Lipobase® Cream Package leaflet: Information for the user 166005PIL02 / 700850 – patient leaflet, side effects, dosage

1. What Lipobase is and what it is used for

Lipobase is an emollient cream which is indicated for the treatment of dry, sensitive and dehydrated skin in adults and children. You may also use it against skin irritations caused by water or detergents and for maintaining improvement. You can use Lipobase alternately with creams or ointments containing corticosteroids.

How Lipobase works

Lipobase enhances the hydration of the outer layer of the skin (epidermis), reduces dryness, prevents scaling and protects the skin from harm. The cream is an oil-in-water emulsion with a high lipid content (70%). It does not contain perfume. The components of the cream are selected to minimise the risk of allergy.

2. What you need to know before you use Lipobase

Do not use Lipobase:

• if you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lipobase.

Lipobase contains paraffin. 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.

Pregnancy and breast-feeding

You may use Lipobase if you are pregnant or if you breast-feed.

Lipobase contains methyl parahydroxybenzoate and cetostearyl alcohol

Lipobase contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

Lipobase also contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Lipobase

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

Apply a thin layer of cream to the skin one to three times per day, or more often if necessary. You may apply Lipobase to your face. It does not stain your clothing and can be easily washed off with water. You can use the cream more often on places where the cream is likely to be removed

IAT004 (LFT148) Page 1+2, 145x170 mm

Mat

Typ

I

Pa

by washing or rubbing.

The duration of treatment depends on the condition of the skin. There is no maximum duration.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Lipobase may cause allergic reactions of the skin.

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 Lipobase

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, after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C (which is normal room temperature).

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 Lipobase contains

• Lipobase contains cetostearyl alcohol, macrogol cetostearyl ether, light liquid paraffin, white soft paraffin, methyl parahydroxybenzoate, sodium citrate, citric acid, purified water.

What Lipobase looks like and contents of the pack

Lipobase is a white cream and is available in aluminium tubes containing 50 g cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

medinfo@karopharma.com

Manufacturer:

Temmler Italia S.r.l.

Via Delle Industrie 2, 20061 Carugate (MI) Italy

This leaflet was last revised in July 2019.

166005PIL02 / 700850