MINOXIDIL BIORGA*TOPICAL SOLUTION 3FL5%

Minoxidil Biorga 5%, cutaneous solution
Minoxidil

What it is and what it is used for
Minoxidil Biorga 5%, cutaneous solution contains minoxidil, at a concentration of 50 mg per ml.

Minoxidil Biorga 5%, 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 for restoring hair growth is unknown.

Minoxidil Biorga 5%, cutaneous solution is indicated for use in adult subjects aged between 18 and 65 years, with gradual 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 5%, cutaneous solution is particularly indicated in men suffering from hair loss or hair thinning on the top of the head and in women who experience generalized 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 5%, cutaneous solution:
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in paragraph 6).

Minoxidil Biorga 5%, 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 an ulcer). Furthermore, Minoxidil Biorga 5%, cutaneous solution should not be used if hair loss is associated with pregnancy, childbirth or serious conditions, such as thyroid malfunction, lupus, hair 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 5%, cutaneous solution: rapid weight gain, particularly if localized to 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.
Talk to your doctor or pharmacist before using Minoxidil Biorga 5%, cutaneous solution.
You should not start applying Minoxidil Biorga 5%, cutaneous solution if your 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 5%, cutaneous solution.
Patients who are about to receive treatment with Minoxidil Biorga 5%, cutaneous solution must first undergo a physical examination. The doctor must determine if the subject has a normal scalp.
If you suffer or have suffered from heart or vascular disease in the past, including irregular heart rate, you should consult a doctor before using Minoxidil Biorga 5%, cutaneous solution.
You should not apply Minoxidil Biorga 5%, cutaneous solution if the affected area is red and inflamed, irritated or painful, as in the case of a severe sunburn or seborrheic dermatitis. You should not apply Minoxidil Biorga 5%, cutaneous solution to other parts of the body or in conjunction with other topical medicines.
If you notice unusual symptoms after applying Minoxidil Biorga 5%, cutaneous solution, stop applying it and contact your doctor. It is particularly important to stop applying Minoxidil Biorga 5%, cutaneous solution if you experience an increased heart rate (palpitations), swelling of the hands and feet, sudden weight gain without apparent cause, chest pain, weakness and/or dizziness. You should also stop applying it if your scalp is red or irritated. Patients with a history of heart disease may experience a worsening of their condition with the use of Minoxidil Biorga 5%, cutaneous solution.

Do not ingest.
Do not inhale.

Minoxidil Biorga 5%, 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.

Inform your doctor or pharmacist if you:
• suffer from heart disease
• have had allergic reactions in the past
• are taking other medicines

Children and adolescents
Minoxidil Biorga 5%, 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 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 decreasing order of frequency.

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

Common (may affect up to 1 in 10 people):
• Depression
• Dyspnea (shortness of breath)
• Itching, hypertrichosis (abnormal hair growth), rash, acneiform rash, dermatitis, inflammatory skin disorder
• Musculoskeletal pain
• Peripheral edema
• Pain

Uncommon (may affect up to 1 in 100 people):
• Dry skin, skin exfoliation, temporary hair loss, changes in hair texture, changes in hair color
• 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, tell 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.