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UNGUENTUM M

Active substance(s): WHITE SOFT PARAFFIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Unguentum M

Cream
The combination of ingredients in this cream work as an emollient (soften and smooth
the skin)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Unguentum M
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Unguentum M is and what it is used for
2. Before you use Unguentum M
3. How to use Unguentum M
4. Possible side effects
5. How to store Unguentum M
6. Further information
1. WHAT UNGUENTUM M IS AND WHAT IT IS USED FOR
Unguentum M is formulated to smooth and soften your skin. It replaces oils in your dry skin and
stops your skin losing moisture. It will also relieve the itching caused by eczema and dermatitis.
Unguentum M is used to treat dry, cracked and damaged skin caused by conditions like eczema,
dermatitis, itchy skin (known as pruritus), or dry harsh scaly skin (known as ichthyosis).
It can also be used for the protection of raw and grazed skin areas.
Unguentum M can also be used to help relieve the symptoms of nappy rash. You can also use
Unguentum M instead of soap when washing which will help to prevent the skin drying out.
2. BEFORE YOU USE UNGUENTUM M
Do not use Unguentum M
• if you are allergic (hypersensitive) to any ingredients of Unguentum M listed below (see section
6- Further information).
• near the eyes or on mucous membranes.
Take special care
Unguentum M should not be swallowed. If this happens talk to your doctor or pharmacist.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
There are no known interactions between Unguentum M and other medicines.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no known harmful effects when this medicine is used in pregnancy or breastfeeding.
Driving and using machines
There are no effects on the ability to drive and use machines when this medicine is used.
Important information about some of the ingredients of Unguentum M
Sorbic acid and Cetostearyl alcohol may cause local skin reactions, (e.g. contact dermatitis which
can be a rash or irritated skin).
Propylene glycol may cause skin irritation.
3. HOW TO USE UNGUENTUM M
Always use Unguentum M exactly as your doctor or pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure.
• Unguentum M should be applied directly to your skin.
• Apply Unguentum M gently to the affected areas three times a day or as often as you need to.
A good time to do this is after you have had a bath.
• Make sure your hands are clean. Use a small amount of Unguentum M and apply it gently to the
affected area. If you are using the 500 g jar, use a spoon or spatula to take the Unguentum M
out as this will help to keep the cream clean.
• If you are using Unguentum M instead of soap, wet the dry skin, and cleanse the skin with
Unguentum M. Then wash it off with water and pat the skin dry with a towel. Do not rub the skin
because you might remove some of the Unguentum M.
• Unguentum M is easily absorbed and leaves your skin feeling softened and soothed.
• If you have very sore skin, there may be a short tingling sensation when you use Unguentum M.
But your skin should feel soothed afterwards.
• Unguentum M should be applied as long as your dry skin condition exists.
• When using Unguentum M as a protective cream apply a small amount before or straight away
after coming into contact with a possible source of irritation (e.g. water, detergents, etc.).
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Marked trade name:

PROOF:

P Unguentum M cream UK Mock up
Regulatory text number:

uk-package-leaflet-ungM-07-2014 (rev) (1/2)
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00000000

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15/07/2014

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Unguentum M can cause side effects, although not everybody gets them.
Rarely (1 in 10 out of 10,000 persons treated)
• Skin irritations such as burning sensation and reddening or allergic contact dermatitis (rash,
itching) may occur.
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, Website: 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 UNGUENTUM M
Keep out of the reach and sight of children.
Aluminium tubes do not require any special storage condition.
Plastic containers: Do not store above 25°C.
Do not use Unguentum M after the expiry date which is printed on the pack after “EXP”. The
expiry date refers to the last day of that month.
After opening: Unguentum M can be used for 6 months.
6. FURTHER INFORMATION
What Unguentum M contains
The ingredients are white soft paraffin, cetostearyl alcohol, polysorbate 40, propylene glycol,
glyceryl monostearate 40-50, liquid paraffin, medium-chain triglycerides, sorbic acid, colloidal
anhydrous silica, purified water, sodium hydroxide
What Unguentum M looks like and contents of the pack
Unguentum M is a white cream.
Unguentum M cream is supplied in:
• aluminium tubes containing 10 g, 15 g, 30 g, 50 g, 60 g, 80 g and 100 g
• plastic jar containing 500 g
• plastic pump dispenser containing 200 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3,
D-21465 Reinbek,
Germany
This leaflet was approved in 07/2014

ADDITIONAL INFORMATION AND EXPLANATIONS FOR PATIENTS
How else can you help your skin?
There are many factors that may worsen dry skin conditions. These are for example low humidity
(air conditioning, central heating), excessive bathing or showering and contact with soap,
detergents or solvents. Try to avoid these factors. For mild cleansing use soapfree products and
consider medicinal bath oils.
If you find that your skin problem gets worse when you come in contact with certain things like
e.g. special food ingredients, metal jewellery or detergents please talk with your doctor about
it. Your doctor will help you to identify and avoid the things that cause a deterioration of your
skin problem.
Useful addresses
Some skin conditions such as eczema are very frustrating. Many people find patient support
groups helpful. The National Eczema Society can give you more information about your condition.
National Eczema Society
163 Eversholt Street
London
NW11BU

8000XXXX / 07 / 2014

Marked trade name:

PROOF:

P Unguentum M cream UK Mock up
Regulatory text number:

uk-package-leaflet-ungM-07-2014 (rev) (2/2)
DRAWING

Item Number:

00000000

Name:

Version number:
Date:

15/07/2014

01

PMS
REFLEX BLUE

1

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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.

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