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Terra-Cortril Ointment

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Document: leaflet INTRAPHARM LABORATORIES_PL 16853-0096 change

Artwork Information

Product Title:

Terra-Cortril PIL

Date:

12-02-15

Product Size:

160 x 240mm

Label Number:

14-264

Version 2

Colours Used:

Black

Fonts Used:

Arial

Font size (min):

8.5pt

Magenta text, keylines and shading are NOT to be printed

PATIENT INFORMATION LEAFLET

TERRA-CORTRIL® OINTMENT (oxytetracycline, hydrocortisone)

Read all of this leaflet carefully before you start taking this medicine

•    Keep this leaflet as you may need to read it again.

•    If you have any further questions ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others as it may harm them, even if their symptoms are the same as yours.

•    If any side effect becomes serious, or if you notice a side effect that is not listed in this leaflet please tell your doctor or pharmacist.

1. What Terra-Cortril Ointment is and what it is used for


2. Before you use Terra-Cortril Ointment


3. How to use Terra-Cortril Ointment


In this leaflet:

1.    What Terra-Cortril Ointment is and what it is used for

2.    Before you use Terra-Cortril Ointment

3.    How to use Terra-Cortril Ointment

4.    Possible side effects

5.    How to store Terra-Cortril Ointment

6.    Further information

Terra-Cortril Ointment contains two different

medicines: oxytetracycline and hydrocortisone.

•    Oxytetracycline is one of a group of medicines called tetracycline antibiotics. It is used to treat infections caused by bacteria and certain other micro-organisms.

•    Hydrocortisone is a corticosteroid used to reduce inflamed skin which has resulted from allergy, infection or injury.

Terra-Cortril Ointment has been prescribed for

you to treat:

•    inflamed skin conditions (such as eczema).

•    allergic skin conditions (such as after contact with certain cosmetics, plants or drugs).

•    infected insect bites.

DO NOT use Terra-Cortril Ointment if:

•    You have ever had an allergic reaction to any of the ingredients of the ointment. This may be itching, reddening of the skin or difficulty in breathing.

•    You have an infection of the skin causing blisters or yellow crusting (a primary bacterial infection) e.g. impetigo, boils (furunculosis).

•    You are pregnant, planning to become pregnant or breast feeding.

•    The patient is an infant or young child whose permanent teeth are growing.

If any of the above applies to you talk to your

doctor.

Check with your doctor or pharmacist before taking Terra-Cortril if:

•    You are going to apply ointment to a very large area of skin.

•    You are going to use a dressing to cover the ointment.

Taking other medicines

Terra-Cortril is not thought to have an effect on any other medicines you might be taking. If you have any concerns about taking other medicines talk to your doctor or pharmacist.

Pregnancy and breast feeding

Do not use Terra-Cortril Ointment if you are pregnant, trying to become pregnant or breastfeeding. Talk to your doctor for advice.

Driving and using machines

Terra-Cortril Ointment is not likely to affect your ability to drive or use machines or tools.

Always use Terra-Cortril Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Pierce the tube by reversing the cap and screwing down to break the seal on the tube. Clean the affected skin area as thoroughly as possible.

Adults and Elderly

Gently apply a small amount of ointment to the affected area. This may be done two to four times a day. The ointment may be applied on a sterile gauze if infection is present.

Do not stop using the ointment too soon after seeing improvement.

If you do not see an improvement within a week, go back and see your doctor.

Terra-Cortril Ointment is for external use only. Do not use it for eye infections.

4. Possible side effects


5. How to store Terra-Cortril Ointment


6. Further information


Children

Terra-Cortril Ointment is not recommended for use in children.

After using the ointment

Wash your hands after use. Always replace the cap.

If the ointment is accidentally swallowed

This ointment is for external use only. If any ointment is accidentally swallowed, tell your doctor immediately, or contact your nearest hospital casualty department.

If you forget to apply the ointment

Do not worry. Apply the ointment in the normal way as soon as you remember.

As with all medicines, Terra-Cortril Ointment can cause side effects, although not everybody gets them.

Check with your doctor or pharmacist immediately if any of the following occur:

•    wheeziness, difficulty breathing or tightness in the chest

•    swelling of eyelids, face or lips

•    skin lumps or itchy red spots

The following may be a problem in the area where the ointment is used:

•    burning

•    itching

•    irritation

•    dryness

•    skin rash or allergic reaction

•    acne

•    thinning or softening of the skin

•    spread or worsening of infection

•    swelling of the hair-roots in the skin (folliculitis)

•    excessive growth of hair on the skin (hypertrichosis)

•    white patches on the skin (hypopigmentation)

•    prickly heat

•    striae (red lines)

These effects should disappear when you stop using Terra-Cortril Ointment. If the discomfort continues tell your doctor or pharmacist.

If you become unwell or have any discomfort whilst using the ointment, tell your doctor or pharmacist.

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.

Keep all medicines out of the reach and sight of children.

Store below 25°C.

Do not use Terra-Cortril Ointment after the expiry date stamped on the pack.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

What Terra-Cortril Ointment contains

Each gram of ointment contains 30 mg oxytetracycline (as oxytetracycline hydrochloride) and 10 mg hydrocortisone. The other inactive ingredients are liquid paraffin and white soft paraffin.

Each tube contains 15 g or 30 g of ointment.

Marketing Authorisation Holder

Alliance Pharmaceuticals Limited,

Avonbridge House

Bath Road, Chippenham, Wiltshire

SN152BB

UK

Manufacturer

Farmasierra Manufacturing S.L.

Ctra. Irun, Km. 26,200,

San Sebastian de los Reyes,

Madrid, 28700, Spain

Distributed by:

Intrapharm Laboratories Ltd Maidenhead Berks SL6 6PT United Kingdom

This leaflet was last revised December 2014.

Terra-Cortril is a registered trademark of Alliance Pharmaceuticals Limited.

Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

For any information on this medicine, please contact the Marketing Authorisation Holder.

© Alliance Pharmaceuticals Limited 2014.

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