Regaine

Package leaflet: Information for the patient

REGAINE 2% topical solution, 5% topical solution, 5% topical foam

Minoxidil
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms.

Contents of this leaflet:

1. What REGAINE is and what it is 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. Contents of the pack and other information

1. What REGAINE is and what it is used for

REGAINE is a medicine containing minoxidil, an active ingredient which, 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, diffuse thinning of hair affecting the upper part of the scalp, starting from the center;
• in men, progressive hair loss in the frontal areas (receding hairline) and upper part of the scalp (balding).

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

2. What you need to know before using REGAINE

Do not use REGAINE if:

• you are allergic to the active substance or to 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 disorders (valvular heart 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 cardiac or vascular disorders, even mild ones, including high blood pressure (hypertension), 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;
• you have had hair loss since birth (congenital alopecia);
• your hair loss is due to childbirth, toxic substances or medications, scarring (e.g. after trauma, infections or psychological causes), or if the cause is unknown;
• you have red, inflamed, infected or painful scalp;

ATTENTION, if you are a woman: you should use REGAINE 2%, as the use of REGAINE 5% does not improve treatment outcomes but increases the incidence of undesirable skin effects, such as irritation at the application site and abnormal hair growth in other body areas (hypertrichosis).
During treatment with REGAINE:

• you may notice increased hair loss due to the action of minoxidil: old hairs fall out as new hairs grow in their place. This temporary increase in hair shedding usually occurs between the 2nd and 6th week after starting treatment and resolves within a couple of weeks. If hair loss persists, stop using REGAINE and consult your doctor.
• initially, regrowth consists of soft, weak hairs with a different colour than your normal hair. After continued treatment, the 'new hairs' will have the same thickness and colour as your natural hair. Results may be seen within 3–4 months. Treatment effectiveness 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.
REGAINE 5% topical foam is extremely flammable: keep away from fire, flames or smoking 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 contact your doctor immediately if you experience:

• severe allergic reactions which may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat with breathing difficulties (angioedema);
• low or high blood pressure (hypotension or hypertension), rapid heartbeat (tachycardia), sensation of pounding heartbeat (palpitations), chest pain (possible angina), weakness, dizziness;
• sudden and unexplained weight gain;
• persistent redness or irritation of the scalp (which may occur due to sensitization from prolonged use of the medicine), or if you develop any other unexpected new 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 body hair growth in young children have been reported following contact with application sites of patients (caregivers) using topical minoxidil. Hair growth returns to normal within a few months once the children 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 a child’s body while using topical minoxidil products.

Other medicines and REGAINE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using medicines 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 a pregnancy, during pregnancy or while breastfeeding.

Driving and using machines
REGAINE may cause dizziness or hypotension (see section 4. "Possible side effects"). If these occur, you are advised not to drive or operate machinery.

REGAINE 2% and 5% topical solution contains:

• propylene glycol: REGAINE 2% contains 207 mg of propylene glycol per single application (1 ml of topical solution), equivalent to 2.95 mg/kg; REGAINE 5% contains 518 mg of propylene glycol per single application (1 ml of topical solution), equivalent to 7.4 mg/kg;
• ethanol (ethyl alcohol): REGAINE 2% topical 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% topical solution contains 237 mg of alcohol (ethanol) in 1 ml of solution, equivalent to 3.38 mg/kg for a 70 kg adult. Ethanol may cause a burning sensation on damaged skin. In case of accidental contact with sensitive surfaces (eyes, abraded skin, mucous membranes), rinse the area with large amounts of fresh water.

REGAINE 5% topical foam contains:

• butylated hydroxytoluene (BHT): 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 topical foam (1 dose), equivalent to 7.66 mg/kg for a 70 kg adult. Ethanol may cause a burning sensation on damaged skin. In case of accidental contact with sensitive surfaces (eyes, abraded skin, mucous membranes), rinse the area with large amounts of fresh water.

3. How to use REGAINE

Use this medicinal product exactly as described in this leaflet or as directed 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, twice daily, preferably in the morning and evening. Apply this dose evenly over all affected areas.
Do not exceed 2 ml or 2 g per day, regardless of the size of the area to be treated. Using more product or applying it more frequently will not improve results.

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

Method of administration
This medicinal product is for external (topical) use only and must be applied to completely dry scalp. Do not use it on other areas of the body.
Avoid contact with the eyes. If contact occurs, rinse the affected area thoroughly with large amounts of fresh water.
Wash your hands thoroughly after using the medicine.
To use REGAINE, carefully read and follow the instructions at the end of this leaflet titled “Instructions for use of REGAINE”.

If you use more REGAINE than you should
If you use doses of REGAINE higher than recommended, apply it to areas of the body other than the scalp, or if accidental ingestion occurs, you may experience: increased heart rate (tachycardia), low blood pressure (hypotension), dizziness, and weakness. Contact your doctor immediately or go to the nearest hospital.

If you forget to use REGAINE
Do not use a double dose to make up for the missed dose. Resume treatment according to the instructions described in this leaflet.

If you stop treatment with REGAINE, new hair growth will cease and the symptoms present before treatment will reappear within 3–4 months.

If you have any questions about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using REGAINE and contact your doctor immediately if you experience any of the following symptoms, as you may require urgent medical treatment:

• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema); allergic reaction (very rare side effects, affecting up to 1 in 10,000 people);
• low blood pressure (hypotension), increased heart rate (tachycardia), sensation of pounding heartbeat (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% topical solution: Common: peripheral oedema, dyspnoea (difficulty breathing), dermatitis, acneiform dermatitis, increased hair growth (hypertrichosis), pruritus, skin rashes. Very common: headache.

Minoxidil 5% topical 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, which may affect nearby areas such as the ears and face, and may include itching, irritation, pain, skin rash, redness (erythema), swelling (oedema), and dry skin; these reactions may sometimes be more severe and include exfoliation, skin desquamation, blister formation, bleeding, and ulceration. Low blood pressure (hypotension), dermatitis, acne, weakness, dizziness, vertigo, tingling sensations, nerve inflammation (neuritis), taste disturbances, burning sensation, ear infection, external otitis, visual disturbances.
Rare side effects (may affect up to 1 in 1,000 people)
sensation of pounding heartbeat (palpitations), increased heart rate (tachycardia), 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 colour, 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 oedema and throat tightness), contact dermatitis, depressed mood.

Reporting of side effects
If you experience any side effect, including those 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/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 stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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% topical solution
This medicine does not require any special storage temperature.

REGAINE 5% topical foam
Store below 25°C.
Pressurized container, extremely flammable. Do not spray onto open flames or glowing materials.
Protect from sunlight and do not expose to temperatures above 50°C.
Do not pierce or burn, even after use. Keep away from sources of ignition and do not smoke near the container.
Do not use near, or place the container on, polished or painted surfaces.

6. Package contents and other information

What REGAINE contains
The active substance is: minoxidil.
1 ml of REGAINE 2% topical solution contains: 20 mg of minoxidil.
1 ml of REGAINE 5% topical solution contains: 50 mg of minoxidil.
1 g of REGAINE 5% topical foam contains: 50 mg of minoxidil.
The other components are:
REGAINE 2% and 5% topical solution: propylene glycol, ethanol, purified water.
REGAINE 5% topical foam: anhydrous ethanol, purified water, butylated hydroxytoluene (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% topical solution is available in 60 ml bottles equipped with a graduated dropper,
spray applicator and corresponding extender, with child-resistant cap. Each bottle contains the amount of
treatment for 1 month.
REGAINE 5% topical foam is available in packs containing 1 or 3 pressurized containers, each
containing 60 grams, with child-resistant cap. Each pressurized container contains the amount of treatment
for 1 month.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Johnson & Johnson S.p.A. Via Ardeatina Km 23.500- 00071 Santa Palomba Pomezia-Roma.
Manufacturer of the medicinal product and attached medical devices (CE)
ASM AEROSOL-SERVICE AG Industriestrasse 11, 4313 Mohlin - Switzerland
Final controller and responsible person for batch release
JNTL Consumer Health (France) SAS - Domain de Magrement F27100 Val de Reuil France.

INSTRUCTIONS FOR USE OF REGAINE
You do not need to change your normal hair care habits (use of gels, conditioners, etc.) regarding the scalp. During treatment with REGAINE, you may 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, REGAINE should be allowed to penetrate the scalp before using hair styling products. Apply REGAINE first, then styling products as usual. Do not mix it with other scalp preparations.

Hair dye or permanent wave
There is no available information on whether these treatments may alter the effect of REGAINE.
However, to avoid possible scalp irritation, ensure that REGAINE has been completely washed off the hair and scalp before using such chemical treatments.

REGAINE TOPICAL SOLUTION
Remove the outer protective cap and the inner screw cap, then attach the chosen applicator depending on the area to be treated.

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

• Insert the graduated dropper into the bottle;
• Fill up to the 1 ml mark;
• Apply several drops of REGAINE onto the scalp and spread the liquid with fingertips over the entire bald area;
• Repeat until the full 1 ml dose has been applied;
• After use, screw the dropper tightly back onto the bottle and replace the protective cap.

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

• Attach the spray applicator to the bottle and screw it on tightly;
• Remove the transparent cap, point the spray towards the center of the bald area, spray once, and spread REGAINE with fingertips over the entire bald area;
• Repeat this procedure a total of 6 times to achieve the application of the 1 ml dose of solution;
• After use, replace the protective cap.

Be careful not to inhale the vapours.

C) Spray applicator extender
The extender, which must be attached to the spray applicator, is suitable for applying REGAINE under the hair.

• Attach the spray applicator to the bottle and screw it on tightly. Remove the transparent cap and the spray nozzle (Fig. 1);

• Attach the extender to the stem (Fig. 2), press to secure it firmly, and remove the cap from the nozzle;
• Point the extender toward the area to be treated, spray once, and spread REGAINE with fingertips over the area to be treated;
• Repeat the procedure a total of 6 times to achieve the application of the 1 ml dose of solution;
• After use, replace the cap on the nozzle.

REGAINE TOPICAL FOAM

• To open the container, align the arrow on the canister ring with the arrow on the cap. Remove the cap (Fig. 1);
• The foam may start to melt upon contact with warm skin. If your fingers are warm, rinse them under cold water first. Dry them thoroughly before handling the foam;
• Hold the canister upside down and press the nozzle to dispense the foam. The total amount of foam applied should not exceed 1 g, equivalent to half the cap volume (Fig. 2);
• Using your fingers, gently massage the foam into the affected areas of the scalp (Fig. 3). After application, wash your hands immediately;
• After each use, close the container by replacing the cap on the canister. Wash your hands thoroughly.

• Figure 1 Figure 2 Figure 3