REGAINE 2% Solution

Зміст інструкції

1. REGAINE 2% cutaneous solution, 5% cutaneous solution, 5% cutaneous foam
   1. What is REGAINE and what is it used for
   2. What you need to know before using REGAINE
   3. How to use REGAINE
   4. Possible side effects
   5. How to store REGAINE
   6. Content of the pack and other information

REGAINE 2% cutaneous solution, 5% cutaneous solution, 5% cutaneous foam

Minoxidil

Read this leaflet carefully before you start to use this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse.

Contents of this leaflet:

• 1. What REGAINE is and what it is used for
• 2. What you need to know before you use REGAINE
• 3. How to use REGAINE
• 4. Possible side effects
• 5. How to store REGAINE
• 6. Contents of the pack and other information

1. What is REGAINE and what is it used for

REGAINE is a medicine containing minoxidil, an active ingredient which, when used on the scalp, is able to stop hair loss and stimulate hair growth in patients who have hereditary hair loss (androgenic alopecia).
This condition manifests as:

• in women with diffuse thinning of the hair affecting the top of the head, starting from the centre;
• in men with progressive hair loss in the frontal areas (receding hairline) and upper part of the head (crown).

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 using REGAINE”).
The start and intensity of regrowth varies from patient to patient. Because hair grows slowly, you may
have to wait up to 4 months to see the first results of treatment. If after this period you do not notice
any improvement, consult your doctor.

2. What you need to know before using REGAINE

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 or heart valve disease, irregular heartbeat (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 heart and vascular disorders, even mild ones, including high blood pressure, as these conditions 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 has been present since birth (congenital alopecia);
• your hair loss is due to childbirth, toxic substances or medications, scars (e.g. after trauma, due to infectious or psychiatric causes), or if you do not know the cause;
• you have redness, inflammation, infection or pain on the scalp;

ATTENTION, if you are a womanyou should use REGAINE 2%, as the use of REGAINE 5% does not improve
treatment results compared 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 therapy with REGAINE:

• 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 starting treatment and decreases 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 than your normal hair. After further treatments, the ‘new hair’ will have the same thickness and color as your hair. Results may be seen in less than 3-4 months. The effectiveness of 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 can cause the growth of unwanted hair.

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

REGAINE 5% cutaneous foamis extremely flammable: keep away from fire, flames or smoke
during and immediately after application. Therefore, do not use the medicine near open flames, lit cigarettes
or some devices (e.g. hair dryers).

Stop taking REGAINE and consult your doctor immediately if you notice:

• severe allergic reactions that can manifest as skin rashes, swelling of the hands, feet, face, eyes, lips, throat with difficulty breathing (angioedema);
• lowering or increase of blood pressure (hypotension or hypertension), acceleration of the heartbeat (tachycardia), feeling of heart in the throat (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp (which can also occur due to sensitization due to prolonged use of the medicine), or if you experience other new unexpected symptoms (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.

Accidental contact
Cases of excessive hair growth on the body of infants have been reported in early childhood 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 in early childhood are no longer
exposed to minoxidil. Care must 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 the child's body during the period when
topical minoxidil-based products are being used.

Other medicines and REGAINE
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines. This is particularly important if you are using drugs that dilate blood vessels
(peripheral vasodilators).
Do not use REGAINE together with other medicines applied directly to the scalp (corticosteroids,
tretinoin, anthralin).

Pregnancy, breastfeeding and fertility
Do not use REGAINE if you are planning to become pregnant, during pregnancy or while breastfeeding.

Driving and operating machinery
REGAINE can cause dizziness or hypotension (See section 4. “Possible side effects”). If this
occurs, it is recommended that you do not drive vehicles or operate machinery.

REGAINE 2% and 5% cutaneous solutioncontains:

• propylene glycol.REGAINE 2% contains 207 mg of propylene glycol per single application (1 ml of cutaneous solution) equivalent to 2.95 mg/kg, while REGAINE 5% contains 518 mg of propylene glycol per single application (1 ml of cutaneous solution) equivalent to 7.4 mg/kg;
• ethyl alcohol: REGAINE 2% cutaneous solution contains 474.4 mg of alcohol (ethanol) in 1 ml of solution, equivalent to 6.76 mg/Kg for a 70 Kg adult. REGAINE 5% cutaneous solution contains 237 mg of alcohol (ethanol) in 1 ml of solution, equivalent to 3.38 mg/Kg for a 70Kg adult. Ethanol can cause a burning sensation on damaged skin. In case of accidental contact with sensitive surfaces (eyes, eroded skin and mucous membranes), wet the area with plenty of fresh water.

REGAINE 5% cutaneous foamcontains:

• butylhydroxytoluene: may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes or mucous membranes;
• cetyl alcohol and stearyl alcohol: may cause localized skin reactions (e.g. contact dermatitis);
• anhydrous ethanol: 536.3 mg of alcohol (ethanol) in 1 g of foam (1 dose), equivalent to 7.66 mg/Kg for a 70 Kg adult. Ethanol can cause a burning sensation on damaged skin. In case of accidental contact with sensitive surfaces (eyes, eroded skin and mucous membranes), wet the area with plenty of fresh water.

3. How to use REGAINE

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 ml of solution or 1 g of foam, 2 times a day, preferably in the morning and
in the evening. Distribute this dose over all affected areas.
Do not exceed 2 ml or 2 g per day, regardless of the extent of the area to be treated. Using more product or
more frequently will not increase the results.

Use in children and adolescents
The use of REGAINE is not recommended in individuals under 18 years of age.

Method of administration
This medicine is for external (topical) use only and should be applied to a perfectly dry scalp. Do not
use it in other areas of the body.
Avoid contact with eyes. If this occurs, rinse the affected area with plenty of fresh water.
Wash your hands thoroughly after using the medicine.
“Instructions for use of REGAINE”.

If you use more REGAINE than you should
With doses of REGAINE higher than those recommended, or applied to areas of the body other than the scalp,
or in case of accidental ingestion, you may notice: increased heart rate (tachycardia),
lowering of blood pressure (hypotension), dizziness and weakness. Immediately inform your doctor or
go to the nearest hospital.

If you forget to use REGAINE
Do not use a double dose to make up for the forgotten dose. Resume treatment following the instructions described in

If you stop treatment with REGAINE, the growth of new hair ceases and the reappearance of pre-treatment symptoms
occurs within 3-4 months.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking REGAINE if you notice any of the following symptoms and seek immediate medical
attention, as urgent medical treatment may be needed:

• swelling of the face, lips, mouth, tongue or throat that 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), increased heart rate (tachycardia), feeling of heart racing (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 growth (hypertrichosis), itching, skin rashes. Very common:headache.

Minoxidil 5% cutaneous foam:
Common:weight gain, headache, itching, 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 scaling, blister formation,
bleeding and ulcerations. Low blood pressure (hypotension), dermatitis, acne,
weakness, dizziness, vertigo, tingling, nerve inflammation (neuritis), taste alterations,
burning sensation, ear infection, external otitis, visual disturbances.

Rare side effects(may affect up to 1 in 1,000 people)
feeling of heart racing (palpitations), increased heart rate (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 structure,
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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store REGAINE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
REGAINE 2% and 5% cutaneous solution
This medicine does not require any particular storage temperature.
REGAINE 5% cutaneous foam
Store at a temperature below 25°C.
Pressurized container, extremely flammable. Do not spray on open flames or incandescent materials.
Protect from sunlight and do not expose to temperatures above 50°C.
Do not puncture or burn, even after use. Keep away from sources of combustion and do not smoke near the container.
Do not use near or place the container on polished or painted surfaces.

6. Content of the pack and other information

What REGAINE contains
The active ingredient is: minoxidil.
1 ml of REGAINE 2% cutaneous solution contains: 20 mg of minoxidil.
1 ml of REGAINE 5% cutaneous solution contains: 50 mg of minoxidil.
1 g of REGAINE 5% cutaneous foam contains: 50 mg of minoxidil.
The other ingredients are:
REGAINE 2% and 5% cutaneous solution: propylene glycol, ethyl alcohol, purified water.
REGAINE 5% cutaneous foam: anhydrous ethanol, purified water, butylhydroxytoluene (E321), lactic acid,
anhydrous citric acid, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60, propellant:
propane/butane/isobutane.

Description of the appearance of REGAINE and contents of the pack
REGAINE 2% and 5% cutaneous solution is available in 60 ml bottles, equipped with a graduated dropper,
spray applicator and related extension, with a child-resistant cap. Each bottle contains the amount for
1 month of treatment.
REGAINE 5% cutaneous foam is available in packs containing 1 or 3 pressurised containers, each
containing 60 grams, with a child-resistant cap. Each pressurised container contains the amount for
1 month of treatment.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Johnson & Johnson S.p.A. Via Ardeatina Km 23,500- 00071 Santa Palomba Pomezia-Roma.
Manufacturer of the medicinal product and related medical devices (CE)
ASM AEROSOL-SERVICE AG Industriestrasse 11, 4313 Mohlin - Switzerland
Final control and batch release responsible
JNTL Consumer Health (France) SAS - Domain de Magrement F27100 Val de Reuil France.

INSTRUCTIONS FOR USE OF REGAINE
It is not necessary to change your usual hygiene habits regarding the scalp (use of gels,
balms, etc.). During treatment with REGAINE, you can use other hair cosmetic products, following
the instructions below.
Shampoo
Use a mild shampoo. Before applying REGAINE, the scalp must be dry. Do not
wash your hair after applying REGAINE.
Hair styling products
For best results, you should allow REGAINE to penetrate the scalp before using
hair styling products. Apply REGAINE first and then hair styling products as usual. Do not
mix it with other preparations to be applied to the scalp.
Hair dye or perm
No information is available on whether these treatments alter the effect of REGAINE.
However, to avoid possible irritation of the scalp, you should ensure that REGAINE has been
completely washed away from the hair and scalp before using these chemical products.
REGAINE CUTANEOUS SOLUTION
Remove the external protective capsule and the screw cap and insert the chosen applicator onto the bottle
depending on the area to be treated.

A) Graduated dropper
This type of applicator is suitable for distributing REGAINE on small bald areas.

• Insert the graduated dropper onto the bottle;
• Fill up to the 1 ml mark;
• Apply a few drops of REGAINE to the scalp and distribute the liquid with your fingertips over the entire bald area;
• Repeat until the entire 1 ml dose has been applied;
• At the end of use, screw the dropper tightly onto the bottle and put the protective capsule on.

B) Spray applicator (for large bald areas)
This type of applicator is suitable for distributing REGAINE on large bald areas.

• Insert the spray applicator onto the bottle and screw it on tightly;
• Remove the transparent cap, point the spray towards the centre of the bald area, spray once and distribute REGAINE with your fingertips over the entire bald area;
• Repeat the operation a total of 6 times to achieve the application of the 1 ml dose of solution;
• At the end of use, put the protective capsule back on.

Be careful not to inhale the vapours.

C) Extension for the spray applicator
The extension, which must be inserted onto the spray applicator, is suitable for distributing REGAINE under the hair.

• Insert the spray applicator onto the bottle and screw it on tightly. Remove the transparent cap and the dispenser head (Fig.1);
• Apply the extension to the stem (Fig. 2), press to fix it securely and remove the capsule from the nozzle;
• Point the extension towards the area to be treated, spray once and distribute REGAINE with your fingertips over the area to be treated;
• Repeat the operation a total of 6 times to achieve the application of the 1 ml dose of solution;
• At the end of use, put the capsule back on the nozzle.

REGAINE CUTANEOUS FOAM

• To open the container, align the arrow on the ring of the can with the arrow on the cap. Remove the cap (Fig. 1);
• The foam may start to dissolve upon contact with warm skin. If your fingers are warm, rinse them in cold water first. Dry them thoroughly before handling the foam;
• Hold the can upside down and press the nozzle to release the foam. The total amount of foam applied must not exceed 1 g, equivalent to the volume of half a cap (Fig. 2);
• Using your fingers, gently massage the foam onto the affected areas of the scalp (Fig. 3) and, after applying it, wash your hands immediately;
• After each use, close the container by putting the cap back on the can. Wash your hands carefully.

• Figure 1 Figure 2 Figure 3