FINASTERIDE ALMUS 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET

FINASTERIDE ALMUS 5 mg film-coated tablets EFG

Read all of this 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.

• Keep this leaflet, as 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

1. What is Finasteride Almus 5 mg film-coated tablets and what is it used for

Finasteride Almus is a film-coated tablet that contains 5 mg of finasteride as the active ingredient.

Your doctor has prescribed Finasteride Almus because you have a condition known as benign prostatic hyperplasia (BPH). BPH is a non-cancerous enlargement of the prostate that is common in men over 50 years of age.

Your prostate (located near your bladder) has become enlarged and is obstructing the flow of urine. You may have symptoms such as frequent need to urinate, especially at night, a sense of urgency to urinate, difficulty starting to urinate, a weak or interrupted stream of urine, or the feeling that you have not completely emptied your bladder.

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

Finasteride Almus belongs to a group of medicines known as 5α-reductase inhibitors of type II. Finasteride causes the prostate to shrink. It may also reduce the risk of complications such as urinary retention or the need for surgery.

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

2. What you need to know before you take Finasteride Almus 5 mg film-coated tablets

Do not take Finasteride Almus 5 mg film-coated 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 lactation).

Finasteride Almus is prescribed only for men. It must not be taken by women or children.

Warnings and precautions

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

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

Finasteride Almus is intended only for the treatment of benign prostatic hyperplasia in men.

Women must not use Finasteride Almus when they are or may be pregnant, nor should they be exposed to Finasteride Almus 5 mg film-coated tablets by handling crushed or broken tablets (see pregnancy and lactation).

If the active ingredient of Finasteride Almus 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 of Finasteride Almus, she should consult a doctor. The tablets of Finasteride Almus are film-coated, which 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.

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 long period of time. Sometimes the symptoms improve quickly, but you may need to take Finasteride Almus for at least six months to check if your symptoms improve. Even if you do not feel any improvement or change in symptoms, treatment with Finasteride Almus 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 BPH is not cancer and does not cause cancer, both conditions can exist at the same time.

Only a doctor can assess the symptoms and their possible causes.

Finasteride Almus 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 Almus.

Mood changes and depression

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

Children and adolescents

Finasteride Almus is not indicated in children.

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

Taking Finasteride Almus 5 mg film-coated tablets with food, drinks, and alcohol

The tablets can be taken with or without food.

Pregnancy, lactation, and fertility

Finasteride Almus is for use in men only.

Finasteride Almus is not indicated in women.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

There are no data to suggest that Finasteride Almus affects the ability to drive or use machines.

Finasteride 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; this is essentially "sodium-free".

3. How to take Finasteride Almus 5 mg film-coated tablets

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, ask your doctor.

Take one Finasteride Almus tablet each day, with or without food.

If you take more Finasteride Almus than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone: 91 562 0420. Also, you should inform your doctor immediately.

If you forget to take Finasteride Almus:

Do not take a double dose to make up for forgotten doses, wait for the next dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The effects are classified as:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

Frequency not known (cannot be estimated from the available data)

Immune system disorders

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

Psychiatric disorders

Common (may affect up to 1 in 10 people): decreased libido.

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

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 people): skin rash

Frequency not known (cannot be estimated from the available data): itching, urticaria.

Reproductive system and breast disorders

Common (may affect up to 1 in 10 people): impotence (inability to have an erection).

Uncommon (may affect up to 1 in 100 people): breast tenderness and enlargement and problems with ejaculation.

Frequency not known (cannot be estimated from the available data): testicular pain, inability to have an erection that continued after stopping the medication; problems with ejaculation that continued after stopping the medication, male infertility or poor semen quality. Improvement in semen quality has been reported after stopping the medication.

Investigations

Common (may affect up to 1 in 10 people): decreased semen volume.

You should inform your doctor immediately of any change 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 disappeared despite the patient continuing to take Finasteride Almus. When the symptoms persisted, they usually disappeared after stopping Finasteride Almus.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance 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 Almus 5 mg film-coated tablets

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

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

Expiry date:

Do not use this medicine after the expiry date which is stated on the carton. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Almus 5 mg film-coated tablets

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

The other ingredients (excipients) are:

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

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

Appearance of the product and pack contents

Finasteride Almus is presented as film-coated tablets, blue and round. It is presented in packs of 28 tablets in aluminum-PVC unit dose blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Tecnimede - Sociedade Técnico Medicinal, S.A.

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

Date of last revision of this leaflet: July 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es