Minoximen

Package leaflet: Information for the user

MINOXIMEN 5% solution for topical use

minoxidil
Please read all of this leaflet carefully before you start 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 would like more information or advice, please consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if you notice worsening of symptoms after 3–4 months.

Contents of this leaflet:

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

1. What Minoximen is and what it is used for

Minoximen contains the active substance minoxidil and is a topical medicine for stimulating hair growth, to be applied to the scalp.
This medicine is indicated for the symptomatic treatment of androgenetic alopecia (baldness).
The efficacy of Minoximen has not been established in the following conditions: congenital alopecia (present since birth), localized or generalized; cicatricial alopecia (irreversible hair loss associated with scar formation, usually affecting the scalp) of various origins (post-traumatic, psychogenic or infectious); diffuse acute alopecia caused by toxic substances or medications, in which hair regrowth depends on the removal of the specific cause; alopecia areata (generally reversible hair loss in well-defined areas, typically affecting the beard and scalp).
Consult your doctor if you do not feel better or if you feel worse after 3–4 months of treatment.

2. What you should know before using Minoximen

Do not use Minoximen

• If you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6).
• If you have coronary heart disease (abnormalities in the blood vessels supplying the heart), arrhythmias (abnormal heart rhythms), congestive heart failure (the heart's inability to deliver sufficient oxygen to meet the body's needs), or valvular heart disease (heart valve disorders).
• If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you suffer from other circulatory or heart disorders, including hypertension (high blood pressure), your doctor will decide whether Minoximen is suitable for you.
If you have hypertension (high blood pressure), even if you are already receiving treatment for it, your doctor must closely monitor you during Minoximen use.
Use of this medicine is not recommended in children and adolescents under 18 years of age (see "Children and adolescents") and in adult patients over 55 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Minoximen.
Before starting treatment with Minoximen, you must undergo a medical examination during which your doctor will ensure that your scalp is healthy.
Prolonged use, especially, of topical products may lead to sensitization (increased reactivity) (see section 4 “Possible side effects”).
If this occurs, stop treatment and consult your doctor to initiate appropriate therapy.
In case of accidental contact with sensitive surfaces (eyes, skin lesions, mucous membranes), Minoximen may cause burning and irritation. In such cases, wash the area thoroughly with plenty of fresh water.
If you have other cardiovascular disorders, including hypertension (high blood pressure), use Minoximen only under strict medical supervision.
Although experience with the use of Minoximen has not demonstrated significant systemic absorption (throughout the body) of minoxidil sufficient to cause systemic effects, some absorption of minoxidil through the scalp does occur, and there is a potential risk of systemic effects such as fluid and salt retention, generalized and localized edema (fluid retention), pericardial effusion (accumulation of fluid in the pericardial sac), pericarditis (inflammation of the pericardium), cardiac tamponade (accumulation of fluid or blood within the pericardial cavity), tachycardia, angina (chest pain caused by insufficient oxygen supply to the heart), or worsening of orthostatic hypotension (sudden drop in blood pressure upon standing) induced by medications used to treat high blood pressure, such as guanethidine and its derivatives (see “Other medicines and Minoximen” and “If you use more Minoximen than you should”).
If you have previously had latent (hidden) heart problems, your doctor will warn you that Minoximen may worsen these conditions. Your doctor will perform periodic checks to detect any possible systemic effects caused by minoxidil.
Stop treatment with Minoximen and consult your doctor if you experience any systemic side effects or dermatological reactions (skin-related).
Cases of excessive body hair growth in young children have been reported following contact with application sites of minoxidil used by patients (caregivers) applying topical minoxidil. Hair growth returns to normal within a few months once the infants are no longer exposed to minoxidil. Care must be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.
Consult a doctor if you notice excessive body hair growth in a child during the time you are using topical minoxidil products.

Children and adolescents
The use of Minoximen is not recommended in individuals under 18 years of age, as its safety and efficacy have not been established.

Other medicines and Minoximen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions associated with the use of Minoximen are currently known.
Consult your doctor and use Minoximen with caution if you are being treated with topical corticosteroids (local anti-inflammatory drugs) or if you have concomitant skin disorders, as the effects of Minoximen in patients with such conditions are currently unknown.
Although not clinically proven, your orthostatic hypotension may increase if you are concurrently taking peripheral vasodilators (medicines used to treat conditions affecting blood vessels in parts of the body such as arms and legs).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Minoximen must not be used during pregnancy (see “Do not use Minoximen”).
The effects of Minoximen during pregnancy are unknown.

Breastfeeding
Minoximen must not be used during breastfeeding (see “Do not use Minoximen”).

Driving and using machines
Minoximen does not affect the ability to drive or operate machinery.

Minoximen 5% cutaneous solution contains 518.8 mg of propylene glycol per single dose (1 ml of cutaneous solution).
Propylene glycol may cause skin irritation.

Minoximen 5% cutaneous solution contains 236.9 mg of alcohol (ethanol) per single dose (1 ml of cutaneous solution).
Ethanol may cause a burning sensation on damaged skin.

3. How to use Minoximen

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The recommended dose is 1 ml applied twice daily to the scalp, starting from the centre of the affected area.
The dose is independent of the size of the area to be treated.
The total daily dose must not exceed 2 ml.
After applying Minoximen, wash your hands thoroughly.
Apply Minoximen only to completely dry hair and scalp. Do not apply Minoximen to other areas of the body.

To open the child-resistant cap, press it downwards while turning it counterclockwise at the same time. Then attach the graduated dropper to the bottle. After filling it up to the 1 ml mark, apply several drops of Minoximen directly onto the scalp and spread the solution with your fingertips over the entire bald (hairless) area.
Repeat this procedure until the full 1 ml dose has been applied. After use, securely screw the dropper back onto the bottle.

Clinical experience with Minoximen indicates that twice-daily application for a period of 3 to 4 months may be necessary before any visible signs of hair growth appear. The onset and extent of such effects vary from patient to patient. In all cases, your doctor should evaluate whether treatment should be discontinued if no therapeutic benefit is observed within this time period.

After stopping treatment, reversal to the pre-treatment condition typically occurs within 3 to 4 months.

If you use more Minoximen than you should

Accidental ingestion of Minoximen may lead to serious adverse effects.
Accidental ingestion results in complete gastrointestinal absorption of the medicine, leading to systemic effects related to its vasodilatory action.

Signs and symptoms of minoxidil overdose may include cardiovascular effects (affecting the heart and blood vessels) associated with fluid retention, low blood pressure, and tachycardia.

If these symptoms occur, consult your doctor, who will prescribe the most appropriate treatment.

For example, fluid retention can be managed with appropriate diuretic therapy (treatment with drugs that increase urine production and thus elimination).
Tachycardia can be controlled by administering a β-blocker (medicines that act on the cardiovascular system, reducing heart rate and blood pressure). Hypotension may be treated by intravenous administration of normal saline solution. Sympathomimetic drugs (medicines that mimic the effects of the sympathetic nervous system on various organs and tissues), such as noradrenaline and adrenaline, should be avoided due to their excessive cardiac stimulant activity.

If you forget to use Minoximen

Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following symptoms, contact your doctor immediately because
urgent medical treatment may be required.

• 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).

Frequent side effects

• Local irritation consisting of desquamation (loss of the upper layer of skin), erythema, dermatitis (inflammation of the skin), pruritus, dry skin, hypertrichosis (increased hair growth) in areas different from those treated with Minoximen, burning sensation and skin rash.

In a clinical study, dermatological reactions were shown to be more frequent in patients treated with Minoximen 5% topical solution compared to patients treated with Minoximen 2% topical solution.
Uncommon side effects

• Dizziness, tingling, headache, weakness, neuritis (inflammation of nerves).
• Edema (fluid accumulation);
• Eczema (inflammatory skin reaction);
• Eye irritation;
• Taste disturbances;
• Ear infections (especially otitis externa);
• Visual disturbances.

Rarely occurring side effects

• Hair abnormalities, exacerbation (increase) of hair loss, alopecia (reduction in hair quantity);
• Chest pain, changes in blood pressure, changes in heart rate;
• Hepatitis (inflammation of the liver), kidney stones;
• Sexual dysfunction.

Side effects with frequency not known

• Allergic reactions (sensitization, urticaria, generalized erythema, facial edema and angioedema)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. You can also report side effects directly
through the national reporting system at the website
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 Minoximen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Minoximen contains
The active substance is: minoxidil
1 ml of Minoximen 5% cutaneous solution contains 50 mg of minoxidil.
The other ingredients are: propylene glycol, ethyl alcohol, purified water.

Description of the appearance of Minoximen and contents of the pack
60 ml bottle with a screw cap and child-resistant closure, containing a clear, colourless or slightly yellow solution with the characteristic odour of ethanol (ethyl alcohol).

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence.
Sales Licensee:
F.I.R.M.A. S.p.A., Via di Scandicci 37 – Florence

Manufacturer
Vamfarma S.r.l., Via Kennedy, 5, 26833 Comazzo, Lodi – Italy

Package leaflet: information for the user

MINOXIMEN 2% 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 would like further 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.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after 3–4 months.

Contents of this leaflet:

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

2. What Minoximen is and what it is used for

Minoximen contains the active substance minoxidil and is a topical medicine for stimulating hair growth, to be applied to the scalp.
This medicine is indicated for the symptomatic treatment of androgenetic alopecia (baldness).
The efficacy of Minoximen has not been established in the following conditions: congenital alopecia (present from birth), localized or generalized; cicatricial alopecia (irreversible hair loss associated with scar formation, usually affecting the scalp) of various origins (post-traumatic, psychogenic or infectious); diffuse acute alopecia caused by toxic substances or medications, in which hair regrowth depends on removal of the specific cause; alopecia areata (generally reversible hair loss in well-defined areas, usually involving the beard and scalp).
Consult your doctor if you do not feel better or if you feel worse after 3–4 months of treatment.

2. What you need to know before using Minoximen

Do not use Minoximen

• If you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6).
• If you have coronary heart disease (abnormalities of the blood vessels supplying the heart), arrhythmias (abnormal heart rhythms), congestive heart failure (the heart's inability to supply sufficient oxygen to meet the body’s needs), or valvular heart disease (diseases affecting the heart valves).
• If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you suffer from other circulatory or heart disorders, including hypertension (high blood pressure), your doctor will decide whether Minoximen is suitable for you.
The use of this medicine is not recommended in children and adolescents under 18 years of age (see "Children and adolescents") and in adult patients over 55 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Minoximen.
Before starting treatment with Minoximen, ensure that your scalp is intact and in good health.
The use, especially prolonged, of topical products may lead to sensitization reactions (increased sensitivity) (see section 4 “Possible side effects”).
If this occurs, stop treatment and consult your doctor to initiate appropriate therapy.
Stop treatment and consult a doctor if you experience:

• Chest pain;
• Tachycardia (increased heart rate);
• Weakness or dizziness;
• Sudden and unexplained weight gain or swelling of the hands and/or feet;
• Persistent redness or irritation of the scalp.

Minoximen contains alcohol which may cause burning and irritation. Therefore, in case of accidental contact with sensitive surfaces (eyes, damaged skin, mucous membranes), wash the area thoroughly with plenty of fresh water.
Although extensive experience with topical minoxidil has not shown significant systemic absorption (throughout the body) sufficient to produce systemic effects, incorrect use, individual variability, or particular sensitivity could lead to increased absorption and potential systemic effects (see “Other medicines and Minoximen” and “If you use more Minoximen than you should”).
Cases of excessive body hair growth in infants have been reported following contact with application sites of minoxidil used by patients (caregivers). Excessive hair growth resolves within a few months once infants are no longer exposed to topical minoxidil. Care must be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.
Consult a doctor if you notice excessive hair growth on a child during the period when topical minoxidil products are being used.

Children and adolescents
The use of Minoximen is not recommended in individuals under 18 years of age, as its safety and efficacy have not been established.

Other medicines and Minoximen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions associated with the use of Minoximen are currently known.
The extent of absorption of topically applied minoxidil is controlled and limited by the stratum corneum (the outermost layer of the epidermis). Topical medicines that alter the corneal barrier, such as tretinoin and antranil, could increase the absorption of minoxidil if applied simultaneously.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Minoximen must not be used during pregnancy (see “Do not use Minoximen”).
The effects of Minoximen during pregnancy are unknown.
Breastfeeding
Minoximen must not be used during breastfeeding (see “Do not use Minoximen”).

Driving and using machines
Minoximen does not affect the ability to drive or operate machinery.

Minoximen 2% cutaneous solution contains 207.2 mg of propylene glycol per single dose (1 ml of cutaneous solution).
Propylene glycol may cause skin irritation.

Minoximen 2% cutaneous solution contains 514 mg of alcohol (ethanol) per single dose (1 ml of cutaneous solution).
Ethanol may cause a burning sensation on damaged skin.

3. How to use Minoximen

Take 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.
The recommended dose is 1 ml twice daily, preferably in the morning and evening, applied to the scalp, starting from the center of the affected area.
The dose is independent of the size of the area to be treated.
The total daily dose must not exceed 2 ml.
After applying Minoximen, wash your hands thoroughly.
Apply Minoximen only to completely dry hair and scalp. Do not apply Minoximen to other areas of the body.
To open the child-resistant cap, press it down while turning it counterclockwise at the same time, then attach the graduated dropper to the bottle. After filling it up to the 1 ml mark, apply several drops of Minoximen to the scalp and spread the solution with your fingertips over the entire bald (hairless) area.
Repeat until the full 1 ml dose has been applied. After use, securely screw the dropper back onto the bottle.
During treatment with Minoximen, you do not need to change your usual hygiene habits regarding the scalp. However, it is advisable to use a mild shampoo.
If you need to wash your hair, do so only before applying Minoximen.
Clinical experience with Minoximen indicates that twice-daily applications for a period of 3–4 months may be necessary before any visible signs of hair growth appear. The onset and intensity of these signs vary from patient to patient. In any case, your doctor should evaluate whether treatment should be discontinued if no therapeutic effect is observed within this time period.
After stopping treatment, reversal to the pre-treatment condition usually occurs within 3–4 months.

If you use more Minoximen than you should
Accidental ingestion of Minoximen may cause adverse reactions related to its systemic pharmacological activity (effects the medicine may have throughout the body).
Signs and symptoms of minoxidil overdose may include cardiovascular effects (affecting the heart and blood vessels) associated with sudden weight gain, tachycardia, weakness, or dizziness. If any of these effects occur, consult your doctor immediately.

If you forget to use Minoximen
Do not use a double dose to make up for a forgotten dose.
If you forget to apply Minoximen for 1 or 2 days, resume treatment according to the recommended dosing schedule (1 ml of Minoximen twice daily).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 which may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated based on available data).

Common side effects

• Local irritation including desquamation (loss of the outer layer of skin), erythema, dermatitis (inflammation of the skin), pruritus, dry skin, hypertrichosis (increased hair growth) in areas different from those treated with Minoximen, burning sensation and skin rash.

Uncommon side effects

• Dizziness, tingling sensations, headache, weakness, neuritis (nerve inflammation);
• Edema (fluid accumulation);
• Eczema (inflammatory skin reaction);
• Eye irritation;
• Taste disturbances;
• Ear infections (especially external otitis);
• Visual disturbances.

Rare side effects

• Hair abnormalities, worsening (increase) of hair loss, alopecia (reduction in hair quantity);
• Chest pain, changes in blood pressure, changes in heart rate;
• Hepatitis (liver inflammation), kidney stones;
• Sexual dysfunction.

Side effects with unknown frequency

• Allergic reactions (sensitization, urticaria, generalized erythema, facial edema and angioedema)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
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 Minoximen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Minoximen contains
The active substance is: minoxidil
1 ml of Minoximen 2% cutaneous solution contains 20 mg of minoxidil.
The other components are: propylene glycol, ethyl alcohol, purified water.

Description of the appearance of Minoximen and the contents of the pack
60 ml bottle with screw cap and child-resistant closure, containing a clear, colourless or slightly yellow solution with a characteristic odour of ethanol (ethyl alcohol).

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 - Florence.
Concessionaire for sale:
F.I.R.M.A. S.p.A., Via di Scandicci 37 – Florence

Manufacturer
Vamfarma S.r.l., Via Kennedy, 5, 26833 Comazzo, Lodi – Italy