KSAMIOL gel 15 g

Indications

Topical treatment of scalp psoriasis

Dosage and administration:

Ksamiol gel should be applied to affected areas of the scalp once daily. The recommended treatment period is 4 weeks. After this period, repeated treatment with Ksamiol gel can be initiated only under medical supervision.

All affected areas of the scalp can be treated with ksamiol gel. Usually 1 to 4 g gel per day is sufficient to treat the scalp.

When using calcipotriol containing products, the maximum daily dose should not exceed 15 g, and the maximum weekly dose should not exceed 100 g body surface area treated with calcipotriol containing products should not exceed 30%.

Shake the bottle before use. For optimal effect it is recommended that the hair is not washed immediately after application of the gel Ksamiol. Ksamiol gel should stay on the scalp during the night or during the day.

In children:

Not recommended for use Ksamiol gel in children under 18 years due to lack of data on safety and efficacy.

CONTRAINDICATIONS:

Hypersensitivity to the active substance or to any of the excipients.

Due to the content of calcipotriol Ksamiol Gel is contraindicated in patients with known disorders of calcium metabolism.

Due to corticosteroid Ksamiol Gel is contraindicated in the following conditions: Viral lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, atrophic skin, atrophic striae, "brittleness" the veins of the skin, ichthyosis, acne, acne rozatsiya, rozatsiya, ulcers and wounds.

Ksamiol Gel is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis.

Ksamiol Gel is contraindicated in patients with severe renal insufficiency or severe hepatic disorders.

Pregnancy and lactation

Pregnancy

There are no adequate data from the use of Ksamiol gel in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies have revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is unknown. Therefore, during pregnancy Ksamiol gel should be used only when the potential benefit outweighs the potential risk.

Breastfeeding

Betamethasone passes into breast milk, but at therapeutic doses, the risk of adverse effects on the infant seems unlikely. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Ksamiol gel lactating women.

Effects on ability to drive and use machines

Ksamiol gel does not affect ability to drive and use machines.

SIDE EFFECTS

Based on data from clinical trials the only known common side effect is itching. Uncommon side effects are burning, pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash and eye irritation.

Eye disorders:

uncommon - eye irritation

Skin and subcutaneous tissue disorders:

common - itching

uncommon - burning sensation of skin pain or irritation, folliculitis, dermatitis, erythema, dry skin, exacerbation of psoriasis, rash, pustular rash

Adverse reactions observed for calcipotriol and betamethasone, respectively:

Calcipotriol:

Itching, irritation, burning and stinging, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial edema. Systemic effects after topical use as hypercalcaemia or hiperkaltsiureya may occur rarely.

Betamethasone

skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and milia.