REGAINE FOR WOMEN REGULAR STRENGTH - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Regaine for Women Regular Strength

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Minoxidil 20 mg/ml (2% w/v).

Contains propylene glycol 200 mg/ml and ethanol 600 mg/ml.

For full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous Solution (to be applied to the scalp)

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Regaine for Women Regular Strength is indicated for the treatment of alopecia androgenetica 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 Regaine for Women Regular Strength, individual responses cannot be predicted.

4.2 Posology and method of administration

Women aged 18–65:

Hair and scalp should be thoroughly dry prior to topical application of Regaine for Women Regular Strength. A dose of 1 ml Regaine for Women Regular Strength cutaneous solution should be applied to the total affected areas of the scalp twice daily. The total dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards.

It may take twice daily applications for four months or more before evidence of hair growth can be expected.

If hair re-growth occurs, twice daily applications of Regaine for Women Regular Strength are necessary for continued hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Regaine for Women Regular Strength application and the balding process will continue.

Users should discontinue treatment if there is no improvement after one year.

Special Populations

There are no specific recommendations for use in patients with renal or hepatic impairment

Paediatric and Elderly Populations

Not recommended. The safety and effectiveness of Regaine for Women Regular Strength in children and adolescents below the age of 18 years or adults over the age of 65 years has not been established.

Method of administration

For topical use only.

The method of application varies according to the disposable applicator 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 6 times to apply a dose of 1 ml. 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.

4.3. Contraindications

Regaine for Women Regular Strength 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 Regaine for Women Regular Strength, the user should determine that the scalp is normal and healthy. Topical minoxidil should not be applied to inflamed, infected, irritated or painful scalp skin (see section 4.3).

Topical minoxidil is only indicated for the treatment of alopecia androgenetica and should not be used in other types of hair loss for example when there is no family history of hair loss, hair loss is sudden and/or patchy, hair loss is due to childbirth or the reason for hair loss is unknown.

The patient should stop using Regaine for Women Regular Strength 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 or irritation of the scalp or other unexpected new symptoms occur (see section 4.8).

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine for Women Regular Strength.

Some patients have experienced changes in hair colour and/or texture with use of Regaine for Women Regular Strength.

Regaine for Women Regular Strength is for external use only. Do not apply to areas of the body other than the scalp.

Using more than the recommended dose or more often will not improve results.

Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.

Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should be avoided.

Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Women Regular Strength. This is most likely due to minoxidil’s 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 Regaine for Women Regular Strength and consult their doctor.

Users should be aware that, whilst extensive use of Regaine for Women Regular Strength 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.

Accidental ingestion may cause serious cardiac adverse events. Therefore, this product has to be kept out of the reach of children.

This medicine contains 600 mg of alcohol (ethanol) in each 1 ml. It may cause burning sensation on damaged skin.

This medicine contains 200 mg of propylene glycol in each 1 ml and may cause skin irritation.

Patients should be advised to consult their doctor or pharmacist if they are concerned at any time during treatment with Regaine for Women Regular Strength.

4.5 Interaction with other medicinal products and other forms of interaction

This product should not be used concomitantly with other medications applied topically on the scalp (see section 4.3).

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.

Guanethidine has been reported to interact with oral formulations of minoxidil resulting in rapid and pronounced lowering of blood pressure.

There is a theoretical possibility that topical minoxidil may also interact with guanethidine.

4.6 Fertility, pregnancy and lactation

This product should not be used during pregnancy or lactation.

There are no adequate and well controlled studies in pregnant women. Studies in animals have shown a risk to the foetus at exposure levels that are very high compared to those intended for human exposure. There is potentially a risk of foetal harm in humans (see section 5.3).

Systemically absorbed minoxidil is secreted in human milk. The effect of minoxidil on newborns/infants is unknown.

4.7 Effects on ability to drive and use machines

This product may cause dizziness or hypotension (see section 4.8). If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebo-controlled randomised clinical trials in adults evaluating a 5% foam formulation.

Adverse drug reactions (ADRs) identified during clinical trials and postmarketing experience with minoxidil are included in the table below by System Organ Class (SOC).

The frequencies are provided according to the following convention:

Very common >1/10

Common >1/100 and < 1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9 Overdose

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of Regaine for Women Regular Strength are applied to larger surface areas of the body or areas other than the scalp.

Because of the concentration of minoxidil in Regaine for Women Regular Strength, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (5 ml of Regaine for Women Regular Strength contains 100 mg minoxidil; 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. Tachycardia, hypotension, dizziness and lethargy can also occur.

Treatment

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other dermatologicals, ATC code: D11AX

Individual responses to Regaine for Women Regular Strength are variable and unpredictable.

The effect of Regaine for Women Regular Strength has been assessed in phase III clinical trials in women conducted over a 48 week treatment period.

In these studies Regaine for Women Regular Strength was compared to the product vehicle without the minoxidil active ingredient. The primary efficacy criterion was non-vellus hair count in a 1.0 cm2 reference area of affected scalp. The mean changes observed in this parameter in these studies were significantly in favour of Regaine and were as follows:

Using non-vellus hair count as an efficacy criteria, Regaine for Women Regular Strength 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 with 73% of patients who received vehicle in a further trial following 32 weeks treatment.

Female patients’ own evaluations in clinical studies have shown that hair growth was reported by approximately 60% of females after 8 months of Regaine for Women Regular Strength usage.

The failure to detect evidence of systemic effects during treatment with Regaine solution reflects the poor absorption of topically applied minoxidil from normal intact skin. Systemic absorption of minoxidil from topically applied solution ranges between 1% and 2% of the total applied dose.

In a study in males, the minoxidil serum concentration time curve (AUC) for the 2% solution averaged 7.54 ng^h/ml compared to a mean AUC of 35.1 ng^h/ml for the 2.5 mg oral formulation. The mean peak plasma concentration (Cmax) for the topical solution was 1.25 ng/ml, compared to 18.5 ng/ml following the 2.5 mg oral dose.

There is some evidence from in vitro studies that minoxidil reversibly binds to human plasma proteins. However, since only 1 – 2% of topically applied minoxidil is absorbed, the extent of plasma protein binding occurring in vivo after topical application would be clinically insignificant. The volume of distribution of minoxidil after intravenous administration has been estimated at 70 litres.

Approximately 60% minoxidil absorbed after topical application is metabolised to minoxidil glucuronide, primarily in the liver. Minoxidil and its metabolites are excreted almost entirely in the urine, with a very minor degree of elimination via the faeces. Following cessation of dosing, approximately 95% of topically applied minoxidil will be eliminated within four days.

5.3 Preclinical safety data

Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.

Cardiac effects of minoxidil in dogs are species-specific in terms of the low doses that cause profound haemodynamic effects and associated changes in the heart. Available data indicate that similar cardiac effects do not occur in humans treated topically or orally with minoxidil.

Teratogenicity

Animal reproduction toxicity studies in rats and rabbits have shown signs of maternal toxicity and a risk to the foetus at exposure levels that are very high compared to those intended for human exposure (from 19 to 570-fold human exposure). A low, albeit remote, risk of foetal harm is possible in humans.

Fertility

Preclinical fertility studies in rats have shown minoxidil doses equal to or greater than 3 mg/kg/day (at least 21-fold human exposure) when administered orally and greater than 9 mg/kg/day (at least 64-fold human exposure) when administered subcutaneously were associated with reduced conception and implantation rates as well as a reduction in the number of live pups.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Propylene glycol, ethanol, water.

6.2 Incompati­bilities

Not applicable.

6.3. Shelf-Life

48 months

6.4. Special Precautions for Storage

Regaine for Women Regular Strength is flammable. Do not store above 25°C

6.5 Nature and contents of container

HDPE bottle with a child-resistant plastic or polypropylene overcap, containing 60 ml of solution.

Pack size: 1 × 60 ml.

6.6 Special precautions for disposal and other handling

The solution is flammable. Do not use while smoking, or near any naked flame or strong heat source. Avoid exposure of the container and contents to naked flames during use, storage and disposal. Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

McNeil Products Limited

50 – 100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 15513/0149