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BOOTS HAIR LOSS TREATMENT REGULAR STRENGTH

Active substance(s): MINOXIDIL / MINOXIDIL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Hair Loss Treatment Regular Strength

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Minoxidil 20mg/ml (2% w/v). For excipients, see 6.1.

3.

PHARMACEUTICAL FORM Cutaneous Solution. A clear, colourless to light yellow solution.

4.
4.1.

CLINICAL PARTICULARS
Therapeutic indications Minoxidil 2% Solution is indicated for the treatment of alopecia androgenetica in men and 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, who have been balding for a shorter period of time or who have a smaller area of baldness on the vertex are more likely to respond to Minoxidil 2% Solution, individual responses cannot be predicted.

4.2.

Posology and method of administration Men and women aged 18 65. Hair and scalp should be thoroughly dry prior to topical application of Minoxidil 2% Solution. A dose of 1ml Minoxidil 2% Solution should be applied to the total affected areas of the scalp twice daily. The total dosage should not exceed 2ml. If fingertips are used to facilitate drug application, hands should be washed afterwards.

It may take twice-daily applications for four months before evidence of hair growth can be expected. If hair regrowth occurs, twice daily applications of Minoxidil 2% Solution are necessary for continued hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Minoxidil 2% Solution and the balding process will continue. Users should discontinue treatment if there is no improvement after one year. The method of application varies according to the disposable applicator being used: Pump spray applicator This is useful for large areas. Aim the pump at the centre of the bald area, press once and spread with fingertips over the entire bald area. Repeat for a total of six times to apply a dose of 1ml. Avoid breathing spray mist. Extended spray tip applicator This is useful for small areas, or under hair. The pump spray applicator must be in place in order to use this additional applicator. Use in the same way as the pump spray. Dropper Fill the dropper to the 1ml mark and apply the Minoxidil 2% Solution to the bald area until the entire dose has been delivered. Children and the Elderly Not recommended. The safety and effectiveness of Minoxidil 2% Solution in users aged under 18 or over 65 has not been established.

The solution is flammable and exposure of the container and contents to naked flames should be avoided during use, storage and disposal.

4.3.

Contraindications Minoxidil 2% Solution is contra-indicated: in users with a history of sensitivity to Minoxidil, ethanol or propylene glycol in users with treated or untreated hypertension in users with any scalp abnormality (including psoriasis and sunburn) in users with a shaved scalp if occlusive dressings or other topical medical preparations are being used.

4.4.

Special warnings and precautions for use

Before using Minoxidil 2% Solution the user should determine that the scalp is normal and healthy. The patient should stop using Minoxidil and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness. Minoxidil 2% Solution is for external use only. Do not apply to areas of the body other than the scalp. Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should be avoided. Minoxidil 2% Solution contains alcohol, which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amount of cool tap water. Minoxidil 2% Solution contains propylene glycol. May cause skin irritation. Some patients have experienced changes in hair colour and/or texture with Minoxidil use. Users should be aware that, whilst extensive use of Minoxidil 2% Solution has not revealed evidence that sufficient Minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.

4.5.

Interactions with other medicinal products and other forms of interaction Topical drugs, such as corticosteroids, tretinoin, dithranol or petrolatum, which alter the stratum corneum barrier, could result in increased absorption of Minoxidil if applied concurrently. Although it has not been demonstrated clinically, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

4.6.

Pregnancy and lactation There is no evidence as to drug safety in human pregnancy nor is there evidence from animal work that it is free from hazard. Minoxidil 2% Solution should not be used during pregnancy or lactation.

4.7.

Effects on ability to drive and use machines Based on the pharmacodynamic and overall safety profile of Minoxidil, it is not expected that Minoxidil 2% Solution would interfere with the ability to drive or operate machinery.

4.8.

Undesirable effects In placebo-controlled trials, the overall frequency of medical events in females in all body system categories was approximately five times that of males. Several thousand patients have used topical Minoxidil in clinical trials where a comparison with an inactive solution was made. Dermatological reactions (eg. irritation, itching) occurred in patients using both solutions. This has been explained by the presence of propylene glycol in both the active and inactive solution. Reactions reported in commercial marketing experience include: hypertrichosis (unwanted non-scalp hair including facial hair growth in women), local erythema, itching, dry skin/scalp flaking, and exacerbation of hair loss. Users should stop using Minoxidil if they experience persistent redness or irritation of the scalp. Some consumers reported increased hair shedding upon initiation of therapy with Minoxidil. This is most likely due to Minoxidils action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Minoxidil and consult their doctor. Particular attention has been paid to body systems, such as cardiovascular and metabolic, which might have some relevance based on the pharmacology of Minoxidil. There was no increased risk to users due to drug related medical reactions in these, or other, body system categories. Users should stop using Minoxidil if they experience chest pain, tachycardia, faintness, dizziness, sudden unexplained weight gain, or swollen hands or feet. Rare cases of hypotension have been reported.

4.9.

Overdose

Increased systemic absorption of Minoxidil may potentially occur if higherthan-recommended doses of Minoxidil 2% Solution are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil 2% Solution. Because of the concentration of Minoxidil in Minoxidil 2% Solution, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (5ml of Minoxidil 2% Solution contains 100mg; the maximum recommended adult dose for oral Minoxidil administration in the treatment of hypertension). Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of beta-adrenergic blocking agent.

5.
5.1.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Individual responses to Minoxidil are variable and unpredictable. The effect of Minoxidil 2% Solution has been assessed in phase III clinical trials in both men and women conducted over a 48 week treatment period. In these studies Minoxidil 2% was compared to the product vehicle without the Minoxidil active ingredient. The primary efficacy criterion was non-vellus hair count in a 1.0cm2 reference area of affected scalp. The mean changes observed in this parameter in these studies were significantly in favour of Minoxidil 2% and were as follows Females Mean change in non-vellus hair count in reference 1cm2 area of scalp compared with the baseline. Minoxidil 2% Baseline 150.4 Mean change from baseline +35.9 +26.7 +20.7 Vehicle 138.4 Mean change from baseline +20.0 +15.2 +9.4 Pairwise comparison

16 weeks 32 weeks 48 weeks

2%> vehicle 2%> vehicle 2%> vehicle

Using non-vellus hair count as an efficacy criteria, Minoxidil 2% has also been shown to stabilise hair loss (defined as regrowth or no loss) in 88% of patients compared with 69% of patients who received vehicle in one trial following 48

weeks treatment and in 87% of patients compared to 73% of patients who received vehicle in a further trial following 32 weeks treatment. Female patients own evaluation in clinical studies have shown that hair growth was reported by approximately 60% of females after eight months of Minoxidil 2% usage. Patient Evaluation of Visible Hair Growth % of Females reporting regrowth after 8 months Minoxidil 2% Solution 30 40 20 25 55 59 % of Females reporting regrowth after 4 months Product vehicle usage 29 33 7 12 40 41

Minimal re-growth Moderate to dense regrowth Total

In addition, Minoxidil 2% has also shown to stabilise hair loss (shown as regrowth or no loss) in four out of five females as calculated from two clinical studies that showed stabilisation with 88 and 87% respectively while corresponding figures for vehicle were 69 and 74%. Males Mean change in non-vellus hair count in reference 1cm2 area of scalp compared with baseline. Minoxidil 2% Baseline 143.6 Mean change from baseline +29.8 +22.2 +12.7 Vehicle 152.4 Mean change from baseline +15.3 +7.7 +3.9 Pairwise comparison

16 weeks 32 weeks 48 weeks

2%> vehicle 2%> vehicle 2%> vehicle

In addition, in males efficacy was further assessed by comparing photographs taken at various timepoints with baseline. Assessment was undertaken by patients using a 100mm visual analogue scale where point 0 represented much less scalp coverage. The results were as follows Patient Evaluation of Change in Scalp Coverage Minoxidil 2% mm 58.2 58.0 56.9 Vehicle mm 51.4 52.0 51.0 Pairwise comparison 2%> vehicle 2%> vehicle 2%> vehicle

16 weeks 32 weeks 48 weeks

Also in males, assessment was undertaken by two blinded reviewers who compared photographs taken at baseline after 48 weeks. Differences were assessed using a seven point categorical scale viz: Dense growth Moderate growth Minimal growth No change Minimal loss Moderate loss Dense loss

The results were as follows Photographic Evaluation of Clinical Response (Reviewer 1) Dense Growth % 2.8 0 Moderate Growth % 19.7 7.0 Minimal Growth % 21.1 22.5 No Change % 50.0 60.6 Hair Loss % 2.8 9.9 Unable to Rate % 3.5 0

Minoxidil 2% Placebo

Photographic Evaluation of Clinical Response (Reviewer 2) Dense Growth % 3.5 0 Moderate Growth % 12.0 7.0 Minimal Growth % 22.5 9.9 No Change % 47.2 60.6 Hair Loss % 1.4 14.1 Unable to Rate % 13.4 8.5

Minoxidil 2% Placebo

Based upon the photographic data around 40% of the patients experienced an increased scalp coverage after 48 weeks treatment with Minoxidil 2% defined by regrowth of hair compared with 23% at an average for those who received vehicle alone. Around 19% treated with Minoxidil 2% experienced dense or moderate growth compared with around 7% who received vehicle alone. In addition 49% of patients who received Minoxidil 2% were adjudged to have no change between photographic assessments of hair growth compared with 60% who received vehicle alone. Stabilisation of hair loss (i.e. regrowth or no loss) can therefore be expected in about four out of five patients using Minoxidil 2% compared with three out of four using vehicle alone. The mechanism by which Minoxidil stimulates hair growth is not fully understood, but Minoxidil can reverse the hair loss process of androgenetic alopecia by the following means:

Increase the diameter of the hair shaft Stimulate anagen growth Prolong the anagen phase Stimulate anagen recovery from the telogen phase As a peripheral vasodilator Minoxidil enhances microcirculation to hair follicles. The Vascular Endothelial Growth Factor (VEGF) is stimulated by Minoxidil and VEGF is presumably responsible for the increased capillary fenestration, indicative of a high metabolic activity, observed during the anagen phase.

5.2.

Pharmacokinetic properties The failure to detect evidence of systemic effects during treatment with Minoxidil 2% Solution reflects the poor absorption of topical Minoxidil, which averages about 1.4% (range 0.3 4.5%) of the total applied dose from normal intact skin. Absorption is about 2% when applied topically to shaved scalps of hypertensive users. Increasing the amount of drug applied or increasing the frequency of application of Minoxidil 2% Solution also results in increased absorption. Results of the extensive pharmacokinetic studies indicate that the three major factors by which topical Minoxidil absorption are increased by are: increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from administration of Minoxidil 2% Solution are governed by the drugs absorption rate through the skin. Minoxidil and its metabolites are excreted principally in the urine.

5.3.

Preclinical safety data No information provided beyond that available elsewhere in the SPC.

6.
6.1.

PHARMACEUTICAL PARTICULARS
List of excipients Propylene Glycol Ethanol Water

6.2.

Incompatibilities None applicable.

6.3.

Shelf Life Four years.

6.4.

Special precautions for storage Minoxidil 2% Solution is flammable. Store below 25C. Protect from light. Store upright.

6.5.

Nature and contents of container HDPE bottle with 24mm polypropylene white cap and spray-pump/dropper applicator containing 60ml of solution.

6.6

Special precautions for disposal Not applicable.

7.

MARKETING AUTHORISATION HOLDER Wrafton Laboratories Limited Wrafton Braunton North Devon EX33 2DL

8.

MARKETING AUTHORISATION NUMBER PL 12063/0038

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/12/2010

10

DATE OF REVISION OF THE TEXT
10/12/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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