablets are not crushed or broken.

Driving and operating machinery

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

Finasterida Stada contains lactose and sodium

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

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

Always take this medication exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.

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

Tablets can be taken either with an empty stomach or with a meal. Tablets should be swallowed whole and not divided or crushed.

Although improvement may be noticed in a short period, it may be necessary to continue treatment for at least 6 months to determine if a satisfactory response has been achieved.

Your doctor will inform you of the duration of treatment with this medication. Do not discontinue treatment prematurely, as symptoms may recur.

• Patients withliver insufficiency

No experience exists with the use of finasteride in patients with liver disorders (see also “Warnings and precautions”)

• Patients withrenal insufficiency

No dose adjustment is necessary. Finasteride has not yet been studied in patients requiring hemodialysis.

• Patients of advanced age

No dose adjustment is necessary.

Consult your doctor or pharmacist if you feel that the effect of this medication 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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: (91) 562 04 20, indicating the medication and the amount taken.

If you forget to take Finasterida Stada

If you forget to take a dose, do not take an extra dose; simply take the next tablet as usual.

Do not take a double dose to compensate for missed doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Reproductive system and breast disorders

Frequent(may affect up to 1 in 10patients): impotence (impossibility of having an erection)

Infrequent(may affect up to 1 in 100 patients): disorders of ejaculation, swelling and increased sensitivity in the chest and breast growth.

Unknown frequency (cannot be estimated from available data): pain in the testicles, persistent difficulty having an erection that continued after suspending the medication; problems with ejaculation that continued after suspending the medication, male infertility or poor semen quality.

You should immediately inform your doctor of any change in breast tissue, such as lumps, pain, breast tissue growth or nipple secretion, as these may be signs of a serious disease, such as breast cancer.

Additional investigations

Frequent (may affect up to 1 in 10 patients):decrease in the amount of semen expelled during sexual intercourse. This decrease in semen volume does not appear to alter normal sexual function.

Psychiatric disorders

Frequent(may affect up to 1 in 10 patients): reduced sexual desire.

Unknown frequency (cannot be estimated from available data): depression, reduced sexual desire that continued after suspending the medication, anxiety.

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

Infrequent(may affect up to 1 in 100 patients): skin rash.

Unknown frequency: pruritus, urticaria

Immune system disorders

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

Stop taking finasteride and immediately inform your doctor if you experience any of the symptoms of angioedema (unknown frequency, cannot be estimated from 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 adverse effects disappeared despite the patient continuing to take finasteride. When symptoms persisted, they generally disappeared after stopping finasteride.

Reporting 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 Pharmacovigilance 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 medication.

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

This medication does not require special storage conditions.

Do not use Finasterida Stada after the expiration date indicated on the packagingafter 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 the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finasterida Stada

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

The other components (excipients) are:

Tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, carboxymethylcellulose sodium (type A) (from potato), magnesium stearate (E470b).

Covering: hypromellose, microcrystalline cellulose, macrogol 8 stearate.

Appearance of the product and contents of the package

Finasterida Stada is presented in an aluminum calendar blister.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing

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

Last review date of this leaflet:May 2024

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/