Label: information for the user

Regaine 50 mg/g topical foam

Minoxidil

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 months.

1.What isRegaineand what is it used for

2.What you need to know before starting to useRegaine

3.How to useRegaine

4.Possible adverse effects

1. Storage ofRegaine

6. Contents of the package and additional information

Regaine contains minoxidil. Minoxidil promotes hair regrowth and stabilizes hair loss in men with receding hairline and baldness on the crown, due to the revitalization of the hair follicle

Regaine is used to treat hereditary hair loss (also known as androgenetic alopecia) in men. Use only on the scalp (head).

Do not useRegaine

-if you are allergic to minoxidil or any of the other components of Regaine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Regaine if:

• you have any heart disease, including abnormal heart rhythm, angina or chest pain and/or circulation problems.

When minoxidil passes into the bloodstream, it can cause side effects related to low blood pressure, such as chest pain, rapid heart rate, weakness, dizziness, sudden and unexplained weight gain, or swollen hands and feet. It may also cause persistent redness or irritation of the scalp. If you experience any of these effects, stop treatment and consult your doctor.

Some patients have experienced changes in hair color and texture while using this medication.

You may experience an increase in hair loss (old hair falls out as new hair grows in its place) during the first 2-6 weeks (small patches of scalp that shed). This is a sign that the medication is working and new hair is replacing old hair. This effect disappears after two weeks. If hair loss persists, stop using Regaine and consult your doctor.

Contact with accidental exposure

Accidental ingestion may cause severe cardiac side effects, so this product should be kept out of the reach of children.

If the foam is accidentally applied to other areas of the body instead of the scalp, rinse immediately with plenty of water to avoid unwanted hair growth.

There have been reports of excessive hair growth on the bodies of infants after contact with the application sites of minoxidil on patients (caregivers) who use topical minoxidil. Hair growth returned to normal after a few months when the infants were no longer exposed to minoxidil. Be careful to ensure that children do not come into contact with areas of their body where you have applied minoxidil topically. Consult a doctor if you notice excessive hair growth on your child's body during the period when they are using minoxidil topical products.

Do not use Regaine if:

-you have a hair loss pattern different from the receding hairline and baldness on the crown.

-you do not have a family history of hair loss.

-you have sudden and/or irregular hair loss.

-you do not know the reason for your hair loss.

-your scalp is inflamed, infected, irritated or painful.

Regaine 50 mg/g foam is EXTREMELY FLAMMABLE!

Avoid contact with fire, flames or smoke during and immediately after application.

Children and adolescents

Regaine should not be used by children and adolescents under 18 years old.

Use of Regaine with other medications

Inform your doctor or pharmacist if you are using, have used recently or will use other medications.

Regaine should not be used in combination with other medications applied topically to the scalp.

Use of Regaine with other hair care products

Use of shampoos during treatment

You should use a mild shampoo in combination with Regaine. The scalp should be perfectly dry before applying Regaine.

Use of hair care products during treatment

For better results, Regaine should soak the scalp before using any hair care products. Apply Regaine first and then apply the hair care products you use in the normal way. Do not mix with other products to use on the scalp.

Advice for people with colored or permanent hair

There is no available information on a change in the effects of Regaine due to these treatments. However, to avoid any possible irritation of the scalp, make sure that Regaine has been removed through a shampoo of the hair and scalp before using these products.

You should inform your hair care professional that you are using Regaine.

Pregnancy, breastfeeding and fertility

Regaine should not be used by women.

This medication is not recommended during pregnancy, breastfeeding or when trying to become pregnant.

Driving and operating machinery

Regaine may cause dizziness or low blood pressure. If you experience these side effects, do not drive or operate machinery.

Regaine contains ethanol (alcohol)

This medication contains 564.6 mg of alcohol (ethanol) in each dose (1 gram) of foam, which is equivalent to 564 mg/g (564.6% p/p). This may cause a burning sensation on damaged skin. If Regaine enters the eyes, mouth or a cut on the skin, rinse the area well with cold water.

Regaine contains butylhydroxytoluene

This medication may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

Regaine contains cetyl and stearic alcohol

This medication may cause local skin reactions (comedodermatitis) because it contains cetyl and stearic alcohol.

Follow exactly the administration instructions of this medication indicated in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.ask your doctor or pharmacist.

Use twice a day to achieve and maintain the desired effect of hair regrowth.

This foam is only for use on normal and healthy scalp. DO NOT apply on other parts of the body.

Make sure to apply directly on the scalp.

Avoid contact with the eyes. If the foam enters the eyes, rinse them with plenty of water.

Before using the foam:

The hair and scalp must be perfectly dry.

How to use the foam:

Apply a dose of1 g(equivalent to the volume of half a cap) in the area of hair loss twice a day.

1. To open the container, align the arrow on the ring of the cap with the arrow on the cap. Remove the cap(Figure 1).
2. The foam may start to melt in contact with warm skin. If your fingers are warm, cool them down first with water. Make sure to dry them before handling the foam.
3. Hold the container upside down and press the nozzle to dispense the foam onto the fingertips (Figure 2). The total amount of foam applied should not exceed 1g (equivalent to the volume of half a cap).
4. Using your fingers, gently massage the foam into the affected areas of the scalp (Figure 3) and wash your hands immediately after applying the foam.
5. After each use, close the container by putting the cap back on the container.

figure 1 figure 2figure 3

Duration of treatment with Regaine

Hair regrowth may take time to appear. Results may not appear until two months after applying the product twice a day. Some men may need to use the product for 4 months before observing results.

What to expect from using Regaine

In the first two months, some users have experienced an increase in hair loss after using the foam for the first time. This may be a sign that Regaine is working. This temporary increase in hair loss usually occurs between 2 and 6 weeks after starting treatment and then disappears.

If the increase in hair loss continues after 6 weeks, consult your doctor.

The hair is normally soft and without color. After subsequent applications, the new hair should have the same color and thickness as the other hairs on your head. As hair grows slowly, it takes time to see results.

Results can be seen in 2-4 months with two daily applications of the product.

If no hair regrowth is observed after four months, stop using Regaine.

The amount of hair that regrows is different for each person. This product may not work for all men.

Continued use is necessary to increase and maintain hair growth, or hair loss will start again.

If you use more Regaine than you should

Follow the usage instructions. Do not use more than2 g(equivalent to the volume of a cap) per day, and never more than twice a day. Hair will not grow faster and no better results will be obtained if more quantity or frequency is used.

If a child swallows some Regaine, take them to the hospital immediately (with the Regaine container if possible, so the doctor can get an idea of how much was swallowed).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20.

If you forget to use Regaine

Do not worry if you forget one or two applications, continue using the product as if you had not forgotten any application. Do not apply a double dose to compensate for the missed dose, as this may cause low blood pressure, rapid heart rate, and dizziness or fatigue.

If you interrupt treatment with Regaine

If you stop using the foam, hair regrowth may stop and the scalp may return to its original state in 3-4 months.

If you have any doubts about using this medication, ask your doctor or pharmacist.

Like all medications,Regainemay cause side effects, although not everyone will experience them.

STOP using the foam and contact your doctor immediately if you notice any of the following side effects.You may need urgent medical treatment..

• Swelling of the hands or feet (infrequent)
• Swelling of the face, lips, or throat that causes difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (Frequency unknown, cannot be estimated from available data)

• Persistent redness, itching, or irritation of the scalp (unknown)
• Weakness or dizziness (infrequent)
• Tachycardia (rapid heartbeat) or irregular heartbeat (rare)
• Chest pain (rare)
• Hypotension (low blood pressure) (unknown)
• Unexplained and sudden weight gain (frequent)

Other side effects that may occur:

• Frequent (may affect up to 1 in 10 people):
• Headache.
• Severe itching or skin rash.
• Shortness of breath or difficulty breathing
• Excessive hair growth

• Infrequent (may affect up to 1 in 100 people):
• • Nausea.

Unknown side effects (whose frequency cannot be estimated from available data:

Reporting side effects

If you experienceany type ofside effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the reach and sight of children.

Danger: Extremely flammable aerosol. Pressurized container: May burst if heated. Keep away from heat sources, sparks, open flames, or hot surfaces and other ignition sources.– Do not smoke.Do not spray onto an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight, and store the container in its box. Do not expose to temperatures above 122°F (50°C).

Do not use this medication after the expiration date that appears on the container after the letters “CAD”. The expiration date is the last day of the month indicated.

Do not expose the container and its contents to flames during application. Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Regaine Composition

• The active ingredient is minoxidil. Each gram of foam contains 50 mg of minoxidil.
• The other components are anhydrous ethanol, purified water, butylhydroxytoluene (E321), lactic acid, anhydrous citric acid, glycerol, cetyl alcohol, stearic alcohol, polysorbate 60, and propano/butano/isobutano (propellant)

Product appearance and packaging contents

This medicine is presented as a foam in a pressurized container with a child-resistant polypropylene cap. The foam is white to yellow in color and has no perfume. It is contained in a 60 g (equivalent to 73 ml) container, which is sufficient for 1 month of treatment. The box may contain 1 or 3 containers.

Only some container sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

JNTL Consumer Health (Spain), S.L.

Pº de las Doce Estrellas 5-7

28042 Madrid - Spain

Manufacturer:JNTL CONSUMER HEALTH (FRANCE) S.A.S.

Domaine de Maigremont, 27100,

Val de Reuil, France

Or

JOHNSON & JOHNSON CONSUMER NV,

Antwerpseweg 15-17,

2340 Beerse, Belgium – (Alternative)

This medicine has been authorized in the Member States of the EEA with the following names:

Finland, Norway, Sweden: Rogaine

Austria, Ireland, Romania, Slovenia, Spain: Regaine

France: Alostil

Last review date of this leaflet: March 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/