Prospecto:Information for the Patient

MinoxidilBiorga50 mg/mlSolution for Cutaneous Use

Minoxidil

Read this entire prospectus carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this prospectus or those indicated by your doctor or pharmacist.

• Keep this prospectus, as you may need to refer to it again.

If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed only to you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.Seesection4.
• You should consult a doctor if your condition worsens or does not improve after 4 months.

MinoxidilBiorga 50mg/mlis a liquid medication intended for direct application to the scalp. It is used as a treatment for hair loss and not as a cure. Minoxidil is a peripheral vasodilator, and the exact mechanism by which it promotes hair growth is unknown.

MinoxidilBiorga 50 mg/mlis indicatedforadults between 18 and 65 years old who experience a gradual weakening or hair loss in the upper part of the head. Weakening or hair loss is a slow process that may become visible after several years of gradual loss.

MinoxidilBiorga50mg/mlis especially indicatedformen who suffer from hair loss or weakening of the hair in the upper part of the head,orin women with generalized hair weakening.

You should consult a doctor if it worsens or does not improve after 4 months.

No use MinoxidilBiorga 50mg/ml:

• if is allergic to minoxidil or any of the other components of this medication (including those listed in section 6).

MinoxidilBiorga 50mg/mlis not indicated for cases of alopeciaareata(sudden or unexplained hair loss) or alopecia cicatricial (characterized by skin with scarring features, such as burns or ulcers). MinoxidilBiorga 50mg/mlshould not be used if hair loss is associated with pregnancy, childbirth, or serious diseases, such as thyroid dysfunction, lupus, hair loss associated with inflammation of the scalp, or other diseases.

Warnings and Precautions

Since alopecia can also be a symptom of serious ovarian, pituitary, or adrenal gland diseases, women should consult their doctor before using MinoxidilBiorga 50mg/mlif they experience any of the following symptoms: rapid weight gain, especially in the trunk and face but not in the limbs (central obesity); facial hair growth following a male distribution pattern (hirsutism); menstrual disorders; hypertension; muscle weakness; lower back pain; osteoporosis; striae; acne.

Consult your doctor or pharmacist before starting to use MinoxidilBiorga 50mg/ml.

Do not start applying MinoxidilBiorga 50mg/mlif your hair loss is sudden or unexplained, or if it occurs after a disease or treatment. If you have doubts about hair loss, consult your doctor before using MinoxidilBiorga 50mg/ml.

Patients treated with Minoxidil Biorga 50 mg/ml should undergo a medical examination prior to treatment. The doctor will determine if the patient's scalp appears normal.

If you have or have had any vascular or cardiac disorders (including irregular heart rate), consult a doctor before using MinoxidilBiorga 50mg/ml.

Do not apply MinoxidilBiorga 50mg/mlto an area that is red, inflamed, irritated, or painful, such as a severe sunburn or seborrheic dermatitis. MinoxidilBiorga 50mg/mlshould not be applied to other parts of the body or concurrently with other topical medications.

If you experience unusual symptoms after applying MinoxidilBiorga 50 mg/ml, discontinue use and consult your doctor. It is especially important to discontinue use of MinoxidilBiorga 50 mg/mlif you experience rapid heart rate (palpitations), swelling of the hands and feet, sudden unexplained weight gain, chest pain, weakness, or dizziness. You should also discontinue use of the product if the scalp appears red or irritated.Patients with a history of cardiac disorders may worsen with the use of Minoxidil Biorga 50 mg/ml.

Do not ingest.

Do not inhale.

MinoxidilBiorga 50mg/mlcontains alcohol in its composition, which may cause stinging and eye irritation. In case of accidental contact with sensitive surfaces (eyes, scalded skin, and mucous membranes), rinse the area with plenty of fresh running water.

You should consult your doctor or pharmacist if:

• you suffer from cardiac disorders
• you have a history of allergic reactions
• you are taking other medications

Children and Adolescents

MinoxidilBiorga 50mg/mlshould not be administered to patients under 18 years old.

Use of MinoxidilBiorga 50mg/mlwith Other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Although not clinically proven, there is a theoretical possibility that absorbed minoxidil may potentiate orthostatic hypotension in patients taking concomitant peripheral vasodilators.

Pregnancy and Lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

MinoxidilBiorga 50mg/mlis not expected to affect the patient's ability to drive or operate machines.

MinoxidilBiorga50mg/mlcontains Propylene Glycol

Thismedicationmayproduceirritationoftheskinbecauseitcontainspropylene glycol.

MinoxidilBiorga 50 mg/mlis a treatment, not a cure. To maintain or increase the results achieved, it is essential not to interrupt the regular application ofMinoxidil Biorga 50 mg/ml as prescribed by your doctor in your case..

You will need to administer DOS VECES AL DÍA,porexample, once in the morning and once at night(or other similar regimens)a dose ofMinoxidil Biorga 50 mg/ml(1 ml) directly on the scalp area where you experience hair loss. Spread the dose over the affected area by massaging it with your fingertips.

Each bottle ofMinoxidil Biorga 50 mg/mlcontains enough for 30 days.This medication should not be used in patients under 18 years old.

Clinical trials have shown that the response to treatment is quite variable and that results are not immediate. In general, new hair growth occurs gradually and it is necessary to continue applying twice a day for at least 4 months to notice.

SinceMinoxidil Biorga 50 mg/mlacts first on hair follicles, you may observe a temporary increase in hair loss between 2 and 6 weeks after starting treatment.

If you had very little hair when starting treatment and responded to it, the new hair will grow soft and fluffy at first, so it will not be very visible. As you continue with treatment, the new hair will acquire a color and texture similar to the rest of your hair. If hair loss is not very pronounced when starting treatment, the new hair will acquire a color and texture similar to the rest of your hair.

The improper use of a medication or an inappropriate dose can cause problems. Therefore, do not use this medication for the treatment of other diseases or other patients..

While usingMinoxidil Biorga 50mg/ml, you do not need to change your usual hair care routine. However, you should first applyMinoxidil Biorga 50mg/ml, then let your hair dry and only apply shampoos, conditioners, gels, or any other product (if you use dye, permanent, etc.) at the end. If you practice swimming or get your head wet, it is best to applyMinoxidil Biorga 50mg/mlon dry scalp after swimming or wait a couple of hours after applying the product. You should allowMinoxidil Biorga 50mg/mlto act on the scalp for at least two hours.

How to apply MinoxidilBiorga 50 mg/ml?

Minoxidil Biorga 50mg/mlis only for cutaneous use. Apply to the hair loss area a dose (1 ml) twice a day. Do not apply doses higher than the recommended doses. Do not apply this medication to areas other than the scalp. If you wash your scalp before applyingMinoxidil Biorga 50mg/ml,you should use a mild and effective shampoo.

Seven sprays are needed to administer a dose (1 ml) ofMinoxidil Biorga 50mg/ml.

Massage the applied amount over the affected area. Wash your hands after each application.

Instructions for use

The instructions for use depend on the type of applicator used.

1. Atomizer for applying the solution to large areas of the scalp.
2. Atomizer with a cannula for applying the solution to small areas of the scalp or hair.

1. Atomizer

It is recommended to use it for large areas of the scalp.

1. Remove the cap from the bottle.
2. Direct the atomizer towards the bald area, press it once and spread the solution with your fingertips over the area. Repeat the procedure six times to apply the required dose of 1 ml (i.e., a total of 7 sprays). Avoid inhaling the medication during its application.
3. Clear the spray and replace the closure capsule on the bottle after use to prevent alcohol evaporation.

1. Atomization with cannula

This is the recommended method for small areas of the scalp or hair.

1. Remove the cap from the bottle.
2. Remove the spray nozzle from the pump. Place the cannula on the spray pump and press until the end.
3. Direct the atomizer towards the bald area, press it once and spread the solution with your fingertips over the area. Repeat the procedure six times to apply the required dose of 1 ml (i.e., a total of 7 sprays). Avoid inhaling the medication during its application.
4. Clear the applicator and replace the closure capsule on the bottle after use to prevent alcohol evaporation.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you use more MinoxidilBiorga50mg/mlthan you should

Minoxidil Biorga 50mg/mlshould not be administered orally.In case of accidental ingestion, consult your doctor or a toxicology information center..

Accidental ingestion may produce systemic effects related to the vasodilating effect of minoxidil.

The signs and symptoms of minoxidil overdose will be mainly cardiovascular effects associated with fluid retention and tachycardia. Fluid retention can be controlled with an appropriate diuretic treatment. Tachycardia can be controlled with the administration of a β-adrenergic receptor blocker. Symptomatic hypotension should be treated with intravenous saline administration. Beta-agonists such as epinephrine and norepinephrine should be avoided, as they cause excessive stimulation of the heart.

If you experience any other effects related to the use ofMinoxidil Biorga 50mg/mland not described in this leaflet, inform your doctor or pharmacist immediately.

Careful clinical trials have been conducted to determine the exact amount ofMinoxidil Biorga 50mg/mlto be applied to achieve satisfactory results. Do not apply higher doses than the recommended (1 ml) or more than twice a day.Increasing the dose or frequency of administration will not make the hair grow faster or in greater quantity and may cause an increase in the appearance of adverse effects.

If you forgot to use MinoxidilBiorga 50mg/ml

If you forget one or two applications ofMinoxidil Biorga 50mg/ml, you should restart your application twice a day following your normal schedule. Do not apply a higher dose to compensate for a missed dose.

If you interrupt treatment with MinoxidilBiorga 50mg/ml

To maintain hair growth, it is necessary to apply the recommended dose ofMinoxidil Biorga 50mg/mlcontinuously. Three or four months after interrupting treatment withMinoxidil Biorga 50mg/ml, new hair growth will stop and the normal hair loss process will resume when the treatment is not applied.

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

Seek immediate medical attention if you experience any of the following symptoms - you may require urgent medical treatment.

• Swelling of the face, lips, or throat that may cause difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from available data).

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Adverse effects are listed in order of frequency from most to least common.

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Depression
• Dyspnea (difficulty breathing)
• Pruritus, hirsutism (excessive hair growth), exanthema, acneiform exanthema, dermatitis, inflammatory skin disorder
• Musculoskeletal pain
• Peripheral edema
• Pain

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

• Dry skin, skin exfoliation, temporary hair loss, changes in hair texture, changes in hair color
• Irritation at the application site

Rare (may affect up to 1 in 1,000 people):

• Palpitations, tachycardia, chest pain
• Erythema at the application site

Very rare (may affect up to 1 in 10,000 people):

• Hypotension

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Flammable product. Protect from heat. Keep the container perfectly closed.

Do not use this medication after the expiration date that appears on the bottle 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. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of MinoxidilBiorga 50mg/ml

• The active ingredient is minoxidil.Each ml of topical solution contains 50 mg of minoxidil.
• The other components are propylene glycol, ethanolal96%and purified water.

Appearance of the product and contents of the packaging

MinoxidilBiorga 50mg/mlis a transparent and colorless or slightly yellowish solution with an alcohol odor, available in the following presentations:

HDPE bottle with a spray pump/applicator(removable actuator with nozzle)and a content of 60 ml of solution.

Packaging sizes:

1 bottle of 60 ml with 1 removable actuator with nozzle and 1 removable actuator with cannula.

3 bottles of 60 ml with 3 removable actuators with nozzle and 2 removable actuators with cannula.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratoires Bailleul S.A.

14-16 Avenue Pasteur

L-2310 – Luxembourg

Responsible manufacturer:

DELPHARM HUNINGUE SAS

26 rue de la Chapelle

68330 Huningue

France

Lichtenheldt GmbH Pharmaceutical Factory

Industriestrasse 7-11

23812 Wahlstedt

Germany

Last review date of this leaflet: January 2019.

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.es/