Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: AS GRINDEKS., Krustpils iela 53, Rīga, LV-1057, Latvia, Tel.: +371 67083205, Fax: +371 67083505, E-mail: grindeks@grindeks.lv
Accidental contact of dexpanthenol with the eyes should be avoided. Dexpanthenol should be discontinued if signs of hypersensitivity occur during use. Patients should be instructed to consult a doctor if they do not feel better or if they feel worse after 14 days.
RECREOL contains propylene glycol – may cause skin irritation. RECREOL contains wool fat and cetostearyl alcohol – may cause local skin reactions (e.g. contact dermatitis).
Interaction studies have not been performed with dexpanthenol. There are no known interactions. There is no evidence that topical dexpanthenol interacts with any medicine.
The possible effect of dexpanthenol on reproduction was not studied. There is no data on the use of dexpanthenol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to dexpanthenol is negligible. Recreol can be used during breast-feeding.
No studies on the effect on human fertility have been conducted with dexpanthenol.
The effects, if any, on the developing foetus are unknown.
Dexpanthenol has no effects on ability to drive and use machines.
Adverse reactions are ranked according to system organ class, 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).
Very rare: allergic reactions and allergic skin reactions.
Very rare: contact dermatitis, allergic dermatitis, itching, redness, eczema, rash, hives, skin irritation and sores.
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.
There is no information regarding possible incompatibilities.
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