Regaine 2 % - Solution

Regaine prevents hereditary hair loss in women and men and stimulates hair growth.

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 still existing downy 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, in which it:

. . over time. .

-	Increased the diameter of the hair shaft
-	Stimulates growth and
-	The growth phases of the hair are prolonged
It	duration
are present, fine light downy hairs may grow back, becoming longer, denser and darker
become. How quickly hair growth starts and how many hairs grow back depends on the patient
different.	Large
less well on Regaine.

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

How is it applied?

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 still existing downy 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:

• Increased the diameter of the hair shaft
.
• Stimulates growth and
• The growth phases of the hair are prolonged
.

But it takes at least four months before you can see success. If hair roots are still present, fine light downy hairs can grow back, which become longer, denser and darker over time. How fast hair growth starts and how much hair grows back varies from patient to patient. Large bald patches or hair loss that has been present for more than 10 years respond less well to Regaine.

.
Children and adolescents under 18 years, patients over 65 years.
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 pay attention to before taking it?

What should you be aware of before using Regaine?

Regaine must not be used
if you are allergic to minoxidil or any of the other ingredients listed in section 6. hair loss after the birth of a child 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
.
• Surface hair loss (e.g. circular hairless patches form)
  
  Regaine will also not work if the hair loss is due to any of the following:
.
• Application or intake of certain medicines (e.g. against cancer).
  Here, at most, a faster regrowth of the hair can be promoted.
• severe nutritional problems (very low iron levels, vitamin A overdose).
• Stop taking the "pills" (The hormonal change can lead to a short-term increase in hair loss. However, this does not normally require medication.)
• Scalp damaged by scarring or burns, as there are no more hair roots.
• Hair styles where the hair is pulled tightly from the scalp (e.g. horse tail). In this case you must eliminate the mechanical irritation.
• Pregnancy and breastfeeding.

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

Warnings and precautions
Please talk to your doctor or pharmacist before using Regaine.

Apply Regaine only to normal healthy scalp. You must not use Regaine if the cause of the hair loss is unknown or if the scalp is red, inflamed or painful.
Do not apply Regaine to the scalp together with other products.

If you suffer from cardiovascular disease or arrhythmia, consult your doctor before use.

Only a very small amount of Regaine's active ingredient penetrates the skin. Especially in hypersensitive patients or patients with heart disease, side effects that do not affect the skin can never be completely ruled out. If you notice oedema (swelling of parts of the body, possibly also of the face, caused by increased water retention) or heart problems (e.g. an accelerated heartbeat), please inform your doctor.

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

The use of Regaine can possibly lead to discolouration or structural changes in the hair.

After the application of Regaine, discolouration may occur under certain circumstances if it comes into contact with sensitive textiles and surfaces, such as pillows or hats. This is especially true while the solution is still wet on the scalp.

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

If a decrease in blood pressure is noticed, on the occurrence of chest pain, accelerated heartbeat, weakness or dizziness, sudden and unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp or other unexpected new complaints, please stop the treatment and contact your doctor.
If Regaine accidentally gets into the eyes, it can cause irritation and stinging. This also applies to sensitive surfaces such as mucous membranes or abraded areas. In such cases, rinse the medicine with plenty of water as soon as possible. To prevent Regaine from accidentally coming into contact with other parts of your body, you should wash your hands after each use of the medicine.
Regaine must not be swallowed! Accidental ingestion can lead to severe adverse effects. It is therefore essential to keep the medicine out of the sight and reach of children.
Inhalation of Regaine should be avoided.
As soon as you stop using Regaine, the hair loss starts all over again.
If your symptoms worsen or do not improve within 12 months, please consult a doctor.

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

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

Use of Regaine with other medicines.
Inform 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. For safety, do 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 about the use of Regaine in pregnancy. Minoxidil absorbed into the body passes into breast milk. Regaine must therefore not be used during pregnancy or breastfeeding.
Driving ability and ability to operate machinery.
A side effect of Regaine may be dizziness or low blood pressure. If this is the case with you, do not drive a vehicle or operate machinery.

Regaine contains propylene glycol.
This medicinal product contains 20 ml propylene glycol per 100 ml solution. Propylene glycol can
Cause skin irritation.

How should the medicine be taken?

How to use Regaine?

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

Regaine is for external use on dry scalp. Please use Regaine only on healthy uninjured scalp and follow the application instructions below carefully. Do not apply Regaine to any part of the body other than the scalp.
The recommended dose is:
In the morning and in the evening, spread 1 ml each of Regaine on the thinned or bald areas of the scalp. Regaine spreads very well - 1 ml is enough even for large areas. You must not use more than a total of 2 ml of solution daily.
Apply the solution starting from the centre of the affected areas by gently spreading. Your scalp and hair must be completely dry. After use, 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 is stopped earlier.

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

Pump spray applicator
This allows you to apply Regaine to larger bald spots.

.

• Screw the screw cap off the bottle.
• Place the spray applicator on the bottle and screw it tight. Remove the small cap.
• To get the dose of 1 ml, you have to press the pump six times. After each pumping, spread the liquid over the hairless area with your fingertips. Avoid inhaling spray vapours in the process.
• Close the spray applicator after use with the small cap.

Pump spray applicator with extended tip.
With this, you can apply Regaine to small bald spots. In addition, you can easily reach the Hair roots.

• First screw the pump spray applicator onto the bottle (see above).
• Then remove the small spray head from it and firmly attach the extended tip instead. Remove the small cap at the tip end.
• To get the dose of 1 ml, you have to press the pump six times. After each pumping, spread the liquid over the hairless area with your fingertips. Avoid inhaling spray vapours in the process.
• After application, the small cap is put back on the tip.

If you have used more Regaine than you should.
Any accidental ingestion can cause serious side effects. This is due to the vasodilating effect of minoxidil. Signs of an overdose are usually manifested in the cardiovascular system (accelerated heartbeat with low blood pressure and reduced fluid excretion, listlessness). It is essential that the treatment is carried out by a doctor.

If you forget to use Regaine.
Do not use twice the amount if you have forgotten to use it before.

If you stop using Regaine.
Continuation of 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 are the possible side effects?

How to store Regaine?

Do not store above 25 °C.

Keep this medicine out of the reach of children.
You must 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 medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How to store Regaine?

Keep this medicine out of the reach of children.
You must 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 medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Regaine contains

.

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

What Regaine looks like and contents of the pack.
It is a clear, colourless to slightly yellowish solution for application on the scalp in a polyethylene bottle with 2 applicators (certified medical devices).
Package sizes:
60 ml, 3 x 60 ml and a bundle pack of 2 x 3 x 60 ml
Not all packs may be placed on the market.