MINOXIMEN 2% Roztwór do stosowania na skórę

Treść ulotki

1. MINOXIMEN 5 % cutaneous solution
   1. What is Minoximen and what is it 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. MINOXIMEN 2 % cutaneous solution
   1. What is Minoximen and what is it 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

MINOXIMEN 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.

• 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 3-4 months.

Contents of this leaflet:

• 1. What Minoximen is and what it is used for
• 2. What you need to know before you use 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 is Minoximen and what is it used for

Minoximen contains the active ingredient minoxidil and is a topical medicine for
stimulating hair growth, to be applied to the scalp.
This medicine is indicated in the symptomatic treatment of androgenetic alopecia
(baldness).
The efficacy of Minoximen has not been determined in the following forms: congenital alopecia
(present from birth) localized or generalized; cicatricial alopecia (irreversible hair loss associated with the formation of scars, usually affecting the scalp) of
various nature (post-traumatic, of psychic or infectious origin); acute diffuse alopecia caused
by toxic substances or medications in which hair regrowth is conditional on
suppression of the specific cause; alopecia areata (hair loss generally reversible in well-defined areas, which typically involves the beard and scalp).
See 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 any of the other ingredients of this medicine (listed in section 6).
• If you have coronary artery disease (alterations of the blood vessels that carry blood to the heart), arrhythmias (alterations of the heart rhythm), congestive heart failure (the heart's inability to provide oxygen in sufficient quantity to the needs of the entire body) or valvular 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 if Minoximen is suitable for you.
If you have hypertension (high blood pressure), even if you are being treated for it, your doctor will need to monitor you closely while using Minoximen.
The use of the 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 taking Minoximen.
Before starting treatment with Minoximen, you must undergo a medical examination during which the doctor will ensure that you have a normal scalp.
The use, especially if prolonged, of products for local use can give rise to sensitization phenomena (increased reactivity) (see section 4 “Possible side effects”).
In such cases, stop treatment and consult your doctor to establish appropriate therapy.
In case of accidental contact with sensitive surfaces (eyes, skin lesions, mucous membranes), Minoximen causes burning and irritation. In such cases, wash the area with plenty of cool water.
In the presence of other cardiovascular disorders, including hypertension (high blood pressure), take Minoximen only under close medical supervision.
Although experience with the use of Minoximen has not shown that there is sufficient absorption of minoxidil to cause systemic effects (throughout the body), some absorption of minoxidil occurs through the scalp and there is a potential risk of systemic effects such as retention of salts and fluids, generalized and local 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 increased orthostatic hypotension (sudden drop in blood pressure when moving from a lying to an upright position) induced by drugs used to treat high blood pressure, such as guanethidine and derivatives (see “Other medicines and Minoximen” and “If you use more Minoximen than you should”).
If you have had latent (hidden) heart problems in the past, your doctor will warn you that Minoximen may worsen these problems. The doctor will perform periodic checks to identify any suspicion of systemic effects caused by minoxidil.
Stop treatment with Minoximen and consult your doctor if systemic side effects or dermatological reactions (at the skin level) occur.
Cases of excessive hair growth on the bodies of young children have been reported following contact with the application sites of minoxidil in patients (assistants) using topical minoxidil. Hair growth returns to normal within a few months when young children 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 hair growth on a child’s body during the period when topical minoxidil products are being used.

Children and adolescents
The use of Minoximen is not recommended in subjects under the age of 18 years as its tolerability and efficacy have not been determined.

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

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 taking this medicine.
Pregnancy
Minoximen should not be used during pregnancy (see “Do not use Minoximen”).
The effects of Minoximen during pregnancy are unknown.
Breastfeeding
Minoximen should not be used during breastfeeding (see “Do not use Minoximen”).

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

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

Minoximen 5 % cutaneous solution contains236.9 mg of alcohol (ethanol) per single dose(1 ml solution).
Ethanol can cause a burning sensation on damaged skin.

3. How to use Minoximen

Take this medicine following exactly as indicated in this leaflet or
by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 ml twice a day, to be applied 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 should not exceed 2 ml.
After applying Minoximen, wash your hands carefully.
Apply Minoximen only to completely dry hair and scalp. Do not apply
Minoximen to other areas of the body.
Unscrew the child-resistant cap by pushing it down and rotating it counterclockwise at the same time and then insert the graduated dropper onto the bottle. After filling it
to the 1 ml mark, apply a few drops of Minoximen to the scalp and
distribute the liquid with your fingertips over the entire bald area (without hair).
Repeat until the entire 1 ml dose has been applied. At the end of use, screw
the dropper firmly back onto the bottle.
Clinical experience gained with Minoximen indicates that 2
applications a day may be necessary for a period of 3-4 months before there are evident
signs of hair growth. The onset and intensity of these signs vary from patient to
patient. In all cases, the doctor must assess the appropriateness of discontinuing treatment if
no therapeutic result is observed within this period.
Following discontinuation of therapy, a return to the pre-treatment condition occurs
within 3-4 months.

If you use more Minoximen than you should
Accidental ingestion of Minoximen may lead to serious side effects.
Accidental ingestion of the medicine leads to its total absorption at the gastrointestinal level,
with consequent systemic effects related to its vasodilating action.
The signs and symptoms of an overdose of minoxidil may be
represented by cardiovascular effects (affecting the heart and blood vessels) associated
with fluid retention, lowering of blood pressure and tachycardia.
If the aforementioned symptoms occur, consult your doctor who will prescribe the
most appropriate treatment.
For example, fluid retention can be treated with appropriate diuretic therapy
(therapy based on drugs that increase the production and, therefore, the elimination of urine).
Tachycardia can be kept under control by administering a beta-blocker
(drugs that act on the cardiovascular system, reducing heart rate and blood pressure). Hypotension could be treated with intravenous administration of normal saline solution. Drugs with sympathomimetic action (drugs
able to mimic the effects of the sympathetic nervous system at various organs and tissues),
such as norepinephrine and epinephrine, should be avoided due to their excessive activity
stimulating the heart.

If you forget to use Minoximen
Do not use a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask 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, seek immediate medical attention as
medical treatment may be urgently needed.

• 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 on the basis of available data).

Frequent side effects

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

In a clinical study, dermatological reactions have been shown to be more frequent
in patients treated with Minoximen 5% cutaneous solution compared to patients treated with
Minoximen 2% cutaneous solution.

Uncommon side effects

• dizziness, tingling, headaches, weakness, neuritis (inflammation of the nerves).
• edema (fluid retention);
• eczema (inflammatory skin reaction);
• eye irritation;
• altered taste;
• ear infections (especially otitis externa);
• visual disturbances.

Rare side effects

• hair abnormalities, exacerbation (increase) of hair loss, alopecia (decrease in the amount of hair);
• chest pain, changes in blood pressure, changes in heart rate;
• hepatitis (inflammation of the liver), 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 get any side effects, even those not listed in this leaflet,
tell 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 Minoximen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient 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 with child-resistant closure, containing a
clear, colourless or slightly yellow solution, with the characteristic odour of ethanol (ethyl
alcohol).

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence. Distributor for sales: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

MINOXIMEN 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.

• 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 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 is Minoximen and what is it 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 in the symptomatic treatment of androgenetic alopecia
(baldness).
The efficacy of Minoximen has not been determined in the following forms: congenital alopecia
(present from birth) localized or generalized; cicatricial alopecia (irreversible hair loss associated with the formation of scars, usually affecting the scalp) of
various nature (post-traumatic, of psychic or infectious origin); acute diffuse alopecia caused
by toxic substances or medications in which hair regrowth is conditional on
suppression of the specific cause; alopecia areata (hair loss generally reversible in well-defined areas, which typically involves the beard and scalp).
See 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 any of the other ingredients of this medicine (listed in section 6).
• If you have coronary artery disease (alterations of the blood vessels that carry blood to the heart), arrhythmias (alterations of the heart rhythm), congestive heart failure (inability of the heart to provide oxygen in sufficient quantity to the needs of the entire body) or valvular 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 if Minoximen is suitable for you.
The use of the 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
Consult your doctor or pharmacist before taking Minoximen.
Before starting treatment with Minoximen, make sure that the scalp is intact and in good health.
The use, especially if prolonged, of topical products can lead to sensitization phenomena (increased reactivity) (see section 4 “Possible side effects”).
In such cases, discontinue treatment and consult your doctor to establish 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 causes burning and irritation. Therefore, in case of accidental contact with sensitive surfaces (eyes, damaged skin, mucous membranes), wash the area with plenty of fresh water.
Despite the extensive experience with the use of minoxidil applied topically, no absorption of the medicine has been shown to produce systemic effects (throughout the body), incorrect use or individual variability or particular sensitivity could cause increased absorption with potential systemic effects (see “Other medicines and Minoximen” and “If you use more Minoximen than you should”).
Cases of excessive hair growth on the bodies of young children have been reported following contact with the application sites of minoxidil in patients (assistants) using topical minoxidil. Hair growth returns to normal within a few months when young children are no longer exposed to minoxidil. Care must be taken to ensure that young children do not come into contact with the areas of the body where topical minoxidil has been applied.
Consult a doctor if you notice excessive hair growth on the child's body during the period in which topical minoxidil-based products are being used.

Children and adolescents
The use of Minoximen is not recommended in subjects under 18 years of age as its tolerability and efficacy have not been determined.

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

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Minoximen should not be used during pregnancy (see “Do not use Minoximen”).
The effects of Minoximen during pregnancy are unknown.
Breastfeeding
Minoximen should not be used during breastfeeding (see “Do not use Minoximen”).

Driving and using machines
Minoximen does not impair the ability to drive vehicles 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 solution).
Ethanol can cause a burning sensation on damaged skin.

3. How to use Minoximen

Take this medicine following exactly as indicated 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 a day, preferably in the morning and evening, to be
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 should not exceed 2 ml.
After applying Minoximen, wash your hands carefully.
Apply Minoximen only to completely dry hair and scalp. Do not apply
Minoximen to other areas of the body.
Unscrew the child-resistant cap by pushing it down and rotating it counterclockwise at the same time and then insert the graduated dropper onto the bottle. After filling it
to the 1 ml mark, apply a few drops of Minoximen to the scalp and
distribute the liquid with your fingertips over the entire bald area (without hair).
Repeat until the entire 1 ml dose has been applied. At the end of use, screw
the dropper tightly onto the bottle.
During treatment with Minoximen, you do not need to change your
hygiene habits regarding the scalp. However, the use of a mild shampoo is recommended.
If you need to wash your hair, do so exclusively before applying Minoximen.
Clinical experience gained with Minoximen indicates that 2
applications a day for a period of 3-4 months may be necessary before there are obvious
signs of hair growth. The onset and intensity of these signs vary from patient to
patient. In all cases, the doctor must assess the appropriateness of stopping treatment if
no therapeutic result is observed within this period.
Following discontinuation of therapy, a return to the pre-treatment condition 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 that the drug can have throughout the body).
The signs and symptoms of an overdose of minoxidil may be 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.

If you forget to use Minoximen
Do not use a double dose to make up for a missed dose.
If you forget to apply Minoximen for 1 or 2 days, resume treatment following the
recommended dosage schedule (1 ml of Minoximen twice a day).
If you have any doubts about the use of this medicine, ask 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, seek medical attention immediately as
medical treatment may be urgently needed.

• 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 on the basis of available data).

Frequent side effects

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

Uncommon side effects

• dizziness, tingling, headaches, weakness, neuritis (inflammation of the nerves);
• edema (fluid retention);
• eczema (inflammatory skin reaction);
• eye irritation;
• altered taste;
• ear infections (especially external otitis);
• visual disturbances.

Rare side effects

• hair abnormalities, exacerbation (increase) of hair loss, alopecia (decrease in the amount of hair);
• chest pain, changes in blood pressure, changes in heart rate;
• hepatitis (inflammation of the liver), 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 get any side effects, talk to 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 Minoximen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is: minoxidil
1 ml of Minoximen 2% cutaneous solution contains 20 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 with child-resistant closure, containing a
clear, colourless or slightly yellow solution, with the characteristic odour of ethanol (ethyl
alcohol).

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence. Distributor for sales: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