MINOVITAL*CUT 60ML 20MG/ML

MINOVITAL 20 mg/ml cutaneous solution
Minoxidil

What it is and what it is used for
MINOVITAL contains the active ingredient minoxidil, belonging to the group of dermatological medicines that stimulate hair growth in individuals suffering from androgenic alopecia.

MINOVITAL is therefore indicated for the treatment of symptoms of a type of baldness called androgenic alopecia.

What you need to know before taking the medicine
Do not use MINOVITAL
- if you are allergic to minoxidil, propylene glycol, ethanol or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from coronary artery disease (diseases of the coronary arteries), arrhythmias (alteration of heart rhythm), congestive heart failure (inability of the heart to supply oxygen in sufficient quantities to the needs of the whole body) or valvular heart disease (diseases affecting the heart valves). If you suffer from other circulatory or heart disorders, your doctor will decide if MINOVITAL is suitable for you.

The use of the medicine is not recommended in children and adolescents under 18 years of age and in adults over 55 years of age (see section 2).

Warnings and precautions
Talk to your doctor or pharmacist before using MINOVITAL.

Pay particular attention with MINOVITAL and talk to your doctor:
- if you suffer from hypertension (high blood pressure). In this case, your doctor will keep you under close observation;
- if you suffer from other circulatory or heart disorders (see section Do not use Minovital);
- if you suffer from concomitant skin diseases (dermatological), or are being treated with corticosteroid-based medicines (anti-inflammatories to be applied to the skin) or other dermatological preparations.

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) MINOVITAL can cause burning and irritation. Therefore, the affected area must be washed thoroughly with fresh water.

Cases of excessive hair growth on the body of young children have been reported following contact with the minoxidil application sites of 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 the 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 you are using topical minoxidil products.

In case of accidental ingestion of the MINOVITAL solution, it can cause serious undesirable effects due to its vasodilating action (see section If you use more MINOVITAL than you should).

It is not yet fully clear whether an occlusive dressing, i.e., the use of gauze on the treated area that does not allow air to pass through, can increase the absorption of the medicine.

Stop treatment with this medicine and consult your doctor if you notice:
- skin reactions;
- other undesirable effects, in particular accelerated heart rate (tachycardia), chest pain (angina), swelling caused by fluid accumulation (edema), or increased orthostatic pressure guanetidine (a sharp drop in pressure when moving from a lying to an upright position) if you are taking guanetidine at the same time (see section Other medicines and MINOVITAL and Possible undesirable effects).
The efficacy of MINOVITAL has not been established in the following forms: congenital localized alopecia (congenital local lack of hair) or generalized (lack of hair all over the body); cicatricial alopecia (from disease or other cause healed with a scar) of various nature (post-traumatic, of psychic or infectious origin); acute diffuse alopecia from toxic substances, from drugs in which hair regrowth is conditioned by the suppression of the specific cause (suspension of the drug); area celsi (hair loss on the nape of the neck, which can spread to the entire scalp).

Special populations
Do not take this medicine if you are over 55 years old because safety and efficacy have not been established.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age because safety and efficacy have not been established.

Possible undesirable effects
Like all medicines, this medicine can cause undesirable 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 that may cause difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from the available data);
- tachycardia (increased heart rate);
- angina (chest pain);
- edema (swelling caused by fluid accumulation);
- increased orthostatic hypotension (low blood pressure when standing).

The most frequent undesirable effects associated with the use of MINOVITAL are minor dermatological reactions.

The most frequent undesirable effect was local irritation, consisting of:
- scaling;
- erythema (skin redness);
- dermatitis (skin inflammation);
- dry skin;
- hypertrichosis (increased hair growth) in areas other than those treated with MINOVITAL;
- burning sensation;
- rash (skin eruption).

Other undesirable effects that have occurred infrequently include:
- allergic reactions (sensitization, urticaria, generalized erythema and facial edema);
- dizziness;
- tingling;
- headache;
- weakness;
- neuritis (inflammation of the nerves);
- edema;
- eye irritation;
- altered taste;
- ear infections (particularly otitis externa);
- vision disturbances.

Undesirable effects that have occurred rarely include:
- hair abnormalities;
- chest pain;
- changes in blood pressure;
- changes in heart rate;
- hepatitis;
- kidney stones.

Reporting of undesirable 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.