FINASTERIDE IFC 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Finasteride IFC1 mg film-coated tablets EFG

Finasteride

Read all of 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 get 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 IFC 1 mg film-coated tablets and what is it used for
2. What you need to know before you take Finasteride IFC 1 mg film-coated tablets
3. How to take Finasteride IFC 1 mg film-coated tablets
4. Possible side effects
5. Storage of Finasteride IFC 1 mg film-coated tablets
6. Contents of the pack and further information

1. What is Finasteride IFC 1 mg film-coated tablets and what is it used for

FINASTERIDE is for use by men only and should not be taken by women or children.

Finasteride IFC contains a medicine called finasteride. Finasteride IFC is used for the treatment of early stages of male pattern hair loss (also known as androgenetic alopecia) in men aged 18-41 years. If, after reading this leaflet, you have any questions about male pattern hair loss, you should consult your doctor.

Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a specific hormone, called dihydrotestosterone (DHT). DHT contributes to the reduction of the hair growth phase and thinning of the hair.

Finasteride IFC reduces the levels of DHT in the scalp by blocking an enzyme (5-alpha reductase type II) that converts testosterone to DHT. Only men with mild to moderate hair loss may expect benefits from using Finasteride IFC, but not those with complete hair loss or bitemporal recession. In most men treated with Finasteride IFC for 5 years, the progression of hair loss was slowed and at least half of them had some improvement in hair growth.

2. What you need to know before you take Finasteride IFC 1 mg film-coated tablets

Do not take Finasteride IFC

• if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• if you are a child or adolescent (<18 years).< li>

• if you are a woman (see also “Pregnancy and breast-feeding”). It has been observed in clinical trials that Finasteride IFC 1 mg film-coated tablets are not effective for the treatment of hair loss (androgenetic alopecia) in women.

Men treated with other medicines containing finasteride, or any other 5α-reductase inhibitor for benign prostatic hyperplasia or for any other condition should not take Finasteride.

Warnings and precautions

Pregnant or potentially pregnant women should not handle crushed or broken tablets. There is a possibility that finasteride may be absorbed through the skin, which could affect the development of the external genitalia of male foetuses. If pregnant women must handle finasteride (the active ingredient), they should inform their doctor.

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

Finasteride may affect fertility in males. Male patients who are planning to have a child should consider discontinuing treatment.

Finasteride tablets may affect the results of a blood test called PSA. If you are going to have a blood test to check your prostate, you should inform your doctor that you are taking finasteride.

Determination of prostate-specific antigen (PSA) in serum should be performed before the start of treatment with finasteride and during treatment.

The effect of hepatic impairment on the metabolism of finasteride has not been studied.

Mood changes and depression

Mood changes, such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride IFC 1 mg film-coated tablets. If you experience any of these symptoms, stop taking Finasteride IFC 1 mg film-coated tablets and consult your doctor as soon as possible.

Using Finasteride IFC with other medicines

Finasteride IFC can be taken normally with other medicines.

However, inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

No data are available on the use of Finasteride IFC in combination with topical minoxidil in men with male pattern hair loss.

Taking Finasteride IFC with food and drinks

Finasteride IFC can be taken with or without food.

Pregnancy and breast-feeding

Women should not take Finasteride IFC. Women who are or may be pregnant should not handle crushed or broken finasteride tablets. If a pregnant woman absorbs finasteride through the skin or after oral ingestion, her male foetus may be born with abnormalities of the genital organs. The tablets are coated to prevent contact with finasteride, provided that the tablets are not crushed or broken.

If the patient's partner is or may become pregnant, they should avoid exposure to semen (e.g. by using a condom) or discontinue treatment with finasteride. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no evidence to suggest that finasteride may affect the ability to drive or operate machinery.

Finasteride IFC contains lactose

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

3. How to take Finasteride IFC 1 mg film-coated tablets

Follow exactly the administration instructions of Finasteride IFC given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Tablet intake:the tablets should be swallowed whole with a little water. They should not be crushed or broken. They can be taken with food or on an empty stomach.

Unless your doctor tells you otherwise, the usual dose for all patients is one tablet per day.

Follow the instructions given by your doctor. Do not change the dose or stop treatment without consulting your doctor first.

Finasteride IFC does not work faster or better if taken more than once a day. To achieve an increase in hair growth or a decrease in hair loss, you must take this medicine every day for 3-6 months or more. Your doctor and you can assess whether treatment with Finasteride IFC has been effective after that. During treatment with Finasteride IFC, there is no need to change your daily hair care routine.

If you consider the effect of Finasteride IFC to be too weak or strong, inform your doctor or pharmacist.

If you take more Finasteride IFC than you should

If you accidentally take too many tablets, inform your doctor or go to a hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to take Finasteride IFC

Do not take a double dose to make up for forgotten doses. Just take the next tablet at the usual time.

If you stop taking Finasteride IFC

In order to maintain the effectiveness of the treatment, it is recommended to use this medicine continuously. Any improvement obtained with respect to hair growth during treatment may disappear 9-12 months after stopping Finasteride IFC.

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

4. Possible side effects

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

The side effects of Finasteride IFC are generally mild and temporary.

Side effects during continuous treatment are usually temporary and disappear when treatment is stopped.

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

• decreased sex drive
• difficulty getting an erection
• problems with ejaculation, such as decreased semen volume.
• depression

Frequency not known (cannot be estimated from the available data):

• allergic reactions such as rash, itching, swelling of the skin (urticaria), lips and face.
• breast tenderness or enlargement.
• testicular pain.
• depressed mood.
• rapid heart rate.
• persistent difficulty getting an erection after stopping treatment.
• infertility has been reported in men who have taken finasteride for a long time and have other risk factors that may affect fertility. After stopping treatment, normalization or improvement in semen quality has been reported. No long-term clinical studies have been conducted in men on the effect of finasteride on fertility.
• increased liver enzymes.
• male breast cancer (see also section 2. Warnings and precautions).
• persistent sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after stopping treatment with finasteride.
• anxiety.

Stop taking Finasteride IFC and immediately inform your doctor if you get any of the following symptoms:

• swelling of the face, lips, tongue or throat.
• difficulty swallowing.
• skin swelling (urticaria).
• difficulty breathing.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Finasteride IFC 1 mg film-coated tablets

Keep out of the sight and reach of children.

Do not use Finasteride IFC after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofFinasteride IFC1 mg film-coated tablets

• The active substance is finasteride. Each tablet contains 1 mg of finasteride.
• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, lauryl macrogolglycerides, sodium starch glycolate - Type A (potato), magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and macrogol 6000.

Appearance of the product and contents of the pack

Finasteride IFC 1 mg film-coated tablets are round, biconvex tablets, reddish-brown in colour and marked with “F1” on one side.

Each pack contains 28, 56, 84 and 98 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander – (Spain)

Manufacturer

Actavis Group PTC ehf

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceland

or

Zentiva k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

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

Spain Finasteride IFC 1 mg film-coated tablets EFG

Italy Carefinast 1 mg film-coated tablets

Date of last revision of this leaflet: August 2018

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