REGAINE FOAM Cutaneous foam Ref.[6415] Active ingredients: Minoxidil

Before using this product, the user should determine that the scalp is normal and healthy. Topical minoxidil should not be applied to inflamed, infected or painful scalp skin (see section 4.3).

Topical minoxidil is not indicated 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 this product and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, 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 this product.

Some patients have experienced changes in hair colour and/or texture with this product use.

This product 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 foam.

Some consumers reported increased hair shedding upon initiation of therapy with this product. 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 this product and consult their doctor.

Users should be aware that, whilst extensive use of this product 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 product contains ethanol (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 amounts of cool tap water.

This product also contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes or mucous membranes, and cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

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 or dithranol or petrolatumwhich 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.

This product should not be used during pregnancy or lactation.

Pregnancy

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).

Lactation

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

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

The safety of topical minoxidil from clinical trials 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 post-marketing 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,<1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), 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’.

Immune System Disorders

Common: Hypersensitivity reactions (The manifestations of Hypersensitivity reactions may include the following MedDRA PTs: Face oedema, Generalised erythema, Pruritus generalized, Swelling face, and Throat tightness)

Not known: Angioedema (The manifestations of angioedema may include following PTs: Lip oedema, Lip swelling, Oedema mouth, Oropharyngeal swelling, Pharyngeal oedema, Swollen tongue and Tongue oedema)

Psychiatric Disorders

Not known: Depressed mood

Nervous System Disorders

Very common: Headache

Uncommon: Dizziness

Eye disorders

Not known: Eye irritation

Cardiac disorders

Common: Chest pain

Uncommon: Palpitations

Not known: Heart rate increased

Vascular disorders

Not known: Hypotension

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Gastrointestinal Disorders

Uncommon: Nausea

Not known: Vomiting

Skin and subcutaneous tissue disorders

Common: Hypertrichosis (unwanted non-scalp hair including facial hair growth in women), Pruritus (including rash pruritic generalised and eye pruritus), Rash (including pustular, papular, generalised, vestibular and macular rash), Dermatitis (including contact, allergic, atopic and seborrhoeic dermatitis)

Rare: Changes in hair texture

Not known: Dry skin, Skin exfoliation (including exfoliative rash and dermatitis exfoliative), Acne (acneiform rash), Temporary hair loss (see section 4.4), Changes in hair colour

General disorders and administration site conditions

Common: Oedema peripheral

Not known: Application site reactions (These sometimes involve nearby structures like the ears and face and typically consist of pruritus, irritation, pain, rash, oedema, dry skin, erythema and rash erythematous but can sometimes be more severe and include exfoliation, dermatitis, blistering, bleeding and ulceration)

Investigations

Common: Weight increased

Reporting of suspected adverse reactions

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.

Not applicable.