FINASTERIDE TEVA-RATIOPHARM 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Finasteride Teva-ratiopharm 5 mg film-coated tablets EFG

finasteride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Finasteride Teva-ratiopharm 5 mg film-coated tablets are and what they are used for
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 side effects
5. Storage of Finasteride Teva-ratiopharm 5 mg film-coated tablets
6. Package Contents and Additional Information

1. What Finasteride Teva-ratiopharm is and what it is used for

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

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

2. What you need to know before taking Finasteride Teva-ratiopharm

Do not take Finasteride 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 may be pregnant, Finasteride Teva-ratiopharm is not indicated for use in women. Special care is required in women who are or may be pregnant and are likely to handle Finasteride Teva-ratiopharm (see "Pregnancy, Breastfeeding, and Fertility").

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

IN CASE OF DOUBT, ALWAYS SEEK ADVICE FROM YOUR DOCTOR OR PHARMACIST

Warnings and Precautions

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

• If you have a large residual urine volume and/or a significant reduction in urine flow. In this case, you should be closely monitored for the possibility of a narrowed urinary tract.
• If you have decreased liver function. Plasma levels of finasteride may be increased in these patients.
• If your sexual partner is or may be pregnant, you should avoid exposing her to your semen, which may contain a tiny amount of the medication.

Breast Cancer

Immediately inform your doctor of any changes in your breast tissue, such as lumps, pain, enlargement, or nipple discharge, as these 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 rectal examination) and determination of serum PSA levels should be performed. This medication decreases PSA levels, which 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 Finasteride Teva-ratiopharm. If you experience any of these symptoms, consult your doctor as soon as possible.

Other Medications and Finasteride Teva-ratiopharm

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

No significant interactions with other medications have been identified.

Pregnancy, Breastfeeding, and Fertility

Finasteride Teva-ratiopharm is only indicated for men.

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

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

Driving and Using Machines

There are no data to suggest that Finasteride Teva-ratiopharm may affect the ability to drive or operate machines.

Finasteride Teva-ratiopharm contains Lactose

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

Finasteride Teva-ratiopharm contains Sodium

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

3. How to take Finasteride Teva-ratiopharm

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

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

The tablets can be taken with or without food. The tablets should be swallowed whole and not crushed or broken.

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

Your doctor will indicate the duration of treatment with Finasteride Teva-ratiopharm. Do not stop treatment before, as symptoms may reappear.

Patients with Hepatic Impairment

There is no experience with the use of Finasteride Teva-ratiopharm in patients with liver failure (see also section 2 "Warnings and Precautions").

Patients with Renal Impairment

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

Elderly Patients

No dose adjustment is required.

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

If you take more Finasteride Teva-ratiopharm than you should

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

If you forget to take Finasteride Teva-ratiopharm

If you forget to take a dose of Finasteride 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 make up for the forgotten dose.

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

4. Possible Side Effects

Like all medications, this medication can have side effects, although not everyone may experience them.

Allergic Reactions

If you have had an allergic reaction, stop taking this medication and visit your doctor immediately.The signs may include:

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

Other Side Effects:

Frequent (may affect up to 1 in 10 patients)

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

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.

Uncommon (may affect up to 1 in 100 patients)

• Rash
• Breast tenderness or swelling
• Ejaculation problems that may continue after stopping the medication

Unknown (frequency cannot be estimated from 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. There have been reports of improvement in semen quality after stopping treatment.
• Depression
• Decreased interest in sex that may continue after treatment is stopped
• Erection and ejaculation problems that may continue after treatment is stopped
• Blood in the semen

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

Finasteride may affect PSA laboratory test results.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Finasteride Teva-ratiopharm

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

Do not use this medication after the expiration date stated on the packaging and blister. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Finasteride 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 starch glycolate (type A) (from potato, gluten-free), pregelatinized starch (from corn), povidone, magnesium stearate, sodium lauryl sulfate, hypromellose (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, Aluminum Lake Carmine Indigo (E132).

Appearance of the Product and Package Contents

Finasteride Teva-ratiopharm are blue, capsule-shaped tablets with the inscription "FNT5" on one side.

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

Netherlands

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 medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet: April 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70122/P_70122.html

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