PROSPECTO

FINASTERIDE ALMUS 5 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine, becauseit contains important information for you.

Keep this prospectus, as you may need to read it again.

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given 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 or nurse, even if they are not listed in this prospectus.

1. What Finasteride Almus 5 mg tablets are and for what they are used.

2.What you need to know before starting to take Finasteride Almus 5 mg tablets.

3. How to take Finasteride Almus 5 mg tablets.

4. Possible side effects

5. Storage of Finasteride Almus 5 mg tablets.

6.Contents of the package and additional information

Finasterida Almus are film-coated tablets containing 5 mg of finasteride as the active ingredient.

Your doctor has prescribed Finasterida Almus because you have a condition known as benign prostatic hyperplasia (BPH). BPH is a benign growth of the prostate gland in men after the age of 50.

Your prostate (located near your bladder) has enlarged and makes it difficult to pass urine. You may have symptoms such as a frequent need to urinate, especially at night, a feeling of urgency to urinate, difficulty starting to urinate, a weak or interrupted urine flow, or the feeling that your bladder is not fully emptied.

In some men, BPH can lead to serious problems such as urinary tract infections, acute urinary retention, and the need for surgical treatment. For this reason, a man with these symptoms should see a doctor.

Finasterida Almus belongs to a group of medicines known as type II 5α-reductase inhibitors. Finasteride causes regression of prostate growth. It may also reduce complications such as urinary retention or surgery.

BPH develops over a long period of time. Some patients may show rapid improvement of symptoms, but you may need to take Finasterida Almus for at least 6 months to see if your symptoms improve.

Do not take Finasterida Almus 5 mg tablets:

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

If you are a woman and are or may be pregnant (see pregnancy and breastfeeding).

Finasterida Almus is prescribed only for men. It should not be used in women or children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Finasterida Almus.

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

Finasterida Almus is only intended for the treatment of benign prostatic hyperplasia (BPH) in men.

Women should not use Finasterida Almus when they are or may be pregnant, nor should they be exposed to Finasterida Almus 5 mg tablets crushing or breaking (see pregnancy and breastfeeding).

If the active ingredient of Finasterida Almus 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 Finasterida Almus, she should consult her doctor. Finasterida Almus tablets are coated, which 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.

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 prolonged period of time. Sometimes symptoms improve immediately, but you may need to take Finasterida Almus for at least six months to see if your symptoms improve. Despite the fact that you may not feel any improvement or change in symptoms, Finasterida Almus 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 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 your symptoms and their possible causes.

Finasterida Almus 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 Finasterida Almus.

Mood changes and depression

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

Children and adolescents

Finasterida Almus is not indicated for children.

Taking Finasterida Almus with other medicinesNo clinically significant interactions have been found with the use of Finasterida Almus and other medicines, however, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Taking Finasterida Almus 5 mg tablets with food, drinks, and alcohol

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finasterida Almus is for exclusive use in men.

Finasterida Almus is not indicated for 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 this medicine.

Driving and operating machinery

No data suggest that Finasterida Almus affects the ability to drive or operate machinery.

Finasterida Almus 5 mg contains lactose

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor.

Take one Finasterida Almus tablet every day, with or without food.

If you take more Finasterida Almus than you should

If you have taken more Finasterida Almus than you should, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420. Additionally, you must inform your doctor immediately.

If you forgot to take Finasterida Almus:

Do not take a double dose to compensate for the missed doses, wait for the next scheduled dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects are classified as:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known (cannot be estimated from available data)

Immune system disorders

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

Mental health disorders

Common (may affect up to 1 in 10 patients): reduced libido.

Frequency not known (cannot be estimated from available data): depression, decreased libido that continued after stopping the medication, anxiety.

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 (cannot be estimated from available data):itching, urticaria.

Reproductive and mammary 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):breast swelling and increased sensitivity, ejaculation problems.

Frequency not known (cannot be estimated from available data):testicular pain, impotence that continued after stopping the medication; ejaculation problems that continued after stopping the medication, male infertility or poor semen quality. Semen quality improvement has been reported after stopping the medication.

Diagnostic procedures

Common (may affect up to 1 in 10 patients):decreased semen volume expelled during sexual intercourse.

This decrease in semen volume does not appear to alter normal sexual function.

You should inform your doctor immediately of any changes in breast tissue, such as lumps, pain, swelling, 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 Finasterida Almus. When symptoms persisted, they generally disappeared after stopping Finasterida Almus.

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 that does not appear in this leaflet. 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 medicine.

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

No special storage conditions are required. Keep in the original packaging.

Expiration Date:

Do not use this medication after the expiration date that appears on the packaging. 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

any unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Finasteride Almus 5 mg tablets

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

The other components (excipients) are:

Core: lactose monohydrate (106.4 mg), microcrystalline cellulose, sodium glycolate starch, pregelatinized cornstarch (gluten-free), sodium docusate, yellow iron oxide (E-172), magnesium stearate,

Coating: Opadry Y-117000 (Methylhydroxypropylcellulose, Titanium dioxide, Polyethylene glycol), indigotin (E-132).

Appearance of the product and contents of the packaging

Finasteride Almus is presented in the form of coated tablets with a blue film coating, round in shape. It is presented in packs of 28 tablets in single-dose aluminum-PVC blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal

Date of the last review of this leaflet: July 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ttp://www.aemps.es