FINASTERIDE SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Finasteride Sandoz 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, 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 leaflet. See section 4.

Contents of the pack:

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

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

Finasteride Sandoz 5 mg is used in men to treat and control:

• Benign prostatic hyperplasia, which is a non-aggressive growth of the prostate.

Finasteride belongs to a group of medicines called 5-alpha-reductase inhibitors. It reduces the size of the prostate gland, improving urine flow and other symptoms of prostate enlargement. Finasteride decreases the risk of sudden inability to urinate and the need for surgical intervention.

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

Do not take Finasteride Sandoz

If you are:

• allergic to finasterideor any of the other ingredients of this medicine (listed in section 6),
• a woman(see section "Pregnancy and breastfeeding"),
• a childunder 18 years of age.

Warnings and precautions

Talk to your doctor before you start taking Finasteride Sandoz.

Tell your doctor if any of the following apply to you:

• difficulty emptying your bladder completelyor significant reduction in urine flow.

Your doctor will examine you before starting finasteride treatment to rule out other urinary tract obstructions,

• you need a blood test for PSA, a protein produced by the prostate gland.

Tell your doctor or nurse that you are taking finasteride as it may affect these results,

• reduced liver function.

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, talk to your doctor as soon as possible to seek medical advice.

Using Finasteride Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Finasteride has no known influenceon or is affected by other medicines.

Pregnancy and breastfeeding

Finasteride must not be used by women.

• If your sexual partner is or may be pregnant:

Semen may contain traces of finasteride. Therefore, avoidyour semencoming into contact with your partner, for example, by using a condom.

• Pregnant women or women who may become pregnant must not handle crushed or broken finasteride tablets.

If a pregnant woman absorbs finasteride, the male fetus may be born with deformed genitals. Therefore, the tablets are coated to prevent contact with finasteride.

Driving and using machines

It does not appear thatfinasteride can affectyour ability to drive or use machines.

Finasteride Sandoz contains lactose and sodium

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

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

3. How to take Finasteride Sandoz

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended doseis:

• 1 tablet once a day.

Method of administration

Swallow the film-coated tablets whole with a glass of water. They can be taken with or without food, always at the same time.

Duration of treatment

Decidedby your doctor. Although you may notice an improvement after a short period, it is necessary to continue treatment for at least 6 months.

If you take more Finasteride Sandoz than you should

If you have taken more finasteride than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Finasteride Sandoz

Do not take a double dose to make up for forgotten doses. Just take the next tablet at the usual time and continue your treatment as normal.

If you stop taking Finasteride Sandoz

Do not change or stop treatment without your doctor's permission, as this may affect you seriously and reduce the effect of your treatment.

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

4. Possible side effects

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

The most common side effects are inability to achieve an erection and decreased sexual desire. These side effects occur during treatment and are resolved with continued treatment in most patients.

Tell your doctor immediately if you experience changes in your breast tissue such as lumps, pain, or discharge from the nipple, as these may be symptoms of serious conditions, such as breast cancer.

Allergic reactions

Stop taking Finasteride Sandoz and contact your doctor immediately if you experience any of the following symptoms:

• skin rash, itching, or lumps under your skin (blisters),
• swelling of the lips, face, tongue, or throat; difficulty swallowing; blisters and difficulty breathing (angioedema; frequency not known, i.e., cannot be estimated from available data).

Side effects may occur with the following frequencies:

Common, may affect up to 1 in 10 people:

• difficulty achieving an erection,
• decreased sexual desire,
• decreased semen volume.

Uncommon, may affect up to 1 in 100 people:

• breast tenderness and/or enlargement,
• difficulty ejaculating.

Frequency not known, cannot be estimated from available data:

• testicular pain,
• inability to achieve an erection that continues after stopping treatment,
• reduced sexual desire that continues after stopping treatment,
• male infertility and/or poor semen quality,
• rapid or irregular heartbeat,
• increased liver enzyme levels,
• depression,
• anxiety.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride Sandoz

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

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

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Finasteride Sandoz 5 mg film-coated tablets

• The active ingredient is finasteride. Each tablet contains 5 mg of finasteride.
• The other ingredients are: sodium docusate, hypromellose, indigo carmine (E132), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium starch glycolate (type A) (from potato), talc, titanium dioxide (E171).

Appearance and packaging of the product

Finasteride Sandoz are round, biconvex, blue tablets, approximately 8 mm in diameter.

The film-coated tablets are available in blisters containing 10, 14, 15, 28, 30, 50, 50x1, 56, 60, 100, and 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Rowa Pharmaceuticals Limited

Newtown (Bantry, Co Cork)

Ireland

or

Lek S.A.

50C, Domaniewska Str.

02-672 Warsaw

Poland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Ireland: Finasteride Rowex 5 mg Film-coated tablets

Netherlands: FINASTERID SANDOZ 5MG FILMTABLETTEN

Date of last revision of this leaflet:May 2020

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/