Regaine 2% Solution

Regaine prevents hereditary hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair in already thinned or bald areas and strengthens existing vellus hair.

Application

What is Regaine and what is it used for?

Regaine prevents hereditary hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair in already thinned or bald areas and strengthens existing vellus hair.

Regaine penetrates the scalp after application and reaches the hair roots. The mechanism by which it stimulates hair growth has not yet been clarified. However, the active ingredient in Regaine can stop hereditary hair loss by:

·	Enlarging the diameter of the hair shaft
·	Stimulating growth and
·	Extending the growth phases of the hair
It	takes
present, fine, light vellus hairs can grow back, which over time become longer, thicker and darker
How quickly hair growth begins and how much hair grows back varies from patient to
patient.	Large
less well to Regaine.

Children and adolescents under 18 years of age, patients over 65 years of age
Regaine 2 % should not be used in these patient groups, as there are no results on efficacy and safety from controlled studies in these age groups.

How is it used?

What is Regaine and what is it used for?

Regaine prevents hereditary hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair in already thinned or bald areas and strengthens existing vellus hair.

Regaine penetrates the scalp after application and reaches the hair roots. The mechanism by which it stimulates hair growth has not yet been clarified. However, the active ingredient in Regaine can stop hereditary hair loss by:

• Enlarging the diameter of the hair shaft
• Stimulating growth and
• Extending the growth phases of the hair

It takes at least four months before you can see any results. If hair roots are still present, fine, light vellus hairs can grow back, which over time become longer, thicker and darker. How quickly hair growth begins and how much hair grows back varies from patient to patient. Large bald patches or hair loss that has existed for more than 10 years respond less well to Regaine.

.
Children and adolescents under 18 years of age, patients over 65 years of age
Regaine 2 % solution should not be used in these patient groups, as there are no results on efficacy and safety from controlled studies in these age groups.

What should you consider before taking it?

What should you consider before using Regaine?

Regaine must not be used,

if you are allergic to minoxidil or any of the other ingredients of this medicine listed in section 6.


Hair loss after childbirth is normal to a certain extent. Therefore, Regaine should not be used in this case.

Certain forms of hair loss can be signs of a physical illness. In this case, Regaine will not work, and it is important for your health that you see a doctor:

• sudden onset of severe hair loss
• patchy hair loss (e.g. circular bald patches)

Regaine will also not work if the hair loss is due to one of the following causes:

• Use or taking of certain medicines (e.g. for cancer).
  Here, at most, faster hair regrowth can be promoted.
• severe nutritional problems (very low iron levels, vitamin A overdose).
• Stopping taking the “pill” (Due to the hormonal change, there may be a short-term increase in hair loss. However, this normally does not require medical treatment.)
• scalp damaged by scarring or burns, as there are no longer any hair roots.
• Hairstyles in which the hair is pulled tightly from the scalp (e.g. ponytail). In this case, you must eliminate the mechanical irritation.
• Pregnancy and breastfeeding.

If you are unsure about the causes of your hair loss, you should consult your doctor.

Warnings and precautions

Please talk to your doctor or pharmacist before using Regaine.

Only use Regaine on a normal, healthy scalp. You must not use Regaine if the cause of your hair loss is unknown or if your scalp is red, inflamed or painful.

Do not apply Regaine to the scalp together with other products.

If you have a cardiovascular disease or heart rhythm disorders, ask your doctor before using it.

Only a very small proportion of the active ingredient in Regaine penetrates the skin. Particularly in hypersensitive or heart patients, side effects that do not affect the skin can never be completely ruled out. If you notice oedema (swelling of body parts, possibly including the face) or heart problems (e.g. a rapid heartbeat), please inform your doctor.

Regaine should not be used in cases of sudden or patchy hair loss or hair loss of unknown cause.

The use of Regaine may possibly lead to a change in the colour or structure of the hair.

After using Regaine, contact with sensitive textiles and surfaces, such as pillows or hats, may cause discolouration. This is especially true as long as the solution is still moist on the scalp.

If severe side effects occur on the skin, please stop treatment (see section 4 What side effects are possible?).

If a drop in blood pressure is detected, if chest pain, rapid heartbeat, weakness or dizziness, sudden and unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp or other unexpected new symptoms occur, please stop treatment and contact your doctor.

If Regaine accidentally gets into your eyes, it can cause irritation and burning. This also applies to sensitive surfaces such as mucous membranes or abrasions. In such cases, rinse the medicine off with plenty of water as quickly as possible. To prevent Regaine from accidentally coming into contact with other parts of the body, you should wash your hands after each application of the medicine.

Regaine must not be swallowed! Accidental ingestion can lead to serious adverse effects. The medicine must therefore be kept out of the sight and reach of children.

Inhalation of Regaine should be avoided.

Once you stop using Regaine, hair loss will start again.

If your symptoms worsen or do not improve within 12 months, please see a doctor.

You will not achieve a better result if you use Regaine in larger quantities or more often.

If you apply Regaine to areas of the body other than the scalp, it may cause unwanted hair growth there.

Use of Regaine with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

No interactions with Regaine are known to date. To be on the safe side, you should not use Regaine on the scalp at the same time as other medicines.

It cannot be completely ruled out that the effect of blood pressure-lowering medicines may be slightly increased.

Pregnancy and breastfeeding

There is little experience with the use of Regaine during pregnancy. Minoxidil absorbed into the body passes into breast milk. Regaine must therefore not be used during pregnancy or breastfeeding.

Driving and operating machinery

As a side effect of Regaine, dizziness or low blood pressure may occur. If this is the case for you, do not drive or operate machinery.

Regaine contains propylene glycol (E 1520) and ethanol

This medicine contains 208 mg propylene glycol (E 1520) per ml of solution.
Propylene glycol (E 1520) can cause skin irritation.

This medicine contains 454 mg ethanol per ml of solution.
It can cause a burning sensation on damaged skin..

How should the medicine be taken?

How to use Regaine?

Always use this medicine exactly as described in this leaflet or exactly
as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Regaine is intended for external use on a dry scalp. Please only use Regaine on a healthy, intact scalp and follow the instructions for use exactly. Do not apply Regaine to any part of the body other than the scalp.

The recommended dose is:
Apply 1 ml of Regaine to the thinned or bald areas of the scalp in the morning and evening. Regaine is very easy to spread - 1 ml is sufficient even for large areas. You must not use more than a total of 2 ml of solution per day.

Apply the solution starting from the centre of the affected areas by gently spreading it. Your scalp and hair must be completely dry. After application, please wash your hands so that the medicine does not accidentally come into contact with eyes or mucous membranes.
If you use Regaine regularly twice a day, you will see new hair after about four months. Hair loss will be stopped even earlier.

Each pack contains two different applicators (certified medical devices).

Pump spray applicator

This allows you to apply Regaine to larger bald patches.

• Unscrew the screw cap from the bottle.
• Place the spray applicator on the bottle and screw it on tightly. Remove the small cap.
• To obtain a dose of 1 ml, you must press the pump six times. After each pump, spread the liquid over the hairless area with your fingertips. Avoid inhaling spray vapours.
• Close the spray applicator with the small cap after use.

Pump spray applicator with extended tip

This allows you to apply Regaine to small bald patches. It also allows you to reach the hair roots easily.

• First, screw the pump spray applicator onto the bottle (see above).
• Then remove the small spray head and replace it with the extended tip. Remove the small cap at the tip end.
• To obtain a dose of 1 ml, you must press the pump six times. After each pump, spread the liquid over the hairless area with your fingertips. Avoid inhaling spray vapours.
• After use, the small cap is placed back on the tip.

If you have used more Regaine than you should

Any accidental ingestion can cause serious side effects. This is related to the vasodilatory effect of minoxidil. Signs of overdose usually manifest themselves in the cardiovascular system (rapid heartbeat with low blood pressure and reduced fluid excretion, apathy). Treatment must be carried out by a doctor.

If you forget to use Regaine

Do not use double the amount if you have forgotten the previous application.

If you stop using Regaine

Continued treatment is necessary to improve and maintain hair growth. Otherwise, hair loss will recur.

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

What side effects are possible?

How should Regaine be stored?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month indicated.
Shelf life after first opening: 60 days

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage conditions

How should Regaine be stored?

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month indicated.
Shelf life after first opening: 60 days

Do not store above 25 °C.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special information on the content

Contents of the pack and further information

What Regaine contains

• The active ingredient is minoxidil. 1 ml contains 20 mg minoxidil.
• The other ingredients are ethanol, propylene glycol (E 1520) and purified water.

What Regaine looks like and contents of the pack

It is a clear, colourless to slightly yellowish solution for application to the scalp in a polyethylene bottle with a child-resistant polypropylene screw cap and 2 applicators (certified medical devices).

Pack sizes:

60 ml, 3 x 60 ml and a bundle pack of 2 x 3 x 60 ml

Not all pack sizes may be marketed.