Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
This product is indicated for the treatment of alopecia androgenetica in women (also known as female pattern hair loss) in women aged between 18 and 65. Onset and degree of hair regrowth may be variable among users. Although trends in the data suggest that those users who are younger, whose hair has been thinning for a shorter period of time or who have a smaller area of thinning on the vertex are more likely to respond to the product, individual responses cannot be predicted.
Hair and scalp should be thoroughly dry prior to topical application of this product. A dose of 1 g (equivalent to the volume of half a capful) of this product should be applied to the total affected areas of the scalp once daily. The total daily dosage should not exceed 1 g.
It may take once-daily applications for 12 to 24 weeks before evidence of hair growth can be expected. Users should discontinue treatment if there is no improvement seen after 24 weeks.
If hair regrowth occurs, once daily applications of this product are necessary for continued hair growth.
Clinical Trials have not investigated the efficacy of this product beyond 24 weeks. Further secondary results and safety were assessed up to 52 weeks (see section 5.1).
There are no specific recommendations for use in older people or in patients with renal or hepatic impairment.
Not recommended. The safety and effectiveness of this product in children and adolescents below the age of 18 years has not been established.
Hold can upside down and press nozzle to dispense foam onto the hand. Spread with fingertips over the affected areas and gently massage the foam into the scalp working from the back to the front of the scalp. Hands should be washed thoroughly after application.
Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of this product are applied to larger surface areas of the body or areas other than the scalp.
Because of the concentration of minoxidil in this product, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (1g of this product contains 50mg minoxidil; the maximum recommended adult dose for oral minoxidil administration in the treatment of hypertension is 100mg per day).
Signs and symptoms of minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia, hypotension, dizziness and lethargy can also occur.
Treatment of minoxidil overdosage should be symptomatic and supportive.
Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
Shelf life: 3 years.
Store below 25°C.
This product is an extremely flammable aerosol.
A lined aluminium pressurised container with a child-resistant plastic or polypropylene overcap, containing 60 gram of product.
Packs contain either one or two cans. Not all pack sizes may be marketed.
Pressurized container: May burst if heated. Protect from sunlight and do not expose to temperatures above 50°C. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Do not use near or place container on polished or painted surfaces.
Any unused product or waste material should be disposed of in accordance with the local requirements.
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