ALOCARE 1 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Alocare 1 mg film-coated tablets EFG

Finasteride

Read the entire leaflet carefully before taking the 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects that you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Alocare 1 mg tablets are and what they are used for
2. Before taking Alocare 1 mg tablets
3. How to take Alocare 1 mg tablets
4. Possible side effects
5. Storage of Alocare 1 mg tablets
6. Additional information

1. What Alocare 1 mg tablets are and what they are used for

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

Your doctor has prescribed Alocare 1 mg because you have male pattern 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) involved in the regulation of the hair follicle.

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

2. Before taking Alocare 1 mg tablets

Do not take Alocare 1 mg:

• If you are allergic (hypersensitive) to finasteride or any of the other components of Alocare 1 mg.
• If you are a child or adolescent.
• If you are a woman (see also the section 'Pregnancy and breastfeeding'). Clinical studies have shown 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 condition.

Be particularly careful while taking Alocare 1 mg:

The determination of prostate-specific antigen (PSA) in serum should 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 medicines:

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

There is no information 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 drinks:

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, split, or crushed. If finasteride is absorbed through the skin or taken orally by pregnant women of a male fetus, the baby may be born with genital 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 medicine.

Driving and using machines:

There is no information to suggest that Alocare 1 mg affects the ability to drive and use machinery.

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

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

3. How to take Alocare 1 mg tablets

Always take Alocare 1 mg exactly as your doctor has indicated. If you are not sure, consult your doctor or pharmacist.

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

The film-coated tablets can be taken with or without food. The film-coated tablets should be swallowed whole and should not be divided or crushed.

• Alocare 1 mg does not work better or faster if you take more than one tablet per day.
• Male hair loss is a disorder 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

There is no experience with the use of Alocare 1 mg in patients with liver disorders (see also 'Be particularly careful while taking Alocare 1 mg').

Patients with kidney disorders

No dose adjustment is necessary in patients with kidney 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. Go to your nearest hospital and take all the remaining tablets or the empty package 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 make up for a forgotten dose.

If you stop taking Alocare 1 mg:

Continuous use of Alocare 1 mg is recommended to achieve the maximum benefit. If treatment is stopped, it is likely that you will lose the regained hair within 9 to 12 months.

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

4. Possible side effects

Like all medicines, Alocare 1 mg can cause side effects, although not everyone gets them.

Normally, side effects have been temporary with continued treatment or have disappeared once treatment was stopped.

Uncommon (between 1 and 10 in every 1,000 patients):

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

Frequency not known:

• allergic reactions, such as skin rash, itching, lumps under the skin (hives), and swelling of the lips and face
• breast tenderness or enlargement
• testicular pain
• increased heart rate
• persistent difficulty getting 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. Normalization or improvement of semen quality has been reported after stopping treatment with finasteride. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.
  • anxiety

Stop your treatment with 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 (hives)
• breathing difficulties

If you think any of the effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Alocare 1 mg tablets

• Keep out of the reach and sight of children.
• This medicine does not require special storage conditions.
• 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 via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Alocare 1 mg:

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

The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium glycolate starch (type A), lauroyl macrogolglycerides, magnesium stearate (E572).

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

Appearance of the product and packaging of Alocare 1 mg:

Film-coated tablet.

Alocare 1 mg tablets are reddish-brown, 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)

Manufacturer:

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.

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/.