Medine.co.uk

Hydrocortisone Ointment

Document: leaflet MAH BRAND_PL 04917-0020 change

148


mm



£

£

©

<N


1


PATIENT INFORMATION LEAFLET

CORTOPIN HYDROCORTISONE OINTMENT 1%

1% Hydrocortisone

Read all of this leaflet because It contains Important Information for you.

This medicine is available without a prescription. However, you still need to use this product 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Cortopin Hydrocortisone Ointment is and what it is used for

2.    Before you use Cortopin Hydrocortisone Ointment

3.    How to use Cortopin Hydrocortisone Ointment

4.    Possible side effects

5.    How to store Cortopin    Hydrocortisone Ointment

6.    Further information

1.    WHAT CORTOPIN HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR

Cortopin Hydrocortisone Ointment is a smooth off-white ointment for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Cortopin Hydrocortisone Ointment is used to reduce inflammation in a variety of inflammatory skin conditions, such as: mild to moderate eczema dermatitis caused by irritants or allergens insect bite reactions

Hydrocortisone should not be confused with anabolic steroids, used by some body builders and taken as tablets or injections.

2.    BEFORE YOU USE CORTOPIN HYDROCORTISONE OINTMENT Do not use Cortopin Hydrocortisone Ointment:

if you are allergic to hydrocortisone or to any of the other ingredients of Cortopin Hydrocortisone Ointment (see Section 6 and end of Section 2).

if you have a bacterial infection (e.g. impetigo), viral infection (e.g. cold sores ‘herpes simplex’, chicken pox) or fungal infection (e.g. tinea, also called ‘athlete’s foot’, ringworm or thrush) of the skin, on your face or near your eyes, on the anal or genital region, or on broken skin.

Take special care with Cortopin Hydrocortisone Ointment

Cortopin Hydrocortisone Ointment is not suitable for use in the following:

allergic skin reactions including temporary red or raised areas on your skin (short lived ‘wheal and flare’ reactions) conditions involving the deeper skin layers, such as granulomas

psoriasis (long term scaly skin condition); only use this product on medical advice and with careful supervision by your doctor.

Do not cover the area with a plaster or dressing of any kind after application of Cortopin Hydrocortisone Ointment.

Take great care to apply the ointment sparingly to the skin of infants or children, especially in the nappy area which can be covered for long periods. Covering the treated area can increase absorption. Treatment for infants must not exceed 7 days.

Do not apply the product to your face for long periods of time.

Taking other medicines

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

Pregnancy and breast-feeding

Tell your doctor if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. There is a very small risk of abnormalities in the unborn child if this product is used during pregnancy.

If you are breast-feeding, do not apply the product to your chest area.

Important Information about some of the Ingredients

Cortopin Hydrocortisqne Ointment contains wool fat (lanolin) which may cause local skin reactions (e.g. contact dermatitis).

23LF01329PW


lAa


r


VENDOR CODE TO BE PRINTED AT THE BOTTOM RIGHT HAND CORNER OF FRONT AND BACK PAGE PRINT FREE AREA I BLEED AREA

[] INSERT PIPS FRONT AND BACK FOR BLANK SHEET DETECTION AT PRINT



148 mm



HOW TO USE CORTOPIN HYDROCORTISONE OINTMENT


FOR EXTERNAL USE ONLY


210 mm


1


Always use Cortopin Hydrocortisone Ointment exactly as instructed in this leaflet. If you are not sure, ask your doctor or pharmacist. Do not exceed the stated dose.

Not for use by children under 10 years of age without medical advice.

For application to the surface of the skin only:

1.    Wash your hands thoroughly before use.

2.    Apply the ointment sparingly to the affected area, once or twice a day for a maximum of 7 days. Massage the ointment gently into the affected area to help absorption into the skin.

3.    Once applied, do not cover the area with a dressing or plaster.

If the condition has not improved after 7 days, or worsens, consult your doctor.

If you use more Cortopin Hydrocortisone Ointment than you should

If you or a child accidentally swallow the ointment, contact your doctor or nearest hospital immediately. Take the packet with you to help identification.

If you forget to use Cortopin Hydrocortisone Ointment

If you miss a treatment, apply the ointment as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Cortopin Hydrocortisone Ointment can cause side effects, although not everybody gets them.

You may notice the following:

rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop using Cortopin Hydrocortisone Ointment Immediately.

‘stretch marks’ may appear, especially in skin folds such as the groin or armpits.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems below:

United Kingdom:

Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

Malta:

ADR Reporting. Website: www.medicinesauthority.gov.uk/adrportal.

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

5.    HOW TO STORE CORTOPIN HYDROCORTISONE OINTMENT

Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package and keep the tube in the outer carton. Do not use Cortopin Hydrocortisone Ointment after the expiry date which is stated on the tube/carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Cortopin Hydrocortisone Ointment contains:

The active substance is hydrocortisone and the ointment contains 10 mg in every 1g (1%).

The other Ingredients are wool fat (lanolin), liquid paraffin and white soft paraffin ('see end of Section 2 for further information).

What Cortopin Hydrocortisone Ointment looks like and contents of the pack

The product is a smooth, off-white ointment and is available in aluminium tubes containing 15g.


Marketing Authorisation

Pinewood Laboratory PL 04917/0020 MA 143/00102 This leaflet was last


Holder and Manufacturer

s Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.


i, pdated in 05/2015


23LF01329PW


s

E



■Q-


r