CALMURID

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

UREA ; LACTIC ACID

Disponible depuis:

Galderma (UK) Ltd

Code ATC:

D02AE01

DCI (Dénomination commune internationale):

UREA ; LACTIC ACID

Dosage:

%w/w

forme pharmaceutique:

Cream

Type d'ordonnance:

Product not subject to medical prescription

Domaine thérapeutique:

carbamide

Statut de autorisation:

Marketed

Date de l'autorisation:

1978-07-28

Notice patient

®
UREA 10% LACTIC ACID 5%
1 0 % / 5 % W / W C R E A M
_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
This approval applies to WHOLE TEXT, including barcodes,
pre-printed mentions and legal or special labelling constraints.
PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.
Product code: P20615-12
Product description: CALMURID CRE
Market: GBR
Article: Leaflet
Flat size: 135x210
Fold size: 135x26,25
Pharmacode: 1418
Font size: 8 pt
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALMURID 10%/ 5% W/W CREAM
Urea 10% w/w
Lactic Acid 5% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. What Calmurid is and what it is used for
2. What you need to know before you use Calmurid
3. How to use Calmurid
4. Possible side effects
5. How to store Calmurid
6. Contents of the pack and other information
1. WHAT CALMURID IS AND WHAT IT IS USED FOR
•
Your doctor or pharmacist has recommended this cream for use as a
moisturising cream for the treatment of dry, rough,
scaly skin such as eczema and similar conditions.
•
The active substances in Calmurid are urea and lactic acid which act
as moisturisers. This helps make your skin soft and supple.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CALMURID
DO NOT USE CALMURID:
•
If you are allergic to urea or lactic acid or any of the other
ingredients of this medicine (listed in section 6).
Please seek immediate medical attention if you experience symptoms of
a

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calmurid 10%/ 5% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 100 mg of Urea (10% w/w) and 50 mg of
Lactic acid (5% w/w).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A homogenous, white, oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of dermatoses characterised by hyperkeratosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Adults, paediatric population and older people
Application:
twice daily or as directed by the physician, ideally after washing.
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
Calmurid is acidic and hypertonic and can cause smarting if applied to
raw areas, fissures or mucous membranes.
Where this is a barrier to therapy the use of Calmurid diluted 50%
with aqueous cream B.P. for one week should result
in freedom from smarting upon use of Calmurid.
Avoid contact with the eyes and surrounding area and do not apply
Calmurid on inflamed skin or open wounds.
Because of potential transcutaneous penetration of urea, the product
should not be used extensively in subjects with
severe renal impairment without medical supervision.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Low pH of the cream might affect stability of other drugs.
Urea may enhance the penetration of other active substances into the
skin. This is particularly well-known for
corticosteroids, dithranol and 5-fluoruracil.
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