Caldesene Adult 10% w/w Medicated Powder

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Calcium undecylenate

Prieinama:

Clonmel Healthcare Ltd

ATC kodas:

D01AE; D01AE04

INN (Tarptautinis Pavadinimas):

Calcium undecylenate

Dozė:

10 percent weight/weight

Vaisto forma:

Cutaneous powder

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Other antifungals for topical use; undecylenic acid

Autorizacija statusas:

Marketed

Leidimo data:

2014-03-14

Prekės savybės

Health Products Regulatory Authority
22 May 2020
CRN008LTK
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caldesene Adult 10% w/w Medicated Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Undecylenate 10% w/w.
Excipient(s) with known effect
Contains benzyl benzoate, benzyl alcohol, eugenol, isoeugenol,
linalool, cinnamyl alcohol and coumarin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Powder.
A white, perfumed, free flowing cutaneous powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Protects against skin irritation and chaffing especially in delicate
skin folds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: Apply to affected area as required or as directed by a
physician.
There is no recommended dosing schedule.
Method of administration:
Topical.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This medicine contains fragrance with: benzyl alcohol, benzyl
benzoate, eugenol , isoeugenol, linalool, cinnamyl alcohol and
coumarin. which may cause allergic reactions. Benzyl alcohol may cause
mild local irritation.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
As this product is applied topically, its use is not contra-indicated
during pregnancy and lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not relevant.
Health Products Regulatory Authority
22 May 2020
CRN008LTK
Page 2 of 3
4.8 UNDESIRABLE EFFECTS
None known.
Reporting of suspected adverse reactions
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL -
Dublin 2; Tel: [phone]
; Fa