PATIENT INFORMATION LEAFLET

Finasteride Kern Pharma 1 mg Film-Coated Tablets

Finasteride

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Finasterida Kern Pharma is for exclusive use in males and should not be taken by women or children.

Finasterida Kern Pharma contains a medication called finasteride.

Finasteride is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). 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). DHT contributes to shortening the hair growth phase and makes the hair thinner.

In the scalp, finasteride specifically reduces DHT levels by blocking an enzyme (5-alpha-reductase type II) that converts testosterone to DHT. Only males with mild to moderate hair loss, but not complete, can expect a benefit from using Finasterida Kern Pharma. In many of the males treated with finasteride for 5 years, the progression of hair loss became slower, and at least half of those males also showed some improvement in hair growth.

Do not take Finasterida Kern Pharma

• If you are a woman (because this medication is for men, see Pregnancy section). Clinical trials have shown that finasteride is not effective in women with hair loss.
• If you are allergic (hypersensitive) to finasteride or to any of the other components of Finasterida Kern Pharma (listed in section 6). If you are unsure, consult your doctor or pharmacist.

Be especially careful with Finasterida Kern Pharma

• Children and adolescents under 18 years old should not take finasteride.
• Inform your doctor or pharmacist of your current and past medical conditions, and of any allergy you have suffered.
• If you are to undergo a Prostate-Specific Antigen (PSA) test, tell your doctor or pharmacist that you are taking Finasterida, as it may affect the results.

Mood changes and depression

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

Use of other medications

Finasterida Kern Pharma can usually be used with other medications. Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Taking Finasterida Kern Pharma with food and drinks

Finasterida Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

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

• Women cannot use finasteride due to the risk of 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 of Finasterida Kern Pharma after oral ingestion or through the skin, her child may be born with genital organ abnormalities.
• If a woman comes into contact with the active ingredient of Finasterida Kern Pharma, she should consult a doctor.
• Finasterida Kern Pharma tablets are coated to prevent contact with the active ingredient during normal handling.

If your partner is or may be pregnant, avoid exposing her to your semen (for example, by using a condom).

In case of doubt, ask your doctor.

Driving and operating machinery

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

Important information about some of the components of Finasterida Kern Pharma

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

Follow exactly the administration instructions for finasteride indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• The usual dose is one tablet per day.
• Tablets can be taken with or without food.
• Finasteride will not act faster or better by taking more than one tablet per day.

Your doctor will help you determine if Finasterida Kern Pharma works for you. It is essential 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 Finasterida Kern Pharma than you should

If you take too many tablets by mistake, go to your doctor immediately.

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.

If you forgot to take Finasterida Kern Pharma

• 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 Finasterida Kern Pharma

To appreciate the effect, it may be necessary to take the medication for 3 to 6 months. It is essential 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 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 medicines, Finasterida Kern Pharma may cause side effects, although not everyone will experience them.

Side effects have been, normally, temporary with continued treatment or have disappeared when treatment is stopped.

Rare (occur in fewer than 1 in 100 patients):

• less desire for sex
• 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, itching, lumps under the skin (hives) and swelling of the lips and face
• sensitivity and breast enlargement
• testicular pain
• rapid heart rate
• persistent difficulty achieving an erection after stopping treatment
• fertility problems have been observed 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 observed after finasteride discontinuation. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.
• high liver enzymes
• anxiety

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

Stop taking Finasterida Kern Pharma and immediately inform your doctor if you experience any of the following symptoms:

• swelling of your face, tongue, or throat
• difficulty swallowing
• lumps under the skin (hives)
• difficulty breathing

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep out of reach and sight of children.

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Finasteride Kern Pharma Composition

• The active ingredient is finasteride. Each tablet contains 1 mg of finasteride.

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized cornstarch, sodium starch glycolate type A (potato starch), sodium lauryl sulfate, magnesium stearate (E-470b).

Coating: talc, hypromellose (E-464), propylene glycol, titanium dioxide (E-171), yellow iron oxide (E-172), and red iron oxide (E-172).

Product Appearance and Packaging Content

Coated tablet.

Finasteride Kern Pharma 1 mg tablets are pink-orange, round, and have “F1” engraved on one side.

Finasteride Kern Pharma is available in blister packs of 28 and 98 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last Review Date of this Leaflet: August 2018.

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