CALMURID HC 10%/5%/1%

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Osta kohe

Laadi alla Infovoldik (PIL)
30-05-2014
Laadi alla Toote omadused (SPC)
30-05-2014

Toimeaine:

UREA ; HYDROCORTISONE ; LACTIC ACID

Saadav alates:

Galderma (UK) Ltd

ATC kood:

D07XA01

INN (Rahvusvaheline Nimetus):

UREA ; HYDROCORTISONE ; LACTIC ACID

Annus:

10/1/5 %w/w

Ravimvorm:

Cream

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

hydrocortisone

Volitamisolek:

Not Marketed

Loa andmise kuupäev:

1978-04-01

Infovoldik

                                CALMURID HC 10%/5%/1% W/W CREAM
U RE A 1 0 % W / W - L A C T I C A C I D 5 % W / W - H Y D RO C O R T
I S O N E 1 % W / W
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
Product code: MOCK UP
Product description: CALMURID HC CRE
Market: IRL
Article: Leaflet
Flat size: 135x210
Fold size: 135x26,25
Font size: 8 pts
Pharmacode: TBD
_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALMURID HC 10%/5%/1% W/W CREAM
Urea 10% w/w
Lactic Acid 5% w/w
Hydrocortisone 1% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness
are the same as yours.
- 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.
WHAT IS IN THIS LEAFLET
1. What Calmurid HC is and what it is used for
2. What you need to know before you use Calmurid HC
3. How to use Calmurid HC
4. Possible side effects
5. How to store Calmurid HC
6. Contents of the pack and other information
1. WHAT CALMURID HC IS AND WHAT IT IS USED FOR
•
This medicine is for the treatment of eczema and other similar
conditions where the skin is inflamed, sore, dry, rough, scaly,
irritated or itchy.
•
The active substances contained in Calmurid HC are urea (10% w/w),
lactic acid (5% w/w), both of which are found in
healthy skin, and hydrocortisone (1% w/w), which is a mild steroid.
•
The urea and lactic acid in Calmurid HC have moisturising and
antibacterial properties, as well as helping to relieve itching,
and to soften
                                
                                Lugege kogu dokumenti
                                
                            

Toote omadused

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calmurid HC 10%/5%/1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Cream.
A smooth white, oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of dermatoses characterised by hyperkeratosis and
inflammation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Apply twice daily to the affected areas or as directed by the
physician.
4.3 CONTRAINDICATIONS
1.
Use in the presence of untreated infections of bacterial, viral,
tuberculous or fungal origin.
2.
Use in acne rosacea or in perioral dermatoses.
3.
Use in plaque psoriasis.
4.
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Continuous treatment longer than three weeks should be avoided in
patients under the age of three years
because of the possibility of adrenocortical suppression and growth
retardation.
2.
Prolonged use of uninterrupted occlusion (including napkins) or use
with extensive occlusive dressings
may suppress adrenocortical function.
3.
Continuous application without interruption will result in local
atrophy of the skin, striae, and superficial
vascular dilation, particularly on the face.
Urea
10.0
% w/w
Lactic acid
5.0
% w/w
Hydrocortisone
1.0
% w/w
For the full list of excipients, see section
6.1.
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_2_
_/_
_1_
_2_
_/_
_2_
_0_
_1_
_3_
_C_
_R_
_N_
_ _
_2_
_1_
_4
                                
                                Lugege kogu dokumenti
                                
                            

Vaadake dokumentide ajalugu