ALOXIDIL*SOLUTION 3FL 60ML20MG/ML

ALOXIDIL 20 mg/ml cutaneous solution
Minoxidil

What it is and what it is used for
ALOXIDIL contains the active ingredient minoxidil, belonging to the group of dermatological medicines.
ALOXIDIL is indicated for the symptomatic treatment of androgenetic alopecia (excessive hair loss in men).

What you need to know before taking this medicine
Do not take ALOXIDIL
- If you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
- If you suffer from coronary artery disease (problems with the coronary arteries), arrhythmias (abnormal heart rhythm), congestive heart failure (a condition in which the heart cannot supply enough blood to the body) or valvular heart disease (diseases affecting the heart valves). In the presence of other cardiovascular disorders, the use of ALOXIDIL is subject to the doctor's judgment.

If you suffer from hypertension (high blood pressure), your doctor will assess whether treatment with this medicine is suitable for you and will keep you under close observation.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALOXIDIL.

Pay particular attention with ALOXIDIL:

- in case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes), ALOXIDIL can cause burning and irritation. Therefore, the affected area should be washed with plenty of fresh water;
- in case of accidental ingestion of the solution: accidental ingestion can cause serious undesirable effects;
- if you experience systemic effects as minoxidil may be absorbed through the scalp and cause effects on all organs such as tachycardia (increased heart rate), angina (pain behind the chest due to closure of the heart arteries), oedema (swelling due to fluid accumulation), pericarditis (inflammation of the membrane covering the outside of the heart), pericardial effusion, cardiac tamponade (compression of the heart by this fluid) or increased orthostatic hypotension (drop in blood pressure when standing up) from antihypertensive drugs such as guanethidine and derivatives. You should be periodically monitored to identify any suspicion of systemic effects caused by minoxidil;
- if you suffer from latent heart disorders, ALOXIDIL may worsen these disorders;
- if you suffer from concomitant skin diseases, or if you are undergoing topical corticosteroid therapy (local cortisone, cortisone ointments) or other dermatological preparations. If you experience systemic undesirable effects (general) or dermatological reactions, stop administering the medicine and consult your doctor;
- if you suffer from congenital localised alopecia (congenital local absence of hair) or generalised alopecia (absence of hair over the entire body); cicatricial alopecia (due to disease or other cause healed with a scar) of various nature (post-traumatic, of psychological or infectious origin); acute diffuse alopecia from toxic substances, from drugs where hair regrowth is conditional on the suppression of the specific cause (discontinuation of the drug); alopecia areata (hair loss on the nape of the neck, which can spread to the entire scalp), as the efficacy of ALOXIDIL has not been established for these forms of alopecia.

Cases of excessive hair growth on the body of infants 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 infants are no longer exposed to minoxidil. Care should be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.
Consult a doctor if excessive hair growth is noticed on the child's body during the period when minoxidil-based topical products are being used.

Children and adolescents
The safety and efficacy of ALOXIDIL in children and adolescents under 18 years of age have not been studied.

Possible undesirable effects
Like all medicines, this medicine can cause undesirable 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).

The most frequent undesirable effects are minor dermatological reactions on the skin.
The most frequent undesirable effect is local irritation, consisting of scaling, erythema (skin redness), dermatitis (skin inflammation), dry skin, hypertrichosis (excessive hair growth) (in areas other than those treated with ALOXIDIL), burning sensation and skin rash.
Other undesirable effects that have occurred infrequently include: allergic reactions (sensitisation, urticaria, generalised erythema and facial swelling), dizziness, tingling, headache, weakness, neuritis (inflammation of the nerves), oedema (swelling due to fluid retention), eye irritation, altered taste, ear infections (particularly otitis externa, inflammation of the outer ear) and visual disturbances.
Undesirable effects that have occurred rarely include hair abnormalities, chest pain, changes in blood pressure, changes in heart rate, hepatitis (inflammation of the liver) and kidney stones.