Calmurid cream

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Urea; Lactic acid

Dostupné z:

Mawdsley-Brooks & Company Ltd

ATC kód:

D02AE51

INN (Medzinárodný Name):

Urea; Lactic acid

Dávkovanie:

100mg/1gram ; 50mg/1gram

Forma lieku:

Cutaneous cream

Spôsob podávania:

Cutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 13020100

Príbalový leták

PATIENT INFORMATION LEAFLET
CALMURID®
10% / 5% W/W CREAM
(urea 10% lactic acid 5%)
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.
Your medicine is called Calmurid Cream but
will be referred to as Calmurid throughout this
leaflet.
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 an allergic
reaction. Signs or symptoms of a severe
allergic reaction may include a rash, with or
without itching, swelling of the face, eyelids or
lips and difficulty in breathing.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Calmurid.
•
Avoid contact with the eyes, eyelids, lips
and other mucous surfaces. Upon
accidental contact, rinse the affected area
with clean water.
•
Calmurid may cause stinging if

Súhrn charakteristických

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 and 50 mg of Lactic acid
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream for topical (cutaneous) use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To be applied topically for the correction of hyperkeratosis and
dryness in
ichthyosis and allied conditions characterised by dry, rough, scaly
skin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Adults, elderly and children:
A thick layer of Calmurid is applied twice daily after washing the
affected area. The cream is
left on the skin for 3-5 minutes and then rubbed lightly in. Excess
cream should be wiped off
the skin with a tissue, not washed off. Frequency of application can
be reduced as the patient
progresses. In hyperkeratosis of the feet apply Calmurid as above
after soaking the feet in
warm water for 15 minutes and drying with a rough towel.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Calmurid should not be used extensively in patients with severe renal
impairment.
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.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Low pH of 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.
4.6.
FERTILITY, PREGNANCY AND LACTATION
There is no specific data available regarding the us