CALMURID

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
UREA ; LACTIC ACID
Available from:
Galderma (UK) Ltd
ATC code:
D02AE01
INN (International Name):
UREA ; LACTIC ACID
Dosage:
%w/w
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
carbamide
Authorization status:
Marketed
Authorization number:
PA0590/008/001
Authorization date:
1978-07-28

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 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.

P2XXXX-X

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

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 (see details below). By reporting side effects you can help provide more information

on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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 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. Each gram of Calmurid contains 100mg of urea and 50mg 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 15 g, 20 g, 30 g, 50g and 100 g tubes and in 400 g and 500 g pump dispensers,

either on prescription from your doctor or indirectly from your pharmacist.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK.

Manufacturer: Laboratoires Galderma, ZI-Montdésir, 74540 Alby-sur-Chéran, France.

Marketing Authorisation Numbers: PL 10590/0009 (UK), PA 590/8/1 (IRE)

This leaflet was last revised in 10/2017.

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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4.6 Fertility, pregnancy and lactation

There is no specific data available regarding the use in pregnant women and during lactation.

In breast-feeding women 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, tissues or mucous membranes.

smarting occurs, wash the cream off.

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: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Unlikely as the product is a topical preparation.

In the case of overuse, wash the cream off.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Carbomide products

ATC code: D02AE

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

Hard Fat

Cholesterol

Sodium Chloride

Purified Water

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6.2 Incompatibilities

Low pH due to lactic acid should be considered if repackaging or admixing other drugs.

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

Pump dispenser: White polypropylene bottle fitted with a white polyethylene closure and a natural polyethylene

follower plate. Package sizes: 400,500g

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

8 MARKETING AUTHORISATION NUMBER

PA 590/8/1

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

July 1978

Date of last renewal:

November 2008

10 DATE OF REVISION OF THE TEXT

November 2017

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