MINOXIDIL BIORGA*TOPICAL SOL 3FL2%

Minoxidil Biorga 2%, cutaneous solution
Minoxidil

What it is and what it is used for
Minoxidil Biorga 2%, cutaneous solution contains minoxidil, at a concentration of 20 mg per ml.

Minoxidil Biorga 2%, cutaneous solution is a liquid medicine, to be applied directly to the scalp. It is used as a treatment for hair loss and not as a cure. Minoxidil is a peripheral vasodilator, whose exact mechanism of hair regrowth restoration is not known.

Minoxidil Biorga 2%, cutaneous solution is indicated for use in adults aged between 18 and 65 years, with gradual hair thinning or gradual hair loss on the top of the head. Hair thinning or loss is a slow process, which may only become evident after several years of gradual loss.

Minoxidil Biorga 2%, cutaneous solution is particularly indicated in men suffering from hair loss or hair thinning on the top of the head and in women with generalised hair thinning.

Consult your doctor if you do not notice improvements or if you notice a worsening of symptoms after 4 months.

What you need to know before taking the medicine
Do not use Minoxidil Biorga 2%, cutaneous solution:
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).

Minoxidil Biorga 2%, cutaneous solution is not indicated in cases of alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with scarring skin, such as a burn or ulcer). Furthermore, Minoxidil Biorga 2%, cutaneous solution should not be used if hair loss is associated with pregnancy, childbirth or serious conditions, such as thyroid malfunction, lupus, hair section loss associated with scalp inflammation or other conditions.

Warnings and precautions
Since alopecia can also be a symptom of serious ovarian, pituitary or adrenal gland diseases, if any of the following symptoms are present, a woman should consult a doctor before using Minoxidil Biorga 2%, cutaneous solution: rapid weight gain, particularly if localised on the trunk and face without affecting the limbs (central obesity); male pattern hair growth on the face (hirsutism); menstrual disorders; hypertension; muscle weakness; back pain; osteoporosis; striae; acne.
Consult your doctor or pharmacist before using Minoxidil Biorga 2%, cutaneous solution.
You should not start applying Minoxidil Biorga 2%, cutaneous solution if hair loss is sudden or unexplained or in case of hair loss following an illness or therapy. If you have other questions about hair loss, consult your doctor before using Minoxidil Biorga 2%, cutaneous solution.
If you suffer or have suffered in the past from a heart or vascular disease, including irregular heart rate, you should consult a doctor before using Minoxidil Biorga 2%, cutaneous solution.
You should not apply Minoxidil Biorga 2%, cutaneous solution if the affected area is red and inflamed, irritated or painful, as in the case of a severe sunburn or seborrhoeic dermatitis. You should not apply Minoxidil Biorga 2%, cutaneous solution to other parts of the body or concurrently with other topical medicines.
If you observe unusual symptoms after applying Minoxidil Biorga 2%, cutaneous solution, stop application and consult your doctor. It is particularly important to stop applying Minoxidil Biorga 2%, cutaneous solution in case of increased heart rate (palpitations), swelling of hands and feet, sudden unexplained weight gain, chest pain, weakness and/or dizziness. You should also stop application if your scalp is red or irritated.

The development of systemic effects (e.g., increased heart rate or fluid retention) is greater in patients with known or suspected coronary heart disease and in patients predisposed to myocardial infarction. When deciding to use Minoxidil Biorga 2%, cutaneous solution, patients with this type of disease and their doctors should be aware of the risks.
Minoxidil Biorga 2%, cutaneous solution should only be applied to the scalp because in other parts of the body the absorption of minoxidil could be greater and increase the incidence of undesirable effects.
If the scalp is irritated or burned after sun exposure, Minoxidil Biorga 2%, cutaneous solution should not be applied.
Furthermore, Minoxidil Biorga 2%, cutaneous solution should not be applied to the scalp together with other topical medicines.

Do not swallow.
Do not inhale.

Minoxidil Biorga 2%, cutaneous solution contains alcohol, which can cause a burning sensation and eye irritation. In case of accidental contact with sensitive surfaces (eyes, broken skin and mucous membranes), the affected area should be washed with plenty of fresh tap water.

Children and adolescents
Minoxidil Biorga 2%, cutaneous solution should not be used in patients under 18 years of age.

Possible side effects
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 which 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).

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are listed in descending order of frequency.

Very common (may affect more than 1 in 10 people):
• Headache

Common (may affect up to 1 in 10 people):
• Depression
• Dyspnoea (shortness of breath)
• Pruritus, hypertrichosis (abnormal hair growth), rash, acne-like rash, dermatitis, inflammatory skin disorder
• Musculoskeletal pain
• Peripheral oedema
• Pain

Uncommon (may affect up to 1 in 100 people):
• Dry skin, skin exfoliation, temporary hair loss, changes in hair texture, changes in hair colour
• Application site irritation

Rare (may affect up to 1 in 1,000 people):
• Palpitations, increased heart rate, chest pain
• Application site erythema

Very rare (may affect up to 1 in 10,000 people):
• Hypotension

Reporting of side effects
If you get any side effects, including any 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.