Savings set: Regaine Men, pcs

This set consists of:

• 2 x Regaine Men foam 5%, 3x60ml

Important notes (compulsory information):

Regaine Men foam 50 mg / g. Active substance: minoxidil. Areas of application: Stabilizes the course of the investment-related hair loss (androgenetic alopecia) in the tonsur area of the scalp in men aged 21 to 49 years. The treatment can counteract the progression of the investment-related hair loss.

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


Regaine Men foam 5%, 3x60 ml

LEAFLET: INFORMATION FOR THE USER

Regaine Men foam 50 mg / g, for use in men from 21 to 49 years.
Foam for use on the skin (scalp)
Active substance: minoxidil

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet or exactly as your doctor's or pharmacist instructions.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet.
• If your complaints worse or no improvement occurs, contact your doctor.

What is in this leaflet:

1. What is Regaine men foam and what is he applied for?
2. What should you consider foam before using regaine men?
3. How is Regaine men to apply foam?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is Regaine men to keep foam?
6. Content of the pack and more information

1. What is REGaine men foam and what is he applied for?

Regaine Men's foam stabilizes the course of asset-related hair loss (androgenetic alopecia) in the tonsur area of the scalp in men aged 21 to 49 years. The treatment can counteract the progression of the investment-related hair loss. Start and extent of this effect can be individually different and are not predictable.

2. What should you consider foam before using regaine men?

Regaine Men's foam must not be used:

• if you allergic against minoxidil or one of the section 6 mentioned ingredients of this medicinal product are,
• if you apply other medicines on the scalp,
• if you suffer from suddenly occurring or uneven hair loss,
• in women (reversible hair growth on the face),
• on the hair approach (forehead, temple),
• for missing family indications for early hair loss or dilution of the head hair.

Warnings and Precautions:
Please talk to your doctor or pharmacist before you Regaine Apply men's foam. Regaine Men's foam is highly flammable. Therefore, you should Regaine Men's foam do not use near fire or open flame. During and immediately after the application of Regaine Men's foam should not smoke. Use Regaine Men foam only on the normal healthy scalp. You should Regaine Men's foam do not apply if the cause of the hair loss is unknown or if the scalp is reddened or ignited Ist. or hurts. Regaine Men's foam is only determined for the external application on the scalp. You are allowed Regaine Men's foam do not apply to other body parts. For hair loss in the temple area (secret council corners) There are no clinical experiences on the effectiveness.

You should Regaine Do not use men's foam:

• if you have signs of a cardiovascular disease or heart rhythmic disorders,
• if you suffer from hypertension,
• if you are means for treating hypertension Apply (antihypertonics.

You should Regaine Remove men's foam and consult a doctor:

• when a lowering of blood pressure is detected, or
• if one or more of the following appearances occur: Chest pain, accelerated heartbeat, weakness or dizziness, sudden and inexplicable weight gain, swollen hands or feet, persistent redness or irritation of the headtha

Hints:
In patients with very bright hair and with simultaneous use of hair care products or after swimming in strongly chlorine-containing water, it may occur to minimal changes in the hair color. If you Regaine Men's foam repeatedly applied to the hair instead of the scalp, this could be due to the ingredients in Regaine Men's foam lead to reinforced dryness and / or stiffness of hair. In accidental contact with sensitive places (eyes, hugging, mucous membranes) Do you have to rinse these places with plenty of cold water. Accidental intake can cause severe side effects in the cardiovascular system. Therefore, they must store this medicine outside the reach of children.

Children and adolescents:
Regaine Men's foam may in children and adolescents under 18 Years are not used because there are no results on effectiveness and safety from controlled clinical trials for this patient group.

Application of Regaine Men's foam along with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / use other medicines. Currently there are no evidence of interactions of Regaine Men's foam with other means. By changing from lying or sitting to stand (change of location) Can lead to a blood pressure drop (orthostatic hypotonic). Although clinically not detected, theoretically, the possibility that this effect is reinforced by the inclusion of the active ingredient minoxidil in the bloodstream. This can especially occur in patients who occupy the simultaneous vascular drugs (peripheral vasodilators). You should Regaine Men's foam along with other dermatics (Externally applicable preparations with active ingredients such. B. Corticosteroids, retinoids, anthraline) or with agents that enhance the drug intake over the skin (skin resorption.

Pregnancy and breast feeding period:
Regaine Men's foam is only displayed for use in male patients.

Driving and ability to operate machines:
It is not expected that the ability to actively participate in road traffic or to operate machines will be affected.

Regaine Men's foam contains butylhydroxytoluene (BHT), Stearyl alcohol and cetyl alcohol:
Located local skin irritation (e.g., contact dermatitis) can cause. Butylhydroxytoluene can also cause irritation of the eyes and mucous membranes.

3. How is Regaine men to apply foam?

Always use this medicine as described in this leaflet or exactly after the arrangement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

The recommended dose and type of application:
Before using Regaine Men's foam should hair and headautomate to be dry. To open the container, bring the arrows to a can and protective cap in a line. Then pull the protective cap.
Step 1: Hold down the container with the spray head and press the spray head to spray the foam on your cleaned palm or fingertips. The amount of foam should always correspond to the volume of half a protective cap (= 1 g foam). Use the protective cap as a comparison scale. Please note: The foam melts quickly when it comes into contact with its warm skin. If your fingers are warm, you should first rinse them with cold water. Dry your fingers carefully before applying the foam.
Step 2: Distribute the foam with the fingertips on the affected areas of the scalp in the tonsur area and massage it gently. Wash your hands after applying the foam to avoid accidental contact with eyes and mucous membranes.
Step 3: Close the tin after each application by replacing the protective cap back on the container. This protects them from accessing children.
Step 4: Wear Regaine Men foam 2 times a day on the affected areas of the scalp (1-time each morning and 1-time in the evening). The amount of foam should always correspond to the volume of half a protective cap (= 1 g of foam). Regardless of the size of the affected scales, a total of 2 G Regaine Men's foam are applied. Under no circumstances if you use more than this amount per day!

After applying Regaine Men's foam can style your hair as usual. However, you should the scalp for about 4 Hours not moistened. So avoid that Regaine Men's foam is washed off.

Duration of application:
Foam for use on the skin (scalp). In general, a 2-time daily treatment is required over 2 to 4 months before an effect is recognizable. If there is no effect after 4 months, the treatment must be terminated. There are sufficient clinical experiences about the effectiveness of the foam up to four months and to compatibility up to 12 Months ago. You do not achieve a better result if you Regaine Men's foam use in larger quantities or more often. In order to maintain the effect, it is recommended to continue the 2 times daily application continuously.

Notes on the increased hair loss:
In the treatment of hair follicles with the active substance minoxidil, the resting phase (telogen phase) of the hair cycle is shortened and the growth phase (anagenphase) is achieved faster. Thus, the growth of new hair is stimulated. These push the "old" no longer active hair from the scalp. It first creates the impression of a increased hair loss. This reaction was observed in some patients two to six weeks after the start of treatment with the active substance minoxidil. However, that does not need to be troubled, because this reaction is accompanied by a reinforced regrowth of the hair. The effect goes back within a few weeks and can be a first sign of the minoxidil effect. Please talk to your doctor or pharmacist if you have the impression that the effect of Regaine Men's foam is too strong or too weak.

Application in children and adolescents:
Regaine Men's foam may in children and adolescents under 18 Years are not used because there are no results on effectiveness and safety from controlled clinical trials for this patient group.

If you have a larger quantity Regaine Men's foam used as you should:
The application of Regaine Men's foam has no evidence of a correspondingly large intake of the active ingredient minoxidil in the bloodstream given to an effect on the whole body (Systemic effect) could lead. If you follow the instructions for use, an overdose is unlikely. A greater recording of the in Regaine Men's foam contained active ingredient in the bloodstream, however, can at least theoretically affect the whole body, e.g. by:

• a wrong application (in higher dosage as recommended and on larger body surfaces or other body surfaces than the scalp),
• Patient-specific differences,
• an unusual sensitivity or impairment of the skin due to inflammation or pathological skin changes of the scalp (e.g., skin abrasions or psoriasis on the scalp).

After accidental swallowing or applying Regaine Men's foam on impaired or pathologically changed skin can lead to effects on the whole body (Systemic effects). This can cause the following side effects: accelerated heartbeat, blood pressure reduction, fluid accumulation and thus sudden weight gain, dizziness. In case of accidental swallowing or signing an overdose, you should consult a doctor. The doctor may initiate symptomatic and supportive treatment when overdosed with the active substance minoxidil.

If you use the application of Regaine Men have forgotten foam
Next time do not wear twice the amount, but continue the treatment with the recommended dose.

If you use the application of Regaine Men's foam cancel
If you interrupt the treatment, it turns within 3 up to 4 months a condition as he without treatment with Regaine Men's foam would have been reached.

If you have further questions about the application of this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. The following data on side effects (frequency over 1% and via placebo) are 7 Placebo-controlled studies with 1,197 men and women treated with topical minoxidil solution (2% and 5%), as well as a placebo-controlled clinical trial of 5% Minoxidil foam at 590 men with an observation time of 12 Months:
Frequently (can concern up to 1 of 10 treated):
Headache, itching, skin extraction, increased hair growth outside the hairy head, high blood pressure (exclusively in the clinical trial with Regaine Men's foam watched).

Side effects since market introduction:
Frequently (can concern up to 1 of 10 treated):
Headache, increased hair growth outside the hairy head.
Unknown (frequency based on the available data not estimable):
Hypersensitivity reactions and angioedems with reactions such. B. swelling of face, lips, tongue and / or mouth-throat room, general itching, general rash, sensing in the throat.

If these signs occur break the treatment and look for a doctor immediately:
Allergic contact dermatitis, dizziness, eye irritation, accelerated heartbeat, palpitations, low blood pressure, respiratory distress, nausea, vomiting, complaints on the administration site, which can also affect the ears and face, such as: As itching, skin irritation, pain, skin extraction, swelling, dry skin and inflammatory rash to skin shot, skin inflammation (Dermatitis), blistering, bleeding and ulcer formation, temporary hair loss, change of hair color, changed hair structure, swelling on arms and legs, chest pain.

If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet.

5. How is Regaine men to keep foam?

Keep this medicine inaccessible to children. You may not use this medicine after the expiration date specified on the outer packaging and the container according to "until". The expiration date refers to the last day of the specified month. Do not store more than 25 ° C.

Hints:
Extremely flammable aerosol. Container is under pressure. Protect over 50 ° C before sunlight and temperatures. Do not crack open or set fire to after using. Do not spray against flame or on glowing object. Keep away from sources of ignition - Do not smoke.

The disposal of medicinal products Solle according to the respective regional specifications. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Regaine Men's foam contains:
The active ingredient is: minoxidil. 1 g foam contains 50 mg 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 gas: propane / butane / 2-methylpropane.

Like Regaine Men's foam looks and content of the pack:
Regaine Men's foam is a white to almost white foam and is available in a coated aluminum container with 60 g of content and a kanned protective cap. The container is under pressure. A pack contains one or three cans each.

Pharmaceutic entrepreneur:
McNeil Consumer HealthCare GmbH
Mailbox 210551
41431 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer:
Janssen-Cilag
Domaine de Maigremont
27100 Val de Reueil
France

This leaflet was last revised in January 2013.

Source: Information of the leaflet
Status: 04/2016