NOTICE RECTO 135x210

PLAN n* 2.GD.02.DRA.0350.R01

Calmurid HC 10%/5%/1% w/w Cream

Urea 10% w/w - Lactic Acid 5% w/w - Hydrocortisone 1% w/w

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 and soothe the skin. Hydrocortisone is an anti-inflammatory agent. It is not one of the steroids used by athletes to increase their muscle strength.

2.    What you need to know before you use Calmurid HC

Do not use Calmurid HC

•    If you are allergic to urea, lactic acid or hydrocortisone or any of the other ingredients of this medicine (listed in section 6).

•    If you are suffering from skin tuberculosis, a viral skin infection (for example herpes simplex, vaccinia (pox), chicken pox or measles), or skin lesions caused by syphilis. If you have a fungal skin infection your doctor will prescribe an antifungal medicine as well.

Warnings and precautions

Talk to your doctor or pharmacist before using Calmurid HC.

•    Avoid contact with the eyes, eyelids, lips and other mucous surfaces. Upon accidental contact, rinse the affected area with clean water.

•    Calmurid HC may cause stinging if applied to damaged skin (raw areas or cracked skin) or sensitive areas of the body such as the mouth or nostrils.

•    In babies and infants, Calmurid HC should not be used on large areas of the skin, as the steroid in it could affect their growth. Long term use of this medicine is not recommended in babies and infants.

Other medicines and Calmurid HC

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

•    This cream might affect other medicines that you apply to your skin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

3. How to use Calmurid HC

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    Calmurid HC is for EXTERNAL USE ONLY

•    First gently wash and dry the affected areas of your skin.

•    Apply a thin layer of cream over the affected skin.

•    If the skin is weeping, dry it before applying the cream.

•    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 on your skin in this way twice a day, or as directed by your doctor.

•    How long you will have to use this medicine will depend on how quickly your condition improves. Your doctor will advise you of this.

One finger tip unit (equal to approx. 0.5 g) is sufficient to cover an area similar to that of two average adult hands (approx. 15 x 15 cm).

If you use more Calmurid HC than you should or accidentally swallow any of the cream

If you use too much Calmurid HC 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 HC

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 doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Effects on the skin

•    Calmurid HC may cause stinging if applied to raw areas or cracks in the skin or the lips.

•    Keep Calmurid HC 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 time it should be alright to use this cream on its own again, but you must consult your doctor or pharmacist for advice first.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Calmurid HC

•    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.

•    Store in the original container.

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 HC contains

•    The active substances are urea, lactic acid, both of which are found in healthy skin, and hydrocortisone, which is a mild steroid. Each gram of Calmurid HC contains 100mg of urea, 50mg of lactic acid and 10mg of hydrocortisone.

•    The other ingredients are glyceryl monostearate, betaine monohydrate, diethanolamine cetyl phosphate, hard fat, cholesterol, sodium chloride and purified water.

What Calmurid HC looks like and contents of the pack

Calmurid HC is a white cream. It is available in 30 g, 50 g and 100 g tubes only on prescription from your doctor. In the UK, a 15g tube is also available.

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 IDS, UK.

Manufacturer: Laboratoires Galderma, ZI-Montdesir, 74540 Alby-sur-Cheran, France.

Marketing Authorisation Number: PL 10590/0010 Calmurid HC is a prescription only medicine.

This leaflet was last revised in 08/2013.

GALDERMA DIELINES