Package Leaflet: Information for the User

Alocare 1 mg Film-Coated Tablets

Finasteride

Read the package leaflet carefully before taking the medicine.

•Keep this package 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 any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

1. What Alocare 1 mg Film-Coated Tablets are and what they are used for

2. Before taking Alocare 1 mg Film-Coated Tablets

3. How to take Alocare 1 mg Film-Coated Tablets

4. Possible side effects

5. Storage of Alocare 1 mg Film-Coated Tablets

6. Further information

Alocare 1 mg contains an active ingredient called finasteride. Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors.

Your doctor has prescribed Alocare 1 mg because you have male hair loss (also known as androgenetic alopecia). Alocare 1 mg prevents further hair loss in men. Men with mild to moderate hair loss but not complete, may benefit from the use of Alocare 1 mg.

Alocare 1 mg blocks an important enzyme(5α-reductase Type II), which is involved in the regulation of the hair follicle.

In the scalp, Alocare 1 mg specifically reduces levels of DHT, a main cause of male hair loss. In this way, Alocare 1 mg helps to reduce the process of baldness and to prevent further hair loss.

Do not take Alocare1 mg:

• If you are allergic (hypersensitive) to finasteride or to any of the other components of Alocare 1 mg.

• If you are a child or adolescent.

• If you are a woman (also see the chapter ‘Pregnancy and breastfeeding’). In clinical studies, it has been proven that Alocare 1 mg is not effective in the treatment of hair loss (Androgenetic alopecia) in women.

• If you are already taking finasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia or for any other disease.

Be especially careful while taking Alocare 1 mg:

The determination of serum prostate-specific antigen (PSA) must be performed before starting treatment with finasteride and throughout the treatment.

Mood changes and depression

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

Use of other medications:

Alocare 1 mg usually does not interfere with other medications. Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

No information is available on the use of Alocare 1 mg with topical minoxidil (applied to the skin) in male hair loss.

Use of Alocare 1 mg with food and beverages:

Alocare 1 mg can be taken with or without food.

Pregnancy and breastfeeding:

Alocare 1 mg is only indicated for men.

Women who are or may be pregnant should not handle Alocare 1 mg, especially if the tablets are broken, crushed, or chewed. If finasteride is absorbed through the skin or taken orally by pregnant women carrying a male fetus, the baby may be born with genital organ malformations.

If your partner is or may be pregnant, you should avoid exposure to your semen (e.g., by using a condom) or discontinue treatment with finasteride.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery:

No information suggests that Alocare 1 mg affects the ability to drive and operate machinery.

Important information about some of the components of Alocare 1 mg:

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

Always take Alocare 1 mg exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The usual dose is one Alocare 1 mg tablet per day.

Coated tablets can be taken either with an empty stomach or with a meal. Coated tablets must be swallowed whole and not divided or crushed.

•Alocare 1 mg does not work better or faster if you take more than one tablet a day.

•Male hair loss is a condition that takes a long time to develop.

In general, daily use for three to six months may be necessary before you notice an increase in hair thickness or a reduction in hair loss.

•Your doctor will help you evaluate if Alocare 1 mg is working. It is essential to continue taking Alocare 1 mg for the full period prescribed by your doctor.

Patients with liver disorders

No experience is available for the use of Alocare 1 mg in patients with liver disorders (see also ‘Be careful while taking Alocare 1 mg’).

Patients with renal disorders

No dose adjustment is necessary for patients with renal disorders.

If you take more Alocare 1 mg than you should:

If you have taken more Alocare 1 mg than prescribed, or if someone else has taken any amount of Alocare 1 mg, contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Go to your nearest hospital and bring with you all remaining tablets or the empty packaging to facilitate identification.

If you forget to take Alocare 1 mg:

If you forget to take a dose of Alocare 1 mg, continue with the next dose as usual. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Alocare 1 mg:

It is recommended to continue using Alocare 1 mg to achieve the maximum benefit. If treatment is interrupted, it is likely that you will lose the regained hair within the next 9 or 12 months.

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

Like all medications, Alocare 1 mg can produce adverse effects, although not all people may experience them.

Adverse effects have usually been temporary with continued treatment or have disappeared once treatment was suspended.

Rare (between 1 and 10 per 1,000 patients):

•Decreased libido

•Difficulty achieving an erection

•Problems with ejaculation such as a decrease in semen volume.

• Depression

Unknown frequency:

•Allergic reactions such as skin rash, itching, lumps under the skin (urticaria) andswelling of the lips and face

•Mastitis or breast sensitivity

•Testicular pain

•Increased heart rate

•Persistent difficulty achieving an erection after stopping treatment

•Cases of infertility have been reported in men who took finasteride for a long time and had other risk factors that could affect fertility. Cases of normalization or improvement in semen volume have been reported after stopping finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.

• Anxiety

Stop taking Alocare 1 mg and consult your doctor immediately if you notice any of the following symptoms:

•Swelling of your face, tongue, or throat

•Difficulty swallowing

•Lumps under the skin (urticaria)

•Respiratory difficulty

If you consider any of the effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, report it to your doctor or pharmacist.

•Keep out of reach and sight of children.

•This medication does not require special conditions for conservation.

•Do not use Alocare 1 mg after the expiration date, which appears on the packaging. 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 pointat your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Alocare 1 mg:

The active ingredient is finasteride. One tablet contains 1 mg of finasteride.

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, sodium starch glycolate type A, lauroyl macrogolglycerides, magnesium stearate (E572).

Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the packaging of Alocare 1 mg:

Coated tablet.

Alocare 1 mg tablets are brownish-red, round, biconvex, marked ‘F1’ on one side and unmarked on the other side.

Alocare 1 mg tablets are packaged in aluminum/aluminum blisters containing 28 and 98 tablets.

Marketing Authorization Holder:

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for Manufacturing:

Wessling Hungay KFT.

Foti ut 56. Budapest H1047 Hungary

Vasut u. 13,

Hungary

or

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona, Spain

This leaflet was approved in June 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/.