ALOXIDIL 20 MG/ML CUTANEOUS SOLUTION 3 GLASS BOTTLES OF 60 ML

Name
ALOXIDIL 20 mg/ml cutaneous solution
Minoxidil


What is it and what is it for?
ALOXIDIL contains the active ingredient minoxidil, which belongs to the group of dermatological drugs.
ALOXIDIL is indicated for 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 fails to deliver adequate blood to the body), or valvular heart disease (diseases affecting the heart valves). In the case of other cardiovascular problems, the use of ALOXIDIL is subject to your doctor's discretion.

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 systemic effects, such as tachycardia (increased heart rate), angina (pain behind the chest caused by blocked arteries), edema (swelling due to fluid accumulation), pericarditis (inflammation of the membrane surrounding the heart), pericardial effusion, cardiac tamponade (compression of the heart by this fluid), or increased orthostatic hypotension (low blood pressure when standing) from antihypertensive drugs such as guanethidine and derivatives. You should be monitored periodically for 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 corticosteroids (local corticosteroids, cortisone ointments) or other dermatological preparations. If you experience systemic (general) side effects or dermatological reactions, discontinue use of the medicine and consult your doctor;
- if you suffer from localized congenital alopecia (congenital local hair loss) or generalized alopecia (hair loss all over the body); cicatricial alopecia (due to disease or another cause that heals with scarring) of various kinds (post-traumatic, psychological, or infectious); acute diffuse alopecia caused by toxic substances or drugs in which hair regrowth depends on the suppression of the specific cause (drug discontinuation); area celsi (hair loss at the nape of the neck, which can spread to the entire scalp), as the effectiveness of ALOXIDIL has not been proven for these forms of alopecia.

Cases of excessive body hair growth in 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 once 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 that may cause difficulty 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 infrequently include: allergic reactions (sensitivity, hives, generalized erythema and swelling of the face), dizziness, tingling, headache, weakness, neuritis (inflammation of the nerves), edema (swelling due to fluid retention), eye irritation, altered taste, 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.