Prospecto:Information for the Patient

MinoxidilBiorga20 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 20mg/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 20mg/mlis indicated for adults between 18 and 65 years old who experience a gradual weakening or hair loss on the upper part of the head. Weakening or hair loss is a slow process that may become visible after several years of gradual loss.

MinoxidilBiorga20mg/mlis especially indicatedinmen who sufferen hair loss or weakening of the hair on the upper part of the head,orinwomen with generalized hair weakening.

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

No use MinoxidilBiorga 20mg/ml:

• If you are allergic to minoxidil or any of the other components of this medication (listed in section 6).

MinoxidilBiorga 20mg/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 20mg/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 20mg/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 20mg/ml.

Do not start applying MinoxidilBiorga 20mg/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 20mg/ml.

If you have or have had vascular or cardiac disorders (including irregular heart rate), consult a doctor before using MinoxidilBiorga 20mg/ml.

Do not apply MinoxidilBiorga 20mg/mlto an area that is red, inflamed, irritated, or painful, such as a severe sunburn or seborrheic dermatitis. Do not apply MinoxidilBiorga 20mg/mlto other parts of the body or concurrently with other topical medications.

If you experience unusual symptoms after applying MinoxidilBiorga 20mg/ml, discontinue use and consult your doctor. It is especially important to discontinue use of MinoxidilBiorga 20mg/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 if the scalp becomes red or irritated.

The occurrence of systemic effects (such as rapid heart rate or fluid retention) is higher in patients with known or suspected coronary artery disease and in patients with a predisposition to myocardial infarction. When deciding to apply MinoxidilBiorga 20mg/ml, patients with these conditions and doctors should be aware of the risks.

MinoxidilBiorga 20mg/mlshould only be used on the scalp because, in other areas of the body, the absorption of minoxidil may be higher and increase the incidence of adverse effects. If the scalp is irritated or sunburned, do not apply MinoxidilBiorga 20mg/ml.

Do not apply MinoxidilBiorga 20mg/mlto the scalp if another topical medication is already being applied.

Do not ingest.

Do not inhale.

MinoxidilBiorga 20mg/mlcontains alcohol in its composition, which can cause stinging and eye irritation. In case of accidental contact with sensitive surfaces (eyes, scalded skin, and mucous membranes), the area should be rinsed with plenty of fresh running water.

Children and Adolescents

MinoxidilBiorga 20mg/mlshould not be administered to patients under 18 years old.

Use of MinoxidilBiorga 20mg/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

It is not expected that MinoxidilBiorga 20mg/mlwill affect the patient's ability to drive or operate machines.

MinoxidilBiorga20mg/mlcontains Propylene Glycol

Thismedicationmayproduceirritationoftheskinbecauseitcontainspropylene glycol.

Minoxidil Biorga 20mg/mlis a treatment, not a cure. To maintain or increase the results achieved, it is essential not to interrupt the regular application ofMinoxidil Biorga 20mg/mltwice a day with the recommended dose.

You must administer a dose ofMinoxidil Biorga 20mg/ml(1 ml) directly to the scalp area where you experience hair loss, twice a day (e.g., once in the morning and once at night). Extend the dose over the affected area by massaging it with your fingertips.

Each bottle ofMinoxidil Biorga 20mg/mlcontains a sufficient amount for 30 days.

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

SinceMinoxidil Biorga 20mg/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 and responded to treatment when you started usingMinoxidil Biorga 20mg/ml, the new hair will grow soft and fluffy at first, so it will not be very visible. As you continue 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 you start treatment, the new hair will acquire a color and texture similar to the rest of your hair.

If you wash your scalp before applyingMinoxidil Biorga 20mg/ml, you should use a mild shampoo.

While usingMinoxidil Biorga 20mg/ml, you do not need to change your usual hair care routine. However, you should first applyMinoxidil Biorga 20mg/ml, then let your hair dry, and only then apply sprays, shampoos, conditioners, gels, or any other product (if you use dye, permanent, etc.). If you practice swimming or get your head wet, it is best to applyMinoxidil Biorga 20mg/mlto a dry scalp after swimming or wait a couple of hours after applying the product. You should allowMinoxidil Biorga 20mg/mlto act on your scalp for at least two hours.

How to apply MinoxidilBiorga 20mg/ml

Minoxidil Biorga 20mg/mlis only for topical use. Apply a dose (1 ml) to the hair loss area 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 20mg/ml, you should use a mild shampoo.

Seven sprays are required to administer a dose (1 ml) ofMinoxidil Biorga 20mg/ml.

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

Instructions for use

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. Point the atomizer at the bald area, press it once, and extend the solution with your fingertips over the affected 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. Clean the spray and replace the closure cap 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 pump and press until it reaches the bottom.
3. Point the atomizer at the bald area, press it once, and extend the solution with your fingertips over the affected 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. Clean the applicator and replace the closure cap on the bottle after use to prevent alcohol evaporation.

Follow the medication 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 MinoxidilBiorga20mg/mlthan you should

No cases of minoxidil overdose have been described as a result of applyingMinoxidil Biorga 20mg/mlto the skin.

Minoxidil Biorga 20mg/mlshould not be administered orally.In case of accidental ingestion, consult your doctor or a toxicology information center.

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 solution. Beta blockers should be avoided, as they cause excessive stimulation of the heart.

If you experience other effects related to the use ofMinoxidil Biorga 20mg/mlthat are not described in this leaflet, you should inform your doctor or pharmacist immediately.

Careful clinical trials have been conducted to determine the exact amount ofMinoxidil Biorga 20mg/mlthat should be applied to achieve satisfactory results. It is not recommended to apply higher doses than the recommended dose (1 ml) or more than twice a day.The increase in 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 20mg/ml

If you forget one or two applications ofMinoxidil Biorga 20mg/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 20mg/ml

To maintain hair growth, it is necessary to apply the recommended dose ofMinoxidil Biorga 20mg/mlcontinuously. Three or four months after interrupting treatment withMinoxidil Biorga 20mg/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 not known, 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 most frequent to least frequent.

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

• Headache

Frequent (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

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

• Dry skin, skin exfoliation, temporary hair loss, changes in hair texture, changes in hair colorIrritation 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 prospectus. 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 containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Minoxidil CompositionBiorga 20mg/ml

• The active ingredient is minoxidil.Each ml of topical solution contains 20 mg of minoxidil.
• The other components are propylene glycol, ethanolal96%and purified water.

Appearance of the product and contents of the packaging

MinoxidilBiorga 20mg/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(removableactuatorwithnozzle)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.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Laboratoires Bailleul S.A.

14-16 Avenue Pasteur

L-2310– Luxembourg

Manufacturer responsible:

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/