MINOXIMEN*SOLUTION FL 60ML 2%

MINOXIMEN 2% cutaneous solution
Minoxidil

What it is and what it is 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 for 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 scar formation, usually on the scalp) of various origins (post-traumatic, psychological or infectious); acute diffuse alopecia caused by toxic substances or medications in which hair regrowth is conditioned by the suppression of the specific cause; alopecia areata (generally reversible hair loss in clearly 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.

What you need to know before taking the medicine
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 heart disease (alterations of the blood vessels that supply blood to the heart), arrhythmias (alterations of the heart rhythm), congestive heart failure (inability of the heart to supply sufficient oxygen to the needs of the entire body) 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 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, you must ensure that your scalp is intact and in good health.

The use of topical products, especially if prolonged, can cause sensitization phenomena (increased reactivity) (see section 4 Possible side effects). In this event, 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 in 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, broken skin, mucous membranes), wash the area with plenty of fresh water. Although extensive experience with the topical use of minoxidil has not shown absorption of the medicine sufficient 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 body of young children have been reported following contact with the application sites of minoxidil in patients (caregivers) 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 body areas where topical minoxidil has been applied.
Consult a doctor if you notice excessive hair growth on your child's body while 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 tolerability and efficacy have not been determined.

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 necessary.
• 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).

Common side effects
- local irritation consisting of desquamation (shedding of the top layer of skin), erythema, dermatitis (skin inflammation), itching, dry skin, hypertrichosis (increased hair growth) in areas other than those treated with Minoximen, burning sensation and skin rash.

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

Rarely occurring side effects
- hair abnormality, exacerbation (increase) of hair loss, alopecia (decrease 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 unknown frequency
- allergic reactions (sensitization, urticaria, generalized erythema, facial oedema and angioedema).

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-averse.
By reporting side effects, you can help provide more information on the safety of this medicine.