Patient Information Leaflet Boots Pharmaceuticals Sore Skin Relief Calendula Cream

Calendula Officinalis

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 it 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

1.    What this medicine is for

2.    Before you use this medicine

3.    How to use this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1. WHAT THIS MEDICINE IS FOR

It is a traditional herbal medicinal product used for the symptomatic relief of sore and rough skin, based on traditional use only.

2. BEFORE YOU USE THIS MEDICINE Do not use this medicine:

•    If you are allergic to any of the ingredients or to plants of the Asteracea (Compositae) family (see section 6)

•    If you are pregnant or breastfeeding

•    If you are under 6 years of age

Talk to your pharmacist or doctor:

If you are taking any other medicine, including medicines prescribed by your doctor and any medicine you have bought for yourself, including herbal and homeopathic remedies

Other important information Information about some of the ingredients:

Cetearyl alcohol may cause skin reactions (e.g. contact dermatitis).

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) in this medicine may cause allergic reactions (possibly delayed).

3. HOW TO USE THIS MEDICINE

For external use only.

This medicine is only to be applied to the skin.

Wash hands before and after use.

Check the tube seal is not broken before first use. If it is, do not use the cream.

Adults, the elderly and children over 6 years: Apply liberally to affected area 4 times a day as required.

Avoid contact with the eyes or mucous membranes.

Do not exceed the recommended dose

Not recommended for use in children under 6 years of age

If symptoms worsen or if signs of a skin infection are observed or if symptoms persist after using the product for 1 week, a doctor or qualified healthcare practitioner should be consulted.

If you use too much (overdose) or accidentally swallow the cream: If you use more than the recommended dose and feel unwell or accidentally swallow the cream, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to use this product: Continue to apply your usual dose at the usual time.

Do not apply a double dose. It does not matter if you miss a dose.

If you have any questions, or are unsure of anything, please speak to your doctor, pharmacist or qualified healthcare practitioner

4. POSSIBLE SIDEEFFECTS

Skin sentisation may occur.

If you notice this side effect or any other side effects, please tell your pharmacist or doctor.

Making medicines safer

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard Alternatively you can get a paper Yellow Card form from your doctor’s surgery or a pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

5. HOW TO STORE THIS MEDICINE

Do not store above 25°C. Store in the original container.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Return any unused medicine to your pharmacist to dispose of for you.

Use by the expiry date shown on the end flap of the carton.

6. FURTHER INFORMATION What is in this medicine

Each gram of cream contains 9.0% v/w tincture of Calendula flowers (Calendula officinalis L.)(1:10) Extraction solvent: Ethanol 3.0 %v/w.

The cream also contains purified water, white soft paraffin, polawax (cetostearyl alcohol, Polyoxyl 20 stearate), methyl parahydroxybenzoate (E218), Fragrance (Compo Cos: benzyl benzoate;propanol -oxybis; benzoate, 2,4-dihydro-3,6-dimethyl-, methyl; oils, oakmoss-resinoid), honey, propyl parahydroxybenzoate (E216).

The pack contains 30 gram of cream.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the

Traditional Herbal Registration holder A Nelson & Co Limited 5-9 Endeavour Way Wimbledon London SW19 8UH.

Leaflet revised April 2013

THR Certification Mark

If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.

Additional Information

Calendula - the golden coloured flowers of this plant, otherwise known as marigold, can be found commonly in many gardens in Britain.

Useful Health Tips

Your skin may be sensitive, so try to avoid potential irritants or things that the skin may be allergic to, for example, soaps with strong perfumes and biological soap powders. Wear cotton and less likely to cause irritation. Avoid bathing in water which is too hot.