MINOXIMEN*SOLUTION FL 60ML 5%

MINOXIMEN 5% 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 androgenic alopecia (baldness).

The effectiveness 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 (hair loss, generally reversible, in well-defined areas, usually involving the beard and scalp).

Contact 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 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 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 have other circulatory or heart disorders, including hypertension (high blood pressure), your doctor will decide if Minoximen is suitable for you.

If you suffer from hypertension (high blood pressure), even if you are being treated for this condition, 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
Consult your doctor or pharmacist before taking Minoximen.

Before starting treatment with Minoximen, you should undergo a medical examination during which the doctor will ensure that you have a normal scalp.

The use, especially prolonged, of topical products 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 establish appropriate 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. In the presence of other cardiovascular disorders, including hypertension (high blood pressure), take Minoximen only under strict 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 salt and fluid retention, generalized and localized edema (fluid retention), pericardial effusion (fluid accumulation 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 disorders in the past, your doctor will warn you that Minoximen may worsen these disorders. 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 (on the skin) occur.

Cases of excessive hair growth on the body of infants have been reported following contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returns to normal within a few months when infants are no longer exposed to minoxidil. Care should 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 your child's body while using topical minoxidil products.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences 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 that 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 (shedding 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 skin rash.

A clinical study showed that dermatological reactions are 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 accumulation);
- 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 dysfunctions.

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, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.