Minoxidil Biorga 20 mg/ml cutaneous solution

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Minoxidil Biorga 20 mg/ml topical solution

Minoxidil

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not see any improvement after 4 months.

Leaflet contents

1. What Minoxidil Biorga 20 mg/ml is and what it is used for
2. What you need to know before using Minoxidil Biorga 20 mg/ml
3. How to use Minoxidil Biorga 20 mg/ml
4. Possible side effects
5. How to store Minoxidil Biorga 20 mg/ml
6. Contents of the pack and other information

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

Minoxidil Biorga 20 mg/ml is a liquid medicine 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 stimulates hair regrowth is unknown.

Minoxidil Biorga 20 mg/ml is indicated for adults aged between 18 and 65 who experience gradual thinning or hair loss on the upper part of the scalp. Hair thinning or loss is a slow process that may become noticeable after several years of gradual hair fall.

Minoxidil Biorga 20 mg/ml is particularly indicated in men experiencing hair loss or thinning of hair on the upper part of the scalp, or in women with generalised 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 using Minoxidil Biorga 20 mg/ml

Do not use Minoxidil Biorga 20 mg/ml:

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

Minoxidil Biorga 20 mg/ml is not indicated for use in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (characterized by scarred skin, such as from burns or ulcers). Minoxidil Biorga 20 mg/ml should also not be used if hair loss is associated with pregnancy, childbirth, or serious illnesses such as thyroid dysfunction, lupus, hair loss associated with scalp inflammation, or other diseases.

Warnings and precautions

Since alopecia may also be a symptom of serious conditions affecting the ovaries, pituitary gland, or adrenal glands, 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 pattern (hirsutism); menstrual disorders; hypertension; muscle weakness; lower 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 medical treatment. If you have any doubts about your hair loss, consult your doctor before using Minoxidil Biorga 20 mg/ml.

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

Do not apply Minoxidil Biorga 20 mg/ml if the affected area is red, inflamed, irritated, or painful—for example, after a severe sunburn or seborrheic dermatitis. Minoxidil Biorga 20 mg/ml should also not be applied to other parts of the body or used concomitantly with other topical medications.

If you experience unusual symptoms after applying Minoxidil Biorga 20 mg/ml, stop using it and consult your doctor. It is especially important to discontinue use if you experience a rapid heartbeat (palpitations), swelling of the hands and feet, sudden unexplained weight gain, chest pain, weakness, or dizziness. You should also stop using the product if your scalp becomes red or irritated.

The risk of systemic effects (e.g., rapid heartbeat or fluid retention) is higher in patients with known or suspected coronary artery disease or those predisposed to myocardial infarction. Patients with such conditions and their physicians should be aware of these risks before deciding to use Minoxidil Biorga 20 mg/ml.

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

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

Cases of excessive body hair growth in infants have been reported following skin contact with areas where caregivers using topical minoxidil had applied the product. Hair growth returned to normal within months once the infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.

Consult your doctor if you notice excessive body hair growth in your child during your use of topical minoxidil products.

Do not swallow.

Do not inhale.

Minoxidil Biorga 20 mg/ml contains alcohol and may cause stinging and eye irritation. In case of accidental contact with sensitive surfaces (eyes, abraded skin, or mucous membranes), wash the area thoroughly with plenty of fresh running water.

Children and adolescents

Minoxidil Biorga 20 mg/ml must not be administered to patients under 18 years of age.

Use of Minoxidil Biorga 20 mg/ml with other medicines

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

Although not clinically proven, there is a theoretical possibility that absorbed minoxidil could enhance orthostatic hypotension in patients concurrently taking peripheral vasodilators.

Pregnancy and breastfeeding

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

Driving and use of machines

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

Minoxidil Biorga 20 mg/ml contains propylene glycol

This medicine 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 improve achieved results, it is important not to interrupt the regular twice-daily application of Minoxidil Biorga 20 mg/ml at the recommended dose.

You should apply Minoxidil Biorga 20 mg/ml twice daily (e.g., once in the morning and once in the evening), administering one dose (1 ml) directly onto the area of the scalp affected by hair loss. Spread the dose evenly over the affected area by gently massaging it in with the fingertips.

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

Clinical trials have shown that response to treatment varies considerably and results are not immediate. In general, new hair growth occurs gradually, and treatment must be continued twice daily for at least 4 months before improvement becomes noticeable.

Since Minoxidil Biorga 20 mg/ml acts primarily on hair follicles, a temporary increase in hair loss may be observed between 2 and 6 weeks after starting treatment.

If you had very little hair when starting treatment and respond to it, the new hair will initially be soft and downy, and therefore not very visible. As treatment continues, the new hair will gradually acquire a color and texture similar to the rest of your hair. If hair loss is not severe at the start of treatment, the new hair will develop a color and texture similar to the surrounding hair.

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

While using Minoxidil Biorga 20 mg/ml, you do not need to change your usual hair care routine. However, you must first apply Minoxidil Biorga 20 mg/ml, then allow your hair to dry completely, and only afterward apply sprays, foams, conditioners, gels, or any other styling products (including hair dyes or permanents). If you go swimming 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 swimming before applying the product. Minoxidil Biorga 20 mg/ml should be allowed to act on the scalp for at least two hours.

How to apply Minoxidil Biorga 20 mg/ml?

Minoxidil Biorga 20 mg/ml is for external use only. Apply one dose (1 ml) twice daily to the area of hair loss. Do not exceed the recommended dose. This medication should not be applied to areas other than the scalp. If you wash your scalp before applying Minoxidil Biorga 20 mg/ml, use a mild shampoo.

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

Massage the applied amount gently into the affected area. Wash your hands thoroughly after each application.

Instructions for use

The instructions depend on the type of applicator used.

1. Spray applicator for treating large areas of the scalp.

2. Spray applicator with cannula for treating small areas of the scalp or hair.

3. Spray applicator

Recommended for large areas of the scalp.

1. Remove the cap from the bottle.

2. Direct the spray nozzle toward the bald area, press once, and spread the solution over the area using the fingertips. Repeat this procedure six more times until the full dose of 1 ml has been applied (a total of 7 sprays). Avoid inhaling the medication during application.

3. Rinse the spray nozzle and replace the closure cap on the bottle after use to prevent alcohol evaporation.

4. Spray applicator with cannula

Recommended for small areas of the scalp or hair.

1. Remove the cap from the bottle.
2. Remove the spray nozzle from the pump. Attach the cannula to the spray pump and press it down firmly until fully secured.
3. Direct the spray nozzle toward the bald area, press once, and spread the solution over the area using the fingertips. Repeat this procedure six more times until the full dose of 1 ml has been applied (a total of 7 sprays). Avoid inhaling the medication during application.
4. Rinse the applicator and replace the closure cap on the bottle after use to prevent alcohol evaporation.

Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

If you use more Minoxidil Biorga 20 mg/ml than you should

No cases of minoxidil overdose have been reported following topical application of Minoxidil Biorga 20 mg/ml to the skin.

Minoxidil Biorga 20 mg/ml must not be taken orally. In case of accidental ingestion, consult your doctor or a poison control center immediately.

Signs and symptoms of minoxidil overdose are primarily cardiovascular effects associated with fluid retention and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled with a β-adrenergic receptor blocker. Symptomatic hypotension should be treated with intravenous saline solution. Sympathomimetic agents such as epinephrine and norepinephrine should be avoided, as they may cause excessive cardiac stimulation.

If you experience any side effects related to the use of Minoxidil Biorga 20 mg/ml that are not listed in this leaflet, inform your doctor or pharmacist immediately.

Careful clinical trials have been conducted to determine the exact amount of Minoxidil Biorga 20 mg/ml needed to achieve satisfactory results. Applying higher doses than recommended (1 ml) or applying it more than twice daily is not advised. Increasing the dose or frequency of application will not make hair grow faster or in greater quantity and may increase the risk of adverse effects.

If you forget to use Minoxidil Biorga 20 mg/ml

If you miss one or two applications of Minoxidil Biorga 20 mg/ml, resume treatment as usual with twice-daily applications according to your regular schedule. Do not apply a higher dose to make up for a missed dose.

If you stop using Minoxidil Biorga 20 mg/ml

To maintain hair growth, it is necessary to continue applying the recommended dose of Minoxidil Biorga 20 mg/ml continuously. Three to four months after stopping treatment, new hair growth will cease, and hair loss will return to its previous rate observed before treatment.

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

4. Possible adverse effects

Contact a doctor immediately 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 medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects are listed in order from most to least frequent.

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), rash, acneiform rash, 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, increased heart rate, chest pain
• Erythema at the application site

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

• Hypotension

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 medicine after the expiry date stated on the bottle after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of MinoxidilBiorga 20 mg/ml

• The active substance 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 contents of the container

Minoxidil Biorga 20 mg/ml is a clear, colourless or slightly yellowish solution with an alcoholic odour, available in the following presentations:

HDPE bottle with spray pump/applicators (removable actuator with cannula) containing 60 ml of solution.

Pack 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 latest revision of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/