MINOXIDIL 5% Топическое решение

Содержание инструкции

1. Minoxidil Biorga 2%, cutaneous solution
   1. What is Minoxidil Biorga 2%, cutaneous solution and what is it for
   2. What you need to know before using Minoxidil Biorga 2%, cutaneous solution
   3. How to use Minoxidil Biorga 2%, cutaneous solution
   4. Possible side effects
   5. How to store Minoxidil Biorga 2%, cutaneous solution
   6. Contents of the pack and other information
2. Minoxidil Biorga 5%, cutaneous solution
   1. What is Minoxidil Biorga 5%, cutaneous solution and what is it for
   2. What you need to know before using Minoxidil Biorga 5%, cutaneous solution
   3. How to use Minoxidil Biorga 5%, cutaneous solution
   4. Possible side effects
   5. How to store Minoxidil Biorga 5%, cutaneous solution
   6. Contents of the pack and other information

Minoxidil Biorga 2%, cutaneous solution

Minoxidil

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 4 months. Contents of this leaflet:
• 1. What Minoxidil Biorga 2%, cutaneous solution is and what it is used for
• 2. What you need to know before using Minoxidil Biorga 2%, cutaneous solution
• 3. How to use Minoxidil Biorga 2%, cutaneous solution
• 4. Possible side effects
• 5. How to store Minoxidil Biorga 2%, cutaneous solution
• 6. Contents of the pack and other information

1. What is Minoxidil Biorga 2%, cutaneous solution and what is it for

Minoxidil Biorga 2%, cutaneous solution contains minoxidil, at a concentration of 20 mg per ml.
Minoxidil Biorga 2%, cutaneous solution is a medicine in liquid form, to be applied directly
to the scalp. It is used as a treatment for hair loss and not as a cure. Minoxidil is a peripheral
vasodilator, whose exact mechanism of restoring hair growth is not known.
Minoxidil Biorga 2%, cutaneous solution is indicated for use in adult subjects aged between 18 and
65 years, with a gradual thinning or gradual loss of hair on the top of the head.
Thinning or loss of hair is a slow process, which may only become evident after
several years of gradual loss.
Minoxidil Biorga 2%, cutaneous solution is particularly indicated in men who suffer from
hair loss or thinning hair on the top of the head and in women who present
with a generalized thinning of the hair.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 4 months.

2. What you need to know before using Minoxidil Biorga 2%, cutaneous solution

Do not use Minoxidil Biorga 2%, cutaneous solution:

• if you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6). Minoxidil Biorga 2%, cutaneous solution is not indicated in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with skin with scarring characteristics, such as a burn or ulcer). Furthermore, Minoxidil Biorga 2%, cutaneous solution should not be used if hair loss is associated with pregnancy, childbirth or serious illnesses, such as

thyroid dysfunction, lupus, hair loss sections associated with inflammation of the
scalp or other diseases.

Warnings and precautions
Since alopecia can also be a symptom of serious diseases of the ovary, pituitary or adrenal
gland, it is advisable that, in the presence of any of the following symptoms, a woman consults her
doctor before using Minoxidil Biorga 2%, cutaneous solution: rapid weight gain, especially
if localized on the trunk and face without affecting the limbs (central obesity); growth of male-type hairs on the face (hirsutism); menstrual disorders; hypertension; muscle weakness; back pain;
osteoporosis; stretch marks; acne.
Talk to your doctor or pharmacist before using Minoxidil Biorga 2%, cutaneous solution.
Do not start applying Minoxidil Biorga 2%, cutaneous solution if hair loss is
sudden or unexplained or in case of hair loss following an illness or therapy. If you have
other questions about hair loss, consult your doctor before using Minoxidil Biorga 2%,
cutaneous solution.
If you suffer from or have suffered in the past from heart or vascular disease, including irregular heartbeat,
you should consult a doctor before using Minoxidil Biorga 2%.
Do not apply Minoxidil Biorga 2%, cutaneous solution if the affected area is red and
inflamed, irritated or painful, such as in the case of a severe sunburn or seborrheic dermatitis. Do not
apply Minoxidil Biorga 2%, cutaneous solution to other parts of the body or in conjunction with
other topical medicines.
If you notice unusual symptoms after applying Minoxidil Biorga 2%, cutaneous solution, stop
applying and consult your doctor. It is particularly important to stop applying
Minoxidil Biorga 2%, cutaneous solution in case of increased heart rate (palpitations),
swelling of hands and feet, sudden weight gain without apparent cause, chest pain,
weakness and/or dizziness. You should also stop applying if the scalp is red or
irritated.
The development of systemic effects (e.g. increased heart rate or fluid retention)
is greater in patients who suffer from known or suspected coronary heart disease and in patients
with a predisposition to myocardial infarction. When deciding to use Minoxidil Biorga 2%,
cutaneous solution, patients with this type of disease and their doctors must be
aware of the risks.
Minoxidil Biorga 2%, cutaneous solution must be applied only to the scalp because in
other parts of the body the absorption of minoxidil may be greater and increase the incidence of
adverse effects.
If the scalp is irritated or burned after exposure to the sun, Minoxidil Biorga 2%, cutaneous
solution should not be applied.
Furthermore, Minoxidil Biorga 2%, cutaneous solution should not be applied to the scalp together
with other topical medicines.
Do not ingest.
Do not inhale.
Minoxidil Biorga 2%, cutaneous solution contains alcohol, which can cause a burning
sensation and irritation of the eyes. In case of accidental contact with sensitive surfaces (eyes, damaged skin and
mucous membranes), the affected area should be washed with plenty of fresh tap water.

Children and adolescents
Minoxidil Biorga 2%, cutaneous solution should not be used in patients under the age of 18.

Other medicines and Minoxidil Biorga 2%, cutaneous solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Although not clinically proven, there is a theoretical possibility that absorbed minoxidil may
potentiate orthostatic hypotension in patients taking peripheral vasodilators
simultaneously.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine

Driving and using machines
Minoxidil Biorga 2%, cutaneous solution should not affect the patient's ability to drive
vehicles or operate machinery.

Minoxidil Biorga 2%, cutaneous solution contains propylene glycol.
It may cause skin irritation.

3. How to use Minoxidil Biorga 2%, cutaneous solution

Minoxidil Biorga 2%, cutaneous solution is a treatment, not a cure. To maintain or improve the results obtained it is important not to interrupt the regular application of Minoxidil Biorga 2%, cutaneous solution twice a day at the recommended dose.
You must apply a dose of Minoxidil Biorga 2%, cutaneous solution (1 ml) directly to the area of the scalp where you observe hair loss, TWICE A DAY, for example morning and evening. Distribute the dose over the entire affected area, massaging it with your fingertips.
Each bottle of Minoxidil Biorga 2%, cutaneous solution contains a sufficient amount of product for 30 days.
Clinical studies have shown that the response to treatment is very variable and that the results are not immediate. Generally, hair regrowth is gradual and it is necessary to continue the application twice a day for at least 4 months for it to be visible.
Since Minoxidil Biorga 2%, cutaneous solution begins to act on the hair follicles, you may observe a temporary increase in hair loss, approximately 2-6 weeks after starting treatment.
If, at the time of starting treatment with Minoxidil Biorga 2%, cutaneous solution you have very few hairs and respond to the treatment, your new hair that grows will initially be soft and velvety, not very visible. Continuing the treatment, the new hair will acquire a color and texture similar to the other hair. If hair loss is not very pronounced at the beginning of treatment, the new hair that grows will have a color and texture similar to the others.
If you wash your hair before applying Minoxidil Biorga 2%, cutaneous solution, you must use a mild shampoo.
During the use of Minoxidil Biorga 2%, cutaneous solution it is not necessary to modify the standard care you usually dedicate to your hair. However, you must apply Minoxidil Biorga 2%, cutaneous solution first, let your hair dry; and only then apply hairsprays, mousses, conditioners, gels or any other product (in case of hair dyes, perms, etc.).
If you plan to swim or wet your hair, it is preferable to apply Minoxidil Biorga 2%, cutaneous solution to the dry scalp after swimming, or wait two hours after applying the product. You must allow Minoxidil Biorga 2%, cutaneous solution to act on the scalp for at least two hours.

How to apply Minoxidil Biorga 2%, cutaneous solution
Minoxidil Biorga 2%, cutaneous solution is for external use only.
Apply one dose (1 ml) twice a day to the area affected by hair loss. You must not apply doses higher than those recommended. The medicine must not be applied to areas other than the scalp. If you wash your hair before applying Minoxidil Biorga 2%, cutaneous solution, you must use a mild shampoo.
Each applicator is designed to deliver one dose (1 ml) of Minoxidil Biorga 2%, cutaneous solution.
Massage the amount of product applied over the entire area to be treated. Wash your hands after each application.

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

• A. Spraying to apply the solution to large areas of the scalp.
• B. Spraying with the applicator to apply the solution to small areas of the scalp or between the hair. To avoid wasting the contents due to changing applicators, keep the chosen applicator on the bottle until it is empty.
• A. Direct Spraying Recommended for large areas of the scalp.
• 1) Remove the cap from the bottle.
• 2) Point the applicator towards the area affected by baldness, press once and distribute the solution with your fingertips over the entire area. Repeat the procedure six times until the application of the required dose of 1 ml is completed (for a total of 7 sprays). Avoid inhaling the medicine during application.
• 3) Replace the cap on the bottle after use to prevent evaporation of the alcohol.
• B. Spraying with the applicator Recommended for small areas of the scalp or between the hair.
• 1) Remove the cap from the bottle.
• 2) Pull the top of the applicator until it is removed. Fit the applicator to the applicator and apply complete pressure.
• 3) Point the applicator towards the area affected by baldness, press once and distribute the solution with your fingertips over the entire area. Repeat the procedure six times until the application of the required dose of 1 ml is completed (for a total of 7 sprays). Avoid inhaling the medicine during application.
• 4) Replace the cap on the bottle after use to prevent evaporation of the alcohol. Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

If you use more Minoxidil Biorga 2%, cutaneous solution than you should
No cases of overdose from minoxidil resulting from the application of Minoxidil Biorga 2%, cutaneous solution to the skin have been reported.
Minoxidil Biorga 2%, cutaneous solution must not be administered orally. In case of accidental ingestion, consult your doctor or a poison control center.
The signs and symptoms of minoxidil overdose would consist mainly of cardiovascular effects associated with fluid retention and tachycardia. Fluid retention can be controlled with adequate diuretic therapy. Tachycardia can be controlled by administering a beta-adrenergic blocking agent. Symptomatic hypotension should be treated by administering physiological solution intravenously. The use of sympathomimetic agents, such as adrenaline and noradrenaline, should be avoided as these medicines cause excessive cardiac stimulation.
If you experience any adverse effect related to the use of Minoxidil Biorga 2%, cutaneous solution, not listed in this leaflet, immediately consult your doctor or pharmacist.
Accurate clinical studies have been conducted to determine the exact amount of Minoxidil Biorga 2%, cutaneous solution to be applied to achieve satisfactory results. Applying higher doses than those recommended (1 ml), or with a frequency greater than twice a day, is not recommended.
Increasing the dose or frequency of administration will not make the hair grow back faster or in greater quantity and may cause an increase in the manifestation of undesirable effects.

If you forget to use Minoxidil Biorga 2%, cutaneous solution
If you skip one or two applications of Minoxidil Biorga 2%, cutaneous solution, you should start the application twice a day again, following the usual schedule. Do not use a double dose to compensate for the missed dose.

If you stop using Minoxidil Biorga 2%, cutaneous solution
To maintain hair growth, it is necessary to continuously apply the recommended dose of Minoxidil Biorga 2%, cutaneous solution. Three or four months after stopping treatment with Minoxidil Biorga 2%, cutaneous solution, the growth of new hair stops and the process of hair loss returns to the normal pre-treatment state.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

If you notice any of the following symptoms, contact your doctor immediately as urgent medical treatment may be required.

• Swelling of the face, lips or throat that may cause difficulty swallowing or breathing. This could be a sign of a serious allergic reaction (frequency not known, cannot be defined based on available data).

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are listed in decreasing order of frequency.
Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Depression
• Dyspnea (shortness of breath)
• Pruritus, hypertrichosis (abnormal hair growth), rash, acneiform eruption, 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 side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Minoxidil Biorga 2%, cutaneous solution

Keep this medicine out of the sight and reach of children.
Flammable product. Protect from heat. Keep the container tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle after “Scad”. The expiry
date refers to the last day of that month.

6. Contents of the pack and other information

What Minoxidil Biorga 2%, cutaneous solution contains

*The active ingredient is minoxidil.
* The other ingredients are propylene glycol, ethanol and purified water.

Description of Minoxidil Biorga 2%, cutaneous solution and contents of the pack
Minoxidil Biorga 2%, cutaneous solution is a clear, colourless or yellowish solution, with an odour of
alcohol, available in the form of:
HDPE bottle with spray/applicators containing 60 ml of solution.
Packs:
1 x 60 ml with 1 removable spray actuator and 1 removable applicator with extension.
3 x 60 ml with 3 removable spray actuators and 2 removable applicators with extension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Bailleul S.A

• 10 - 12 Avenue Pasteur L-2310 Luxembourg Luxembourg Manufacturer Laboratoires OPODEX Industrie 36-42 avenue Marc Sangnier 92390 Villeneuve La Garenne France

O
DELPHARM HUNINGUE SAS
26 rue de la Chapelle
68330 Huningue
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Cyprus Androxil 2%, δερματικό διάλυμα
Czech Republic Minorga 20 mg/ml, kožní roztok
Greece Androxil 2%, δερματικό διάλυμα
Malta Minorga 2%, taħlita likwida għall-ġilda
Poland Minorga 20 mg/mL, roztwór na skórę
Portugal Minoxidil Biorga 2%, solução cutânea
Romania Minorga 20 mg/ml, soluƫie cutanată
Slovakia Minorga 2%, dermálny roztok
Spain Minoxidil Biorga 20 mg/mL solución cutánea

Minoxidil Biorga 5%, cutaneous solution

Minoxidil

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any undesirable effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 4 months. Contents of this leaflet:
• 1. What Minoxidil Biorga 5%, cutaneous solutionis and what it is used for
• 2. What you need to know before using Minoxidil Biorga 5%, cutaneous solution
• 3. How to use Minoxidil Biorga 5%, cutaneous solution
• 4. Possible side effects
• 5. How to store Minoxidil Biorga 5%, cutaneous solution
• 6. Contents of the pack and other information

1. What is Minoxidil Biorga 5%, cutaneous solution and what is it for

Minoxidil Biorga 5%, cutaneous solutioncontains minoxidil, at a concentration of 50 mg per ml.
Minoxidil Biorga 5%, cutaneous solutionis a medicinal product in liquid form, to be applied directly
to the scalp. It is used as a treatment for hair loss and not as a cure. Minoxidil is a peripheral vasodilator, whose exact mechanism of restoring hair growth
is not known.
Minoxidil Biorga 5%, cutaneous solutionis indicated for use in adult subjects between 18
and 65 years of age, with a gradual thinning or gradual loss of hair on the top of the head.
Thinning or loss of hair is a slow process, which may only become evident after
several years of gradual loss.
Minoxidil Biorga 5%, cutaneous solutionis particularly indicated in men who suffer from
hair loss or thinning hair on the top of the head and in women who present
with generalized hair thinning.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 4 months.

2. What you need to know before using Minoxidil Biorga 5%, cutaneous solution

Do not use Minoxidil Biorga 5%, cutaneous solution:

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

Minoxidil Biorga 5%, cutaneous solutionis not indicated in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with skin with scarring characteristics, such as a burn or ulcer). Furthermore, Minoxidil Biorga 5%, cutaneous solutionshould not be used if hair loss is associated with pregnancy, childbirth or serious illnesses, such as thyroid dysfunction, lupus, hair loss in patches associated with scalp inflammation or other diseases.

Warnings and precautions
Since alopecia can also be a symptom of serious diseases of the ovary, pituitary gland or adrenal gland, it is advisable that a woman consult her doctor before using Minoxidil Biorga 5%, cutaneous solutionif she experiences any of the following symptoms: rapid weight gain, particularly if localized to the trunk and face without affecting the limbs (central obesity); growth of male-type hair on the face (hirsutism); menstrual disorders; hypertension; muscle weakness; back pain; osteoporosis; stretch marks; acne.
Consult your doctor or pharmacist before using Minoxidil Biorga 5%, cutaneous solution.
Do not start applying Minoxidil Biorga 5%, cutaneous solutionif hair loss is sudden or unexplained or in case of hair loss following an illness or therapy. If you have any other questions about hair loss, consult your doctor before using Minoxidil Biorga 5%, cutaneous solution.
Patients who are about to receive treatment with Minoxidil Biorga 5%, cutaneous solution must first undergo a physical examination. The doctor must establish whether the subject has a normal scalp.
If you suffer from or have suffered in the past from a heart or vascular disease, including irregular heartbeat, you should consult a doctor before using Minoxidil Biorga 5%, cutaneous solution.
Do not apply Minoxidil Biorga if the affected area is red and inflamed, irritated or painful, as in the case of a severe sunburn or seborrheic dermatitis. Do not apply Minoxidil Biorga to other parts of the body or in conjunction with other topical medicines. If you experience unusual symptoms after applying Minoxidil Biorga 5%, cutaneous solution, stop application and consult your doctor. It is particularly important to stop applying Minoxidil Biorga in case of increased heart rate (palpitations), swelling of hands and feet, sudden weight gain without apparent cause, chest pain, weakness and/or dizziness.
You should also stop if the scalp is red or irritated. Patients with a history of heart disease may experience worsening of their conditions with the use of Minoxidil Biorga 5%, cutaneous solution.
Do not ingest.
Do not inhale.
Minoxidil Biorga 5%, cutaneous solutioncontains alcohol, which can cause a burning sensation and irritation of the eyes. In case of accidental contact with sensitive surfaces (eyes, damaged skin and mucous membranes), the affected area must be washed with plenty of fresh tap water.
Inform your doctor or pharmacist if:

• you suffer from heart disease
• you have had allergic reactions in the past
• you are taking other medicines

Children and adolescents
Minoxidil Biorga 5%, cutaneous solutionshould not be used in patients under the age of 18 years.

Other medicines and Minoxidil Biorga
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Although not clinically proven, there is a theoretical possibility that absorbed minoxidil may potentiate orthostatic hypotension in patients taking peripheral vasodilators concurrently.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Minoxidil Biorga 5%, cutaneous solutionshould not affect the patient's ability to drive vehicles or operate machinery.

Minoxidil Biorga contains propylene glycol.
It may cause skin irritation.

3. How to use Minoxidil Biorga 5%, cutaneous solution

Minoxidil Biorga 5%, cutaneous solutionis a treatment, not a cure. To maintain or improve the
results obtained, it is important not to interrupt the regular application of the medicine according to the
instructions of your doctor and for your problem.
You must apply a dose of Minoxidil Biorga 5%, cutaneous solution(1 ml) directly to the
area of the scalp where you observe hair loss, TWICE A DAY, for example
morning and evening (or other similar administration schedules). Distribute the dose over the entire
affected area, massaging it with your fingertips.
Each bottle of Minoxidil Biorga 5%, cutaneous solutioncontains enough product for
30 days. This medicine should not be used in patients under the age of 18 years.
Clinical studies have shown that the response to treatment is very variable and that the results are not
immediate. Generally, hair regrowth is gradual and it is necessary to continue
application twice a day for at least 4 months for it to be visible.
Since Minoxidil Biorga begins to act on hair follicles, you may observe a temporary increase in hair loss, about 2-6 weeks after starting treatment.
If, at the time of starting treatment with Minoxidil Biorga 5%, cutaneous solutionyou really
have very little hair and respond to treatment, the new hair that grows will initially
be soft and velvety, not very visible. Continuing treatment, the new hair will acquire a
color and texture similar to other hair. If hair loss is not very pronounced
at the beginning of treatment, the new hair that grows will have a color and texture similar
to the others.
Using an inappropriate medicine or incorrect doses can cause problems. Therefore, do not
ever use this medicine to treat other diseases or other patients.
While using Minoxidil Biorga 5%, cutaneous solutionit is not necessary to change the care
standards that you usually dedicate to your hair. However, you must apply Minoxidil Biorga 5%,
cutaneous solutionfirst, let your hair dry; and only then apply
hairsprays, mousses, conditioners, gels or any other product (in case of hair dyes, perms, etc.).
If you plan to swim or wet your hair, it is preferable to apply Minoxidil Biorga 5%,
cutaneous solutionto dry scalp after swimming, or wait two hours after
application of the product. You must allow Minoxidil Biorga 5%, cutaneous solutionto act on the
scalp for at least two hours.

How to apply Minoxidil Biorga 5%, cutaneous solution
Minoxidil Biorga 5%, cutaneous solutionis for external use only.
Apply one dose (1 ml) twice a day to the area affected by hair loss. You should not
apply doses higher than those recommended. The medicine should not be applied to areas
other than the scalp. If you wash your hair before applying Minoxidil Biorga 5%,
cutaneous solution, you should use a mild and effective shampoo.
Each applicator is designed to deliver one dose (1 ml) of Minoxidil Biorga 5%, cutaneous
solution.
Massage the amount of product applied onto the entire area to be treated. Wash your hands after each
application.

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

• A. Nebulization to apply the solution to large areas of the scalp.
• B. Nebulization with the applicator to apply the solution to small areas of the scalp or between the hair. To avoid wasting content due to changing applicators, keep the chosen applicator on the bottle until it is empty.
• A. Direct Nebulization Recommended for large areas of the scalp.
• 1) Remove the cap from the bottle.
• 2) Point the applicator towards the bald area, press once and distribute the solution with your fingertips over the entire area. Repeat the procedure six times until the application of the required dose of 1 ml is completed (for a total of 7 sprays). Avoid inhaling the medicine during application.
• 3) Replace the cap on the bottle after use to prevent evaporation of the alcohol.
• B. Nebulization with the applicator Recommended for small areas of the scalp or between the hair.
• 1) Remove the cap from the bottle.
• 2) Pull the top of the applicator until it is removed. Fit the applicator to the applicator and apply full pressure.
• 3) Point the applicator towards the bald area, press once and distribute the solution with your fingertips over the entire area. Repeat the procedure six times until the application of the required dose of 1 ml is completed (for a total of 7 sprays). Avoid inhaling the medicine during application.
• 4) Replace the cap on the bottle after use to prevent evaporation of the alcohol. Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

If you use more Minoxidil Biorga 5%, cutaneous solution than you should
Minoxidil Biorga 5%, cutaneous solutionshould not be administered orally. In case of
accidental ingestion, consult your doctor or a poison control center.
Accidental ingestion may cause systemic effects related to the vasodilator effect of
minoxidil. The signs and symptoms of minoxidil overdose would mainly consist of cardiovascular effects associated with fluid retention and tachycardia. Fluid retention can be
controlled with appropriate diuretic therapy. Tachycardia can be controlled by
administration of a beta-adrenergic blocking agent. Symptomatic hypotension should be
treated with intravenous administration of physiological solution. The use of sympathomimetic agents, such as adrenaline and noradrenaline, should be avoided as these medicines
cause an excessive cardiac stimulation effect.
If you experience any adverse effect related to the use of Minoxidil Biorga 5%, cutaneous
solution, not listed in this leaflet, immediately consult your doctor or pharmacist.
Accurate clinical studies have been conducted to determine the exact amount of Minoxidil Biorga to
apply to achieve satisfactory results. Applying higher doses than recommended (1
ml), or with a frequency greater than twice a day, is not recommended. Increasing the dose or
frequency of administration will not make hair grow back faster or in greater quantity and
may cause an increase in the manifestation of undesirable effects.

If you forget to use Minoxidil Biorga 5%, cutaneous solution
If you skip one or two applications of Minoxidil Biorga, you should start applying twice a day again, following the usual schedule. Do not use a double dose to make up for the forgotten
dose.

If you stop treatment with Minoxidil Biorga 5%, cutaneous solution
To maintain hair growth, it is necessary to apply continuously the recommended dose
of Minoxidil Biorga 5%, cutaneous solution. About three or four months after stopping
treatment with Minoxidil Biorga 5%, cutaneous solution, the growth of new hair stops and the
process of hair loss returns to normal, as it was before starting treatment.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

If you notice any of the following symptoms, contact your doctor immediately as urgent medical treatment may be necessary.

• 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 defined based on available data)Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are listed in decreasing order of frequency.

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

• Headache

Common (may affect up to 1 in 10 people):

• Depression
• Dyspnea (shortness of breath)
• Pruritus, hypertrichosis (abnormal 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 side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Minoxidil Biorga 5%, cutaneous solution

Keep this medicine out of the sight and reach of children.
Flammable product. Protect from heat. Keep the container tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle after “Scad”. The expiry
date refers to the last day of that month.

6. Contents of the pack and other information

What Minoxidil Biorga 5%, cutaneous solution contains

*The active ingredient is minoxidil.
* The other ingredients are propylene glycol, ethanol and purified water.

Description of Minoxidil Biorga 5%, cutaneous solution and contents of the pack
Minoxidil Biorga 5%, cutaneous solutionis a clear, colourless or yellowish solution, with an odour of
alcohol, available in the form of:
HDPE bottle with spray nozzle/applicators containing 60 ml of solution.
Packs:
1 x 60 ml with 1 removable spray actuator and 1 removable applicator with extension.
3 x 60 ml with 3 removable spray actuators and 2 removable applicators with extension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Bailleul S.A

• 10 - 12 Avenue Pasteur L-2310 Luxembourg Luxembourg

Manufacturer
Laboratoires OPODEX Industrie
36-42 avenue Marc Sangnier
92390 Villeneuve La Garenne
France
O
DELPHARM HUNINGUE SAS
26 rue de la Chapelle
68330 Huningue
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Cyprus Androxil 5%, δερματικό διάλυμα
Czech Republic Minorga 50 mg/ml, kožní roztok
Greece Androxil 5%, δερματικό διάλυμα
Malta Minorga 5%, taħlita likwida għall-ġilda
Poland Minorga 50 mg/mL, roztwór na skórę
Portugal Minoxidil Biorga 5%, solução cutânea
Romania Minorga 50 mg/ml, soluƫie cutanată
Slovakia Minorga 5%, dermálny roztok
Spain Minoxidil Biorga 5% solución cutánea