Patient Information Leaflet (PIL) For Regaine Foam

regaine foamWhat the medicine is for

Regaine for Men Extra Strength Scalp Foam is a medicine used to treat common hereditary hair loss in men aged 18-65 years, by preventing further hair loss and helping hair re-growth. It contains minoxidil which is thought to work by aiding the blood flow to the hair follicles on your scalp.

  • The medicine is for use in men aged between 18 and 65 years.
  • Regaine for Men Extra Strength Scalp Foam works best in men with hair loss or thinning at the top of the scalp.
  • Those who are younger, have been losing hair for a short period of time or have a small area of baldness are likely to experience the best results.
  • You are unlikely to benefit from Regaine for Men Extra Strength Scalp Foam if you have been bald for many years or have a large area of hair loss.

Hereditary hair loss is recognisable because:

  • Of the pattern of hair loss.
  • It starts gradually and progresses.
  • You have a family history of hair loss.
  • No other symptoms are present with your hair loss.Before using this medicineThis medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.Do not use this medicine…
    • If you are female.
    • If you are under the age of 18 or over the age of 65.
    • If you have had a bad reaction to minoxidil or any of the other ingredients.
    • If you have hair loss caused by drug treatment.
    • If you have total baldness or complete loss of all body hair.
    • If the cause of your hair loss is unknown, or it is sudden and unexpected.
    • If you have high blood pressure, even if it is not being treated.
    • If you have any condition that affects your scalp, including sunburn and psoriasis.
    • If you have a shaved scalp.
    • If you are using creams, ointments or lotions used to treat scalp conditions, e.g.
      • Dithranol – used to treat psoriasis.
      • Tretinoin – used to treat acne or other skin disorders.
      • Corticosteroids – a type of anti-inflammatory e.g. hydrocortisone, betamethasone dipropionate.
    • If you have any kind of dressing or bandage on your scalp.
    • Unless you know that your scalp is normal and healthy.If any of these apply to you, get advice from a doctor or pharmacist before using Regaine.Talk to your doctor or pharmacist…
      • If you suffer from heart disease, including abnormal heart rhythms or rates, angina or chest pains and / or circulation disorders.
      • If you are at all unsure whether your scalp is normal and healthy
      • If you are taking or using any other medicines including:
        • certain blood pressure medicines called ‘vasodilators’ e.g. hydrazaline. There is a potential risk that minoxidil, the active ingredient in Regaine for Men Extra Strength Scalp Foam, may interact with these medicines and increase their effect.

      If any of these bullet points apply, talk to a doctor or pharmacist.

      If you are not sure about the medicine you are taking or using, show the bottle or pack to your pharmacist.

      If you are pregnant or breast-feeding:

      • This product is for men and should NOT be used by women. It should NOT be used if you are pregnant or breast-feeding.

      Some of the ingredients can cause problems

      • Cetyl alcohol or stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
      • Regaine for Men Extra Strength contains ethanol (alcohol) which will cause burning and irritation if you get it in the eye. If you get Regaine for Men Extra Strength Scalp Foam in your eye, mouth or on a cut or damaged skin, wash the area well with lots of cool tap water.
      • Butylated hydroxytoluene (E321) may cause local skin reactions (eg contact dermatitis), or irritation to the eyes and mucous membranes.Special warnings relating to Regaine for Men Extra Strength Scalp Foam
        When Regaine for Men Extra Strength Scalp Foam is used as recommended, it is extremely unlikely that these effects will occur. However there is a chance the drug could get into the blood stream if it is over used or if there is a scalp condition such as psoriasis present. Therefore it is very important that you use your medicine as recommended and follow the instructions very carefully.

        • If minoxidil passes into the blood stream it can cause some side-effects related to low blood pressure such as chest pain, rapid heart beat, faintness, dizziness, swollen hands and feet or persistent redness. If you experience any of these side-effects, stop using the medicine and tell your doctor.
        • The product in this pressurized container, is extremely flammable, therefore exposure of the container or its contents to naked flames should be avoided. Protect from sunlight and do not expose to temperatures above 50C/122F. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition – No smoking. Do not use near, or place container on, polished or painted surfaces.
        • Avoid contact with the eyes, mouth, broken skin and sensitive areas. If the solution is accidentally applied to areas of the body other than the scalp, rinse thoroughly with plenty of water.
        • Do not apply to areas of the body other than the scalp.
        • Exceeding the recommended dose will NOT re-grow your hair any more quickly and you have an increased likelihood of getting side-effects.

        How to use this medicine

        Regaine for Men Extra Strength Scalp Foam is for topical and external use only. It should only be applied directly to the scalp area.

        • Do not apply to areas of the body other than the scalp.
        • Wash your hands thoroughly before and after applying the solution and rinse other areas that have come into contact with the foam.
        • Make sure your hair and scalp are completely dry before applying the foam.
        • To open container: Match arrow on can ring with arrow on cap. Pull off cap.
        • Hold the can upside down and press nozzle to dispense the foam onto your fingers. The total amount of foam applied should not exeed 1g (equivalent to the volume of half a capful).
        • The foam may begin to melt on contact with warm skin. If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.
        • The foam should be massaged lightly into the affected areas of the scalp.Daily dose for Adult Men:Age- Male Adults aged 18 to 65 years
          Dose – On a completely dry scalp and hair, apply a dose of 1g (equivalent to the volume of half a capful) to the total affected area twice daily..

          • Leave at least 12 hours between each use.
          • Do not exceed 2g in a day.
          • Do not use more than twice a day.
          • This product should NOT be used by women.

          Continued use of Reagine

          • You may need to use this medicine twice daily for at least 8 weeks before you see new hair growth. This is because hair growth is a slow process.
          • Hair growth may be soft and downy at the start but should eventually become the same as normal hair.
          • Once the hair has begun to re-grow, you need to continue using this medicine twice a day for the growth to continue.
          • If you have no improvement in your hair growth after 16 weeks of use, you should discontinue treatment.
          • If at any time during your treatment you are concerned you should consult your doctor or pharmacist.
          • Clinical trails on Regaine Foam efficany have not been carried out beyond 16 weeks.If anyone uses too muchSeek immediate medical advice if anyone, including a child, uses too much of this medicine. Take the medicine and container with you.
            If you forget to apply a dose of the foam

            If you miss one or two applications just carry on as normal as if you had not missed the dose – do not use twice as much or twice as often.If you accidentally swallow the foam

            If anyone, including a child, swallows any of the foam, take them to a hospital immediately with the Regaine for Men Extra Strength Scalp Foam pack if possible, as the doctor may like to have some idea of how much they have swallowed.

            Possible side-effects

            Regaine for Men Extra Strength Scalp Foam can have side-effects, like all medicines, although these don’t affect everyone and are usually mild.
            If you experience any of the following, stop using the medicine and seek immediate help:

            • Chest pain.

            If you experience any of the following, stop using the medicine and tell your doctor:

            • Low blood pressure.
            • Rapid heart beat.
            • Faintness or dizziness.
            • Commonly: swollen hands or feet, shortness of breath, high blood pressure.
            • Sudden unexplained weight gain.
            • Persistent local redness or rash.
            • Commonly: Depression

            Other effects which may occur, include:

            • Very Commonly: headache.
            • Commonly; itching, excessive hair growth, acne rash, irritated skin, inflammatory skin disorders causing redness and itching, muscle pain, general pain.
            • Scalp irritation such as local redness, itchiness, dryness, flaky skin have all been reported. This may be due to the hydroxybutylated toluene, cetyl alcohol and/or stearyl alcohol in the product. This is usually only a temporary effect, but if it is persistent you should stop using this product.
            • Unwanted non-scalp hair has occasionally been reported. Always wash your hands thoroughly after application and if you accidentally apply the foam to parts of the body other than the scalp, rinse thoroughly with plenty of water.
            • Temporary hair loss may occur during the 2 -6 weeks of use. This is likely to be as a result of a change within the growth cycle and it should stop within a couple of weeks. If this hair loss continues for longer than 2 weeks, stop using the product and talk to your doctor.
            • Change in hair colour and/or texture may occur. If this happens you should stop using Regaine.If you experience any side-effects not included in this leaflet or are unsure of anything, tell your doctor or pharmacist. Also you can help to make sure that medicines remain as a safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am – 2pm Monday to Friday) or fill in the paper form available from your local pharmacy.Storing the medicineKeep out of the reach and sight of children.
              Do not store above 25C.
              Do not use after the expiry date on the base of the can.
              The product in the pressurized container, is extremely flammable, therefore exposure of the container or its contents to naked flames or any incandescent material should be avoided.
              Protect from sunlight and do not expose to temperatures above 50C/122F.
              Do not pierce or burn the container, even after use. Do not use while smoking.
              Do not use near, or place container on, polished or painted surfaces.
              Medicines should not be disposed of via wasterwater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the enviroment.

              Further information

              Whats in this medicine?

              The active substance in 1g of Regaine is Minoxidil 50mg.
              Other ingredients are: Ethanol anhydrous, purified water, butylated hydroxytoluene (E321), lactic acid, citric acid anhydrous, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60, propane, butane, isobutane, nitrogen.

              What the medicine looks like

              Regaine for Men Extra Strength Scalp Foam is a foam contained in a 73ml (equivalent to 60g) can, enough for 1 month of treatment. Packs contain 1 or 3 cans.Product Licence holder:
              McNeil Products Ltd,
              Maidenhead, Berkshire,
              SL6 3UG, UK.

              Manufacturer:
              Janssen Cilag.
              Domaine de Maigremont, 27100,
              Val de Reuill, France

              or

              McNeil Product Ltd, Maidenhead,
              Berkshire, SL6 3UG, UK.

              If you are looking to buy Regaine For Men Foam, please go to www.ukmeds4u.com for your free consultation.

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