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Kamillosan Chamomile Ointment

/omega

PHARMA


PATIENT INFORMATION LEAFLET

KAMILLOSAN®

CHAMOMILE OINTMENT

(Chamomile extract 10.5%w/w)

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 Kamillosan Ointment 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 after 7 days.

If any of the side effects become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Always consult a Healthcare Professional for advice on correct breastfeeding technique.



In this leaflet:

1.    What is Kamillosan Ointment and what is it used for

2.    Before you use Kamillosan Ointment

3.    How to use Kamillosan Ointment

4.    Possible side effects

5.    How to store Kamillosan Ointment

6.    Further information

1.    What Is Kamillosan Ointment and what Is It used for

Kamillosan contains chamomile, which soothes soreness, redness and inflammation associated with a wide range of sore skin conditions, including:

•    Prevention and treatment of sore nipples in breastfeeding mothers. When used regularly, Kamillosan can prevent nipples becoming sore or, if soreness occurs, Kamillosan relieves the symptoms so that breastfeeding may continue.

•    The prevention and treatment of nappy rash and nappy chafe.

•    Chapped hands and other minor sore skin conditions.

2.    Before you use Kamillosan Ointment Do Not use Kamillosan Ointment if:

•    You know that you are allergic to chamomile or any of the other ingredients of Kamillosan Ointment (see section 6 of the leaflet)

•    You know that you are allergic to other plants like ragwort and chrysanthemum (plants belonging to Compositae family).

Taking other medicines

•    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including, Warfarin.

There are no known problems with using Kamillosan Ointment with other medicines, but if in doubt, please speak to your doctor or pharmacist.

Pregnancy and breastfeeding

Kamillosan is safe to use during pregnancy and breastfeeding. If you are unsure, ask your doctor or pharmacist for advice before taking this medicine.


Important information about some of the ingredients of

Kamillosan Ointment

This medicine also contains:

•    Wool fat (Lanolin) which may cause local skin reactions.

•    Nipasept (containing E214, E216 and E218) which may cause allergic reactions (possibly delayed) and could be a mild irritant to the skin, eyes and mucous membranes.

   Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

3.    How to use Kamillosan Ointment

Kamillosan Ointment is for use on the skin only. You should check with your doctor or pharmacist if you are not sure.

Prevention and treatment of sore niooles: apply after breastfeeding. It is recommended you use breast pads to stop your clothes from getting discoloured. Remove ointment before breastfeeding.

Naonv rash and nanny chafe: apply to sore area at nappy change.

Other minor skin conditionss apply twice a day, as necessary. If there is no improvement or if the condition gets worse, speak to your doctor or pharmacist.

If you use more Kamillosan Ointment than you should:

There are no known side effects of using too much of this medicine. If you are not sure, please speak to your doctor or pharmacist.

If you forget to use your Kamillosan Ointment:

If you forget to use this medicine, use it as soon as you remember.

4.    Possible side effects

While all medicines can have side effects, the likelihood of having side effects from Kamillosan Ointment is very low.

If you think you are having an allergic (hypersensitivity & anaphylaxis) reaction to Kamillosan Ointment, tell your doctor immediately. The symptoms may include,

•    Severe skin rash, itching or hives.

•    Swelling of the face, lips, mouth or throat.

•    Difficulty in breathing or swallowing.

•    Fever

•    Low blood pressure (feeling faint or dizzy).

If you are at all concerned about any side effects you believe are a result of using this medicine, please speak to your doctor or pharmacist.

5.    How to store Kamillosan Ointment

Keep out of the reach and sight of children. Keep the tube in the outer carton in order to protect from moisture. Do not use Kamillosan Ointment after the expiry date which is stated on the tube and carton after EXP. Do not store above 25°C.

6.    Further Information

Each tube of Kamillosan Ointment contains 10.5% extracts of chamomile standardised to give 0.01% L - a - bisabolol active ingredient.

Kamillosan Ointment also contains maize oil, wool fat (lanolin), yellow soft paraffin, yellow beeswax, emulsifying wax (containing cetostearyl alcohol and sodium laurilsulfate) and Nipasept (Methyl parahydroxybenzoate E218, Ethyl parahydroxybenzoate E214 and Propyl parahydroxybenzoate E216).

What Kamillosan Ointment looks like and contents of pack

Light brown ointment with a distinctive smell.

Kamillosan Ointment is available in aluminium tubes containing 50g of ointment.

Product license holder Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, United Kingdom.

Product Authorisation holder Chefaro Ireland Limited, First Floor, Block A,

The Crescent Building, Northwood Office Park, Dublin 9, Ireland.

Manufacturer Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, U.K.

This leaflet was last updated November 2012 KAM01771112v1    PL 02855/0035 PA 1186/7/1