MINOXIMEN - PACKAGE LEAFLET - LEAFLETS

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Minoximen - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

Active ingredients: Minoxidil

MINOXIMEN 5% cutaneous solution

Package inserts of Minoximen are available for pack sizes:

MINOXIMEN 5% cutaneous solution
MINOXIMEN 2% cutaneous solution

Why is Minoximen used? What is it 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 for the symptomatic treatment of androgenic 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 kinds ( post-traumatic, psychic or infectious origin); acute diffuse alopecia caused by toxic substances or medications in which hair regrowth is conditioned by the suppression of the specific cause; celsi area (generally reversible hair loss in clearly defined areas, which typically involves the beard and scalp).

Talk to your doctor if you do not feel better or if you feel worse after 3-4 months of treatment.

Contraindications When Minoximen should not be used

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 (changes in the blood vessels that carry blood to the heart), arrhythmias (changes in the rhythm of the heart), congestive heart failure (inability of the heart to provide enough oxygen for the whole body to need) or heart disease (diseases that affect the heart valves).
If you are pregnant or breast-feeding (see "Pregnancy and breast-feeding").

If you have other circulatory or heart problems, 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 this condition, your doctor will need to monitor you closely while using Minoximen.

It is not recommended for use in children and adolescents under 18 years (see "Children and adolescents") and in adult patients over the age of 55.

Precautions for use What you need to know before taking Minoximen

Talk to your doctor or pharmacist before taking Minoximen.

Before starting treatment with Minoximen you must undergo a medical examination during which your doctor will make sure 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 this case, stop the treatment and consult your doctor to set up a " adequate therapy.

In case of accidental contact with sensitive surfaces (eyes, skin lesions, mucous membranes) Minoximen causes burning and irritation. In this case, wash the area with plenty of fresh water.

If you have other cardiovascular problems, including hypertension (high blood pressure), only take Minoximen under close medical supervision.

Although experience with the use of Minoximen has not shown that there is sufficient absorption of minoxidil to cause systemic (whole organism) effects, some absorption of minoxidil occurs through the scalp and there is a potential risk of effects. systemic such as salt and fluid retention, generalized and local edema (fluid retention), pericardial effusion (collection 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 pressure when moving from lying to standing) induced by drugs used to treat high blood pressure, 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 can make these problems worse. Your doctor will periodically check for any suspicion of systemic effects caused by minoxidil.

Stop taking Minoximen and consult your doctor if you experience any systemic side effects or dermatological (skin) reactions.

Children and adolescents

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

Interactions Which drugs or foods can modify the effect of Minoximen

Tell 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 in case of treatment with topical corticosteroids (local anti-inflammatory drugs) or in case of concomitant dermatological diseases, as the effects of Minoximen in patients with these diseases are currently unknown.

Although not clinically proven, your orthostatic hypotension may increase if you are treated concomitantly with peripheral vasodilators (medicines used to treat conditions affecting the blood vessels of parts of the body such as the arms and legs).

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Minoximen must not be used during pregnancy (see "Do not use Minoximen"). The effects of Minoximen in pregnancy are not known.

Feeding time

Minoximen should not be used if you are breastfeeding (see "Do not use Minoximen").

Driving and using machines

Minoximen does not affect the ability to drive or use machines.

Minoximen 5% cutaneous solution contains propylene glycol which may cause skin irritation.

Dose, Method and Time of Administration How to use Minoximen: Posology

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 1 ml twice a day, 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 cap and insert the graduated dropper on the bottle. After filling it up to the 1ml mark, apply a few drops of Minoximen to the scalp and distribute the liquid with your fingertips over the entire bald area (no hair).

Repeat until the full 1 ml dose has been applied. At the end of use screw the dropper firmly onto the bottle.

Clinical experience with Minoximen indicates that 2 applications per day may be required over a period of 3-4 months before there are obvious signs of hair growth. The onset of these signs and their intensity vary from patient to patient. per patient. In all cases, the doctor will have to evaluate the opportunity to suspend the treatment if no therapeutic result is observed within this period

Following discontinuation of therapy, the return to the pre-treatment condition occurs within 3-4 months.

Overdose What to do if you have taken too much Minoximen

If you use more Minoximen than you should

Accidental ingestion of Minoximen could lead to serious undesirable effects. Accidental ingestion of the drug leads to its total absorption from the gastrointestinal tract, with consequent systemic effects related to its vasodilating action.

The signs and symptoms of taking too much minoxidil could be cardiovascular effects (affecting the heart and blood vessels) associated with fluid retention, lowering of blood pressure and tachycardia.

If the above symptoms occur, please contact your doctor who will prescribe the most appropriate treatment for you.

For example, fluid retention can be treated with appropriate diuretic therapy (drug therapy that increases urine production and, therefore, elimination). Tachycardia can be controlled by administering a ß-blocking agent ( drugs that act on the cardiovascular system, reducing heart rate and blood pressure.) Hypotension could be treated with intravenous administration of normal saline. Sympathomimetic drugs (drugs capable of mimicking the effects of the sympathetic nervous system at the level of various organs and tissues), such as noradrenaline and adrenaline, should be avoided due to their excessive cardiac stimulating activity.

If you forget to use Minoximen

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Minoximen

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects that may occur are:

Frequent side effects

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

In a clinical study it was shown that dermatological reactions are more frequent in patients treated with Minoximen 5% cutaneous solution than in patients treated with Minoximen 2% cutaneous solution.

Infrequent side effects

allergic reactions (sensitization, urticaria, generalized erythema and facial edema).
dizziness, tingling, headaches (headache), weakness, neuritis (inflammation of the nerves).
edema (accumulation of fluid).
eczema (inflammatory skin reaction).
eye irritation.
change in taste.
ear infections (especially otitis externa).
visual disturbances.

Side effects that occur rarely

hair abnormality, exacerbation (increase) of hair loss, alopecia (decrease in the amount of hair).
chest pains, changes in blood pressure, changes in heart rate.
hepatitis (inflammation of the liver), kidney stones.
sexual dysfunctions.

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 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

Expiry and Retention

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 package. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

What Minoximen contains

1 ml of cutaneous solution contains 50 mg of minoxidil

The other components are propylene glycol, alcohol, purified water.

What Minoximen looks like and contents of the pack

60 ml bottle with screw cap, containing a clear, colorless or slightly yellow solution, with the characteristic odor of ethanol (ethyl alcohol).

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Minoximen can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 AUTHORIZATION NUMBER" PLACING ON MARKET09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIOPharmaceuticals, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORAN PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

MINOXIMEN 5% SKIN SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 mL of cutaneous solution contains:

Active ingredient: minoxidil 5 g

Excipient with known effects: propylene glycol

For the full list of excipients see section 6.1.

03.0 PHARMACEUTICAL FORM

Skin solution.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

MINOXIMEN is indicated for the symptomatic treatment of androgenic alopecia.

The efficacy of MINOXIMEN in the following forms has not been ascertained: localized or generalized congenital alopecia; cicatricial alopecia of various kinds (post-traumatic, psychic or infectious origin); acute alopecia diffused by toxic substances, by medicines in which the regrowth of hair is conditioned by the suppression of the specific cause; celsi area.

Furthermore, the tolerability and efficacy of MINOXIMEN in patients under the age of 18 and in patients over the age of 55 have not been established.

04.2 Posology and method of administration

FOR EXTERNAL USE ONLY. Use MINOXIMEN only following the instructions.

Dosage

A 1 mL dose of MINOXIMEN should be applied twice daily 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 on completely dry hair and scalp. Do not apply MINOXIMEN to other areas of the body.

Clinical experience with MINOXIMEN indicates that bi-daily applications lasting 3-4 months may be required before there are obvious signs of hair growth. The onset of these signs and their intensity vary from patient to patient. In all cases, the doctor will have to evaluate the opportunity to suspend treatment if no therapeutic result is observed within this period. Relapse to the pre-treatment state following suspension of therapy occurs within 3-4 months.

Method of administration

Precautions to be taken before handling or administering the medicinal product

Unscrew the cap and insert the dropper. 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. Repeat until the full 1 mL dose has been applied. "use, screw the dropper firmly onto the bottle.

04.3 Contraindications

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

MINOXIMEN should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure or valvulopathies. Faced with other cardiovascular disorders, the use of MINOXIMEN is subject to the judgment of the physician. Patients suffering from hypertension, including those being treated for this pathology, must be kept under close medical supervision.

04.4 Special warnings and appropriate precautions for use

Patients who are planned to undergo therapy with MINOXIMEN should have a medical history and undergo physical examinations. The physician should ascertain that the patient has a normal scalp.

Although extensive clinical studies performed with MINOXIMEN have not shown that there is sufficient absorption of minoxidil to cause systemic effects, some absorption of minoxidil occurs through the scalp and there is a potential risk of systemic effects such as salt and fluid retention, edema. generalized and local, pericardial effusion, pericarditis, cardiac tamponade, tachycardia, angina or increased orthostatic hypotension induced by antihypertensive drugs such as guanethidine and derivatives.

Patients with a history of underlying heart disease should be advised that MINOXIMEN may worsen these disorders. Patients should be monitored periodically for any suspicion of systemic effects caused by minoxidil.

In the event of systemic side effects or dermatological reactions, discontinue administration of the drug and consult your doctor.

Cases of mammary tumors in female mice and tumors of the adrenal glands and foreskin in male rats have been reported in carcinogenicity experiments performed on rats and mice. However, there is no evidence that these results are predictive of a similar risk for humans.

Keep this medicine out of the reach of children.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, stop the treatment and consult the doctor to institute suitable therapy.

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) Minoximen causes burning and irritation. Therefore, the area should be washed with plenty of fresh water.

04.5 Interactions with other medicinal products and other forms of interaction

The effects of MINOXIMEN in patients with concomitant dermatological diseases, or patients treated with topical corticosteroid therapy or other dermatological preparations, are currently unknown.

No interactions associated with the use of MINOXIMEN are currently known. Although it has not been clinically demonstrated, there is a potential for increased orthostatic hypotension in patients receiving concomitant therapy with peripheral vasodilators.

04.6 Pregnancy and lactation

The effects of MINOXIMEN in pregnancy are not known. Systemically administered minoxidil is excreted in human milk. MINOXIMEN should not be used in pregnant or lactating women.

04.7 Effects on ability to drive and use machines

MINOXIMEN does not affect the ability to drive or use machines.

04.8 Undesirable effects

The most frequent side effects that occurred during clinical trials with MINOXIMEN were minor dermatological reactions. The most frequent side effect was local irritation, consisting of peeling, erythema, dermatitis, itching, dry skin, hypertrichosis (in areas other than those treated with MINOXIMEN), burning sensation and rash. In a clinical study conducted with MINOXIMEN 5% cutaneous solution, MINOXIMEN 2% cutaneous solution and placebo, dermatological reactions, generally of moderate severity, were more frequent in the group treated with the 5% solution. The nature and severity of reactions occurring in the 2% Solution and 5% Solution groups were similar, but their incidence was higher in the latter. Other undesirable effects, which occurred infrequently, include: reactions allergies (sensitization, hives, generalized erythema and facial edema), dizziness, tingling, headaches, weakness, neuritis, edema, eczema, eye irritation, taste disturbance, ear infections (particularly otitis externa) and visual disturbances.

Rarely occurring side effects include hair abnormalities, exacerbation of hair loss, alopecia, chest pain, blood pressure changes, heart rate changes, hepatitis, kidney stones and sexual dysfunction.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

04.9 Overdose

Accidental ingestion of MINOXIMEN could lead to serious undesirable effects.

Following accidental ingestion, minoxidil is totally absorbed through the gastrointestinal tract and can cause systemic effects related to its vasodilating action. The signs and symptoms of drug overdose are likely to be cardiovascular effects associated with fluid retention, lowering blood pressure, and tachycardia. Fluid retention can be treated with appropriate diuretic therapy. Tachycardia can be controlled by administering a b-blocking agent. Hypotension could be treated with intravenous administration of normal saline. Sympathomimetic drugs, such as norepinephrine and adrenaline, should be avoided due to their excessive cardiac stimulating activity.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Minoxidil, by topical application, has been shown to stimulate hair growth in individuals with androgenic alopecia. The stimulation of hair growth generally begins after about 3-4 months of application of the product and varies from patient to patient. On the basis of the "non-fleece" hair count, the stimulus to regrowth was found to be higher following the use of MINOXIMEN 5% solution instead of the 2% solution. With the suspension of the use of MINOXIMEN, the new hair growth and recurrence of pre-treatment symptoms occur within 3-4 months. The exact mechanism of action of MINOXIMEN in the treatment of androgenic baldness is not known.

05.2 "Pharmacokinetic properties

MINOXIMEN, applied topically, is little absorbed by normal and healthy skin and less than 2% of the total applied dose reaches the systemic circulation. The effect of concomitant dermatological diseases on absorption is unknown.

After discontinuing the topical application of MINOXIMEN, approximately 95% of the systemically absorbed minoxidil is eliminated within 4 days. The biotransformation processes that minoxidil undergoes after topical application of MINOXIMEN have not yet been fully determined.

Minoxidil does not cross the blood brain barrier.

Minoxidil and its metabolites are haemodialysable and are mainly excreted in the urine.