Bailleul Minoxidil 2% 3x60 ml

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Bailleul Minoxidil 2% 3x60 ml

Bailleul Minoxidil 2% 3x60 ml

$0.00
Product Information

Minoxidil 2% is a medication indicated for men and women in cases of moderate hair loss. This solution for cutaneous application helps promote hair growth  and slow hair loss in cases of androgenetic alopecia .

WHY USE MINOXIDIL 2%?

Minoxidil 2% solution treats androgenetic alopecia , i.e. chronic, significant and daily hair loss , leading to baldness , in adult men or women. These falls can appear for different reasons: age, following childbirth, during seasonal changes. 

Minoxidil is a substance that, when applied directly to the scalp,  stimulates hair growth and helps slow hair loss . Minoxidil at a dosage of 2% is used in the treatment of hormonal hair loss, namely in cases of androgenetic alopecia only.

HOW TO APPLY MINOXIDIL 2% TO STIMULATE REGROWTH?

Twice a day, apply 1 dose of 1 ml to the scalp, starting from the center of the affected area. Spread the product with your fingertips, so as to cover the entire area. 

Precautions for use :

The dose of 1 ml should be respected regardless of the surface area to be treated. The daily dose should not exceed 2 ml. Before and after applying the Minoxidil 2% solution, wash your hands thoroughly. Apply to perfectly dry hair and scalp. 

If exposed to the sun after application, cover your head with a hat or cap.

Wash your hair with a mild shampoo and limit colorings which can be aggressive for the scalp.

MINOXIDIL 2% HAIR GROWTH MEDICATION: INFORMATION AND INDICATIONS

This medication based on Minoxidil is indicated in cases of moderate hair loss  or  alopecia of hormonal origin in adults, men or women. It promotes hair growth and stabilizes the hair loss phenomenon.

Presentation offered by your online pharmacy 

  • Minoxidil 2% Bailleul Solution for cutaneous application 3 bottles of 60 ml
  • Alostil Minoxidil 2% from Johnson and Johnson laboratories in solution for cutaneous application 3 bottles of 60 ml
  • Alopexy Minoxidil 2% from Pierre Fabre laboratories in solution, box of 3 bottles of 60ml
  • Unipexil Minoxidil 2% 3 bottles of 60ml 

MINOXIDIL 2% DOSAGE 

Apply 1 ml of Minoxidil 2% to the scalp twice a day, starting at the centre of the area to be treated. This dose should be respected regardless of the size of the area concerned. The total daily dose should not exceed 2 ml.

Spread the product with your fingertips to cover the entire area to be treated. 

Wash your hands thoroughly before and after applying the solution.

Minoxidil 2% should be applied to perfectly dry hair and scalp.

HOW TO APPLY MINOXIDIL 2%?

For large areas of scalp to be treated, use the spray provided in Minoxidil 2%:

  1. Remove the cap from the bottle.
  2. Point the pump towards the centre of the area to be treated, press it once and spread the product with your fingertips to cover the entire area to be treated. Repeat 6 times to apply a dose of 1 ml.
  3. Rinse the sprayer and/or applicator and replace the cap on the bottle after each use.

For small areas of scalp to be treated or to apply under the hair, use the sprayer with the applicator.

  1. Remove the cap from the bottle.
  2. Remove the top element of the pump. Fit the applicator and press firmly.
  3. Then operate according to the process described for the sprayer.

In all cases, avoid inhaling Minoxidil 2% product.

MINOXIDIL 2%: CONTRAINDICATIONS

Pregnancy and breast feeding : 

The safety of this medicine has not been established during pregnancy or breastfeeding. As a precautionary measure, its use is not recommended in pregnant or breastfeeding women.

POSSIBLE SIDE EFFECTS OF THE MEDICATION MINOXIDIL 2%

Like any medication, Minoxidil can cause non-systematic side effects:

  • Minor skin reactions: irritation, redness, burning sensation, itching, dryness of the skin; excessive hair growth outside the treated area;
  • Rarely: allergy, dizziness, tingling, headache, weakness, eye irritation, vision disturbances, taste disturbance, ear infection, edema, neuritis;
  • Hair loss (paradoxical effect), irregular hair, chest pain, drop in blood pressure, rapid pulse, increased transaminases;
  • Due to the presence of propylene glycol: risk of eczema.
  • Please read the following full disclosure before taking or using this product.
  • PRODUCT CHARACTERISTICS SUMMARY

    ANSM - Updated: 13/04/2022

    1. NAME OF THE MEDICINE

    MINOXIDIL BAILLEUL 2%, solution for topical application

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    • Minoxidil: 2 g per 100 ml.
    • Notable excipients: propylene glycol, 96% ethanol.
    • For the full list of excipients, see section 6.1.

    3. PHARMACEUTICAL FORM

    • Solution for topical application.

    4. CLINICAL DATA

    4.1. Therapeutic Indications
    • This medication is indicated for moderate hair loss (androgenetic alopecia) in adults, both men and women. It promotes hair growth and stabilizes the hair loss process.
    4.2. Dosage and Method of Administration

    Dosage

    • For topical application.
    • RESERVED FOR ADULTS.
    • Apply a dose of 1 ml twice a day to the scalp, starting from the center of the area to be treated. This dose should be followed regardless of the extent of the affected area. The total daily dose should not exceed 2 ml.
    • Spread the product with fingertips to cover the entire area to be treated.
    • Wash hands thoroughly before and after applying the solution.
    • Apply to completely dry hair and scalp.

    Pediatric Population

    • Not applicable.

    Method of Administration

    • Depending on the delivery system used with the bottle:

    Spray:

    • This system is suitable for application to large areas.
      1. Remove the bottle cap.
      2. Direct the pump towards the center of the area to be treated, press once and spread the product with fingertips to cover the entire area. Repeat the process 6 times to apply a 1 ml dose. Avoid inhaling the product.
      3. Rinse the spray and/or applicator and replace the cap on the bottle after each use.

    Spray with applicator:

    • This system is suitable for application to small areas or under the hair.
      1. Remove the bottle cap.
      2. Remove the upper part of the pump. Attach the applicator and press firmly.

        3. Then proceed as described for the spray.

        4.3. Contraindications

        • Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

        4.4. Special Warnings and Precautions for Use

        Special Warnings:

        • Before using topical minoxidil, ensure that the scalp is normal and healthy. Increased percutaneous absorption of minoxidil, which may cause systemic effects, is possible in the following cases:

          • Scalp dermatitis or lesion,
          • Concurrent application of retinoic acid, anthralin, or any other irritating topical substance,
          • Increased dose and/or frequency of applications: it is essential to follow the prescribed dosage and method of administration.
        • Although extensive use of minoxidil solution has not revealed systemic effects, it cannot be excluded that increased absorption due to individual variability or unusual sensitivity may cause systemic effects. Patients should be informed about this.

        • If systemic effects occur (e.g., low blood pressure, tachycardia, signs of fluid and salt retention, chest pain) or severe dermatological reactions, the treatment should be discontinued.

        • For patients with a history of heart conditions, the benefits of treatment should be weighed carefully. They should be specifically warned about potential side effects and advised to discontinue treatment and consult a doctor if any side effects appear.

        • Do not apply minoxidil in the following situations:

          • Sudden hair loss, hair loss due to a disease or medication,
          • On other parts of the body.
        • This medication contains:

          • Propylene glycol: may cause skin irritation.
          • Alcohol: may cause skin irritation and dryness with frequent applications.

        Precautions for Use:

        • Accidental ingestion may cause severe adverse effects (see Overdose). In case of accidental contact with eyes, broken skin, or mucous membranes, the solution (containing ethyl alcohol) may cause burning and irritation: rinse thoroughly with running water.
        • Sun exposure is not recommended when applying minoxidil.

        4.5. Interactions with Other Medicines and Other Forms of Interaction

        • Not applicable.

        4.6. Fertility, Pregnancy, and Breastfeeding

        Pregnancy:

        • Animal studies have not shown teratogenic effects. In the absence of teratogenic effects in animals, a malformative effect in humans is not expected. To date, substances causing malformations in humans have also shown teratogenic effects in animal studies conducted on two species.
        • In clinical practice, there are currently no sufficiently relevant data to evaluate any potential malformative or foetotoxic effects of minoxidil when administered during pregnancy.
        • Consequently, as a precautionary measure, it is preferable not to use minoxidil during pregnancy.

          Breastfeeding:

          • When administered systemically, minoxidil passes into breast milk; therefore, the medication should be avoided in breastfeeding women.

          4.7. Effects on the Ability to Drive and Use Machines

          • Not applicable.

          4.8. Undesirable Effects

          • Due to the presence of ethanol, frequent applications on the skin can cause irritation and dryness.
          • Due to the presence of propylene glycol, there is a risk of contact eczema.
          • Most commonly, minor skin reactions may occur: local irritation with particular desquamation, erythema, dermatitis, dry skin, hypertrichosis (at a distance), burning sensation, and pruritus.
          • Frequency not determined: Allergic reactions, including angioedema (hypersensitivity, rhinitis, rash, generalized erythema, facial edema), dizziness, tingling, headaches, weakness, neuritis, edema, taste alterations; ear infection (especially otitis externa), vision disturbances, eye irritation.
          • Additionally, a few cases of alopecia, irregular hair, chest pain, changes in blood pressure, and pulse have been reported.
          • Liver function test abnormalities may occur.
          • It should be noted, however, that these medical events, particularly the rarest ones, have been reported without establishing a formal causal relationship with the treatment.

          Reporting Suspected Adverse Reactions:

          • Reporting suspected adverse reactions after the authorization of the medicine is important. It allows continuous monitoring of the benefit-risk ratio of the medication. Healthcare professionals should report any suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

          4.9. Overdose

          • Accidental ingestion can cause systemic effects due to the vasodilatory action of minoxidil (5 ml of solution contains 100 mg of minoxidil, which is the maximum dose used for oral administration in adults treated for hypertension). Signs and symptoms of a possible overdose would be cardiovascular in nature, with low blood pressure, tachycardia, and fluid retention.
          • Fluid retention can be treated with appropriate diuretic therapy, tachycardia, and angina with a beta-blocker or another sympathetic nervous system inhibitor. Symptomatic hypotension could be treated with intravenous administration of isotonic sodium chloride solution. The use of sympathomimetics such as norepinephrine and epinephrine should be avoided due to excessive cardiac stimulation.

          5. PHARMACOLOGICAL PROPERTIES

          5.1. Pharmacodynamic Properties

          • Pharmacotherapeutic class: OTHER DERMATOLOGICAL MEDICINES, ATC code: D11AX01.
          • The efficacy and tolerance in subjects under 18 years and over 65 years have not been studied.
          • When applied topically, minoxidil stimulates the growth of keratinocytes in vitro and in vivo and promotes hair growth in some subjects with androgenetic alopecia. This phenomenon appears after about 4 months (or more) of product use and varies among individuals.
          • On cessation of treatment, hair regrowth stops and a return to the initial state is expected within 3 to 4 months. The precise mechanism of action is unknown. Topical application of minoxidil in controlled clinical trials in normotensive or hypertensive patients has not resulted in systemic manifestations related to minoxidil absorption.

            5.2. Pharmacokinetic Properties

            • Minoxidil, when applied topically, is only slightly absorbed: an average of 1.4% (ranging from 0.3% to 4.5%) of the applied dose reaches the general circulation. Thus, for a dose of 1 ml of 2% solution (i.e., application of 20 mg of minoxidil on the skin), the amount of minoxidil absorbed corresponds to about 0.28 mg.
            • By comparison, when administered orally (in the treatment of certain hypertensions), minoxidil is almost completely absorbed from the gastrointestinal tract.
            • It has also been shown that the smallest dose of minoxidil administered intravenously that induces clinically significant hemodynamic effects in patients with mild to moderate hypertension is 6.86 mg.

            The pharmacokinetic studies indicate that the three main factors increasing the absorption of topical minoxidil are:

            • Quantitative increase in the applied dose,
            • Increased frequency of applications,
            • Decreased barrier function of the stratum corneum of the epidermis.

            This increase is quickly limited by a saturation effect.

            • The absorption of minoxidil after topical application is not altered by gender, UV exposure, simultaneous application of a moisturizer, under occlusion (wearing a hairpiece), the effect of solvent evaporation (hairdryer), or the application area.
            • Serum levels of minoxidil following topical administration depend on the rate of percutaneous absorption. After cessation of topical application, about 95% of the absorbed minoxidil is eliminated within 4 days.
            • The biotransformation of absorbed minoxidil after topical application is not entirely known.

            5.3. Preclinical Safety Data

            • Not applicable.

            6. PHARMACEUTICAL DATA

            6.1. List of Excipients

            • Propylene glycol, 96% ethanol, purified water.

            6.2. Incompatibilities

            • In the absence of compatibility studies, this medication should not be mixed with other drugs.

            6.3. Shelf Life

            • 3 years.

            6.4. Special Precautions for Storage

            • Flammable product.

            6.5. Nature and Contents of the Outer Packaging

            • White bottle (HDPE) of 60 ml with a pump (Polypropylene) protected by a cap (Polypropylene) with a push nozzle (Polypropylene) present on the pump and an applicator (PP). Box of 1 or 3 bottles. Not all pack sizes may be marketed.

            6.6. Special Precautions for Disposal and Handling

            • Not specified.
            • No special requirements.

              7. MARKETING AUTHORIZATION HOLDER

              LABORATOIRES BAILLEUL S.A 10-12 Avenue Pasteur L-2310 Luxembourg LUXEMBOURG

              8. MARKETING AUTHORIZATION NUMBER(S)

              • 34009 363 598 6 4: 3 high-density polyethylene (HDPE) bottles of 60 ml with polypropylene (PP) pump and applicator(s).
              • 34009 279 261 4 3: 1 high-density polyethylene (HDPE) bottle of 60 ml with polypropylene (PP) pump and applicator(s).

              9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

              • [to be completed later by the holder]

              10. DATE OF TEXT REVISION

              • [to be completed later by the holder]

              11. DOSIMETRY

              • Not applicable.

              12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

              • Not applicable.

              PRESCRIPTION AND DISPENSING CONDITIONS

              • Medication not subject to medical prescription.