Minoxidil Biorga

Patient Information Leaflet

Minoxidil Biorga 2%, cutaneous solution

Minoxidil
Please read this entire 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement 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 Minoxidil Biorga 2% Cutaneous Solution Is and What It Is Used For

Minoxidil Biorga 2%, cutaneous solution contains minoxidil at a concentration of 20 mg per ml.
Minoxidil Biorga 2%, cutaneous solution is a liquid medicine intended 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, and its exact mechanism of promoting hair regrowth is not known.
Minoxidil Biorga 2%, cutaneous solution is indicated for use in adult patients aged between 18 and 65 years who have gradual thinning or gradual hair loss on the top of the scalp.
Thinning or hair loss is a slow process, which may only become noticeable after several years of progressive hair loss.
Minoxidil Biorga 2%, cutaneous solution is particularly indicated in men experiencing hair loss or thinning on the crown of the head and in women presenting with generalised hair thinning.
Consult your doctor if you do not notice any improvement or if you observe 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 scarred skin, such as from a burn or ulcer). Furthermore, Minoxidil Biorga 2%, cutaneous solution must not be used if hair loss is associated with pregnancy, childbirth, or serious medical conditions such as:

thyroid dysfunction, lupus, hair loss associated with inflammation of the
scalp, or other diseases.
Warnings and precautions
Since alopecia may also be a symptom of serious diseases of the ovaries, pituitary gland, or adrenal glands, women experiencing any of the following symptoms should consult a physician before using Minoxidil Biorga 2%, cutaneous solution: rapid weight gain, particularly localized on the trunk and face without affecting the limbs (central obesity); growth of male-pattern facial hair (hirsutism); menstrual disorders; hypertension; muscle weakness; back pain; osteoporosis; striae; 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 if it occurs after an illness or medical treatment. If you have further questions about hair loss, consult your doctor before using Minoxidil Biorga 2%, cutaneous solution.
If you suffer or have previously suffered from heart or vascular disease, including irregular heartbeat, you must consult a doctor before using Minoxidil Biorga 2%.
Do not apply Minoxidil Biorga 2%, cutaneous solution if the affected area is red, inflamed, irritated, or painful, 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 simultaneously with other topical medicines.
If you notice unusual symptoms after applying Minoxidil Biorga 2%, cutaneous solution, stop using it and consult your doctor. It is particularly important to discontinue use of Minoxidil Biorga 2%, cutaneous solution if you experience increased heart rate (palpitations), swelling of hands and feet, sudden unexplained weight gain, chest pain, weakness and/or dizziness. You should also stop using it if your scalp becomes red or irritated.
The risk of systemic effects (e.g., increased heart rate or fluid retention) is higher in patients with known or suspected coronary heart disease or those predisposed to myocardial infarction. When considering the use of Minoxidil Biorga 2%, cutaneous solution, patients with such conditions and their physicians should be aware of the potential risks.
Minoxidil Biorga 2%, cutaneous solution should be applied only to the scalp, as absorption of minoxidil may be greater in other body areas, increasing the likelihood of adverse effects.
Do not apply Minoxidil Biorga 2%, cutaneous solution if the scalp is irritated or sunburned.
In addition, Minoxidil Biorga 2%, cutaneous solution must not be applied to the scalp together with other topical medicines.
Do not swallow.
Do not inhale.
Minoxidil Biorga 2%, cutaneous solution contains alcohol, which may cause a burning sensation and eye irritation. In case of accidental contact with sensitive surfaces (eyes, damaged skin, or mucous membranes), the affected area should be washed thoroughly with plenty of fresh tap water.
Children and adolescents
Minoxidil Biorga 2%, cutaneous solution must not be used in patients under 18 years of age.
Other medicines and Minoxidil Biorga 2%, cutaneous solution
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 enhance orthostatic hypotension in patients concurrently taking peripheral vasodilators.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Minoxidil Biorga 2%, cutaneous solution is not expected to affect the 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 daily at the recommended dose.

You should apply one dose of Minoxidil Biorga 2%, cutaneous solution (1 ml) directly to the area of scalp where you observe hair loss, TWICE A DAY, for example in the morning and evening. Spread the dose over the entire affected area, massaging gently with the fingertips.

Each bottle of Minoxidil Biorga 2%, cutaneous solution contains enough product for 30 days.

Clinical studies have shown that the response to treatment is highly variable and results are not immediate. Generally, hair regrowth is gradual, and treatment must be continued twice daily for at least 4 months before results become visible.

Since Minoxidil Biorga 2%, cutaneous solution begins acting on the hair follicles, you may notice a temporary increase in hair loss approximately 2–6 weeks after starting treatment.

If, when starting treatment with Minoxidil Biorga 2%, cutaneous solution, you have very few hairs and respond to treatment, the new hairs that grow will initially be soft and downy, and not very visible. With continued treatment, the new hairs will gradually acquire color and texture similar to your other hairs. If hair loss is not severe at the beginning of treatment, the new hairs will have a color and texture similar to your existing hairs.

If you wash your hair before applying Minoxidil Biorga 2%, cutaneous solution, you should use a mild shampoo.

While using Minoxidil Biorga 2%, cutaneous solution, you do not need to change your usual hair care routine. However, you must apply Minoxidil Biorga 2%, cutaneous solution first, allow your hair to dry, and only then apply hair sprays, mousses, conditioners, gels, or any other hair products (including hair dyes, permanents, etc.).

If you plan to swim or wet your hair, it is preferable to apply Minoxidil Biorga 2%, cutaneous solution to dry scalp after swimming, or wait two hours after applying the product. You must allow Minoxidil Biorga 2%, cutaneous solution to remain 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 daily to the affected area of hair loss. Do 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, use a mild shampoo.

Each applicator is designed to deliver one dose (1 ml) of Minoxidil Biorga 2%, cutaneous solution.

Massage the applied amount of product over the entire treatment area. Wash your hands after each application.

Instructions for use

Instructions for use depend on the type of applicator used.

A. Direct spray for applying the solution to large areas of the scalp.
B. Spray with applicator for applying the solution to small areas of the scalp or among the hair.

To avoid wasting product due to changing applicators, keep the chosen applicator on the bottle until it is empty.

A. Direct spray
Recommended for large areas of the scalp.

1. Remove the cap from the bottle.
2. Direct the spray nozzle toward the affected area, press once, and distribute the solution with your fingertips over the entire area. Repeat this procedure six times to complete the required dose of 1 ml (a total of 7 sprays). Avoid inhaling the medicine during application.
3. Replace the cap on the bottle after use to prevent alcohol evaporation.

B. Spray with applicator
Recommended for small areas of the scalp or among the hair.

1. Remove the cap from the bottle.
2. Pull the top part of the spray nozzle upward to remove it. Attach the applicator to the spray nozzle and press firmly until securely in place.
3. Direct the spray nozzle toward the affected area, press once, and distribute the solution with your fingertips over the entire area. Repeat this procedure six times to complete the required dose of 1 ml (a total of 7 sprays). Avoid inhaling the medicine during application.
4. Replace the cap on the bottle after use to prevent alcohol evaporation.

Use this medicine 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 minoxidil overdose resulting from topical application of Minoxidil Biorga 2%, cutaneous solution to the skin have been reported.

Minoxidil Biorga 2%, cutaneous solution 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 would mainly involve cardiovascular effects associated with fluid retention and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled by administering a beta-adrenergic blocking agent. Symptomatic hypotension should be treated with intravenous administration of physiological saline. The use of sympathomimetic agents such as adrenaline and noradrenaline should be avoided, as these medicines may cause excessive cardiac stimulation.

If you experience any adverse effects related to the use of Minoxidil Biorga 2%, cutaneous solution not listed in this leaflet, contact your doctor or pharmacist immediately.

Careful clinical studies have been conducted to determine the exact amount of Minoxidil Biorga 2%, cutaneous solution to apply for satisfactory results. Applying higher doses than recommended (1 ml), or more frequently than twice daily, is not recommended. Increasing the dose or frequency of administration will not make hair grow back faster or in greater quantity and may increase the risk of adverse effects.

If you forget to use Minoxidil Biorga 2%, cutaneous solution

If you miss one or two applications of Minoxidil Biorga 2%, cutaneous solution, resume treatment twice daily according to the usual schedule. Do not use a double dose to make up 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 to four months after stopping treatment with Minoxidil Biorga 2%, cutaneous solution, new hair growth will cease and the hair loss process will return to its 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 you may require urgent medical treatment.

• Swelling of the face, lips or throat, which may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data).

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are listed below 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)
• Itching, 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 peeling, temporary hair loss, changes in hair texture, changes in hair colour
• Application site irritation

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 effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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% Topical 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 stated on the bottle after "Exp". The expiry date refers to the last day of that month.

6. Package contents and other information

What Minoxidil Biorga 2% topical solution contains
* The active substance is minoxidil.
* The other components are propylene glycol, ethanol and purified water.

Description of the appearance of Minoxidil Biorga 2% topical solution and contents of the pack
Minoxidil Biorga 2% topical solution is a clear, colourless or slightly yellow solution with an alcoholic odour, available as:
HDPE bottle with spray nozzle/applicators containing 60 ml of solution.

Pack sizes:
1 x 60 ml with 1 removable spray actuator and 1 removable applicator with extender.
3 x 60 ml with 3 removable spray actuators and 2 removable applicators with extenders.

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
Or
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 names:
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, soluție cutanată
Slovakia Minorga 2%, dermálny roztok
Spain Minoxidil Biorga 20 mg/mL solución cutánea

Patient Information Leaflet

Minoxidil Biorga 5%, solution for topical use

Minoxidil
Please read this leaflet carefully before using this medicine because it contains important
information for you.
Use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4 months. Contents of this leaflet:
  1. What Minoxidil Biorga 5%, solution for topical use is and what it is used for
  2. What you need to know before using Minoxidil Biorga 5%, solution for topical use
  3. How to use Minoxidil Biorga 5%, solution for topical use
  4. Possible side effects
  5. How to store Minoxidil Biorga 5%, solution for topical use
  6. Package contents and other information

1. What Minoxidil Biorga 5% topical solution is and what it is used for

Minoxidil Biorga 5% topical solution contains minoxidil at a concentration of 50 mg per ml.
Minoxidil Biorga 5% topical solution is a liquid medicine intended 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, and its exact mechanism of action in restoring hair growth is unknown.
Minoxidil Biorga 5% topical solution is indicated for use in adults aged between 18 and 65 years who have gradual thinning or gradual hair loss on the top of the scalp.
Thinning or hair loss is a slow process, which may only become noticeable after several years of gradual hair loss.
Minoxidil Biorga 5% topical solution is particularly indicated in men experiencing hair loss or thinning on the upper part of the scalp and in women with generalised hair thinning.
Consult your doctor if you do not notice any improvement or if you observe 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 solution is not indicated in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with scarred skin, such as from a burn or an ulcer). Furthermore, Minoxidil Biorga 5%, cutaneous solution must not be used if hair loss is associated with pregnancy, childbirth, or serious medical conditions such as thyroid dysfunction, lupus, hair loss associated with inflammation of the scalp, or other diseases.
Warnings and precautions
Since alopecia may also be a symptom of serious diseases of the ovary, pituitary gland, or adrenal gland, women experiencing any of the following symptoms should consult a doctor before using Minoxidil Biorga 5%, cutaneous solution: rapid weight gain, particularly localized on the trunk and face without affecting the limbs (central obesity); growth of male-pattern facial hair (hirsutism); menstrual disorders; hypertension; muscle weakness; back pain; osteoporosis; striae; acne.
Talk to your doctor or pharmacist before using Minoxidil Biorga 5%, cutaneous solution.
You must not start applying Minoxidil Biorga 5%, cutaneous solution if hair loss is sudden or unexplained, or if it occurs following an illness or medical treatment. If you have any questions about hair loss, consult your doctor before using Minoxidil Biorga 5%, cutaneous solution.
Patients about to begin treatment with Minoxidil Biorga 5%, cutaneous solution should first undergo a physical examination. Your doctor must determine whether you have a normal scalp.
If you suffer from, or have previously suffered from, heart or vascular disease, including irregular heartbeat, you must 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 severe sunburn or seborrheic dermatitis. Do not apply Minoxidil Biorga to other parts of the body or concurrently with other topical medicines. If you notice unusual symptoms after applying Minoxidil Biorga 5%, cutaneous solution, stop using it and consult your doctor. It is particularly important to discontinue use of Minoxidil Biorga if you experience increased heart rate (palpitations), swelling of hands and feet, sudden unexplained weight gain, chest pain, weakness, and/or dizziness.
You should also stop application if your scalp becomes red or irritated. Patients with a history of heart disease may experience worsening of their condition with the use of Minoxidil Biorga 5%, cutaneous solution.
Do not swallow.
Do not inhale.
Minoxidil Biorga 5%, cutaneous solution contains alcohol, which may cause a burning sensation and eye irritation. In case of accidental contact with sensitive surfaces (eyes, damaged skin, or mucous membranes), the affected area should be thoroughly rinsed with plenty of fresh tap water.
Inform your doctor or pharmacist if:

• you suffer from heart disease
• you have previously experienced allergic reactions
• you are taking other medicines

Children and adolescents
Minoxidil Biorga 5%, cutaneous solution must not be used in patients under 18 years of age.
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 could enhance orthostatic hypotension in patients concurrently taking peripheral vasodilators.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Minoxidil Biorga 5%, cutaneous solution should not affect the patient's ability to drive or operate machinery.
Minoxidil Biorga contains propylene glycol.
It may cause skin irritation.

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

Minoxidil Biorga 5%, topical solution is a treatment, not a cure. To maintain or improve the results achieved, it is important not to interrupt the regular application of the medicine as directed by your doctor and for your specific condition.
You must apply one dose of Minoxidil Biorga 5%, topical solution (1 ml) directly to the area of the scalp where you observe hair loss, TWICE DAILY, for example in the morning and evening (or other similar dosing regimens). Spread the dose over the entire affected area, massaging it gently with the fingertips.
Each bottle of Minoxidil Biorga 5%, topical solution contains enough product for 30 days. This medicine must not be used in patients under 18 years of age.
Clinical studies have shown that the response to treatment is highly variable and results are not immediate. Generally, hair regrowth is gradual, and treatment must be continued twice daily for at least 4 months before results become visible.
Since Minoxidil Biorga begins acting on the hair follicles, you may notice a temporary increase in hair loss approximately 2–6 weeks after starting treatment.
If, when starting treatment with Minoxidil Biorga 5%, topical solution, you have very few hairs remaining and respond to treatment, the new hairs that grow will initially be soft and downy, and not very noticeable. With continued treatment, the new hairs will gradually acquire a color and texture similar to your other hairs. If hair loss is not severe at the beginning of treatment, the new hairs that grow will have a color and texture similar to your existing hair.
Using an inappropriate medicine or incorrect doses may cause problems. Therefore, you must never use this medicine to treat other diseases or give it to other patients.
While using Minoxidil Biorga 5%, topical solution, you do not need to change your usual hair care routine. However, you must apply Minoxidil Biorga 5%, topical solution first, allow your hair to dry completely, and only then apply hair sprays, mousses, conditioners, gels, or any other products (in case of hair dyes, permanents, etc.).
If you plan to swim or wet your hair, it is preferable to apply Minoxidil Biorga 5%, topical solution to a dry scalp after swimming, or wait two hours after application of the product. You must allow Minoxidil Biorga 5%, topical solution to remain on the scalp for at least two hours.

How to apply Minoxidil Biorga 5%, topical solution
Minoxidil Biorga 5%, topical solution is for external use only.
Apply one dose (1 ml) twice daily to the affected area of 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 5%, topical solution, you should use a mild and effective shampoo.
Each applicator is designed to deliver one dose (1 ml) of Minoxidil Biorga 5%, topical solution.
Massage the applied amount of product gently into 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. Spray for applying the solution to extensive areas of the scalp.
B. Spray with the applicator for applying the solution to small areas of the scalp or through the hair.
To avoid wasting the contents due to changing applicators, keep the chosen applicator attached to the bottle until it is completely empty.

A. Direct spray application
Recommended for extensive areas of the scalp.

1. Remove the cap from the bottle.
2. Direct the spray nozzle toward the affected area of alopecia, press once, and spread the solution over the entire area with the fingertips. Repeat this procedure six times to complete the required dose of 1 ml (for a total of 7 sprays). Avoid inhaling the medication during application.
3. Replace the cap on the bottle after use to prevent alcohol evaporation.

B. Spray with applicator
Recommended for small areas of the scalp or through the hair.

1. Remove the cap from the bottle.
2. Pull the upper part of the spray nozzle to remove it. Attach the applicator to the spray nozzle and press firmly until securely fitted.
3. Direct the spray nozzle toward the affected area of alopecia, press once, and spread the solution over the entire area with the fingertips. Repeat this procedure six times to complete the required dose of 1 ml (for a total of 7 sprays). Avoid inhaling the medication during application.
4. Replace the cap on the bottle after use to prevent alcohol evaporation.

Use this medicine exactly as indicated in this leaflet or as directed 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 solution must not be administered orally. In case of accidental ingestion, consult your doctor or a poison control center immediately.
Accidental ingestion may cause systemic effects related to the vasodilatory action of minoxidil. Signs and symptoms of minoxidil overdose would primarily involve cardiovascular effects associated with fluid retention and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled by administering a beta-adrenergic blocking agent. Symptomatic hypotension should be treated with intravenous administration of physiological saline. The use of sympathomimetic agents such as adrenaline and noradrenaline should be avoided, as these medicines may cause excessive cardiac stimulation.

If you experience any adverse reaction related to the use of Minoxidil Biorga 5%, cutaneous solution not listed in this leaflet, contact your doctor or pharmacist immediately.

Carefully conducted clinical studies have determined the exact amount of Minoxidil Biorga to apply for satisfactory results. Applying higher doses than recommended (1 ml), or more frequently than twice daily, is not recommended. Increasing the dose or frequency of application will not make hair grow back faster or in greater quantity and may increase the risk of adverse effects.

If you forget to use Minoxidil Biorga 5%, cutaneous solution
If you miss one or two applications of Minoxidil Biorga, resume treatment twice daily according to the usual schedule. Do not use a double dose to make up for the missed dose.

If you stop using Minoxidil Biorga 5%, cutaneous solution
To maintain hair growth, it is necessary to continue applying the recommended dose of Minoxidil Biorga 5%, cutaneous solution on a continuous basis. Approximately three to four months after stopping treatment with Minoxidil Biorga 5%, cutaneous solution, new hair growth will cease and hair loss will return to the state it was in before treatment began.

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

4. Possible side effects

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

• Swelling of the face, lips or throat which may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data).

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are listed below in order of decreasing 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)
• Itching, 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 peeling, temporary hair loss, changes in hair texture, changes in hair color
• Application site irritation

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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the bottle after “Exp”. The expiry date refers to the last day of that month.

6. Package contents and other information

What Minoxidil Biorga 5% topical solution contains
* The active substance is minoxidil.
* The other components are propylene glycol, ethanol, and purified water.

Description of the appearance of Minoxidil Biorga 5% topical solution and package contents
Minoxidil Biorga 5% topical solution is a clear, colourless or slightly yellow solution with an alcoholic odour, available as:
HDPE bottle with spray pump/applicators containing 60 ml of solution.

Pack sizes:
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
or
DELPHARM HUNINGUE SAS
26 rue de la Chapelle
68330 Huningue
France

This medicinal product is authorised in the European Economic Area Member States under the following names:
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, soluție cutanată
Slovakia Minorga 5%, dermálny roztok
Spain Minoxidil Biorga 5% solución cutánea