MINOVITAL*CUT SOL. 60ML 2%

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 androgenetic alopecia.

MINOVITAL is therefore indicated for the treatment of symptoms of a type of baldness called androgenetic 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 paragraph 6);
- If you suffer from coronary artery disease, arrhythmias (alteration of heart rhythm), congestive heart failure (inability of the heart to supply sufficient oxygen to the needs of the whole body) or valvulopathies (heart valve diseases). If you suffer from other circulatory or heart problems, 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 paragraph 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 monitor you closely.
- If you suffer from other circulatory or heart problems (see paragraph "Do not use Minovital").
- If you suffer from concomitant skin diseases (dermatological), or are being treated with corticosteroid-based medicines (anti-inflammatory drugs to be applied to the skin) or other dermatological preparations.

In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) MINOVITAL may cause burning and irritation. Therefore, the affected area should be washed thoroughly with fresh water.
In case of accidental ingestion of MINOVITAL solution, it can cause serious side effects due to its vasodilatory action (see paragraph "If you use more MINOVITAL than you should").

It is not yet entirely 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 side effects, in particular accelerated heartbeat (tachycardia), chest pain (angina), swelling caused by fluid accumulation (edema), or increased orthostatic pressure from guanethidine (a sudden drop in pressure when changing from a lying to an upright position) if you are simultaneously taking guanethidine (see paragraph "Other medicines and MINOVITAL" and "Possible side effects").
The effectiveness of MINOVITAL has not been established in the following forms: localized congenital alopecia (congenital local lack of hair) or generalized (lack of hair all over the body); cicatricial alopecia (from disease or other cause healed with scarring) of various nature (post-traumatic, of psychic or infectious origin); acute diffuse alopecia from toxic substances, from drugs where hair regrowth is conditioned by the suppression of the specific cause (suspension of the drug); alopecia areata (hair loss on the nape, which can spread to the entire scalp).

Special populations
Do not take this medicine if you are over 55 years of age 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 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 because 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).
- tachycardia (increased heart rate)
- angina (chest pain)
- edema (swelling caused by fluid accumulation)
- increased orthostatic hypotension (drop in pressure when standing).

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

The most frequent side 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.

Other side effects that occurred infrequently include:
- allergic reactions (sensitization, urticaria, generalized erythema and facial edema)
- dizziness
- tingling
- headache
- weakness
- neuritis (nerve inflammation)
- edema
- eye irritation
- altered taste
- ear infections (especially otitis externa)
- visual disturbances.

Side effects that occurred rarely include:
- hair abnormality
- chest pain
- blood pressure changes
- heart rate changes
- hepatitis
- kidney stones

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