MINORGA Cutaneous solution Ref.[51130] Active ingredients: Minoxidil

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Minorga 2%, cutaneous solution.

Minorga 2%, cutaneous solution 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.

Minorga 2%, cutaneous solution should only be used on a normal, healthy scalp. Do not use if scalp is red, inflamed, infected, irritated or painful or if using other medications on the scalp.

Some excipients in Minorga 2%, cutaneous solution may cause burning and irritation. 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.

Inhalation of the spray mist should be avoided. Do not swallow.

The patient should stop using Minorga 2%, cutaneous solution and see a doctor if hypotension is detected or if experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden weight gain, swollen hands or feet or persistent redness or irritation of the scalp.

Some patients have experienced changes in hair colour and/or texture with Minorga 2%, cutaneous solution use.

Paediatric population

Accidental ingestion may cause serious cardiac adverse events. Therefore, Minorga 2%, cutaneous solution has to be kept out of the reach of children.

Pharmacokinetic drug interaction studies in humans revealed percutaneous minoxidil absorption is enhanced by tretinoin and anthralin, as a result of increased stratum corneum permeability; betamethasone dipropionate increases local tissue concentrations of minoxidil and decreases systemic minoxidil absorption.

Although not clinically proven, there is a theoretical possibility that absorbed minoxidil may potentiate orthostatic hypotension in patients concomitantly taking peripheral vasodilators.

Pregnancy: There are no adequate and well controlled studies in pregnant women. Animal studies have shown a risk to the fetus at exposure levels that are very high compared to those intended for human exposure. A low, albeit remote, risk of fetal harm is possible in humans (See Section 5.3, Preclinical Safety Data).

Breast-feeding: Systemically absorbed minoxidil is secreted in human milk.

Topical minoxidil should only be used during pregnancy or lactation if the benefit to the mother outweighs the potential risk to the fetus or nursing infant.

Based on the pharmacodynamic and overall safety profile of minoxidil for topical use, it is not expected that Minorga 2%, cutaneous solution would interfere with the ability to drive or operate machinery.

The frequency of adverse reactions to topical minoxidil solution is defined using 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). The following adverse events were associated with the use of minoxidil solution (2% and 5% combined) in males and females, at an incidence greater than 1%, and greater than placebocontrolled clinical trials.

The following adverse events have been associated with topical minoxidil solution during postmarketing use.

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 national reporting system: ADR Reporting – Website: www.medicinesauthority.gov.mt/adrportal

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.