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SPC, UK: CALCIPOTRIOL Cutaneous solution (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Calcipotriol 50 micrograms/ml Scalp Solution.

Qualitative and quantitative composition

One ml of calcipotriol cutaneous solution contains 50 micrograms calcipotriol. Excipient with known effect: Propylene glycol 30 mg/ml. For the full list of excipients, see section 6.1.

Pharmaceutical form

Cutaneous solution. Clear, colourless solution with an odour of menthol.

Therapeutic indications

Calcipotriol 50 micrograms/ml Scalp Solution is indicated for the topical treatment of mild to moderate scalp psoriasis (psoriasis vulgaris).

Posology and method of administration

Posology Adults Calcipotriol 50 micrograms/ml Scalp Solution should be applied to the affected areas twice daily (morning and evening). The maximum weekly dose should not exceed 60 ml. If this solution ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe renal or liver impairment. Known disorders of calcium metabolism or treatment with other ...

Special warnings and precautions for use

Calcipotriol 50 micrograms/ml Scalp Solution should not be used on the face. Patients should be advised to wash their hands after applying the solution and to avoid inadvertent transfer to other body areas, ...

Interaction with other medicinal products and other forms of interaction

Concomitant administration of calcipotriol and salicylic acid externals may cause an inactivation of calcipotriol. There is no experience of concomitant therapy with other antipsoriatic products applied ...

Fertility, pregnancy and lactation

Pregnancy The safety of the use of calcipotriol during human pregnancy has not been established. Studies in animals have shown reproductive toxicity when calcipotriol was administered orally (see section ...

Effects on ability to drive and use machines

Calcipotriol has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Based on the clinical data, approximately 25% of the patients treated with calcipotriol could experience an adverse reaction. These reactions are usually mild. The most frequently reported undesirable ...

Overdose

Use above the recommended dose (see section 4.2) may cause elevated serum calcium which disappears rapidly after cessation of treatment. The clinical signs of hypercalcaemia include anorexia, nausea, vomiting, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antipsoriatics for topical use ATC code: D05AX02 Calcipotriol is a vitamin D derivative. In vitro data show that calcipotriol induces differentiation and suppresses proliferation ...

Pharmacokinetic properties

No data are available on the absorption of calcipotriol following use of the scalp solution. Data from a single study containing 5 evaluable patients with psoriasis treated with 0.3–1.7 g of a 50 micrograms/g ...

Preclinical safety data

The effect on calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D3. A dermal carcinogenicity study in mice revealed no special hazards for humans. Calcipotriol ...

List of excipients

Sodium citrate Hypromellose Propylene glycol Isopropyl alcohol Levomenthol Water, purified

Incompatibilities

Not applicable.

Shelf life

Shelf life Before opening: 2 years. After first opening: 3 months.

Special precautions for storage

Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. Do not refrigerate or freeze. Keep the cutaneous solution away from fire or flames (the alcohol base is inflammable). ...

Nature and contents of container

Polyethene bottle fitted with polyethene nozzle and closed with polypropylene screw cap. Pack sizes: 30, 60, 100 and 120 ml. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization number(s)

PL 04416/0888

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 May 2009 Date of latest renewal: 25 August 2014

Date of revision of the text

04/12/2017

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