Patient leaflet - Unguentum M

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. What you need to know before you use Unguentum M

Do not use Unguentum M

if you are allergic to any ingredients of this medicine (listedin section 6).
near the eyes or on mucous membranes.

Warnings and precautions

Talk to your doctor or pharmacist before using Unguentum M.

Take special care

Unguentum M should not be swallowed. If this happens talk to your doctor or pharmacist.

Other medicines and Unguentum M

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

There are no known interactions between Unguentum M and other medicines.

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 using this 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.

Unguentum M contains sorbic acid (E200), cetostearyl alcohol, propylene glycol (E1520) and white soft parafﬁn contains buthylhydroxytoluene (E321)

Sorbic acid (E200), cetostearyl alcohol and buthylhydroxytoluene (E321) may cause local skin reactions, (e.g. contact dermatitis which can be a rash or irritated skin and irritation to the eyes and mucous membranes).

Propylene glycol (E1520) may cause skin irritation.

Warning of ﬁre hazard with emollients

Do not smoke or go near naked ﬂames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious ﬁre hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

3. How to use Unguentum M

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

This medicine should be applied directly to your skin.
Apply this medicine 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 this medicine and apply it gently to the affected area. If you are using the 500 g jar, use a spoon or spatula to take the medicine out as this will help to keep the cream clean.
If you are using this medicine instead of soap, wet the dry skin, and cleanse the skin with this medicine. 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 medicine.
This medicine 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 this medicine. But your skin should feel soothed afterwards.
This medicine should be applied as long as your dry skin condition exists.
When using this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side-effects you can help provide more information on the safety of this medicine

5. How to store Unguentum M

Keep this medicine 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 stated on the label after “EXP”. The expiry date refers to the last day of that month.

After opening: Unguentum M can be used for 6 months.

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 Unguentum M contains

The ingredients are white soft parafﬁn (contains buthylhydroxytoluene (E321)), cetostearyl alcohol, polysorbate 40, propylene glycol (E1520), glyceryl monostearate 40-55, liquid parafﬁn, medium-chain triglycerides, sorbic acid (E200), 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 last revised in 05/2019

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.

Other sources of information

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.

Active substance	White soft paraffin
Excipients	Purified water, white soft paraffin (contains buthylhydroxytoluene (E321)), cetostearyl alcohol, polysorbate 40, propylene glycol (E1520), glycerol monostearate 40 – 55, liquid paraffin, medium-chain triglycerides, sorbic acid (E200), colloidal anhydrous silica, sodium hydroxide.
Shelf life	Aluminium tubes: 5 years Plastic containers: 3 years After first opening, use within 6 months.
Storage	None.
Marketing authorisation	PL 33016/0014 (first authorised 12 September 2005)
Marketing authorisation holder	Almirall Hermal GmbH

Unguentum M – patient leaflet, side effects, dosage