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HYDROCORTISONE OINTMENT 1%, CORTOPIN HYDROCORTISONE OINTMENT - patient leaflet, side effects, dosage

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Patient leaflet - HYDROCORTISONE OINTMENT 1%, CORTOPIN HYDROCORTISONE OINTMENT

1. what hydrocortisone ointment is and what it is used for

  • 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. 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 hydrocortisone ointment

Do not use Hydrocortisone Ointment:

  • if you are allergic to hydrocortisone or to any of the other ingredients of 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 Hydrocortisone Ointment

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 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

Hydrocortisone Ointn ent contains wool fat (lanolin) which may cause local skin reactions (e.g. contact dermatitis).

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3. how to use hydrocortisone ointment

| FOR EXTERNAL USE ONLY |

Always use 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 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 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. 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 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:.

Malta:

ADR Reporting. Website:.

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

5. how to store 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 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 Hydrocortisone Ointment contains:

  • The active substance is hydrocortisone and the ointment contains 10 mg in every 1 g (1 %).
  • The other ingredients are wool fat (lanolin), liquid paraffin and white soft paraffin (see end of Section 2 for