CAREXIDIL*3FL CUTANEOUS SOLUTION 60ML 5%

CAREXIDIL 5% cutaneous spray, solution
Minoxidil
Equivalent medicine

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

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

This condition manifests itself as:
• in women, diffuse thinning of the hair affecting the top of the head, starting from the centre;
• in men, progressive hair loss in the frontal areas (receding hairline) and upper part of the head (bald patch).

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 you do not notice any improvement after this period, 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 heart disease);
- if you are pregnant or breastfeeding.

Warnings and precautions
Carexidil is not indicated in the following conditions:
• there is no history of hair loss in your family;
• your hair loss is sudden and/or patchy;
• your hair loss has been present since birth (congenital alopecia);
• your hair loss is due to childbirth, toxic substances or medicines, scars (e.g. after trauma, due to infectious or psychological causes), or if you do not know the cause;
• you have a red, inflamed, infected, or painful 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 2^nd and 6^th week after starting treatment and decreases within a couple of weeks. If shedding persists, stop using Carexidil and consult your doctor;
• initially, the regrowth consists of soft, weak hair with a different colour than your normal hair. After further treatments, the new hair will have the same thickness and colour as your hair. Results can be seen in less than 3-4 months. The effectiveness of the treatment varies from patient to patient;
• some patients have experienced changes in hair colour or hair texture.

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

If you do not notice any improvement after 4 months of treatment, 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 breathing difficulties (angioedema);
• drop or increase in blood pressure (hypotension or hypertension), accelerated heart rate (tachycardia), pounding heart sensation (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 sensitisation phenomena caused by prolonged use of the medicine);
• other new unexpected symptoms (See section 4. Possible side effects).

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

Children and adolescents
The use of Carexidil is not recommended in patients under 18 years of age.
Cases of excessive hair growth on the body of infants have been reported following contact with the application sites of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returns to normal within a few months when infants are no longer exposed to minoxidil. Care must be taken to ensure that children do not come into contact with the 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 breathing difficulties (angioedema);
• drop in blood pressure (hypotension), accelerated heart rate (tachycardia), pounding heart sensation (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 as follows:

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 oedema, dyspnoea (difficulty breathing), dermatitis, acneiform dermatitis, weight gain.

Uncommon side effects (may affect up to 1 in 100 people)
Drop in blood pressure, irritation, redness (erythema, generalised erythema), swelling (oedema), skin flaking, eczema, allergic reaction, sensitisation, urticaria, facial swelling, pain, dermatitis (including contact, application site, allergic, atopic, and seborrheic dermatitis), dry skin (including dry 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)
Pounding heart sensation (palpitations), accelerated heart rate (tachycardia), bleeding and ulceration, blister formation, hair loss (alopecia) or worsening 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 colour, 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.