Leaflet: information for the user

Finasteride Tarbis 5 mg film-coated tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms to yours, 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 Tarbis is and what it is used for

2. What you need to know before you start taking Finasteride Tarbis

3. How to take Finasteride Tarbis

4. Possible side effects

5. Storage of Finasteride Tarbis

6. Contents of the pack and additional information

This medication contains the active ingredient finasteride, which belongs to a group of medications known as 5-alpha reductase inhibitors, whose action reduces the size of the prostate in men.

This medication is used in the treatment and control of benign enlargement (non-cancerous) of the prostate (benign prostatic hyperplasia or BPH), as it reduces the risk of you developing acute urinary retention and requiring surgical intervention.

Do not take Finasterida Tarbis:

-if you are allergic to finasteride or any of the other components of this medication (listed in section 6).

-if you are a woman (see “Pregnancy, breastfeeding, and fertility”)

-if you are a minor

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Finasterida Tarbis.

-if you have kidney dysfunction

-if you have difficulty emptying your bladder completely or reduced urine flow; your doctor will thoroughly review you before you start taking Finasterida Tarbis to rule out other urinary tract obstructions.

-if you notice 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. If you notice any of these changes, inform your doctor immediately.

If your sexual partner may be pregnant or potentially become pregnant, avoid exposing her to your semen, as it may contain a small amount of the medication (see also “Pregnancy, breastfeeding, and fertility”).

If you need to undergo a blood test known as “PSA,” inform your doctor or nurse that you are taking finasteride, as this medication lowers PSA levels.

Mood changes and depression

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

Other medications and Finasterida Tarbis

Finasteride usually does not interact with other medications. Inform your doctor before taking other medications simultaneously.

Also inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Use of Finasterida Tarbis with food, drinks, and alcohol

Finasteride can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride is for exclusive use in men.

If your sexual partner may be pregnant or potentially become pregnant, avoid exposing her to your semen, as it may contain a small amount of the medication.

Women who are or may become pregnant should not handle crushed or broken Finasterida Tarbis tablets.

If a pregnant woman with a male fetus absorbs finasteride through oral ingestion or skin contact, her child may be born with genital organ abnormalities. The tablets are coated, preventing direct contact as long as they are not broken or crushed.

Driving and operating machinery

There is no evidence that finasteride affects the ability to drive or operate machinery.

Finasterida Tarbis contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Finasterida Tarbis contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day (equivalent to 5 mg of finasteride).

Tablets with a film coating should be swallowed whole and not broken or crushed. They can be taken with or without food.

Your doctor may prescribe finasteride along with another medication (called doxazosin) to help you better control your BPH.

If you take more Finasterida Tarbis than you should

Consult a doctor immediately, the nearest hospital emergency department, or the nearest toxicology center to receive medical advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Finasterida Tarbis

Do not take a double dose to compensate for the missed doses. Take the next dose when it is due.

If you interrupt treatment with Finasterida Tarbis

Although some improvement may be noted after a short period, it may be necessary to continue treatment for at least 6 months. Do not modify or interrupt the dose without consulting your doctor first.

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

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

Stop taking Finasterida Tarbis and inform your doctor immediately if you experience any of the following symptoms (angioedema):swelling of the face, tongue, and throat; difficulty swallowing; urticaria and difficulty breathing. These may be symptoms of an allergic reaction, which is reported as a rare side effect (or that its frequency cannot be estimated from the available data).

Frequent(may affect up to 1 in 10 people):

- Reduction in semen volume ejaculated

- Inability to achieve an erection (impotence)

- Decreased libido

Occasional(may affect up to 1 in 100 people):

- Hives

- Ejaculation problems after stopping treatment

- Swelling or discomfort in the breasts

Unknown frequency(frequency cannot be estimated from available data):

- Pruritus (itching), urticaria

- Palpitations (abnormal heart rate)

- Elevated liver enzymes (levels evaluated through blood analysis)

- Testicular pain

- Inability to achieve an erection after stopping treatment

- Male infertility and/or low-quality semen

- Depression

- Persistent decrease in libido that may continue after stopping treatment

- Anxiety

You should inform your doctor of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as they may be signs of a serious disease, such as breast cancer.

Combined therapy with doxazosin

The following side effects have been reported more frequently when finasteride was used with the alpha-blocker known as doxazosin: fatigue 16.8% (placebo 7.1%), postural hypotension 17.8% (placebo 8.0%), dizziness 23.2% (placebo 8.1%), and ejaculation disorders 14.1% (placebo 2.3%).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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 side 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after 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 point of your 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 Tarbis 5 mg film-coated tablets

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

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, sodium starch glycolate, sodium docusate, and magnesium stearate.

Coating: hypromellose (E464), titanium dioxide (E171), indigocarmine lake (E132), talc, and yellow iron oxide (E172).

Appearance of the product and contents of the package

Film-coated tablet

Round tablets, 7 mm in diameter, film-coated in blue, engraved with an ‘H’ on one face and the number ‘37’ on the other.

Finasteride tablets are presented in blister packs of 15, 28, 30, 50, 90, 98, or 100 film-coated tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanyFinasterid Amarox 5 mg Filmtabletten

DenmarkFinasterid Amarox 5 mg Filmovertrukne tabletter

SpainFinasterida Tarbis 5 mg film-coated tablets

FranceFinasteride Amarox 5 mg comprimé pelliculé

ItalyFinasterida Amarox

NetherlandsFinasteride Amarox 5 mg filmomhulde tabletten

PortugalFinasterida Amarox

United KingdomFinasteride 5 mg film-coated tablets

SwedenFinasteride Amarox 5 mg Filmdragerad tablett

United KingdomFinasteride 5 mg film-coated tablets

Last review date of this leaflet: March 2020.

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