Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Laboratoires Bailleul S.A., 10-12 Avenue Pasteur, L-2310 Luxembourg – Luxembourg
Minorga 2%, cutaneous solution is indicated for the treatment of alopecia.
Minorga 2%, cutaneous solution is particularly indicated in men who suffer from hair loss or weakening on top of the headand in women with generalized hair weakening.
Minorga 2%, cutaneous solution is indicated in adults aged 18 to 65 years.
The dose of 1 ml of Minorga 2%, cutaneous solution should be applied on the scalp twice daily (once in the morning, once at night). This dose should be administered regardless of the affected area size. The total daily dose should not exceed 2 ml.
It is not recommended below 18 years old and over 65 years old due to a lack of data on safety and efficacy.
Minorga 2%, cutaneous solution is for external use only. It is not recommended below 18 years and over 65 years due to a lack of data on safety and efficacy.
Minorga 2%, cutaneous solution should be applied in accordance with the instructions and only on the scalp. Minorga 2%, cutaneous solution should be applied only on dry hair and scalp. After applying Minorga 2%, cutaneous solution, hands should be washed thoroughly.
The application of the product may be required twice daily, for four months or more. In all cases, physician should consider discontinuing treatment if no results are observed within 4 months. If hair growth occurs, it is necessary to continue the administration of Minorga 2%, cutaneous solution, twice daily, in order to maintain its effect. After treatment discontinuation with minoxidil topical lotion, hair growth arrest and, sometimes, the return to the previous appearance within the 3 to 4 months after treatment discontinuation have been occasionally reported.
There is no evidence that topically applied minoxidil is absorbed in sufficient quantity to cause systemic effects. When used as directed, overdose is unlikely.
If this product is applied to an area with decreased integrity of the epidermal barrier caused by trauma, inflammation, or disease process in the skin, there is the potential for a systemic overdose effect.
The following very rare adverse events may occur due to the systemic effects of minoxidil:
| Body system | Incidence | Reported adverse event |
|---|---|---|
| Nervous system disorders | Very rare | Dizziness |
| Cardiovascular disorders | Very rare | Heart rate increased, hypotension |
| General disorders and administration site conditions | Very rare | Fluid retention resulting in weight increase |
Treatment of minoxidil overdosage should be symptomatic and supportive. The fluid retention can be managed with appropriate diuretic therapy. Clinical significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent. Symptomatic hypotension should be treated with intravenous administration of saline. Sympathomimetics, such as epinephrine and norepinephrine, should be avoided since these medicinal products cause excessive heart stimulating effect.
3 years.
Flammable product.
Protect from heat. Keep the container tightly closed.
HDPE Bottle with spray pump/applicators containing 60 ml of solution.
Pack sizes:
1 × 60 ml with 1 removable actuator with nozzle and 1 removable actuator with rod.
3 × 60 ml with 3 removable actuators with nozzle and 2 removable actuators with rod.
Not all pack sizes may be marketed.
The instructions for use depend on the type of applicator used.
A. Spray to apply the solution on large areas of the scalp.
B. Spray with applicator to apply the solution on small areas of scalp or in the hair.
A. Spray:
It is recommended on large areas of scalp.
1) Take out the cap of the bottle.
2) Place the spray towards the bald area, pressure it once and spread the solution with the tip of the fingers throughout all area. Repeat this procedure six times until complete application of the required dose of 1 mL (i.e. a total of 7 sprays). Avoid inhaling the medicinal product during application.
3) Rinse the spray and replace the cap on the bottle after use to avoid the evaporation of alcohol.
B. Spray with applicator:
It is recommended on small areas of scalp or in the hair.
1) Take out the cap of the bottle.
2) Pull the upper part out of the spray, removing it. Adapt the applicator to the spray and make full pressure.
3) Place the spray towards the bald area, pressure it once and spread the solution with the tip of the fingers throughout all area. Repeat this procedure six times until complete application of the required dose of 1 mL (i.e. a total of 7 sprays). Avoid inhaling the medicinal product during application.
4) Rinse the applicator and replace the cap on the bottle after use to avoid the evaporation of alcohol.
Any unused product or waste material should be disposed of in accordance with local requirements
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