Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Soolantra has not been studied in patients with renal or hepatic impairment.
The medicinal product contains:
No interaction studies have been performed (see section 5.2 for Biotransformation).
Concomitant use of Soolantra with other topical or systemic medicinal products for the treatment of rosacea has not been investigated.
In vitro studies have shown that ivermectin is primarily metabolised by CYP3A4. Consequently, caution is advised when ivermectin is administered concomitantly with potent CYP3A4 inhibitors as the plasma exposure may be significantly increased.
There are no or a limited amount of data from the topical use of ivermectin in pregnant women. Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits (see section 5.3), however due to the low systemic exposure following topical administration of the product at the proposed posology, there is a low safety concern for a human foetus. Soolantra is not recommended during pregnancy.
Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. Available pharmacokinetic/toxicological data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Soolantra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
No human data on the effect of ivermectin on fertility are available. In rats, there was no effect on mating or fertility with ivermectin treatment.
Soolantra has no or negligible influence on the ability to drive and use machines.
The most commonly reported adverse reactions are skin burning sensation, skin irritation, pruritus and dry skin, all occurring in 1% or less of patients treated with the medicinal product in clinical trials.
They are typically mild to moderate in severity, and usually decrease when treatment is continued.
No meaningful differences in the safety profile were observed between subjects 18 to 65 years and subjects ≥65 years of age.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: 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) and were reported with Soolantra in clinical studies (see Table 1).
Table 1. Adverse reactions:
Common: Skin burning sensation
Uncommon: Skin irritation, pruritus, dry skin, Rosacea aggravation*
Not known: Erythema, dermatitis contact (allergic or irritant), swelling face
Not known: Transaminases increased*
* Adverse reaction reported from post-marketing data.
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.
Not applicable.
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