MINOXIDIL BIORGA 50 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet:information for the patient

MinoxidilBiorga50 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 4 months.

Contents of the leaflet

1. What is Minoxidil Biorga 50 mg/ml and what is it used for
2. What you need to know before starting to use Minoxidil Biorga 50 mg/ml
3. How to use Minoxidil Biorga 50 mg/ml
4. Possible side effects
5. Storage of Minoxidil Biorga 50 mg/ml
6. Package contents and additional information

1. What is Minoxidil Biorga 50 mg/ml and what is it used for

Minoxidil Biorga 50 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 of action to renew hair growth is unknown.

Minoxidil Biorga 50 mg/ml is indicated in adults between 18 and 65 years old who experience gradual thinning or hair loss on the top of the head. Thinning or hair loss is a slow process that can become visible after several years of gradual hair loss.

Minoxidil Biorga 50 mg/ml is especially indicated in men who suffer from hair loss or thinning of the hair on the top of the head, or in women with generalized hair thinning.

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

2. What you need to know before starting to use Minoxidil Biorga 50 mg/ml

Do not use MinoxidilBiorga 50mg/ml:

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

Minoxidil Biorga 50 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 serious 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 50 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 50 mg/ml.

Do not start applying Minoxidil Biorga 50 mg/ml if your hair loss is sudden or unexplained, or if it occurs after suffering from an illness or receiving treatment. If you have doubts about hair loss, consult your doctor before using Minoxidil Biorga 50 mg/ml.

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

If you have or have had vascular or cardiac disorders (including irregular heartbeat), you should consult a doctor before using Minoxidil Biorga 50 mg/ml.

Minoxidil Biorga 50 mg/ml should not be applied if the affected area is red, inflamed, irritated, or painful, for example, if you have suffered from severe sunburn or seborrheic dermatitis. It should not be applied to other parts of the body or concomitantly with other topical medications.

If you experience unusual symptoms after applying Minoxidil Biorga 50 mg/ml, interrupt the application and consult your doctor. It is especially important that you interrupt the application of Minoxidil Biorga 50 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 interrupt the application 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.

There have been reports of excessive body hair growth in infants after skin contact with the application areas of minoxidil in patients (caregivers) using topical minoxidil. The hair growth normalized 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 areas of the body where minoxidil has been applied topically.

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

Do not ingest.

Do not inhale.

Minoxidil Biorga 50 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.

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

Minoxidil Biorga 50 mg/ml should not be administered to patients under 18 years old.

Using MinoxidilBiorga 50mg/mlwith other medications

Inform 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 50 mg/ml is not expected to affect the patient's ability to drive or use machines.

MinoxidilBiorga50mg/mlcontains propylene glycol

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

3. How to use Minoxidil Biorga 50 mg/ml

Minoxidil Biorga 50 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 50 mg/ml as prescribed by your doctor in your case.

You should administer TWO APPLICATIONS PER DAY, for example, once in the morning and once at night (or similar regimens), a dose of Minoxidil Biorga 50 mg/ml (1 ml) directly to the area of the scalp where you experience hair loss. Spread the dose over the entire affected area, massaging it with your fingertips.

Each bottle of Minoxidil Biorga 50 mg/ml contains 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 the results are not immediate. In general, new hair growth occurs gradually, and it is necessary to continue applying the medication twice a day for at least 4 months to notice the effects.

Since Minoxidil Biorga 50 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 50 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 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.

The improper use of a medication or an inappropriate dose can cause problems. Therefore, you should not use this medication to treat other diseases or other patients.

While using Minoxidil Biorga 50 mg/ml, you do not need to change your usual hair care routine. However, you should first apply Minoxidil Biorga 50 mg/ml, then let your hair dry, and finally apply sprays, foams, conditioners, gels, or any other product (in case you use dye, permanent wave, etc.). If you swim or get your head wet, it is preferable to apply Minoxidil Biorga 50 mg/ml to the dry scalp after swimming or wait a couple of hours after applying the product. You should allow Minoxidil Biorga 50 mg/ml to act on the scalp for at least two hours.

How to apply MinoxidilBiorga 50 mg/ml?

Minoxidil Biorga 50 mg/ml is for cutaneous 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. If you wash your scalp before applying Minoxidil Biorga 50 mg/ml, you should use a gentle and effective shampoo.

Seven sprays are needed to administer one dose (1 ml) of Minoxidil Biorga 50 mg/ml.

Masage 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 to apply the solution to large areas of the scalp.
2. Spray applicator with nozzle to apply 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. Clear the spray and put the closure 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 down.
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. Clear the applicator and put the closure 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. If in doubt, ask your doctor or pharmacist.

If you use more MinoxidilBiorga 50mg/mlthan you should

Minoxidil Biorga 50 mg/ml should not be administered orally. In case of accidental ingestion, consult your doctor or a poison control center.

Accidental ingestion may produce systemic effects related to the vasodilatory 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 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 such as epinephrine and norepinephrine should be avoided, as these medications cause excessive cardiac stimulation.

If you experience other effects related to the use of Minoxidil Biorga 50 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 50 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 in greater quantity and may cause an increase in the appearance of side effects.

If you forget to use MinoxidilBiorga 50mg/ml

If you forget one or two applications of Minoxidil Biorga 50 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 interrupt treatment with MinoxidilBiorga 50mg/ml

To maintain hair growth, it is necessary to continuously apply the recommended dose of Minoxidil Biorga 50 mg/ml. Three or four months after interrupting treatment with Minoxidil Biorga 50 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 side 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 side effects, although not everyone will experience them.

Side effects are listed in order of frequency, from highest to lowest.

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 side effects

If you experience any type of side 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 Medicines: www.notificaram.es.

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

5. Storage of Minoxidil Biorga 50 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 collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of MinoxidilBiorga 50mg/ml

• The active ingredient is minoxidil. Each ml of cutaneous solution contains 50 mg of minoxidil.
• The other components are propylene glycol, 96% ethanol, and purified water.

Appearance of the Product and Packaging Content

Minoxidil Biorga 50 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.

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 marketed.

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 Prospectus: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/