REGAINE

REGAINE Men 50 mg/ml Solution for scalp application

Important notes (mandatory information)

Regaine Men 50 mg/ml solution for application to the scalp. Active ingredient: Minoxidil. Indications: Regaine Men stabilises the course of hereditary hair loss (androgenetic alopecia) in the crown area of the scalp measuring 3 - 10 cm in diameter in men aged 18 - 49.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Regaine Men 50 mg/ml solution for application to the skin (scalp) in men aged 18 to 49
Active ingredient: Minoxidil

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

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

What this package leaflet contains

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

1. WHAT IS REGAINE MEN AND WHAT IS IT USED FOR?

Regaine Men is a medicine for treating male-pattern hair loss (androgenetic alopecia). Indications: Regaine Men stabilises the course of hereditary hair loss (androgenetic alopecia) in the crown area of the scalp measuring 3 - 10 cm in diameter in men aged 18 - 49. Treatment can thus counteract the progression of hereditary hair loss. The onset and extent of this effect can vary from person to person and cannot be predicted. The onset of androgenetic alopecia in men is characterised by the receding of the hairline at the temples, with the formation of receding hairlines. This is followed by increasing hair thinning in the crown area (crown area).

2. WHAT SHOULD YOU CONSIDER BEFORE USING REGAINE MEN?

Regaine Men must not be used:

• if you are allergic to minoxidil or any of the other ingredients of this medicine listed in section 6,
• in women, due to occasional reports of cosmetically disturbing reversible hair growth on the face during treatment,
• if you are using other medicines on the scalp,
• if you suffer from sudden or uneven hair loss.

Warnings and precautions

Please talk to your doctor or pharmacist before using Regaine Men. Only use Regaine Men on normal, healthy scalp. You should not use Regaine Men if the cause of hair loss is unknown or if the scalp is red, inflamed or painful. There is no clinical experience with the effectiveness of hair loss in the temple area (receding hairline). If effects on organ systems (systemic effects) or severe skin reactions occur, the preparation must be discontinued.

You should not use Regaine Men:

• 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 Men and see a doctor:

• if your blood pressure drops, 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 Men than you should")

In rare cases, patients with very light hair have reported slight changes in hair colour when using hair care products at the same time or after swimming in heavily chlorinated water. If you apply Regaine Men repeatedly to the hair instead of the scalp, this could lead to increased dryness and/or stiffness of the hair due to the ethanol and propylene glycol content of Regaine Men. Regaine Men contains alcohol and can cause eye irritation and burning. In case of accidental contact with sensitive areas (eyes, abrasions, mucous membranes), rinse these areas with plenty of water. Avoid inhaling the spray vapours. Accidental ingestion can cause serious cardiovascular side effects. Therefore, you must keep this medicine out of the reach of children.

Children and adolescents

Regaine Men 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.

Using Regaine Men 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 Men and other agents. Although not clinically proven, there is a theoretical possibility that absorption of the active ingredient of Regaine Men (minoxidil) into the body could increase orthostatic hypotension (drop in blood pressure when changing from lying to standing) in patients who are also taking peripheral vasodilators (certain vasodilators to lower blood pressure). Regaine Men should not be used together with other dermatological preparations (topical preparations with active ingredients such as corticosteroids, retinoids, anthralin) or with agents that increase the absorption of active ingredients through the skin (skin absorption).

Pregnancy and breast-feeding

Regaine Men is only indicated for use in male patients.

Driving and using machines

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

Regaine Men contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW TO USE REGAINE MEN?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Apply 1 ml of Regaine Men twice a day (morning and evening) to the affected areas of the scalp. The daily dose of 2 x 1 ml solution should not be exceeded, regardless of the size of the affected skin area.

Use in children and adolescents

Regaine Men 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.

Method of administration

Application to the skin (scalp). Each pack of Regaine Men contains 3 different applicators: Pump spray applicator for large-area application in the crown area, pump spray applicator with extended tip for small bald areas in the crown area and contact applicator for direct application to the crown area of the scalp (for largely bald areas). The dose of 1 ml requires 6 sprays (pump sprays) or one chamber filling (contact applicator).

Pump spray applicator

Remove the large and small caps from the bottle. Place the spray applicator on the bottle and screw it on. Press the pump six times. After each pumping process, spread the liquid over the affected area with your fingertips. Avoid inhaling spray vapours. Close the bottle with the large cap after use. Discard the small cap. Wash your hands thoroughly after use.

Pump spray applicator with extended tip

First screw the pump spray applicator onto the bottle (see above). Remove the small spray head and firmly attach the extended tip. Remove the small cap at the tip end. Press the pump six times. After each pumping process, spread the liquid over the affected area with your fingertips. Avoid inhaling spray vapours. The small cap should be replaced on the tip after use. Wash your hands thoroughly after use.

Contact applicator

Remove the large and small caps from the bottle. Instead, insert the contact applicator and screw it on. Hold the bottle upright and squeeze once so that the upper chamber fills up to the black mark. The chamber now contains 1 ml of solution. Turn the bottle upside down and apply the solution evenly to the affected area until the chamber is completely empty. After use, close the bottle again with the large cap. Wash your hands thoroughly after use.

What else do you need to pay attention to when using it?
Regaine Men should be applied to dry scalp. Regaine Men should not be used on other parts of the body. After applying Regaine Men, wash your hands thoroughly to avoid accidental contact with mucous membranes and eyes. After applying Regaine Men, you can style your hair as usual. However, you should not wet your scalp for about 4 hours. This will prevent Regaine Men from being washed off.

Duration of use

The onset and extent of hair growth varies from patient to patient. In general, twice-daily treatment for 2 to 4 months is required before an effect is noticeable. To maintain the effect, it is recommended to continue the twice-daily application continuously. You will not achieve a better result if you use Regaine Men in larger quantities or more often. There is sufficient clinical experience with a duration of use of up to one year regarding a possible therapeutic effect. If no effect is seen after 4 months, treatment should be discontinued.

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 was observed in some patients two to six weeks after starting treatment with the active ingredient minoxidil. However, you do not need to worry about this, as this reaction is accompanied by increased hair regrowth. The effect subsides within a few weeks and can be an early sign of the minoxidil effect. Please talk to your doctor or pharmacist if you feel that the effect of Regaine Men is too strong or too weak.

If you have used more Regaine Men than you should

Using Regaine Men in a higher dose than recommended and on larger areas of the body or areas other than the scalp may increase the absorption of minoxidil into the body. To date, there have been no cases where the external application of minoxidil solution has led to poisoning. After accidental ingestion, systemic effects corresponding to the pharmacological action of the active ingredient may occur due to the concentration of minoxidil in Regaine Men. Signs and symptoms of minoxidil overdose would likely manifest as cardiovascular effects in conjunction with increased water retention in the tissues (salt and water retention) and rapid heartbeat (tachycardia). In the event of accidental ingestion or the occurrence of symptoms of overdose, please contact a doctor immediately so that they can decide on the further course of action! Please have the medicine package ready so that the doctor can find out about the active ingredient taken.

If you forget to use Regaine Men

Do not apply double the amount next time, but continue treatment with the recommended dose. It does not make sense to catch up on the missed application and could lead to undesirable effects.

If you stop using Regaine Men

If treatment is interrupted, a condition will develop within 3 to 4 months as would have been achieved without therapy with Regaine Men.

If you have any further questions about 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 (frequency over 1% and over placebo) are from 7 placebo-controlled studies with 1,197 men and men who were treated with topical minoxidil solution (2% and 5%) and from a placebo-controlled clinical study of 5%

Minoxidil foam in 590 men with an observation period of 12 months

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

• Headache
• Itching, skin redness
• Increased hair growth outside the hairy head
• High blood pressure (observed exclusively in the clinical study with Regaine Men foam).

Side effects since market launch

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

• Headache
• Increased hair growth outside the hairy head.

Unknown(frequency cannot be estimated from the available data):

• Hypersensitivity reactions and angioedema with reactions such as swelling of the face, lips, tongue and/or mouth-throat area, generalised itching, generalised rash, tightness in the throat.

Stop treatment and seek medical attention immediately if you experience any of these symptoms:

• Allergic contact dermatitis
• Dizziness
• Eye irritation
• Rapid heartbeat, palpitations, low blood pressure
• Shortness of breath
• Nausea, 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, altered hair structure
• Swelling of the arms and legs, pain in the chest area.

The propylene glycol contained in Regaine Men can cause intolerance in patients who are sensitive to this substance. Due to the ethanol contained in Regaine Men, frequent use of the medicine can lead to irritation and dry skin.

Reporting of side effects

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

5. HOW TO STORE REGAINE MEN?

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. This medicinal product does not require any special storage conditions. Note on shelf life after opening: The solution is stable for 1 month after opening the bottle. Medicines should be disposed of in accordance with local regulations. 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 Men contains

The active ingredient is: Minoxidil. 1 ml solution contains 50 mg minoxidil. The other ingredients are: Ethanol 96% (V/V), propylene glycol, purified water.

What Regaine Men looks like and contents of the pack

Regaine Men is a solution for application to the crown area of the scalp. Regaine Men is available in packs of 60 ml solution or 3 x 60 ml solution. Not all pack sizes may be marketed. Each pack contains 3 different applicators that are certified as medical devices (CE 0120): Pump spray applicator with extended tip, pump spray applicator and contact applicator.

Manufacturer of the medical devices

ASM Aerosol-Service AG
Industriestr. 11
4313 Möhlin
Switzerland

Pharmaceutical entrepreneur

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer

Janssen-Cilag
Domaine de Maigremont
27100 Val de Reuil
France

This leaflet was last revised in February 2015.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Minoxidil. Indications: Regaine Men stabilises the course of hereditary hair loss (androgenetic alopecia) in the crown area of the scalp measuring 3 - 10 cm in diameter in men aged 18 - 49.