Regaine 5% foam for scalp application

Regaine 5% Foam contains Minoxidil.

Application

What is Regaine 5% Foam and what is it used for?

Regaine 5% Foam contains Minoxidil. Minoxidil promotes hair growth and stabilises the course of hair loss in receding hairlines and bald spots on the scalp in men by revitalising the hair follicles.
Regaine 5% Foam is used to treat men with hereditary hair loss (androgenetic alopecia). The medicine is only intended for external use on the scalp.

How is it used?

What is Regaine 5% Foam and what is it used for?

Regaine 5% Foam contains Minoxidil. Minoxidil promotes hair growth and stabilises the course of hair loss in receding hairlines and bald spots on the scalp in men by revitalising the hair follicles.
Regaine 5% Foam is used to treat men with hereditary hair loss (androgenetic alopecia). The medicine is only intended for external use on the scalp.

What should you consider before taking it?

What should you consider before using Regaine 5% Foam?

Regaine 5% Foam must not be used,

- if you are allergic to Minoxidil or any of the other ingredients of this medicine listed in section 6. __________________________________________
* Abbreviated as Regaine 5% Foam in the following
Warnings and precautions

Please talk to your doctor or pharmacist before using Regaine 5% Foam,

• if you have any signs of heart disease, for example
  heart rhythm disorders, abnormal heart rate, angina or chest pain and/or circulatory disorders.

If Minoxidil enters the bloodstream, it can cause side effects due to low blood pressure such as chest pain, rapid heartbeat, feeling faint, dizziness, sudden and unexplained weight gain, swollen hands or feet, as well as persistent redness or irritation of the scalp. If you experience such symptoms, stop treatment and inform your doctor.

Changes in hair colour and hair structure have been observed in some patients using this medicine.

2 to 6 weeks after the start of treatment, increased hair loss may occur (old hair falls out while new hair grows in its place). This is an initial sign of the
effect of the medicine and indicates that new hair is replacing the old hair. The effect should subside within a few weeks. If hair loss persists, stop treatment and talk to your doctor.

Accidental ingestion can cause serious cardiovascular side effects. Therefore, keep this medicine out of the reach of children.
If the foam is accidentally applied to areas of the body other than the scalp, rinse thoroughly with plenty of water immediately to avoid unwanted hair growth.

Regaine 5% Foam must not be used,

• if hair loss is not in the form of a receding hairline and bald spots
• in the absence of a family history of hair loss
• if you suffer from sudden and/or uneven hair loss
• if the cause of hair loss is unknown
• if the scalp is inflamed, infected or irritated or painful

Regaine 5% Foam is EXTREMELY FLAMMABLE!
Do not use near fire or naked flame, do not smoke during and immediately after application.

Children and adolescents

Regaine 5% Foam must not be used in children and adolescents under 18 years of age.

Using Regaine 5% Foam with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines.
Regaine 5% Foam must not be used together with other medicines that are applied to the scalp.
Using Regaine 5% Foam with hair care products

Using shampoo during treatment
It is recommended to use a mild shampoo during treatment with Regaine 5% Foam. The scalp must be dry before you apply Regaine 5% Foam.

Using hair care products during treatment
To ensure the best results, allow Regaine 5% Foam to be fully absorbed into the scalp before applying styling products. Apply Regaine 5% Foam first, then style your hair as usual. Do not mix with other medicines for use on the scalp.

Note on hair dyes and perms
There is no information on whether hair dyes or perms affect the action of Regaine 5% Foam. However, to avoid possible irritation of the scalp, wash Regaine 5% Foam completely out of your hair and off your scalp before using these chemical products. Also, inform your hairdresser that you are using Regaine 5% Foam.

Pregnancy, breast-feeding and fertility

Regaine 5% Foam is only intended for use in men.
The use of this medicine during pregnancy or breast-feeding, as well as when trying to conceive, is not recommended.

Driving and using machines

Regaine can cause dizziness or low blood pressure. Do not drive or operate machinery if you experience these side effects.

Regaine 5% Foam contains:

Ethanol (alcohol), which can cause burning and/or irritation if the medicine accidentally gets into the eyes. In case of contact with eyes, mouth or broken skin, rinse the affected area with plenty of cold tap water.

Butylhydroxytoluene, which can cause local skin irritation (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

Cetyl alcohol and stearyl alcohol, which can cause local skin irritation (e.g. contact dermatitis).

How should the medicine be taken?

How to use Regaine 5% Foam?

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist or healthcare professional has told you. Check with your doctor or pharmacist if you are not sure.
Apply the foam twice a day to achieve and maintain the desired effect on hair growth.

This foam is only intended for use on the normal healthy scalp. You should NOT use Regaine 5% Foam if your scalp is inflamed, infected or irritated or painful. You must NOT apply the medicine to other parts of the body.
Apply the foam directly to the scalp.
Avoid accidental contact with the eyes. If foam gets into your eyes, rinse your eyes immediately with plenty of cold tap water.

Before applying the foam:

Your hair and scalp should be dry.

Applying the foam:

Apply one 1 g dose (corresponding to the volume of half a capful) twice a day to the affected areas of the scalp.

To open the container, align the arrows on the container and the cap. Then pull off the cap (Fig. 1).
The foam may melt quickly when it comes into contact with your warm skin. If your fingers are warm, rinse them with cold water beforehand. Dry your fingers thoroughly before applying the foam.
Hold the container with the spray head pointing downwards and press the spray head to spray the foam onto your fingertips (Fig. 2). The amount of foam should always correspond to the volume of half a capful (= 1 g of foam).
Spread the foam with your fingertips over the affected areas of the scalp and massage it in gently (Fig. 3). Wash your hands immediately after applying the foam.
Close the can after each use by replacing the cap on the container.





Fig. 1
Fig. 2 Fig. 3

Duration of use of Regaine 5% Foam

It takes time for hair to regrow. With twice-daily application, an effect may occur after 2 months. In some men, it has been observed that the medicine had to be used for at least 4 months before an effect was noticeable.

What to expect when using Regaine 5% Foam?

In the first few months, some users may initially experience the impression of increased hair loss (shedding). This can be an initial sign of the action of Regaine 5% Foam. This reaction generally occurs 2 to 6 weeks after the start of treatment and then subsides within a few weeks.
See your doctor if the increased hair loss lasts for more than 6 weeks.

The new hair is usually fine, downy and colourless. After prolonged use, the new hair should have the same colour and thickness as the other hair on your head. Hair grows slowly, which is why the effect of Regaine 5% Foam only becomes visible after a certain period of time. In general, twice-daily treatment for 2-4 months is necessary before an effect is noticeable.
If no new hair grows after 4 months, stop treatment with Regaine 5% Foam.
The extent to which hair regrows varies from user to user. This medicine is not equally effective in all men.
To promote and maintain hair growth, it is necessary to continue using the product continuously. Otherwise, hair loss will occur again.

If you have used more Regaine 5% Foam than you should

Follow the instructions for use. Do not apply more than 2 g (corresponding to the volume of one capful) per day in total, and do not apply the medicine more than twice a day. Your hair will not grow back faster, and you will not achieve a better result,
if you use the medicine in larger amounts or more often.
If a child swallows Regaine 5% Foam, take them to a hospital immediately. (If possible, take the Regaine 5% Foam container with you so that the doctor can determine how much the child has swallowed.)

If you forget to use Regaine 5% Foam

Do not worry if you forget one or two applications and continue using the medicine as usual, as if you had applied the missed dose. Do not apply double the amount the next time you forget an application, as excessive use can lead to a drop in blood pressure, rapid heartbeat and drowsiness or fatigue.

If you stop using Regaine 5% Foam

If you stop using the foam, hair loss will resume and within 3 to 4 months your scalp will return to its previous condition.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

How to store Regaine 5% Foam?

Keep this medicine out of the reach of children.

Danger. Extremely flammable aerosol. Pressurised container: May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not spray on an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight. Store the aerosol can in the outer carton. Do not expose to temperatures above 50 °C.

Do not use this medicine after the expiry date which is stated on the container after "Use by:". The expiry date refers to the last day of the specified month.

When disposing of the container and contents, do not expose to naked flames. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

Special storage conditions

How to store Regaine 5% Foam?

Keep this medicine out of the reach of children.

Danger. Extremely flammable aerosol. Pressurised container: May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not spray on an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight. Store the aerosol can in the outer carton. Do not expose to temperatures above 50 °C.
Do not use Regaine 5% Foam after the expiry date which is stated on the container after "Use by:". The expiry date refers to the last day of the specified month.

When disposing of the container and contents, do not expose to naked flames. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

Special information on the contents

Contents of the pack and further information

What Regaine 5% Foam contains

The active substance is Minoxidil.
1 g of foam for application to the scalp contains 50 mg of Minoxidil (5 %).

The other ingredients are anhydrous ethanol, purified water, butylhydroxytoluene (E321), lactic acid, anhydrous citric acid, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60 and propane/butane/isobutane (propellant).

What Regaine 5% Foam looks like and contents of the pack

This medicine is available as a foam for application to the scalp. The foam is white to yellowish and has no fragrance. It is available in an aerosol can containing 60 g (corresponding to
73 ml) and with a child-resistant polypropylene cap. The container is pressurised.
The aerosol can is sufficient for a treatment period of 1 month. One pack contains 1 or
3 aerosol cans.

Not all pack sizes may be marketed.