REGAINE

REGAINE Women Foam 50 mg/g

Important notes (mandatory information)

Regaine Women Foam. Active ingredient: Minoxidil. Areas of application: promotes hair growth and can thus counteract the progression of this hair loss.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Regaine Women Foam, 50 mg/g foam for application to the skin (scalp)
Active ingredient: Minoxidil

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If your symptoms worsen or do not improve, contact your doctor.

What this leaflet contains

1. WHAT IS REGAINE WOMEN FOAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING REGAINE WOMEN FOAM?
3. HOW TO USE REGAINE WOMEN FOAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE REGAINE WOMEN FOAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS REGAINE WOMEN FOAM AND WHAT IS IT USED FOR?

Regaine Women Foam stabilises the course of female-pattern androgenetic alopecia (characteristic hereditary diffuse thinning of the hair in the crown area) in women. Treatment with Regaine Women Foam promotes hair growth and can thus counteract the progression of this hair loss. The onset of female-pattern hair loss is characterised by a decrease in hair density in the crown area. It almost never leads to complete baldness, but to diffuse thinning of the hair in the middle parting area.

2. WHAT SHOULD YOU CONSIDER BEFORE USING REGAINE WOMEN FOAM?

Regaine Women Foam must not be used:

• if you are allergic to minoxidil or any of the other ingredients of this medicine listed in section 6.
• if you are using other medicines on your scalp.
• if you suffer from sudden or uneven hair loss.
• if you are pregnant.
• if you are breastfeeding your child.

Warnings and precautions

Please talk to your doctor or pharmacist before using Regaine Women Foam. Regaine Women Foam is highly flammable. Therefore, you should not use Regaine Women Foam near fire or naked flames. You should also not smoke during and immediately after using Regaine Women Foam.

• Hormonal causes, underlying diseases of the body or malnutrition must be ruled out. In these cases, you must receive targeted treatment. You should not use Regaine Women Foam if the cause of hair loss is unknown, if there is no family history of hair loss or thinning of the scalp hair (in male or female relatives), if hair loss occurs after childbirth or if the scalp is red or inflamed, or painful.
• Apply Regaine Women Foam only to normal healthy scalp.
• Regaine Women Foam is for external use on the scalp only. You must not apply Regaine Women Foam to other parts of the body.

You should not use Regaine Women Foam:

• if you have signs of cardiovascular disease or heart rhythm disorders.
• if you have high blood pressure.
• if you are taking medicines to treat high blood pressure (antihypertensives).

You should stop using Regaine Women Foam and see a doctor:

• if a decrease in blood pressure is detected, or
• if one or more of the following symptoms occur: chest pain, rapid heartbeat, feeling faint or dizzy, sudden and unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp (see section "If you have used more Regaine Women Foam than you should") or other unexpected new symptoms.
• You will not achieve a better result if you use Regaine Women Foam in larger quantities or more often.
• To maintain the effect, it is recommended to continue the 1-time daily application continuously. If you stop using minoxidil, hair loss will occur again.

Notes on increased hair loss
When treating hair follicles with the active ingredient minoxidil, the resting phase (telogen phase) of the hair cycle is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair. This pushes the "old" inactive hair out of the scalp. Initially, this gives the impression of increased hair loss. This reaction has been observed in some patients two to six weeks after starting treatment with the active ingredient minoxidil. This accelerated hair loss, which is accompanied by increased hair regrowth, subsides within a few weeks and can be an early sign of minoxidil's effect.

Notes

If you apply minoxidil to areas of the body other than the scalp, it may cause unwanted hair growth there. In rare cases, slight changes in hair colour (slight blonding) have been reported in patients with very light hair and when using hair care products at the same time or after swimming in heavily chlorinated water. If you repeatedly apply Regaine Women Foam to the hair instead of the scalp, this could lead to increased dryness and/or stiffness of the hair due to the ingredients in Regaine Women Foam. In case of accidental contact with sensitive areas (eyes, abrasions, mucous membranes), rinse these areas with plenty of cold water. Accidental ingestion can cause serious cardiovascular side effects. Therefore, you must keep this medicine out of the reach of children.

Children and adolescents

Regaine Women Foam must not be used in children and adolescents under 18 years of age, as there are no results on efficacy and safety from controlled clinical studies for this patient group.

Use of Regaine Women 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. There is currently no evidence of interactions between Regaine Women Foam and other agents. Due to the change from lying or sitting to standing (change of position), a drop in blood pressure may occur. Although not clinically proven, there is a theoretical possibility that this effect may be enhanced by the absorption of the active ingredient minoxidil into the bloodstream. This can occur especially in patients who are taking vasodilatory medicines at the same time. You should not use Regaine Women Foam together with other dermatics (external preparations with active ingredients such as corticosteroids, retinoids, dithranol) or with agents that increase the absorption of active ingredients through the skin.

Pregnancy and breastfeeding

Regaine Women Foam must not be used by pregnant or breastfeeding women, as there are no studies in pregnant women and minoxidil can pass into breast milk.

Driving and using machines

The ability to actively participate in road traffic or to operate machines is not expected to be impaired.

Regaine Women Foam contains butylhydroxytoluene (BHT), stearyl alcohol and cetyl alcohol

These can cause local skin irritation (e.g. contact dermatitis). Butylhydroxytoluene can also cause irritation of the eyes and mucous membranes.

3. HOW TO USE REGAINE WOMEN FOAM?

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

The recommended dose and method of use

Apply 1 g of Regaine Women Foam once a day. This corresponds to the volume of half a protective cap. Please note:

• It is not necessary to wash your hair before use.
• Your hair and scalp should be dry before using Regaine Women Foam. Wash your hands thoroughly before and after using the foam.
• 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.
• Especially with long hair, you may need to part your hair several times to apply the foam to the scalp. It is therefore advisable to spray the foam onto a smooth, flat bowl or saucer.
• Regaine Women Foam has no hair styling properties. You can style your hair as usual once the scalp is dry again after applying the foam. However, you should not wet your scalp for about 4 hours. This will prevent Regaine Women Foam from being washed off.
• Wash your hands and any bowl/saucer used immediately after applying the foam to avoid accidental contact with eyes and mucous membranes.
• To open the container, align the arrows on the can and protective cap. Then pull off the protective cap.

Step 1

Hold the container with the spray head vertically downwards and press the spray head to spray the foam onto your hand or onto a smooth, flat bowl or saucer. The amount of foam should always correspond to the volume of half a protective cap (= 1 g of foam). Use the protective cap as a reference. Regardless of the size of the affected scalp area, a total of 1 g of Regaine Women Foam should be applied each day. Under no circumstances should you use more than this amount per day!

Step 2

Part your hair in the thinning area. This will help to distribute the foam over as much of the scalp as possible. Spread a sufficient amount of foam with your fingertips over the affected areas of the scalp and massage it in gently. Start at the back of the head and work your way towards the front. Part your hair at least 2 more times on each side from the middle parting and distribute the remaining foam as described above until all the foam has been used up.

Step 3

Close the can after each use by replacing the protective cap on the container. This will protect it from access by children. In general, a 1-time daily treatment for 3 months is necessary before an effect is noticeable. To maintain the effect, it is recommended to continue the 1-time daily application continuously. No better result is achieved if Regaine Women Foam is used in larger quantities or more often than 1-time daily. Sufficient clinical experience with the efficacy of the foam in women is currently available for use up to 52 weeks. If the desired treatment success does not occur within 6 months, the therapy should be discontinued.

Duration of use

Foam for application to the skin (scalp). In general, a 1-time daily treatment for 3 months is necessary before an effect is noticeable. If no effect is seen after 6 months, the treatment should be discontinued. Sufficient clinical experience with the efficacy of the foam is currently available for up to 12 months.

Please talk to your doctor or pharmacist if you have the impression that the effect of Regaine Women Foam is too strong or too weak.

Use in children and adolescents

Regaine Women Foam must not be used in children and adolescents under 18 years of age, as there are no results on efficacy and safety from controlled clinical studies for this patient group.

If you have used more Regaine Women Foam than you should

The use of Regaine Women Foam has shown no evidence of a correspondingly large absorption of the active ingredient minoxidil into the bloodstream, which could lead to an effect on the whole body. If you follow the instructions for use, an overdose is unlikely. A larger absorption of the active ingredient contained in Regaine Women Foam into the bloodstream can have effects on the whole body, e.g. through:

• incorrect use (in higher doses than recommended and on larger areas of the body or areas of the body other than the scalp),
• patient-specific differences.
• an unusual sensitivity or impairment of the skin due to inflammation or pathological skin changes on the scalp (e.g. abrasions or psoriasis on the scalp).

After accidental ingestion or after application of Regaine Women Foam to impaired or pathologically altered skin areas, effects on the whole body (systemic effects) may occur. This can lead to the following side effects: rapid heartbeat, drop in blood pressure, fluid retention and sudden weight gain, dizziness, sluggishness. In case of accidental ingestion or signs of overdose, you should consult a doctor. The doctor can initiate symptomatic and supportive treatment in case of overdose with the active ingredient minoxidil.

If you forget to use Regaine Women Foam

Do not apply double the amount next time, but continue treatment with the recommended dose.

If you stop using Regaine Women Foam

If you interrupt treatment, a condition will develop within 3 to 4 months as would have been achieved without treatment with Regaine Women Foam.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following data on side effects are available

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Weight gain
• Increased hair growth on the face
• Itching, skin redness and rash
• Shortness of breath
• Swelling of arms and legs
• High blood pressure
• Scalp irritation such as stinging/burning, dryness/itching/scaling; hair follicle inflammation

Uncommon (may affect up to 1 in 100 people):

• Dizziness
• Nausea

Not known (frequency cannot be estimated from the available data):

• Hypersensitivity reactions and angioedema with reactions such as swelling of the face, lips, tongue and/or oropharynx, generalised itching, generalised rash, tightness in the throat. If you experience these signs, stop treatment and seek medical attention immediately.
• Allergic contact dermatitis
• Eye irritation
• Rapid heartbeat, palpitations, low blood pressure
• Vomiting
• Discomfort at the site of administration, which may also affect the ears and face, such as itching, skin irritation, pain, skin redness, swelling, dry skin and inflammatory rash up to skin peeling, dermatitis, blistering, bleeding and ulceration.
• Temporary hair loss, changes in hair colour, changed hair structure
• Chest pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE REGAINE WOMEN FOAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C.

Notes

Danger. Extremely flammable aerosol. Container is pressurised: may burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not spray towards naked flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight. Do not expose to temperatures above 50°C.

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of the medicine if you no longer use it. You will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Regaine Women Foam contains

The active ingredient is: Minoxidil. 1 g of foam contains 50 mg of minoxidil. The other ingredients are: Ethanol, butylhydroxytoluene (Ph. Eur.) (E321), lactic acid, citric acid, glycerol, cetyl alcohol (Ph. Eur.), stearyl alcohol (Ph. Eur.), polysorbate 60, purified water. Propellant: Propane/butane/2-methylpropane.

What Regaine Women Foam looks like and contents of the pack

Regaine Women Foam is a white to off-white foam and is available