REGAINE*SOLUTION 60ML 2%

REGAINE 2% cutaneous solution
REGAINE 5% cutaneous solution
REGAINE 5% cutaneous foam
Minoxidil

What it is and what it is used for
REGAINE is a medicine containing minoxidil, an active ingredient that, when applied to the scalp, can stop hair loss and stimulate hair growth in patients with hereditary hair loss (androgenetic alopecia).

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

REGAINE is available in two different concentrations: REGAINE 2% and REGAINE 5%.

If you are a woman, you should use REGAINE 2% (See "What you need to know before taking REGAINE").

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

What you need to know before taking the medicine
Do not use REGAINE if:
• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• you have heart conditions such as coronary artery disease (coronary heart disease) or heart valve disease (valvulopathy), irregular heartbeats (arrhythmias), congestive heart failure;
• you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using REGAINE:
• if you have other, even mild, heart and vascular disorders, including hypertension (high blood pressure), as these disorders may worsen.
REGAINE 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 (e.g., after trauma, due to infectious or psychological causes), or if you do not know the cause;
• your scalp is red, inflamed, infected, or sore;

CAUTION, if you are a woman, you should use REGAINE 2%, as the use of REGAINE 5% does not improve treatment results, but leads to a higher incidence of skin side effects, such as irritation at the application site and abnormal hair growth in other areas of the body (hypertrichosis).

During REGAINE therapy:
• you may notice an increase in hair loss due to the action of minoxidil: old hairs fall out as new hairs grow in their place. Generally, this temporary increase in hair loss occurs between the 2nd and 6th week after the start of treatment and subsides within a couple of weeks. If hair loss persists, stop using REGAINE and consult your doctor.
• initially, regrowth consists of soft, weak hair with a different color from your normal hair. After further treatments, the 'new hair' will have the same thickness and color 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 color 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.

REGAINE 5% cutaneous foam is extremely flammable: stay away from fire, flames, or smoke during and immediately after application. Do not use the medicine near open flames, lit cigarettes, or certain devices (e.g., hair dryers).

Stop taking REGAINE 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 due to prolonged use of the medicine), or if other new unexpected symptoms appear (See section 4. "Possible side effects").

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

Children and adolescents:
The use of REGAINE is not recommended in patients under 18 years of age.

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

Stop taking REGAINE, if you notice any of the following symptoms, contact your doctor immediately as urgent medical treatment may be necessary:
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), allergic reactions (very rare side effects, may affect up to 1 in 10,000 people);
• low 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.

Side effects reported during clinical studies:
• Minoxidil 2% or 5% cutaneous solution:
Common: peripheral edema, dyspnea (difficulty breathing), dermatitis, acneiform dermatitis, increased hair (hypertrichosis), pruritus, skin rashes.
Very common: headache.

• Minoxidil with 5% cutaneous foam:
Common: weight gain, headache, pruritus, skin rashes.

Side effects reported during post-marketing experience with both pharmaceutical forms:
Common side effects (may affect up to 1 in 10 people)
increased blood pressure (hypertension);

Uncommon side effects (may affect up to 1 in 100 people)
reactions at the application site that may affect nearby areas such as the ears, face and consist of itching, irritation, pain, rash, redness (erythema), swelling (edema), and dry skin which can sometimes be more severe and include exfoliation, skin desquamation, blistering, bleeding and ulcerations. Low blood pressure (hypotension), dermatitis, acne, weakness, dizziness, vertigo, tingling, inflammation of a nerve (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), 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 color, abnormal hair texture, nausea, vomiting, allergic reactions including angioedema (with symptoms such as swelling of the lips, mouth, tongue, oropharynx, and pharynx), hypersensitivity (manifestations may include generalized itching, generalized erythema, facial edema and throat constriction), contact dermatitis, depressed mood.

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.