Regaine For Men 5% Foam - 9 Month Supply Regaine For Men 5% Foam - 9 Month Supply

This 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 49.
• If you have ever 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.

  Petrolatum - a common ingredient in hair wax or gel.

• 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 bullet points apply to you now or in the past, get advice from a doctor or pharmacist before using Regaine.

Talk to your doctor or pharmacist…

• If you are at all unsure whether your scalp is normal and healthy.
• If you suffer from heart disease, including abnormal heart rhythms or rates, angina or chest pains and/or circulation disorders
• 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 you are not sure about the medicine you are taking or using, show the bottle or pack to your pharmacist.

If any of these bullet points apply now or in the past, talk to a doctor or 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.

Driving and using machines

• Regaine may cause dizziness or low blood pressure. If you experience these side effects do not drive or operate machinery.

Some of the ingredients can cause problems

• Regaine for Men Extra Strength Scalp Foam contains ethanol (alcohol), which will cause burning and irritation if you get it in the eye. If you 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.
• Cetyl alcohol or stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
• 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

• If minoxidil passes into the blood stream it can cause some side-effects related to low blood pressure such as chest pain, rapid heartbeat, faintness,dizziness, swollen hands and feet, persistent redness or irritation of the scalp. If you experience any of these side-effects, stop using the medicine: and tell your doctor.

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. See the directions tab.

• Danger. Extremely flammable aerosol. Pressurised container: may burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not spray on an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight. Do not expose to temperatures exceeding 50°C.
• Avoid contact with the eyes, mouth, broken skin and sensitive areas. If the foam 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.

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

If you experience any of the following, stop using the medicine and seek immediate medical help:

• Chest pain.
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.

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

• Allergic reactions including swollen face, skin redness or itching or throat tightness.
• Low blood pressure.
• Fast heart beat or an increased awareness of the heart beat (palpitations).
• Faintness or dizziness.
• Swollen hands or feet, shortness of breath.
• Sudden unexplained weight gain.
• Persistent local redness or rash.

Other effects which may occur, include:

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

• Headache

Common (may affect up to 1 in 10 people)

• Itching or dermatitis.
• Unwanted non scalp hair has been reported (including facial hair growth in women). Always wash your hands thoroughly after application and if you accidentally apply the foam to parts of your body other than the scalp, rinse thoroughly with plenty of water.

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

• Nausea.

Rare (may affect up to 1 in 1,000 people)

• Change in hair texture may occur. If this happens you should stop using Regaine.

Other effects which may occur but it is not know how often:

• Depressed mood.
• Eye irritation.
• Vomiting
• Scalp irritation such as local redness, 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.
• Acne like rash, itchy rash, blistering, bleeding or ulceration.
• Temporary hair loss may occur during the first 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 may occur. If this happens you should stop using Regaine.

If you experience any side-effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not included in this leaflet. You can also report any side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

And in Malta directly via

ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GZR-1368 Gzira.

website: www.medicinesauthority.gov.mt

email: [email protected]

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance in 1 g of Regaine is Minoxidil 50 mg.

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.