Name
Minoxidil Biorga 5%, cutaneous solution
Minoxidil


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

Minoxidil Biorga 5%, cutaneous solution is a liquid medication applied directly to the scalp. It is used as a treatment for hair loss, not as a cure. Minoxidil is a peripheral vasodilator, and its exact mechanism for restoring hair growth is unknown.

Minoxidil Biorga 5%, cutaneous solution is indicated for use in adults aged 18 to 65 with gradual thinning or hair loss on the crown of the head. Hair thinning or hair loss is a slow process that may only become noticeable after several years of gradual hair loss.

Minoxidil Biorga 5%, cutaneous solution is particularly indicated for men suffering from hair loss or thinning hair on the crown of the head and for women with generalized thinning of the hair.

Contact your doctor if you notice no improvement or if you notice 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 section 6).

Minoxidil Biorga 5%, cutaneous solution is not indicated for alopecia areata (sudden or unexplained hair loss) or cicatricial alopecia (associated with scarring skin, such as a burn or ulcer). Furthermore, Minoxidil Biorga 5%, cutaneous solution should not be used if hair loss is associated with pregnancy, childbirth, or serious medical conditions, such as thyroid dysfunction, lupus, patchy hair loss associated with scalp inflammation, or other medical conditions.


Warnings and precautions
Since alopecia can also be a symptom of serious diseases of the ovaries, pituitary gland, or adrenal gland, a woman should consult her doctor before using Minoxidil Biorga 5% cutaneous solution if she experiences any of the following symptoms: rapid weight gain, especially if localized to the trunk and face without involving 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 using Minoxidil Biorga 5% cutaneous solution if your hair loss is sudden or unexplained, or if your hair loss is due to an illness or treatment. If you have any other questions about your hair loss, talk to your doctor before using Minoxidil Biorga 5% cutaneous solution.
Patients about to receive treatment with Minoxidil Biorga 5% cutaneous solution must first undergo a physical examination. The physician must determine whether the patient has a normal scalp.
If you suffer or have suffered in the past from heart or vascular disease, including irregular heartbeat, 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, such as from 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 medications.
If you experience any unusual symptoms after applying Minoxidil Biorga 5% cutaneous solution, discontinue use and contact your doctor. It is especially important to discontinue use of Minoxidil Biorga 5% cutaneous solution if you experience increased heart rate (palpitations), swelling of the hands and feet, sudden unexplained weight gain, chest pain, weakness, and/or dizziness. You should also discontinue use if your scalp is red or irritated. Patients with a history of heart disease may experience worsening of their condition with the use of Minoxidil Biorga 5% cutaneous solution.

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.

Do not ingest.
Do not inhale.

Minoxidil Biorga 5% cutaneous solution contains alcohol, which may 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 rinsed thoroughly with fresh tap water.

Tell your doctor or pharmacist if:
• suffers from heart disease;
• have had allergic reactions in the past;
• is 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 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).

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 flaking, temporary hair loss, changes in hair texture, changes in hair color
• Irritation at the application site

Rare (may affect up to 1 in 1,000 people):
• Palpitations, increased heart rate, chest pain
• Erythema at the application site

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

Reporting of side effects
If you experience 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.