Patient leaflet - Brolene Antibiotic 1.0 % w/w eye ointment
1. What Brolene Antibiotic Eye Ointment is and what it is
Brolene Antibiotic Eye Ointment contains a medicine called chloramphenicol. This belongs to a group of medicines called antibiotics. It works by stopping the growth of bacteria, allowing your body to fight off the infection.
It is used for infections of the eye or eyelid caused by bacteria (bacterial conjunctivitis). Signs include sore, red or inflamed eyes, sticky discharge or crust on the lids.
Eye Ointment
2. What you need to know before you use Brolene Antibiotic
Do not take this medicine and tell your doctor if:
You are allergic to chloramphenicol or any of the other ingredients of Brolene
Antibiotic Eye Ointment (listed in section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid.
You or anyone in your family have had any problems with your blood, including
‘aplastic anaemia’
Do not use this medicine if the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Brolene Antibiotic Eye Ointment.
Warnings and Precautions
Take special care with Brolene Antibiotic Eye Ointment. Check with yourdoctor or pharmacist before taking your medicine if:
▲ You have problems with your eyesight
▲ You have severe pain within the eye
▲ Your eyes are sensitive to light
▲ You have eye inflammation and a rash on your face or scalp
▲ Your eye looks cloudy
▲ The pupil of your eye looks unusual
▲ You think that you have a foreign object in your eye
▲ You have recently had conjunctivitis
▲ You have glaucoma
▲ Your eyes produce fewer tears (dry eye syndrome)
▲ You have had eye surgery or laser treatment in the last 6 months ▲ You have an eye injury
▲ You are using other eye drops or eye ointment
▲ You wear contact lenses. You should not wear contact lenses while using this eye ointment and for at least 24 hours after completing your treatment. If you are not sure if the above apply to you, talk to your doctor or pharmacist before using Brolene Antibiotic Eye Ointment.
Other medicines and Brolene Antibiotic Eye Ointment
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Brolene Antibiotic Eye Ointment can affect the waysome other medicines work. Also some medicines can affect the way Brolene Antibiotic Eye Ointment work.
In particular, tell your doctor if you are taking any of the following: • Medicines for cancer
- Medicines for the immune system such as azathioprine.
| w to use | Brolene Antibiotic Eye Ointment |
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
You should not breast-feed if you are taking Brolene Antibiotic Eye Ointment.This is because small amounts may pass into mothers’ milk.
If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using any medicine.
Driving and using machines
You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly.
Always use Brolene Antibiotic Eye Ointment exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are notsure.
Using this medicine
- Do not use for more than 5 days without talking to your doctor
How to use this medicine
- Wash your hands
- Remove the cap from the tube
- Tilt your head back
- Squeeze 1cm of the ointment inside the lower lid without touching your eye
- Close your eye
- Wipe away any excess ointment with a clean tissue
- Always put the cap back on the tube as soon as you have used it
How much to use
Adults, Elderly and Children over 2 years of age
- Apply the ointment to the eye(s) three or four times each day
- If you are using Brolene Antibiotic Eye Drops during the day, you shouldapply the ointment to the eye(s) at night
- If symptoms do not improve within 2 days talk to your doctor or pharmacist • Keep using the eye drops for 5 days even if your symptoms improve
If you forget to use Brolene Antibiotic Eye Ointment
If you forget a dose, use your ointment as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.
If you stop using Brolene Antibiotic Eye Ointment
Keep using the eye ointment for 5 days even if your symptoms improve. Do not stop using Brolene Antibiotic Eye Ointment just because your eye(s) feel better. Ifyou stop, your infection may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Brolene Antibiotic Eye Ointment can cause side effects,although not everybody gets them.
Stop using Brolene Antibiotic Eye Ointment and see a doctor as soon aspossible if:
- You get any kind of skin problem, such as a rash or itching around your eyes or they become more red
- You bruise more easily than usual or you get infections more easily or frequently than usual. You may also feel tired or weak
- You notice any swelling of your face, lips or tongue, itching or rash with swelling of skin.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
- Stinging or burning in your eyes. This should only last for a short time and occurs immediately after using the eye ointment
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for the 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 Brolene Eye Ointment
Keep this medicine out of the sight and reach of children.
Do not use Brolene Antibiotic Eye Ointment after the expiry date which isstated on the label and carton. The expiry date refers to the last day of that month. Store below 25°C
Brolene Antibiotic Eye Ointment is sterile when you buy it. Discard anyointment remaining after 5 days of use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Brolene Antibiotic Eye Ointment contains
- The ointment contains 1%w/w of the active substance, chloramphenicol • The other ingredients are liquid paraffin and paraffin (soft white)
What Brolene Antibiotic Eye Ointment looks like and contents of the pack
Brolene Antibiotic Eye Ointment is smooth and translucent. Sometimes on the first opening of the ointment tube, the product may be liquid at the very beginning. If thisis the case, squeeze through until the firmer ointment appears. The liquid sometimes occurs as part of the normal manufacturing process, but does not affect the quality of the product. Brolene Antibiotic Eye Ointment is supplied in 4g aluminum collapsible tubes.
Marketing Authorisation Holder and Manufacturer
Thornton & Ross Ltd, trading as STADA
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
Manufacturer
Zentiva k.s.,
Prague 10, Dolní Měcholupy
U Kabelovny 130
102 37
Czech Republic
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.