Calmurid cream

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Lactic acid; Urea
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
D02AE51
INN (International Name):
Lactic acid; Urea
Dosage:
50mg/1gram ; 100mg/1gram
Pharmaceutical form:
Cream
Administration route:
Cutaneous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 13020100

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:

What Calmurid is and what it is used for

What you need to know before you use

Calmurid

How to use Calmurid

Possible side effects

How to store Calmurid

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 applied to

damaged skin (raw cracked areas or

cracked skin) or sensitive areas of the

body such as the mouth or nostrils.

If you have ever had kidney disease, ask

your doctor or pharmacist for advice

before taking this medicine.

Other medicines and Calmurid

Tell your doctor or pharmacist if you are

taking, have recently taken or might take any

other medicines.

Calmurid might interfere with other medicines

applied to the skin such as:

topical corticosteroids, which are a group

of medicines used on the surface of the

skin to reduce the redness and itchiness

caused by certain skin problems.

5-fluorouracil, used to treat skin

conditions such as horny growths of the

skin (keratoses) and some skin cancers.

dithranol, which is used to treat psoriasis.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think

you may be pregnant or are planning to have

a baby, ask your doctor or pharmacist for

advice before taking this medicine.

Do not apply Calmurid Cream to your

chest if you are breast-feeding.

3.

How to use Calmurid

Always use this medicine exactly as

described in this leaflet or as your doctor or

pharmacist have told you. Check with your

doctor or pharmacist if you are not sure.

Calmurid Cream is for EXTERNAL USE

ONLY.

First gently wash and dry the affected

areas of your skin.

Apply a thick layer over the affected

areas. Do not rub it in yet.

Leave it on your skin for 3 to 5 minutes,

then rub it in gently.

Wipe off any excess cream with a tissue

(do not wash it off).

The cream should be used in this way

twice a day, or as advised by your doctor,

ideally after washing.

If you need to use Calmurid on your feet,

soak them in water for 15 minutes and

then dry them with a rough towel before

use.

How long you will have to use this

medicine will depend on how quickly your

condition improves. Always seek the

advice of your doctor or pharmacist.

If you use more Calmurid than you should

or accidentally swallow any of the cream

If you use too much Calmurid and stinging

occurs, wash the cream off with water.

In the rare event that you accidentally swallow

any of this medicine, seek medical advice.

If you forget to use Calmurid

Do not worry if you forget to use your cream

at the right time. When you remember, start

using the medicine again as you did before.

If you have any further questions on the use

of this medicine, ask your pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

Effects on the skin

Calmurid may cause stinging if applied to

raw areas or cracks in the skin or the lips.

Keep Calmurid away from other sensitive

areas of your body.

If stinging occurs, wash the cream off with

water.

Should stinging be a problem, you can

mix it with an equal amount of Aqueous

Cream BP (ask your pharmacist for this)

for a week, after which it would be alright

to use the cream on its own again, but

you must consult your doctor or

pharmacist first.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

You can also report side effects directly via

the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

or search for

MHRA Yellow Card in the Google Play or

Apple App Store.

By reporting side effects, you can help

provide more information on the safety of this

medicine.

5.

How to store Calmurid

Keep this medicine out of the sight and

reach of children

Do not use this medicine after the expiry

date which is stated on the tube and the

carton. The expiry date refers to the last

day of that month.

Do not store above 25° C.

Do not refrigerate or freeze.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines you

no longer use. These measures will help

protect the environment.

6. Contents of the pack and other

information

What Calmurid contains

The active substances are urea and lactic

acid. One gram of cream contains 100 mg

of urea and 50 mg of lactic acid.

The other ingredients are glyceryl

monostearate, betaine monohydrate,

diethanolamine cetyl phosphate, hard fat,

cholesterol, sodium chloride and purified

water.

What Calmurid looks like and contents of

the pack

Calmurid is a white cream. It is available in

100 g and 500 g tubes either on prescription

from your doctor or indirectly from your

pharmacist.

Manufacturer: Laboratoires GALDERMA

Zone Industrielle Montdesir

F-74540 Alby Sur Cheran France.

Procured within the EU

Product Licence holder: Ecosse

Pharmaceuticals Limited

3 Young Place, East Kilbride G75 0TD.

Re-packaged by: Munro Wholesale Medical

Supplies Limited

3 Young Place East Kilbride G75 0TD.

PL19065/0413

This leaflet was last revised 22/02/2018

E0413/3

If you are blind or

partially sighted and

require this leaflet in a

different format, call

01355 574450 and ask

for the Regulatory

Department.

Calmurid® is a registered trade mark of

Galderma S.A..

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 use in pregnant women and during

lactation.

In breast-feeding woman Calmurid should be removed from the breast area before

breast feeding.

4.7

Effects on ability to drive and use machines

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

4.8

Undesirable effects

Calmurid is acidic and hypertonic and can cause smarting if applied to raw

areas, fissures or mucous membranes.

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 the Yellow Card Scheme. Website:

www.mhra.gov.uk/yellowcard

4.9.

Overdose

Unlikely. In the case of smarting, wash the cream off.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Carbomide products

ATC code: D02AE

Urea at a concentration of 10% has keratolytic, anti microbial, anti pruritic and

hydrating effects on the skin. Lactic acid has keratolytic, hydrating and anti

microbial properties also. Treatment of ichthyotic patients shows a parallel

between clinical improvement and increase in the otherwise depressed binding

capacity of the horny layer.

5.2

Pharmacokinetic properties

Not applicable.

5.3

Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are

additional to those already included in other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glyceryl Monostearate

Betaine Monohydrate

Diethanolamine Cetylphosphate (``Amphisol'')

Hard Fat

Cholesterol

Sodium chloride

Purified water

6.2.

Incompatibilities

The low pH due to lactic acid means care in choice of other packages or other

drugs admixed.

6.3

Shelf life

2 years.

6.4

Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5

Nature and contents of container

Tubes

White low density polyethylene tubes fitted with white polypropylene screw

caps

Package sizes: 15, 20, 30, 50, 100 g.

Pump dispenser

White polypropylene bottle fitted with a white polyethylene closure and a

natural polyethylene follower plate.

Package sizes: 400, 500 g.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements.

7

MARKETING AUTHORISATION HOLDER

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

8

MARKETING AUTHORISATION NUMBER(S)

PL 10590/0009

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

22/05/2008

10

DATE OF REVISION OF THE TEXT

19/10/2017

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