ALOXIDIL 20 MG/ML CUTANEOUS SOLUTION 1 BOTTLE OF 60 ML

Name
ALOXIDIL 20 mg/ml cutaneous solution
Minoxidil


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


What you need to know before taking the 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), arrhythmia (altered heart rhythm), congestive heart failure (a condition in which the heart is unable to supply adequate blood to the body) or valvular heart disease (diseases affecting the heart valves). In the case of other cardiovascular disorders, the use of ALOXIDIL is subject to the doctor's judgement.

If you suffer from hypertension (high blood pressure) your doctor will assess whether treatment with this medicine is suitable for you and will monitor you closely.


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

Take special care 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 must be washed with plenty of fresh water;
- in case of accidental ingestion of the solution: accidental ingestion can cause serious adverse 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), edema (swelling due to fluid accumulation), pericarditis (inflammation of the membrane that covers the heart on the outside), pericardial effusion, cardiac tamponade (compression of the heart by this fluid) or increased orthostatic hypotension (lowering of blood pressure when standing up) from antihypertensive drugs such as guanethidine and derivatives. You should be monitored periodically to detect any suspicion of systemic effects caused by minoxidil;
- if you suffer from latent heart problems ALOXIDIL may worsen these problems;
- if you suffer from concomitant skin diseases, or if you are being treated with topical corticosteroid therapy (local cortisone, cortisone ointments) or other dermatological preparations. If you experience systemic (general) side effects or dermatological reactions, stop taking the medicine and consult your doctor;
- if you suffer from 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 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 whole scalp), since the efficacy of ALOXIDIL has not been proven for these forms of alopecia.

Cases of excessive hair growth on the body of young children 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 young children 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 safety and efficacy of ALOXIDIL in children and adolescents under 18 years of age have not been studied.


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 you may need urgent medical treatment.
• Swelling of the face, lips or throat which may cause difficulty in swallowing or breathing. This could be a sign of a serious allergic reaction (frequency not known, cannot be estimated from the available data).

The most frequent side effects are minor dermatological reactions on the skin.
The most common side effect is local irritation, consisting of flaking, erythema (redness of the skin), dermatitis (inflammation of the skin), dry skin, hypertrichosis (excessive growth of hair and scalp hair) (in areas other than those treated with ALOXIDIL), burning sensation and skin rash.
Other side effects that have occurred uncommonly include: allergic reactions (sensitivity, urticaria, generalized erythema and swelling of the face), dizziness, tingling, headache, weakness, neuritis (inflammation of the nerves), oedema (swelling due to fluid retention), eye irritation, taste disturbance, ear infections (particularly otitis externa, inflammation of the external ear) and vision disturbances.
Side 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.