Unguentum M

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 leaf et:

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.

Warning of fire hazard with paraffin based emollients

This product contains 50% white soft paraffin which is flammable. The risk is greater if applied to large areas of the body and clothing or dressings become soaked. Keep away from fire or flames and do not smoke when using Unguentum M.

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.

ARTWORK INFORMATION PANEL

Almirall

Name Description:

PIL Unguentum M GB Mock up

PROOF:

3

Regulatory text number:

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

Name

ThinKinpress!

Item number: 00000000

In Line Control Code

Printing Colours

Reflex Blue

Date

09/06/2016

Version number: 01

Non Printing Colours

Material size: 148 x 297 mm

• 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.

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.aov.uk/vellowcard.

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 sight and reach 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 100 g and 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 06/2016

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

00000000 / GB / 0516