Prospect: Patient Information

Finasteride Teva-ratiopharm 5 mg Film-Coated Tablets

finasteride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, or pharmacist.
• This medicine has been prescribed to you alone and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, or pharmacist, even if they are not listed in this prospect. See section 4.

1 What is Finasteride Teva-ratiopharm 5 mg Film-Coated Tablets and for what it is used

2 What you need to take before starting to take Finasteride Teva-ratiopharm 5 mg Film-Coated Tablets

3 How to take Finasteride Teva-ratiopharm 5 mg Film-Coated Tablets

4 Possible adverse effects

5 Storage of Finasteride Teva-ratiopharm 5 mg Film-Coated Tablets

6 Contents of the package and additional information

The active ingredient of Finasterida Teva-ratiopharm is finasteride, which belongs to a group of medicines called 5-alpha reductase inhibitors. These medicines act by reducing the size of the prostate in men.

Finasterida Teva-ratiopharm is used in the treatment and control of benign prostatic hyperplasia (BPH). This medicine reduces an enlarged prostate, improves urine flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgical intervention.

Do not take Finasterida Teva-ratiopharm:

• If you are allergic to finasteride or any of the other components of this medication listed in section 6.
• If you are pregnant or could be pregnant, Finasterida Teva-ratiopharm is not indicated for use in women. Special care is required in women who are or may be pregnant and who are likely to handle Finasterida Teva-ratiopharm (see “Pregnancy, breastfeeding and fertility”).

Finasterida Teva-ratiopharm is not recommended for use in children.

IN CASE OF DOUBT, ALWAYS ASK YOUR DOCTOR OR PHARMACIST

Warnings and precautions

Consult your doctor or pharmacist before taking Finasterida Teva-ratiopharm;

• If you have a large volume of residual urine and/or a significant reduction in urine flow. In this case, you must be closely monitored for the possibility of a narrowing of the urinary tract.
• If you have a reduction in liver function. Finasteride plasma levels may be increased in these patients.
• If your sexual partner is or could be pregnant, you must avoid exposing her to your semen that may contain a small amount of the medication.

Breast cancer

Inform your doctor immediately about any change in your breast tissue such as lumps, pain, increase in breast tissue or nipple secretion, as they may be signs of a serious condition, such as breast cancer.

Effects of prostate-specific antigen (PSA)

Before starting treatment with finasteride and during treatment, a clinical examination (including digital rectal examination) and a determination of serum levels of prostate-specific antigen (PSA) should be performed. This medication decreases PSA levels, so this should be taken into account when making a differential diagnosis.

Mood changes and depression

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

Other medications and Finasterida Teva-ratiopharm

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

No significant interactions with other medications have been identified.

Pregnancy, breastfeeding and fertility

Finasterida Teva-ratiopharm is only indicated for men.

If you are pregnant or could be pregnant do not handle broken or crushed Finasterida Teva-ratiopharm tablets.If finasteride is absorbed through the skin or taken by a pregnant woman from a male fetus, the male fetus may be born with genital organ malformations. Finasteride tablets have a coating that prevents contact with the active ingredient, as long as the tablets are not broken or crushed.

When the patient's sexual partner is or may become pregnant, the patient should avoid exposing their partner to semen (for example, by using a condom) or interrupting treatment with finasteride. It is unknown whether this medication is excreted in breast milk.

Driving and operating machines

No data suggest that Finasterida Teva-ratiopharm may affect the ability to drive or operate machines.

Finasterida Teva-ratiopharm contains lactose

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

Finasterida Teva-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; this 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.

The recommended dose is 1 tablet per day (equivalent to 5 mg of finasteride).

Tablets can be taken either with an empty stomach or with food. Tablets must be swallowed whole, not broken or crushed.

Although improvement may be seen in a short period of time, treatment may be necessary for at least 6 months to determine if a satisfactory response to treatment has been achieved.

Your doctor will indicate the duration of treatment with Finasterida Teva-ratiopharm. Do not discontinue treatment beforehand, as symptoms may reappear.

Patients with liver insufficiency

No experience is available on the use of Finasterida Teva-ratiopharm in patients with liver insufficiency (see also in section 2 “Warnings and precautions”).

Patients with renal insufficiency

No dose adjustment is required. The use of Finasterida Teva-ratiopharm in patients undergoing hemodialysis has not been studied.

Older patients

No dose adjustment is required.

Inform your doctor or pharmacist if you feel that the effect of Finasterida Teva-ratiopharm is too strong or too weak.

If you take more Finasterida Teva-ratiopharm than you should

If you take more Finasterida Teva-ratiopharm than you should or if a child has accidentally taken the medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Finasterida Teva-ratiopharm

If you forget to take a dose of Finasterida Teva-ratiopharm, take it as soon as you remember, unless it is almost time to take the next dose; in that case, continue with the treatment as usual. Do not take a double dose to compensate for the missed dose.

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

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

Allergic reactions

If you have had an allergic reaction, stop taking this medicine and visit your doctor quickly.The symptoms may include:

• Swelling of the lips, face, tongue, or throat
• Difficulty swallowing
• Rash on the skin, itching, lumps under the skin (rash)
• Difficulty breathing

Other side effects:

Frequent (may affect up to 1 in 10 patients)

• Difficulty achieving an erection (impotence)
• You may have less desire to have sex
• Decreased amount of semen released during sex. This decrease in semen amount appears not to affect normal sexual functions.

These side effects may disappear over time if you continue taking Finasteride Teva-ratiopharm. If not, they usually disappear when you stop taking Finasteride Teva-ratiopharm.

Rare (may affect up to 1 in 100 patients)

• Rash
• Swelling or breast sensitivity
• Problems with ejaculation that may continue after stopping the medicine

Unknown (frequency cannot be estimated based on available data)

• Anxiety
• Palpitations (feeling heartbeats)
• Changes in liver function, which can be seen in a blood test
• Testicular pain
• Male infertility and/or poor semen quality. Cases of improved semen quality have been reported after stopping treatment.
• Depression
• Decreased interest in sex that may continue after treatment interruption
• Problems with erection and ejaculation that may continue after suspending treatment
• Blood in semen

You should inform your doctor of any changes in breast tissue such as lumps, pain, enlargement, or discharge from the nipple, as these may be symptoms of something more serious, such as breast cancer.

Finasteride may affect the results of laboratory tests for APS.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 website: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 on the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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 collection point at the pharmacy. 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 Teva-ratiopharm

• The active ingredient is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, sodium glycolate (type A) (from potato, gluten-free), pregelatinized cornstarch, povidone, magnesium stearate, sodium lauryl sulfate, hypromellose (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, aluminum lake carmine (E132).

Appearance of the product and contents of the package

Finasterida Teva-ratiopharm are blue tablets, in capsule shape, with the inscription “FNT5” on one side.

Finasterida Teva-ratiopharm is available in packages of 14, 15, 20, 28, 30, 50, 50x1 (hospital pack), 56, 60, 84, 90, 98, 100, and 120 tablets.

Finasterida Teva-ratiopharm is available in an HDPE bottle with a polypropylene screw cap containing 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

Holland

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Teva Operations Poland Sp z.o.o.

Ul. Mogilska 80

31-546 Krakow,

Poland

This medicine is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: April 2023

"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/ "