Patient leaflet - Chloramphenicol 1% w/w eye ointment
1. WHAT CHLORAMPHENI-COL 1% W/W EYE
OINTMENT IS AND WHAT IT IS USED FOR
It is an eye ointment and each tube contains 4 grams of the medicine. The active ingredient in Chloramphenicol Eye Ointment is chloramphenicol, which is an antibiotic.
Chloramphenicol Eye Ointment is used to treat acute bacterial conjunctivitis, which is an infection of the outer surface of eye that causes redness, discomfort and discharge from the affected eye. Your doctor, pharmacist or nurse can provide further advice about these symptoms.
Chloramphenicol Eye Ointment is suitable for use in both adults and children.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAMPHENICOL 1% W/W EYE OINTMENT
Do not use Chloramphenicol 1% w/w Eye Ointment:
- If you are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in section 6) • Are wearing contact lenses
Have previously had problems with your blood (in particular very low numbers of any type of blood cells) after taking chloramphenicol • Or anyone in your family, have had blood or bone marrow problems.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Chloramphenicol 1% w/w Eye Ointment if you:
- Are pregnant or intending to become pregnant
- Are breast-feeding
- Are taking other medicines.
Before using Chloramphenicol Eye Ointment, please tell your doctor, pharmacist or nurse if you have any other eye disorder. Also, if you are applying any other type of eye drops or eye ointment, your medicine may affect their action and could alter their effect. Other medicines and Chlorampheni-col 1% w/w Eye Ointment
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines for any condition, including medicines obtained without any prescription, or if the dose of any of your current medicines is changed.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. Chloram-phenicol 1% w/w Eye Ointment should not be used by pregnant women or women who are breast-feeding unless necessary.
Driving and using machines
Do not drive or operate machines if you have blurred vision after using Chloram-phenicol 1% w/w Eye Ointment. You should wait until your vision clears before driving or using machines.
3. HOW TO USE CHLORAMPHENICOL 1% W/W EYE OINTMENT
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Do not wear contact lenses whilst using Chloramphenicol 1% w/w Eye Ointment. Do not use the product if the seal is broken.
The recommended dose for adults, children and infants of all age groups is as follows:
About 1 cm of ointment to be applied into the affected eye (every three hours or more frequently if required), as directed by your doctor, pharmacist or nurse. You should continue using this ointment for at least 48 hours after your eye has got better.
Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to their immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.
Apply your ointment in the following way: 1. Always wash your hands before applying the eye ointment
- 2. Remove the cap
- 3. Take special care that the nozzle of the tube does not touch your eye, the skin around your eye or your fingers 4. You may use the mirror to help you to see what you are doing
- 5. Place the nozzle of the tube close to your eye and gently pull the lower eyelid downwards and look up 6. Squeeze the tube gently and apply about 1 cm of ointment to the space between the lower lid and the eye 7. Blink a few times to ensure the ointment is evenly spread into your eye and close your eye for a moment 8. Where both eyes are to be treated, repeat steps from 3 to 6
- 9. Replace the cap securely after use. If you use more Chloramphenicol 1% w/w Eye Ointment than you should
If you accidentally use too much or swallow your ointment, contact your doctor although it is unlikely to cause you any harm.
If eye irritation, soreness, swelling, watering or sensitivity to light occur after accidental use in the eye, you should wash out your eye for 15 minutes. If symptoms still persist you should see a doctor, pharmacist or nurse.
If you forget to use Chloramphenicol 1% w/w Eye Ointment
If you forget to take a dose, apply it as soon as possible, but if it is almost time for the next dose then miss the skipped dose and return to your normal dosing schedule.
If you stop using Chloramphenicol 1% w/w Eye Ointment
Do not stop using this ointment without talking to your doctor, pharmacist or nurse first.
If your symptoms are not getting better you should tell your doctor immediately. Chloramphenicol may not work against certain types of infections and other types of bacteria or fungi, which are not killed, may take over from the original infection. This may seem as if the original infection has not cleared up or has got worse.
Your doctor, or nurse may want to take blood samples to make sure the chloramphenicol has not affected your blood in any way.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Chloramphenicol 1% w/w Eye Ointment and immediately contact your doctor, pharmacist or nurse if you get any of the following symptoms (general allergic reaction): • Breathing problems
- Fever
- Swelling of the face, lips or tongue • Rash with swelling of the skin
Or, very rarely,
Bruising, bleeding, infections and weakness (symptoms of blood disorder).
As with other eye preparations, you may occasionally experience eye burning, stinging, sensitivity or visual blurring after initial application. If this persists or increases, stop using the ointment and contact your doctor, pharmacist or nurse immediately.
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 1% W/W EYE OINTMENT
Keep this medicine out of the sight and reach of children.
Do not store the tube at a temperature above 25˚C.
Do not use this medicine for longer than 4 weeks after first opening the tube even if the tube is not empty.
Do not use Chloramphenicol 1% w/w Eye Ointment after the expiry date which is stated on the tube and on the carton the tube is packed in.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Chloramphenicol 1% w/w Eye Ointment contains
- The active substance is chlorampheni-col 1% w/w which is equivalent to chloramphenicol 10 mg per gram • The other excipients are: liquid paraffin and white petroleum What Chloramphenicol 1% w/w Eye Ointment looks like and contents of the pack
Ointment comes in a pack of 1 tube.
Marketing Authorisation Holder:
Blumont Pharma Ltd.,
23 Moortown Close, Grantham, United Kingdom NG31 9GG
Manufacturer:
Tubilux Pharma, Via Costarica 20/22, 00040 Pomezia (Rome), Italy
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This leaflet was last revised in 09/2024.
PL31103/0021
PACKAGE LEAFLET: INFORMATION FOR THE USER
Chloramphenicol 1% w/w eye ointment