MINOXIDIL BIORGA 20 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet:information for the patient

MinoxidilBiorga20 mg/mlcutaneous solution

Minoxidil

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

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.

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

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

Contents of the leaflet

1. What is Minoxidil Biorga 20 mg/ml and what is it used for
2. What you need to know before starting to use Minoxidil Biorga 20 mg/ml
3. How to use Minoxidil Biorga 20 mg/ml
4. Possible adverse effects
5. Storage of Minoxidil Biorga 20 mg/ml
6. Contents of the package and additional information

1. What is Minoxidil Biorga 20 mg/ml and what is it used for

Minoxidil Biorga 20 mg/ml is 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 its exact mechanism for renewing hair growth is unknown.

Minoxidil Biorga 20 mg/ml is indicated for adults between 18 and 65 years old who experience gradual thinning or hair loss on the top of the head. Hair thinning or loss is a slow process that can become visible after several years of gradual hair loss.

Minoxidil Biorga 20 mg/ml is especially indicated for men who suffer from hair loss or thinning on the top of the head, or for women with generalized hair thinning.

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

2. What you need to know before starting to use Minoxidil Biorga 20 mg/ml

Do not use MinoxidilBiorga 20mg/ml:

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

Minoxidil Biorga 20 mg/ml is not indicated in cases of alopecia areata (sudden or unexplained hair loss) or scarring alopecia (characterized by skin with scarring characteristics, such as burns or ulcers). It should not be used if hair loss is associated with pregnancy, childbirth, or severe illnesses, such as thyroid dysfunction, lupus, or 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 Minoxidil Biorga 20 mg/ml if 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; back pain; osteoporosis; stretch marks; acne.

Consult your doctor or pharmacist before starting to use Minoxidil Biorga 20 mg/ml.

Do not start applying Minoxidil Biorga 20 mg/ml if your hair loss is sudden or unexplained, or if it occurs after an illness or treatment. If you have doubts about your hair loss, consult your doctor before using Minoxidil Biorga 20 mg/ml.

If you have or have had vascular or cardiac disorders (including irregular heartbeat), you should consult a doctor before using Minoxidil Biorga 20 mg/ml.

Minoxidil Biorga 20 mg/ml should not be applied if the affected area is red, inflamed, irritated, or painful, for example, if you have suffered a severe sunburn or seborrheic dermatitis. It should not be applied to other parts of the body or concomitantly with other topical medications.

In case you experience unusual symptoms after applying Minoxidil Biorga 20 mg/ml, stop the application and consult your doctor. It is especially important to stop the application of Minoxidil Biorga 20 mg/ml if you experience an accelerated heart rate (palpitations), swelling of the hands and feet, sudden weight gain without apparent cause, chest pain, weakness, or dizziness. You should also stop the application of the product if the scalp becomes red or irritated.

The appearance of systemic effects (e.g., accelerated heart rate or fluid retention) is greater in patients with known or suspected coronary arteriopathy and in patients with a predisposition to myocardial infarction. When deciding to apply Minoxidil Biorga 20 mg/ml, patients with these types of diseases and doctors should be aware of the risks.

Minoxidil Biorga 20 mg/ml should only be used on the scalp, as absorption of minoxidil may be greater in other areas of the body, increasing the incidence of adverse effects. If the scalp is irritated or sunburned, Minoxidil Biorga 20 mg/ml should not be applied.

Minoxidil Biorga 20 mg/ml should not be applied to the scalp if another topical medication is already being applied.

Cases of excessive body hair growth have been reported in infants after skin contact with minoxidil application areas in patients (caregivers) using topical minoxidil. Hair growth returned to normal within a few months when the infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with the body areas where minoxidil has been applied topically.

Consult your doctor if you observe excessive hair growth on your child's body during the period you are using topical minoxidil products.

Do not ingest.

Do not inhale.

Minoxidil Biorga 20 mg/ml contains alcohol in its composition, which may cause eye irritation and stinging. In case of accidental contact with sensitive surfaces (eyes, scraped skin, and mucous membranes), the area should be rinsed with plenty of fresh running water.

Children and adolescents

Minoxidil Biorga 20 mg/ml should not be administered to patients under 18 years old.

Using MinoxidilBiorga 20mg/mlwith other medications

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

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

Pregnancy and breastfeeding

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

Driving and using machines

Minoxidil Biorga 20 mg/ml is not expected to affect your ability to drive or use machines.

MinoxidilBiorga 20mg/mlcontains propylene glycol

This medication may cause skin irritation because it contains propylene glycol.

3. How to use Minoxidil Biorga 20 mg/ml

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

You should administer TWO APPLICATIONS A DAY (e.g., once in the morning and once at night) of a dose of Minoxidil Biorga 20 mg/ml (1 ml) directly to the area of the scalp where you experience hair loss. Spread the dose over the entire affected area by massaging it with your fingertips.

Each bottle of Minoxidil Biorga 20 mg/ml contains enough for 30 days.

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

Since Minoxidil Biorga 20 mg/ml acts primarily on the 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 you started using Minoxidil Biorga 20 mg/ml and responded to treatment, the new hair will grow soft and downy 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 your hair loss was not very pronounced when you started treatment, the new hair will acquire a color and texture similar to the rest of your hair.

In case you wash your scalp before applying Minoxidil Biorga 20 mg/ml, you should use a mild shampoo.

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

How to apply MinoxidilBiorga 20mg/ml?

Minoxidil Biorga 20 mg/ml is for topical use only. Apply one dose (1 ml) twice a day to the area of hair loss. Do not apply more than the recommended doses. It is not advisable to apply this medication to areas other than the scalp. In case you wash your scalp before applying Minoxidil Biorga 20 mg/ml, you should use a mild shampoo.

Seven sprays are required to administer one dose (1 ml) of Minoxidil Biorga 20 mg/ml.

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

Instructions for use

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

1. Spray applicator for applying the solution to large areas of the scalp.
2. Spray applicator with nozzle for applying the solution to small areas of the scalp or hair.

1. Spray applicator

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

1. Remove the cap from the bottle.
2. Direct the spray applicator to the bald area, press it once, and spread the solution with your fingertips over the entire area. Repeat the procedure six times until the required dose of 1 ml is fully applied (i.e., a total of 7 sprays). Avoid inhaling the medication during application.
3. Clean the spray and put the cap back on the bottle after use to avoid alcohol evaporation.

1. Spray applicator with nozzle

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 nozzle on the spray pump and press it to the bottom.
3. Direct the spray applicator to the bald area, press it once, and spread the solution with your fingertips over the entire area. Repeat the procedure six times until the required dose of 1 ml is fully applied (i.e., a total of 7 sprays). Avoid inhaling the medication during application.
4. Clean the applicator and put the cap back on the bottle after use to avoid alcohol evaporation.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

If you use more MinoxidilBiorga 20mg/mlthan you should

No cases of minoxidil overdose have been reported as a result of applying Minoxidil Biorga 20 mg/ml to the skin.

Minoxidil Biorga 20 mg/ml should 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 adequate diuretic treatment. Tachycardia can be controlled with the administration of a beta-adrenergic receptor blocker. Symptomatic hypotension should be treated with intravenous saline solution. Sympathomimetics like epinephrine and norepinephrine should be avoided, as they can cause excessive heart stimulation.

In case you experience other effects related to the use of Minoxidil Biorga 20 mg/ml that 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 of Minoxidil Biorga 20 mg/ml that should be applied to achieve satisfactory results. It is not recommended to apply higher doses than recommended (1 ml) or more than twice a day. Increasing the dose or frequency of administration will not make the hair grow faster or more abundantly and may increase the appearance of adverse effects.

If you forget to use MinoxidilBiorga 20mg/ml

If you forget one or two applications of Minoxidil Biorga 20 mg/ml, you should restart your application twice a day following your normal schedule. Do not apply a larger dose to make up for a forgotten dose.

If you stop treatment with MinoxidilBiorga 20mg/ml

To maintain hair growth, it is necessary to continuously apply the recommended dose of Minoxidil Biorga 20 mg/ml. Three or four months after stopping treatment with Minoxidil Biorga 20 mg/ml, new hair growth will stop, and the hair loss process will return to normal when the treatment is not applied.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Immediately contact a doctor if you notice any of the following symptoms - you may need 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 can cause adverse effects, although not everyone will experience them.

Adverse effects are listed in order of higher to lower frequency.

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, hypertrichosis (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, accelerated heart rate, 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 not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es.

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

5. Storage of Minoxidil Biorga 20 mg/ml

Keep out of sight and reach of children.

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

Do not use this medication after the expiration date shown on the bottle after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of MinoxidilBiorga 20mg/ml

• The active ingredient is minoxidil. Each ml of cutaneous solution contains 20 mg of minoxidil.
• The other components are propylene glycol, 96% ethanol, and purified water.

Appearance of the Product and Container Content

Minoxidil Biorga 20 mg/ml is a transparent and colorless or slightly yellowish solution, with an alcoholic odor, available in the following presentations:

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

Container 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

Marketing authorization holder:

Laboratoires Bailleul S.A.

14-16 Avenue Pasteur

L-2310 – Luxembourg

Manufacturer:

DELPHARM HUNINGUE SAS

26 rue de la Chapelle

68330 Huningue

France

Lichtenheldt GmbH Pharmazeutishe Fabrik

Industriestrasse 7-11

23812 Wahlstedt

Germany

Date of the Last Revision of this Leaflet:September 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/