Agispor Shampoo

/ Perrigo

Seborrhoeic dermatitis of the scalp: 4 weeks.
Method of administration: Patients should be instructed to shake the bottle well and apply Agispor shampoo to the hair or affected areas of the skin.
The recommended dose is one scalp wash three times a week, with two applications of the shampoo each time. The shampoo should be left on the scalp for 5 minutes before rinsing. Sufficient shampoo should be used to ensure a good lathering of the scalp.
Use in Children: No in-depth studies have been performed in children. From a survey of the clinical data reported there is no indication that harmful effects should be anticipated in children.
However, in infants and toddlers, the medicinal product should only be used under medical supervision.

Pityriorisis versicolor and sebarrrhoeic dermatitis of the scalp caused by pityrosporum.

Hypersensitivity to the active substance(s) or to any of the excipients.

Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole containing products with caution.
If symptoms continue/persist after treatment, seek medical advice.
Generally:
– Keep medicine out of the reach of children. Avoid contact with eyes.
– Do not swallow.

The following adverse reactions have been identified during post-approval use of bifonazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
– General disorders and administration site conditions: Administration site pain, oedema peripheral (at administration site).
– Skin and subcutaneous tissue disorders: Dermatitis contact, dermatitis allergic, erythema, pruritus, rash, urticaria, blister, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, skin burning sensation.
These side effects are reversible after discontinuation of the treatment.

Limited data suggest that an interaction between topical bifonazole and warfarin may be  possible, leading to increases in INR. If bifonazole is used in a patient on warfarin therapy, they should be appropriately monitored.

Pregnancy: Preclinical safety data and pharmacokinetic data in humans give no indication that harmful effects on the mother and child should be anticipated when bifonazole is used during pregnancy. However, no clinical data are available.
As a precautionary measure, it is preferable to avoid the use of bifonazole during the first trimester of pregnancy.
Lactation: It is unknown whether bifonazole is excreted in human breast milk.
The excretion of bifonazole in milk has been studied in animals.
Available pharmacodynamic/toxicological data in animals have shown excretion of bifonazole/metabolites in milk. Breast-feeding should be discontinuedb during treatment with bifonazole.

No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion.