Patient Information Leaflet

Finasteride Sandoz 1 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 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 Sandoz is and what it is used for

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

3.How to take Finasteride Sandoz

4.Possible side effects

5.Storage of Finasteride Sandoz

6.Contents of the pack and additional information

Finasterida Sandoz is for exclusive use in men and its use is not indicated in women or children (<18)

Finasterida Sandoz contains a medicine called finasteride.Finasteride is used totreat the early stages of male pattern hair loss(also known as androgenetic alopecia) in men aged18 to41 years. If after reading this leaflet you have any questions about male pattern hair loss, consult your doctor.

Male pattern hair loss is a common disorder that is believed to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). The DHT hormone contributes to shortening the hair growth phase and making the hair thinner.

In the scalp, finasteride specifically reduces the levels of the DHT hormone by blocking the enzyme (type II 5-alpha reductase) that converts testosterone into DHT. Only men with mild to moderate alopecia, who have not completely lost their hair or have lost it on both sides of the head, can expect to benefit from the use of finasteride. In most men who have been treated with finasteride for 5 years, hair loss became slower and, in at least half of these men, hair growth also improved in some way.

Do not take Finasterida Sandoz

-if you are a woman (also see the section “Pregnancy, breastfeeding and fertility”). Clinical trials have shown that finasteride is ineffective in the treatment of hair loss (androgenetic alopecia) in women,

-if you areallergic (hypersensitive) to finasterideor to any of the other components of this medication (listed in section 6),

• men who are being treated with any other medication that contains finasteride or any other 5-alpha reductase inhibitor for benign prostatic hyperplasia or any other disease, should not take finasteride.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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. If you experience any of these symptoms, stop taking this medication and consult your doctor as soon as possible for medical advice.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called Prostate-Specific Antigen (PSA) for detecting prostate cancer. If you have had a PSA test, inform your doctor that you are taking finasteride.

PSA determination in serum should be performed before starting finasteride treatment and during the same.

Breast cancer

During the post-marketing period, breast cancer has been reported in men taking finasteride 1 mg. Doctors should inform their patients to immediately report any changes in breast tissue, such as lumps, pain, enlargement of the breasts (gynecomastia), or nipple discharge.

Children and adolescents

Finasteride should not be used in children. There is no data to demonstrate the efficacy and safety of finasteride in children under 18 years.

Finasterida Sandoz with other medications

Finasteride Sandoz usually does not interfere with treatment with other medications.

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

Finasterida Sandoz with food and drinks

Finasteride Sandoz can be taken with or without food.

Pregnancy, breastfeeding and fertility

Finasteride is intended for the treatment of male pattern hair loss exclusively in men.

• Women cannot use finasteride due to the risk of pregnancy.
• Women who are or may be pregnant should not touch crushed or broken Finasterida Sandoz tablets.
• If a pregnant woman with a male fetus absorbs the active ingredient of Finasterida Sandoz after oral ingestion or through the skin, her child may be born with abnormalities of the genital organs.
• If a pregnant woman comes into contact with the active ingredient of Finasterida Sandoz, she should consult a doctor.
• Finasterida Sandoz tablets are coated to prevent contact with the active ingredient during normal handling.

The excretion of finasteride in breast milk is unknown.

Infertility has been reported in men who took finasteride for a long period and had other risk factors affecting fertility. Normalization and improvement of semen quality were reported after discontinuing finasteride. Long-term studies have been conducted on the effect of finasteride on fertility in men.

Ask your doctor if you are unsure.

Driving and operating machinery

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

Finasterida Sandoz contains lactose and sodium

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; it is essentially “sodium-free”.

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

Unless your doctor tells you otherwise, the usual dose is1 tablet per day.

Do not change the dose or stop taking this medication without consulting your doctor first.

Finasterida does not work faster or more effectively by taking more doses than indicated per day. To achieve greater hair thickness or reduce hair loss, you must take this medication every day for3 to6 months or more. You and your doctor must then evaluate whether treatment with finasterida is beneficial for you. It is not necessary to make any changes to your usual hair care routine during treatment with finasterida.

If you feel that the effect of finasterida is too weak or too strong, please consult your doctor or pharmacist.

The tablets should be swallowed whole with a little water. Do not break or crush them. You can take the tablets with food or on an empty stomach.

If you take more Finasterida Sandoz than you should

If you have taken more Finasterida than you should,consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used..

If you forget to take Finasterida Sandoz

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

If you interrupt treatment with Finasterida Sandoz

To maintain the benefits of treatment, it is recommended to continue using this medication. If you interrupt treatment with finasterida, it is likely that any increase in hair thickness you have experienced will be lost within 9 to 12 months.

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

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

The nature of finasteride side effects are usually mild and of a temporary nature.

Stop taking finasteride and inform your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, tongue, or throat; difficulty swallowing; urticaria and difficulty breathing.The frequency is unknown (cannot be estimated from available data).

You must inform your doctor immediately if you notice any changes in breast tissue such as lumps, pain,increased breast tissue or nipple discharge, as these may be signs of a serious disease, such as breast cancer. The frequency is unknown (cannot be estimated from available data).

Side effects have usually been temporary with continued treatment or have disappeared once treatment has been discontinued.

Rare(may affect up to 1 in 100 people)

• decreased libido,
• depression,
• difficulty achieving an erection,
• difficulty with ejaculation, such as decreased semen volume.

Frequency unknown(cannot be estimated from available data):

• allergic reactions including rash and itching,
• swelling or sensitivity in the breasts,
• testicular pain,
• rapid heartbeat,
• persistent difficulty maintaining an erection after treatment has been discontinued,
• persistent decrease in libido after treatment has been discontinued,
• persistent ejaculation problems after treatment has been discontinued,
• male infertility and/or poor semen quality,
• elevated liver enzymes,
• anxiety.

Reporting of 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: https://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.

Do not use this medication after the expiration date that appears on the packaging and in the blister or bottle after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

HDPE containers with LDPE cap and screw cap: use within 4 months after the first opening of the container.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Finasteride Sandoz

• The active ingredient is finasteride.Each coated tablet contains 1 mg of finasteride.
• The other components are
• • Tablet core:lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch,lauril macrogolglycerides,carboxymethylcellulose sodium (Type A) from potatoand magnesium stearate (E572).
  • Tablet coating:hypromellose,titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and macrogol 6000.

Appearance of the product and contents of the package

Round, biconvex tablets, brown-red in color, and carry the imprint “F1” on one face.

Finasteride Sandoz 1 mg coated tablets are available in the following formats:

PVC/Alu blister (aluminum/PVC, aluminum/aluminum): 7, 14, 28, 30, 56, 84 and 98 coated tablets.

HDPE containers with LDPE caps: 7, 14, 28, 30, 56, 84 and 98 coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek S.A.

ul. Podlipie

95-010 Strykow

Poland

or

Actavis Group PTC ehf

Reykhavikurvegur 76 - 78

220 Hafnarfjordur

Island

or

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

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

Germany:Finasterid -1A PharmA 1 mg Filmtabletten

France:Finasteride Sandoz 1mg, coated tablet

Italy:FINACAPIL

This leaflet was approved in September 2019.

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