Leaflet: information for the user

Finasteride cinfa 1 mg film-coated tablets

Read this leaflet carefully before you start taking this medicinebecause 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 youonly, and you should not give it to others even if they have the same symptomsas you, as it may harm them.

• Ifyou experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

finasteride cinfacontains the active ingredient finasteride.

finasteride cinfa is for exclusive use in males.

Finasterideis used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in males aged 18 to 41 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 believed to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). DHT contributes to shortening the hair growth phase and making the hair thinner.

On the scalp,finasteridespecifically reduces DHT levels by blocking an enzyme (Type II 5-alpha-reductase) that converts testosterone to DHT. Only males with mild to moderate hair loss, but not complete, can expect a benefit from the use offinasteride. In many of the males treated withfinasteridefor 5 years, the progression of hair loss became slower, and at least in half of those males, the hair growth also improved in some way.

Do not take finasteride cinfa

• If you are a woman (because this medicine is for men, see Pregnancy, breastfeeding and fertility section). Clinical trials have shown thatfinasterideis not effective in women with hair loss.
• If you are allergic to finasteride or to any of the other components of this medicine (included in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take finasteride cinfa.

Effects on Prostate-Specific Antigen (PSA)

Finasteride may affect a blood test called PSA (Prostate-Specific Antigen) to detect prostate cancer. If you have had a PSA test, you must inform your doctor or pharmacist that you are taking finasteride, because it decreases PSA levels.

Effects on fertility

Fertility problems have been reported in men who took finasteride for a long time and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been reported after stopping finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.

Breast cancer

See section 4.

Mood changes and depression

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

Children and adolescents

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

Other medicines and finasteride cinfa

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

Taking finasteride cinfa with food and drinks

Finasteridecan be taken with or without food.

Pregnancy, breastfeeding and fertility

Finasterideis intended for the treatment of male pattern hair loss exclusively in males. For the effects on fertility in men, see section 2.

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

In case of doubt, ask your doctor.

Driving and operating machinery

There is no evidence to indicate thatfinasterideaffects the ability to drive or operate machinery.

finasteride cinfa contains lactose

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

finasteride cinfa contains docusate sodium benzoate

This medicine contains 0.50 mg of docusate sodium benzoate in each tablet.

finasteride cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

The recommended dose is one tablet per day. Tablets can be taken with or without food.

Your doctor will help you determine if finasteride works for your case. It is important to take finasteride for the entire time your doctor indicates. Finasteride only acts in the long term if its administration is maintained.

If you take more finasteride cinfa than you should

If you accidentally take too many tablets, go to your doctor immediately. Finasteride will not act faster or better by taking more than one tablet per day.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take finasteride cinfa

If you forget a dose, skip the missed dose.

Resume the usual regimen of one tablet per day.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with finasteride cinfa

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is important that you try to take finasteride for the entire period of time indicated by your doctor. If you stop taking finasteride, you will probably lose the hair you have gained in the 9 to 12 months following the interruption of treatment.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects have been, normally, transient with continued treatment or have disappeared when treatment is interrupted.

Stop taking finasteride and immediately inform your doctor if you experience any of the following symptoms: swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (hives) and difficulty breathing.

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

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

• decreased libido
• difficulty achieving an erection
• problems with ejaculation, including a decrease in the amount of semen ejaculated
• depression

Unknown frequency (cannot be estimated from available data):

• allergic reactions, including rash and itching
• breast sensitivity and enlargement
• testicular pain
• blood in semen
• rapid heart rate
• persistent difficulty achieving an erection after stopping treatment
• persistent decrease in libido after stopping treatment
• persistent ejaculation problems after stopping treatment
• male infertility and/or poor semen quality
• increased liver enzymes
• anxiety

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of sightand out of reachof children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. In case of doubt,ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Finasteride cinfa composition

• The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.
• The other components are:

Tablet core:monohydrate lactose, cornstarch, carboxymethylcellulose sodium (type A) (from potato), anhydrous colloidal silica,sodium docusate benzoate andmagnesium stearate.

Coating:hydroxypropylmethylcellulose, titanium dioxide (E-171), polyethylene glycol 6000, brown iron oxide (E-172) and red iron oxide (E-172).

Product appearance and packaging contents

The tablets are coated with a film, cylindrical, scored and reddish in color.

The tablets are available in PVC-PVDC/Aluminum blisters.

Each package contains 28 or 98 tablets.

Marketing authorization holder and manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:September 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/76704/P_76704.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/76704/P_76704.html