CAREXIDIL*4 VIALS CUTANEOUS SOLUTION 60ML2%

CAREXIDIL 2% cutaneous spray, solution
Minoxidil
Equivalent medicinal product

What it is and what it is used for
Carexidil is a solution to be used on the scalp that contains a medicine called minoxidil.

Carexidil is indicated for the treatment of some types of baldness (androgenetic alopecia), a condition characterized by excessive hair loss, due to the action of certain hormones present in the body (androgenic hormones).

This condition manifests itself as:
• in women, with diffuse thinning of the hair that affects the upper part of the head, starting from the center;
• in men, with progressive hair loss in the frontal (receding hairline) and upper (crown) areas of the head.

The onset and intensity of regrowth vary from patient to patient. Since hair grows slowly, you may wait up to 4 months to see the first results of the treatment. If after this period you do not notice any improvement, consult your doctor.

What you need to know before taking the medicine
Do not use Carexidil:
- if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from heart conditions (coronary artery disease, arrhythmias, congestive heart failure, or valvular disease);
- if you are pregnant or breastfeeding.

Warnings and precautions
Carexidil is not indicated in the following conditions:
• there is no family history of hair loss;
• your hair loss is sudden and/or patchy;
• hair loss is present from birth (congenital alopecia);
• your hair loss is due to childbirth, toxic substances or drugs, scars (for example after trauma, due to infectious or psychological causes), or if you do not know the cause;
• you have a red, inflamed, infected, or sore scalp.

During minoxidil therapy:
• you may notice an increase in hair shedding due to the action of minoxidil: old hairs fall out as new hairs grow in their place. Generally, this temporary increase in shedding occurs between the 2nd and 6th week after the start of treatment and subsides within a couple of weeks. If shedding persists, stop using Carexidil and consult your doctor.
• initially, regrowth consists of soft, weak hairs with a different color from your normal hair. After further treatments, new hairs will have the same thickness and color as your hair. Results may be seen in less than 3-4 months. The effectiveness of the treatment varies from patient to patient.
• some patients have reported changes in hair color or hair texture.

Transfer of the product to areas other than the scalp may cause unwanted hair growth.

If after 4 months of treatment you do not notice any improvement, contact your doctor.

Stop taking Carexidil and consult your doctor immediately if you notice:
• severe allergic reactions that may manifest as skin rashes, swelling of the hands, feet, face, eyes, lips, throat with difficulty breathing (angioedema);
• decrease or increase in blood pressure (hypotension or hypertension), accelerated heartbeat (tachycardia), feeling of a racing heart (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp (which may also occur due to sensitization phenomena caused by prolonged use of the medicine);
• other unexpected new symptoms (See section 4. Possible side effects).

Special populations
Carexidil is not recommended for use in patients over 55 years of age.

Children and adolescents
Carexidil is not recommended for use in patients under 18 years of age.

There have been reports of excessive hair growth on the bodies of infants following contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returns to normal within a few months when infants are no longer exposed to minoxidil. Care should be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.
Consult a doctor if you notice excessive hair growth on your child's body during the period you are using topical minoxidil products.

Possible side effects
Like all medicines, Carexidil can cause side effects, although not everybody gets them.

Stop taking Carexidil and consult your doctor immediately if you notice:
• severe allergic reactions that may manifest as skin rashes, swelling of the hands, feet, face, lips, throat with difficulty breathing (angioedema);
• decrease in blood pressure (hypotension), accelerated heartbeat (tachycardia), feeling of a racing heart (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp.

The side effects that may occur are the following:
Very common side effects (may affect more than 1 in 10 people)
Headache.

Common side effects (may affect up to 1 in 10 people)
Itching at the application site or throughout the body and eye, skin rashes at the application site or throughout the body, increased hair (hypertrichosis), increased blood pressure (hypertension), peripheral edema, dyspnea (difficulty breathing), dermatitis, acneiform dermatitis, weight gain.

Uncommon side effects (may affect up to 1 in 100 people)
Decreased blood pressure, irritation, redness (erythema, generalized erythema), swelling (edema), skin peeling, eczema, allergic reaction, sensitization, urticaria, facial swelling, pain, dermatitis (including contact dermatitis, at application site, allergic, atopic and seborrheic), dry skin (including dry skin at application site), blister formation, acne, weakness, dizziness, vertigo, tingling, nerve inflammation (neuritis), taste disturbances, burning sensation, ear infection, otitis externa, visual disturbances.

Rare side effects (may affect up to 1 in 1,000 people)
Feeling of a racing heart (palpitations), accelerated heartbeat (tachycardia), bleeding and ulcerations, blister formation, hair loss (alopecia) or worsening of hair loss, eye irritation, kidney stones, liver inflammation (hepatitis), sexual dysfunction.

Very rare side effects (may affect up to 1 in 10,000 people)
Chest pain, temporary hair loss, changes in hair color, abnormal hair texture, nausea, vomiting, angioedema, hypersensitivity, contact dermatitis.

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.