Skip to Content

URELAC 10% / 5 % W/W CREAM

Active substance(s): LACTIC ACID / UREA

View full screen / Print PDF » Download PDF ⇩
Transcript
Calmurid® 10%/5% w/w Cream

2548
02.01.14[2]

(Urea 10% w/w, Lactic Acid 5% w/w)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as Calmurid throughout the following
leaflet.
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.
Other medicines and Calmurid
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. Tell
your doctor or pharmacist if you are using other medicines in this way.
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.
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.
- 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.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE CALMURID
- Keep out of the sight and reach of children.
- Do not use Calmurid 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 a dry place. Do not refrigerate or
freeze.
- Store in the original package in order to protect from moisture.
Shelf life after first opening of the container: 30 days
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calmurid contains
- Calmurid contains the active substances urea 100mg/g and lactic acid
50mg/g.
Each gram of cream contains 100 mg urea and 50 mg 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 tubes either on prescription from your doctor or
indirectly from your pharmacist.
Manufacturer and Product Licence Holder
Manufactured by Jaba Recordati, S.A., Lagoas park, Edificio 5, Torre C,
Piso 3, 2740-298 Porto Salvo, Portugal.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/2548

Leaflet issue and revision date: (Ref) 02.01.14[2]
Calmurid is a trademark of Galderma S.A.

Urelac® 10%/5% w/w Cream

2548
02.01.14[2]

(Urea 10% w/w, Lactic Acid 5% w/w)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as Urelac throughout the following leaflet.
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 Urelac is and what it is used for
2. What you need to know before you use Urelac
3. How to use Urelac
4. Possible side effects
5. How to store Urelac
6. Contents of the pack and other information
1. WHAT URELAC 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 Urelac 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 URELAC
Do not use Urelac:
- 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 Urelac.
- Avoid contact with the eyes, eyelids, lips and other mucous surfaces.
Upon accidental contact, rinse the affected area with clean water.
- Urelac 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.
Other medicines and Urelac
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. Tell
your doctor or pharmacist if you are using other medicines in this way.
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.
3. HOW TO USE URELAC
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.
- Urelac 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.
- If you need to use Urelac 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 Urelac than you should or accidentally swallow any of
the cream
If you use too much Urelac 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 Urelac
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
- Urelac may cause stinging if applied to raw areas or cracks in the skin or
the lips.
- Keep Urelac 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.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE URELAC
- Keep out of the sight and reach of children.
- Do not use Urelac 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 a dry place. Do not refrigerate or
freeze.
- Store in the original package in order to protect from moisture.
Shelf life after first opening of the container: 30 days
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Urelac contains
- Urelac contains the active substances urea 100mg/g and lactic acid
50mg/g.
Each gram of cream contains 100 mg urea and 50 mg lactic acid.
- The other ingredients are glyceryl monostearate, betaine monohydrate,
diethanolamine cetyl phosphate, hard fat, cholesterol, sodium chloride
and purified water.
What Urelac looks like and contents of the pack
Urelac is a white cream.
It is available in 100 g tubes either on prescription from your doctor or
indirectly from your pharmacist.
Manufacturer and Product Licence Holder
Manufactured by Jaba Recordati, S.A., Lagoas park, Edificio 5, Torre C,
Piso 3, 2740-298 Porto Salvo, Portugal.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/2548

Leaflet issue and revision date: (Ref) 02.01.14[2]
Urelac is a registered trademark.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide