Summary of Product Characteristics (SmPC) - Minoxidil 50 mg / ml cutaneous spray solution
1 NAME OF THE MEDICINAL PRODUCT
Minoxidil 50 mg/ml cutaneous spray, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 mg minoxidil.
Excipients with known effect: 1 ml solution contains 509 mg propylene glycol (E1520) and 248 mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray, solution
Clear, colourless to pale yellow solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Minoxidil 50 mg/ml is indicated for the treatment of alopecia androgenetica in men aged 18 to 65 years.
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 50 mg/ml cutaneous solution, individual responses cannot be predicted.
4.2 Posology and method of administration
Posology
Apply 1 ml Minoxidil 50 mg/ml twice daily (morning and evening) to the affected areas of the scalp.
The daily amount applied of 2 x 1 ml solution should not be exceeded, regardless of the size of the affected scalp area.
Paediatric population under 18 years, patients aged 65 years and older
Minoxidil 50 mg/ml must not be used in these patient groups, as no efficacy and safety results from controlled studies are available in these age groups.
Women
Minoxidil 50mg/ml should not be used in women. For women, Minoxidil 20 mg/ml is available.
Method of administration
Cutaneous use.
Prior to applying Minoxidil 50 mg/ml, it must be ensured that the scalp is dry. Minoxidil 50 mg/ml should not be applied to other parts of the body.
Hands should be washed carefully after applying Minoxidil 50 mg/ml, in order to avoid accidental contact with mucous membranes and eyes.
After applying Minoxidil 50 mg/ml, the hair can be styled as normal. However, the scalp should not be moistened for about 4 hours. This will prevent Minoxidil 50 mg/ml from being washed off.
Each pack of Minoxidil 50 mg/ml contains 2 different pump spray applicators:
- pre-assembled applicator for large-area application
- separate applicator with extended tip for smaller areas Both applicators can be swapped by detaching the one applicator and replacing it with the other.
For a dose of 1 ml 6 spray actuations are needed.
Instructions for use/application
The solution is sprayed directly onto the scalp within the area of hair loss. For this, depress the pump six times. After each actuation, the liquid should be distributed over the affected area with the fingertips, thereby avoiding inhalation of the spray mist.
Duration of use
The onset and extent of hair growth are different in individual patients. In general, twice-daily treatment for 2 to 4 months is required before an effect is seen. In order to maintain the effect, it is recommended to continue the twice-daily application without interruption. No better result will be achieved by applying Minoxidil 50 mg/ml in larger amounts or more frequently. Regarding a possible therapeutic effect, there is sufficient clinical experience for a treatment period of up to one year.
Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Minoxidil 50 mg/ml application and the balding process will continue.
If no effect is seen after 12 months, treatment should be discontinued.
Too low dosage
If too little Minoxidil 50 mg/ml has been applied or a dose has been missed, the user must not make up for the missing amount. In this case, treatment should be continued at the recommended dose.
The solution is flammable. Do not use while smoking, or near any naked flames or heat source.
4.3 Contraindications
Minoxidil 50 mg/ml must not be used in the following cases:
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1,
in women, due to occasional signs of cosmetically distressing,
reversible, facial hair growth during treatment,
- use of occlusive dressings or other topical medical preparations on the scalp,
- sudden or uneven hair loss,
- in users with any scalp abnormality (including psoriasis, sunburn, or if the scalp is damaged by burns or scarring),
- in users with a shaved scalp,
- in users with treated or untreated hypertension.
4.4 Special warnings and precautions for use
Prior to treatment with Minoxidil 50 mg/ml, 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.
Endocrinological causes, underlying systemic diseases or malnutrition must be excluded. In these cases, if necessary, a specific treatment should be initiated.
Minoxidil 50 mg/ml is intended only for external use on the scalp. Do not apply Minoxidil 50 mg/ml to other parts of the body.
There is no clinical experience to date with regard to efficacy for hair loss in the temporal region (receding hairline).
Using more than the recommended dose or more often will not improve results.
Users should be aware that, whilst extensive use of Minoxidil 50 mg/ml 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.
The consumer should discontinue the product and consult a doctor if a reduction in blood pressure is detected or if one or more of the following manifestations occur: chest pain, accelerated heartbeat, asthenia or dizziness, sudden unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp or if other not expected new symptoms appear (see section 4.8).
In some consumers, a transient increase in the amount of hair shedding has been observed two to six weeks after the start of treatment. This effect is due to the fact that the resting phase (telogen phase) of the hair cycle is shortened in hair follicles treated with minoxidil and the growth phase (anagen phase) is reached more quickly. This stimulates new hair growth, which pushes the “old”, no longer active hairs out of the scalp. This gives the initial impression of increased hair loss. However, it is accompanied by increased hair regrowth. This effect regresses within a few weeks and can be interpreted as a first sign of the minoxidil effect. If shedding persists (>2 weeks), users should stop using Minoxidil 50 mg/ml and consult their doctor.
Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.
Hypertrichosis in children following inadvertent topical exposure to minoxidil: Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hypertrichosis was reversible, within months, when infants were no longer exposed to minoxidil. Contact between children and minoxidil application sites should therefore be avoided.
Treatment with Minoxidil 50 mg/ml should not take place in consumers with signs of cardiovascular disease or cardiac arrhythmias or in hypertensive patients, including patients on treatment with antihypertensives.
Isolated cases of slight changes in hair colour have been reported by consumers with very fair hair upon concomitant use of hair care products or after swimming in heavily chlorinated water.
Inadvertent ingestion can cause severe cardiovascular adverse reactions. This product must therefore be kept out of the reach of children.
When treatment with minoxidil is stopped, shedding of the hairs will occur again. Due to the ethanol and propylene glycol content in Minoxidil 50 mg/ml, repeated spraying of Minoxidil 50 mg/ml on the hair rather than the scalp might result in increased hair dryness and/or stiffness.
Minoxidil 50 mg/ml contains ethanol 96%and can cause eye stinging and irritation. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), these must be rinsed with plenty of water.
Inhalation of the spray mist should be avoided.
This medicine contains 509 mg propylene glycol (E 1520) in each ml solution.
This medicine contains 248 mg alcohol (ethanol) in each ml solution. It may cause burning sensation on damaged skin.
4.5 Interaction with other medicinal products and other forms of interaction
To date, no information is available on interactions between Minoxidil 50 mg/ml and other agents. Although not clinically proven, there is a theoretical possibility that absorbed minoxidil may potentiate orthostatic hypotension in patients concomitantly taking 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.
Minoxidil 50 mg/ml should not be used together with other dermatological products applied to the scalp or with agents that enhance skin absorption.
Pharmacokinetic drug interaction studies in humans showed that the percutaneous absorption of minoxidil is enhanced by tretinoin, dithranol and petrolatum as a result of increased permeability of the stratum corneum. Betamethasondipropionat increases the local tissue concentration of minoxidil and reduces the systemic absorption of minoxidil
4.6 Fertility, pregnancy and lactation
Minoxidil 50 mg/ml is indicated for use in males only and must not be used by pregnant women and breastfeeding mothers.
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).
Breastfeeding
Systemically absorbed minoxidil is excreted 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, users should not drive or operate machinery.
4.8 Undesirable effects
The following frequencies are used for the evaluation of adverse reactions: Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 20 mg/ml or 50 mg/ml minoxidil solution, and two placebo-controlled randomised clinical trials in adults evaluating a 50 mg/ml 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).
| System Organ Class (SOC) | Frequency | Adverse Drug Reaction (ADR) |
| Immune system disorders | Common | Hypersensitivity (including facial oedema, generalised skin rash, general pruritus, facial swelling and throat tightness) |
| Not known | Allergic reactions including angioedema (with symptoms such as oedema of the lips, mouth, tongue and throat, swelling of the lips, tongue and oropharynx) | |
| 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 | Common | Hypertension |
| Not known | Hypotension | |
| Respiratory, thoracic and mediastinal disorders | Uncommon | Dyspnoea |
| Gastrointestinal disorders | Uncommon | Nausea |
| Not known | Vomiting | |
| Skin and subcutaneous tissue disorders | Common | Pruritus (including rash pruritic generalised and eye pruritus), hypertrichosis (including facial hair growth in women), dermatitis (including contact, allergic, atopic and seborrhoeic dermatitis), dermatitis acneiform, skin rash (including pustular, popular, generalised, vestibular and macular rash) |
| Common | 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), and changes in hair colour. | |
| General disorders and administration site conditions | Common | Peripheral oedema |
| 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 Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms of intoxication
Application of Minoxidil 50 mg/ml at higher than the recommended dosage and to relatively large body surfaces or areas other than the scalp may possibly lead to increased systemic absorption of minoxidil. To date, there have been no known cases where the topical use of minoxidil solution has resulted in intoxication. After inadvertent swallowing, the concentration of the active compound minoxidil in Minoxidil 50 mg/ml may lead to systemic effects corresponding to the pharmacological action of the active substance (2 ml Minoxidil 50 mg/ml contains 100 mg minoxidil, which is equivalent to the maximum recommended daily dose for the treatment of hypertension).
Due to the systemic effects of minoxidil, the following adverse reactions may occur: Cardiac disorders: accelerated heartbeat, hypotension
General disorders: fluid accumulation and subsequent sudden weight gain, lethargy Nervous system disorders: dizziness
Treatment of intoxication
Treatment of minoxidil overdosage should be symptomatic and supportive. Clinically significant tachycardia can be controlled with β
-blockers and oedema with diuretics.
An excessive decrease in blood pressure can be treated by intravenous infusion of physiological saline solution. Sympathomimetics such as adrenaline and noradrenaline are to be avoided due to their excessive cardiotonic effect.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other dermatological preparations; other dermatologicals ATC code: D11AX01
Minoxidil 50 mg/ml stimulates hair growth in persons with androgenetic alopecia.
Mechanism of action
The exact mechanism of action by which minoxidil stimulates hair growth is not fully known. However, minoxidil can reverse the hair loss process of androgenetic alopecia by:
- increasing the diameter of the hair shaft,
- stimulating hair growth in the anagen phase,
- extending the anagen phase,
- shortening the telogen phase, whereby the anagen phase is reached more quickly.
Pharmacodynamic effects
As a peripheral vasodilator, minoxidil increases the microcirculation to hair follicles. Minoxidil stimulates vascular endothelial growth factor (VEGF) which is probably responsible for the increased capillary permeability and hence shows a high metabolic activity which can be observed during the anagen phase.
Excessive hair loss is halted with regular use after a few weeks. Furthermore, new hair growth may occur. This becomes noticeable at the earliest approximately four months after the start of therapy. Cosmetically satisfactory regrowth of terminal hair is observed in up to 40% of patients treated with minoxidil 20 mg/ml after one year of treatment. The success rate rises to approximately 50% with Minoxidil 50 mg/ml.
The onset of action and the extent of scalp hair thickening varies depending on the patient. In particular, advanced or more than 10 years’ standing androgenetic alopecia is less responsive to minoxidil. This is probably due to the lack of hair roots, the presence of which is necessary for the effect.
Upon discontinuation of treatment, growth of new hair ceases and within 3 to 4 months, the condition reverts to that before the start of therapy.
5.2 Pharmacokinetic properties
Absorption
When minoxidil solution is topically applied, about 1-2% of the active substance is systemically absorbed, compared to 90-100% with oral formulations.
The following study data refer to the topical minoxidil-containing medicinal products of the originator MAH:
In a study on men, the mean minoxidil serum concentration AUC for the 20 mg/ml solution was 7.54 ng*hr/ml, compared to a mean AUC of 35 ng*hr/ml for 2.5 mg of an oral formulation. The mean plasma concentration (Cmax) for the topical solution was 1.25 ng/ml compared to 18.5 ng/ml following oral administration of 2.5 mg.
In another study on men, systemic absorption of a 50 mg/ml foam formulation was about half as much as that of a 50 mg/ml solution. The mean AUC (0-12 h) and Cmax for the 50 mg/ml foam, i.e. 8.81 ng*hr/ml and 1.11 ng/ml, respectively, were about 50% of AUC (0-12 h) and Cmax for the 50 mg/ml solution, i.e. 18.71 ng*hr/ml and 2.13 ng/ml, respectively.
For the 50 mg/ml foam, the time to peak plasma concentration (tmax) of 5.42 h was similar to the tmax for the solution, i.e. 5.79 h. No haemodynamic effect of minoxidil is evident up to a mean serum concentration of 21.7 ng/ml.
Distribution
The volume of distribution after intravenous administration of 4.6 mg and 18.4 mg minoxidil was 73.1 L and 69.2 L, respectively.
Biotransformation
Following topical administration, about 60% of absorbed minoxidil is metabolised to glucuronides, primarily via the liver.
Elimination
The half-life of topical minoxidil is 22 hours, compared to 1.49 hours with oral dosage forms. 97% of minoxidil is excreted via the urine and 3% via the faeces.
Mean renal clearance of minoxidil and its glucuronides, based on data from oral dosage forms, is 261 ml/min and 290 ml/min, respectively.
Upon discontinuation of treatment, about 950 mg/ml of the minoxidil absorbed after topical administration is excreted within 4 days.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Mutagenicity
Minoxidil showed no evidence of mutagenic or genotoxic potential in a series of in vivo and in vitro assays.
Carcinogenicity
A high incidence of hormone-induced tumours was observed in rats and mice. These tumours were caused by a secondary hormonal effect (hyperprolactinaemia), which was observed only in rats at extremely high doses and was similar to the effect of reserpine.
The use of topical minoxidil has shown no effect on the hormonal status of women. Therefore, hormone-induced tumours do not pose a carcinogenic risk to humans.
Teratogenicity
Reproductive toxicity studies on rats and rabbits, with very high exposure rates compared to the anticipated exposure level in humans, have revealed signs of maternal toxicity and a risk to the foetus. There is a low risk to the human foetus.
Fertility
Minoxidil doses of more than 9 mg/kg (at least 25 times the human exposure), administered subcutaneously in rats, were associated with a reduced rate of conception and implantation, as well as a reduction in the number of viable pups.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol 96% (v/v)
propylene glycol (E 1520)
purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
Shelf life after opening: 6 weeks.
6.4 Special precautions for storage
Do not freeze.
Contains ethanol which is flammable. Store away from heaters or naked flames.
6.5 Nature and contents of container
60 ml white HDPE bottle
Packs with 60 ml solution or 3 x 60 ml solution.
The medicinal product Minoxidil 50 mg/ml contains two pump spray applicators, one pre-assembled applicator and one applicator with extended tip.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Trading as Numan Health Ltd.
Vir Health Limited,
4th Floor, Farringdon Point,
33 Farringdon Road,
EC1M 3JF,
London,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL50551/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/09/2022
10 DATE OF REVISION OF THE TEXT
07/11/2025