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Chloramphenicol 1.0% w/w Antibiotic Eye Ointment

Active Ingredient:
chloramphenicol
Company:  
Martindale Pharma, an Ethypharm Group Company See contact details
ATC code: 
S01AA01
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 14 Jul 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 00156/0363 .

Chloramphenicol 1.0% w/w Antibiotic Eye Ointment

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chloramphenicol 1.0% w/w

Antibiotic Eye Ointment

Chloramphenicol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. This medicine is available without a prescription. However, you still need to use it carefully to get the best results from it. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist told you.
  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.

What is in this leaflet:

1. What Chloramphenicol Antibiotic Eye Ointment is and what it is used for
2. What you need to know before you use Chloramphenicol Antibiotic Eye Ointment
3. How to use Chloramphenicol Antibiotic Eye Ointment
4. Possible side effects
5. How to store Chloramphenicol Antibiotic Eye Ointment
6. Contents of the pack and other information

1. What Chloramphenicol Antibiotic Eye Ointment is and what it is used for

Chloramphenicol belongs to a group of medicines called antibiotics. Antibiotics are used for infections caused by bacteria. Chloramphenicol eye ointment is for simple eye infections called “acute bacterial conjunctivitis”. This is sometimes known as “red eye” because the white part of the affected eye(s) will be red and/or the eyelid(s) will be red or swollen. There may also be a sticky discharge which can make the eye difficult to open in the morning, and the eye may feel ‘gritty’ or ‘irritated’. Chloramphenicol eye ointment is not suitable for treating eye infections that have spread to the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper and more serious infections.

2. What you need to know before you use Chloramphenicol Antibiotic Eye Ointment

Chloramphenicol 1.0% w/w Eye ointment is recommended for Children over 2 years, adults and the elderly.

It is recommended that any child below the age of two years with an eye infection should be seen by a doctor.

Do not use the ointment if:
  • You are allergic to Chloramphenicol or any of the other ingredients of this medicine listed in section 6 “Contents of the pack and other information”.
  • Have ever had problems with your blood (in particular with low numbers of blood cells) during previous treatments with chloramphenicol.
  • Have a family history of blood problems such as low white blood cell, red blood cell or platelet count.
  • You or a member of your family has had problems with their blood or bone marrow. These problems can include a severe reduction in red blood cells or lower than normal blood count.

Warnings and precautions

Tell your doctor if:

  • Your eye is painful (rather than just feeling sore or gritty) or you have pain or swelling around the eye or face.
  • Your sight is affected by loss of vision, reduced or blurred vision or you see halos around lights.
  • It is too painful to open your eyes properly.
  • Your pupil (the black circle in the centre of your eye) looks different. It may be torn, not round, very big or does not change size in the light.
  • Your eye looks cloudy.
  • Your eyes are sensitive to light.
  • you have (or think you have) a foreign body in your eye, which has not been removed.
  • You have had an eye infection in the past month.
  • You have glaucoma (high pressure inside your eye).
  • You have “dry eye syndrome”.
  • You have injured your eye.
  • You think there may be something in your eye or you have splashed something in your eye.
  • You are already using other eye drops or eye ointment.
  • You have had eye surgery or laser treatment in the last 6 months.

If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product.
  • You should not wear your contact lenses during the course of treatment. Wear your glasses instead.
  • If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished the eye ointment.
  • Suffer from any other eye problems.

Other medicines and Chloramphenicol Antibiotic Eye Ointment

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

  • Other eye ointments or eye drops
  • Medicines which may affect your bone marrow
  • If you are taking bone marrow medicines (medicines which decrease the activity of the bone marrow, causing low blood cell counts) such as azathioprine or receiving chemotherapy, seek the advice of your pharmacist or your doctor before using this product.

Pregnancy and breast-feeding

Chloramphenicol should not be used during pregnancy and breast-feeding unless considered essential by your doctor, as the effects are unknown.

If you are a pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

The ointment may cause blurred vision due to smearing or stinging.

  • This will only happen for a short period after it is put in your eye.
  • If this happens do not drive or use machinery until you can see clearly.

3. How to use Chloramphenicol Antibiotic Eye Ointment

Chloramphenicol eye ointment is used by placing a small amount (about 1cm) in the space between the lower eyelid and the eye. Always follow your pharmacist’s instructions. To be used in the eye(s) only.

  • Check the tube seal is not broken before first using the eye ointment.
  • Wash and dry your hands.
  • Do not take it by mouth.

Adults and children aged 2 years and over:

A course of treatment lasts 5 days:

  • If the eye ointment is being used alone, squeeze a thin line of ointment inside the lower eyelid of each affected eye 3 to 4 times a day.
    This means that you should use it about every 4 – 6 hours.
  • If you are using Chloramphenicol eye drops during the day and the eye ointment at night – apply the ointment at night, before going to bed.

When using the ointment
  • Wash your hands before and after using the ointment
  • Sit or stand in front of a mirror
  • Take off the tube cap
  • Tilt the head gently backwards
  • Gently pull lower eyelid down
  • Gently squeezing the tube, put about 1cm of ointment into the space between the lower eyelid and the eye
  • Close for a moment.
  • Let go of the eyelid and blink a few times. This will help spread the ointment over the eye
  • Try not to touch the eye, eyelashes, or anything else with the tip of the tube
  • Repeat for the other eye, if affected
  • Replace the cap securely after use

Whilst applying the ointment, do not

  • Breathe on or touch the nozzle of the tube.
  • Touch the eyes or eyelids with the nozzle of the tube.

It is important to complete the course of treatment even if your eyes feel better-this could make your condition worse.

Talk to your doctor immediately if:
  • Your eyes get worse at any time
  • There is no improvement within 2 days

Do not repeat the course of treatment without consulting your doctor or pharmacist.

If you forget to take Chloramphenicol Antibiotic Eye Ointment

If you have only just missed a dose and it is a long time before the next dose is due, put in the missed dose of ointment straight away. If it is nearly time for your next dose, just put in the next dose of ointment at the usual time. Do not take a double dose to make up for a forgotten. dose.

Do not share your eye ointment with anyone else.

If you use more Chloramphenicol Antibiotic Eye Ointment than you should

If the contents of this tube are swallowed, contact your doctor straight away or go to your nearest hospital casualty department. Take with you the tube and container so that the medicine can be identified.

4. Possible side effects

Like all medicines, Chloramphenicol Eye Ointment can cause side effects, although not everybody gets them. Some people may get one or more of these side effects. Some effects happen straight away but do not last long - others may only happen after several days of use.

Stop using your medicine and tell your doctor or pharmacist immediately if you experience the following side effects:

  • The use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including funghi. If any new infection appears during treatment you should tell your doctor.
  • Blurred vision or mild burning or stinging when you put the ointment in. These should subside quickly.
  • Wheeziness (shortness of breath), fever, swelling of your face, lips or tongue, itching or rash with swelling of skin (the rash could be puffy (swollen) or blotchy, or look like little blisters.
  • A sore throat, bruising or being unable to overcome an infection. On very rare occasions, patients using chloramphenicol have had changes in their blood cells causing severe tiredness or easy bruising

Possible side effects include:
  • burning
  • itching
  • mild stinging
  • mild inflammation of the skin (dermatitis).
  • irritation

Rare side effects include:

  • bone marrow depression (a condition where the marrow is unable to produce blood cells)
  • a reduced production and death of red blood cells (anaemia)

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, or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How to store Chloramphenicol Antibiotic Eye Ointment

Keep out of the sight and reach of children.

Do not use Chloramphenicol Antibiotic Eye Ointment after the expiry date printed on the crimp seal of the tube. The expiry date refers to the last day of that month. Once the tube is open use within 28 days.

You are advised to dispose of the tube once you have finished your 5 day course of treatment.

This medicine needs to be stored below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. The measures will help to protect the environment.

6. Contents of the pack and other information
What Chloramphenicol Antibiotic Eye Ointment contains

The name of this medicine is Chloramphenicol 1.0% w/w Antibiotic Eye Ointment.

This medicine contains the active ingredient Chloramphenicol 1.0 w/w.Other ingredients are Liquid Paraffin and White Soft Paraffin.

Each tube contains 4 grams of yellowish-white eye ointment.

Manufacturer:
Tubilux Pharma S.p.A.
Via Costarica 20/22
00071 Pomezia (RM)
Italy

Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd.
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom

This leaflet was last revised in: March 2022

MARTINDALE PHARMA
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

D05741

Martindale Pharma, an Ethypharm Group Company
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Address
Jupiter House, Mercury Park, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH, UK
Telephone
+44 (0) 1277 266 600
Medical Information e-mail
[email protected]