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PACKAGE LEAFLET: INFORMATION FOR THE USER Skincalm Bite and Sting Relief 1% Ointment Hydrocortisone

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 this medicine 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 3 days.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Skincalm Bite and Sting Relief 1 % Ointment is and what it is used for

2.    What you need to know before you use Skincalm Bite and Sting Relief 1% Ointment

3.    How to use Skincalm Bite and Sting Relief 1 % Ointment

4.    Possible side effects

5.    Howto store Skincalm Bite and Sting Relief 1% Ointment

6.    Contents of the pack and other information.

1.    What Skincalm Bite and Sting Relief 1% Ointment Is and what It Is used for

This medicine contains hydrocortisone which belongs to a group of medicines called corticosteroids, which act to relieve pain and swelling. It can be used to relieve the swelling, itching and irritation caused by insect bite and sting reactions.

2.    What you need to know before you use Skincalm Bite and Sting Relief 1% Ointment

Do not use this medicine

•    If you are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Skincalm Bite and Sting Relief 1% Ointment (See section 6, Further information)

•    If you are a child under 10 years old

•    On broken or infected skin, e.g acne, impetigo, cold sores, athletes foot, scabies, chicken pox, ringworm, infected bites and stings

•    On the eyes and face, anal or genital area

•    For other bites and stings or for other skin conditions

•    In pregnancy without medical advice.

Other medicines and Skincalm Bite and Sting Relief 1% Ointment

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

Pregnancy and breast-feeding

This product should not be used in pregnancy and breast-feeding without medical advice.

If you are unsure please talk to your doctor or pharmacist before use.

Skincalm Bite and Sting Relief 1% Ointment contains wool fat (lanolin)

This may cause local skin reactions (e.g. dermatitis).

3.    Howto use Skincalm Bite and Sting Relief 1% Ointment

Always use this medicine exactly as this leaflet tells you. You should check with your doctor or pharmacist if you are not sure.

For use on the skin only.

Adults and elderly: Apply a small amount to a small area once or twice daily for a maximum period of 2-3 days. If the condition does not improve consult your doctor. Wash hands after use unless the hands are the area being treated.

Children aged 10 years and above: As for adults and the elderly. Do not use for children under 10 years old.

If you use too much ointment

Do not use more of this ointment than recommended. This medicine is for use on the skin only and should not be used in the mouth or swallowed. If it is accidently swallowed, rinse out the mouth with water and talk to a doctor.

4.    Possible Side Effects

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

Hydrocortisone preparations are usually well tolerated, but if any signs of allergic reaction appear, application should stop immediately: this may include allergic contact dermatitis (rash which may be red, itchy and burning) or worsening of your condition.

Other side effects:

•    Stretch marks may occur in areas where the skin may rub, for example at the joints and at folds in the skin.

•    Thinning of the skin, changes in skin pigmentation (colour) and hair growth.

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.    Howto store Skincalm Bite and Sting Relief 1% Ointment

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer reguired.

These measures will help to protect the environment.

6.    Contents of the pack and other information

What Skincalm Bite and Sting Relief 1% Ointment contains

The active substance is micronised hydrocortisone.

The other ingredients are wool fat, liguid paraffin and white soft paraffin.

What Skincalm Bite and Sting Relief 1% Ointment looks like and contents of the pack

A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacguer, latex endseal band in the crimp seal area and a white plastic cap for reclosure after piercing membrane.

This medicine is available in a 10 g tube.

Marketing Authorisation Holder

Co-Pharma Ltd.

Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS.

Manufacturer

Beltapharm SpA - via Stelvio, 66 - 20095 Cusano Milanino - Milan - Italy This leaflet was last revised 11/2015.