Medine.co.uk

Brochlor 1.0% W/W Eye Ointment

Document: leaflet MAH GENERIC_PL 04425-0367 change

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Brolene Antibiotic® 1.0%w/w Eye Ointment

Brochlor Antibiotic® 1.0%w/w Eye Ointment

Chloramphenicol

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Brochlor Brolene Antibiotic Eye Drops carefully to get the best results from them.

-    Always use this medicine exactly as described in this leafet or as your pharmacist or doctor has 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 pharmacist or doctor. 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 2 days.

In this leaflet:

1.    What Brochlor Brolene Antibiotic Eye Ointment are and what they are used for

2.    Before you use Brochlor Brolene Antibiotic Eye Ointment

3.    How to use Brochlor Brolene Antibiotic Eye Ointment

4.    Possible side effects

5.    How to store Brochlor Brolene Antibiotic Eye Ointment

6.    Contents of the pack and other information

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

Brochlor 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.

Brochlor Brolene Antibiotic Eye Ointment is used to treat minor infections of the eye or eyelid caused by bacteria (bacterial conjunctivitis) in adults and children. Signs include sore, red or inflamed eyes, sticky discharge or crust on the lids.

2. What you need to know before you use Brochlor Brolene Antibiotic Eye Ointment_

Do not take this medicine and tell your doctor if:

x You are allergic to chloramphenicol or any of the other ingredients of Brochlor 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.

x 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 Brochlor Brolene Antibiotic Eye Ointment.

Warnings and Precautions

Take special care with Brochlor Brolene Antibiotic Eye Ointment. Check with your doctor 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 these eye drops 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 Brochlor Brolene Antibiotic Eye Ointment.

Other medicines and Brochlor 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 Brochlor Brolene Antibiotic Eye Drops can affect the way some other medicines work. Also some medicines can affect the way Brochlor Brolene Antibiotic Eye Drops 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.

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 Brochlor Brolene Antibiotic Eye Drops. 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.

3. How to use Brochlor Brolene Antibiotic Eye Ointment

Always use Brochlor Brolene Antibiotic Eye Ointment exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

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

•    Apply the ointment to the eye(s) three or four times each day

• If you are using Brochlor Brolene Antibiotic Eye Drops during the day, you should apply 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

Newborn Infants

Talk to your doctor before giving this medicine to a newborn infant. Dosage adjustment may be necessary. The maximum duration of treatment is 10-14 days.

If you forget to use Brochlor Brolene Antibiotic Eye Drops

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 Brochlor Brolene Antibiotic Eye Ointment

Keep using the eye ointment for 5 days even if your symptoms improve. Do not stop using Brochlor Brolene Antibiotic Eye Ointment just because your eye(s) feel better. If you 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, Brochlor Brolene Antibiotic Eye Ointment can cause side effects, although not everybody gets them.

Stop using Brochlor Brolene Antibiotic Eye Drops and see a doctor as soon as possible 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

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, 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.

5. How to store Brochlor Brolene Eye Drops

Keep this medicine out of the sight and reach of children.

Do not use Brochlor Brolene Antibiotic Eye Ointment after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Store below 25°C

Brochlor Brolene Antibiotic Eye Ointment is sterile when you buy it. Discard any ointment 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 Brochlor 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 Brochlor Brolene Antibiotic Eye Ointment looks like and contents of the pack

Brochlor 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 this is 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. Brochlor Brolene Antibiotic Eye Ointment is supplied in 4g aluminum collapsible tubes.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sanofi , One Onslow Street, Guildford Surrey, GU1 4YS, UK Tel: 0845 372 7101

Email: uk-medicalinformation@sanofi.com

Manufacturer Zentiva k.s.,

Prague 10, Dolni Mecholupy 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.

This leaflet was last approved 08/2016

© Sanofi , 1986 - 2016

Reference: 121454 1.3.1.3 - Leaflet Text - MOD 1 1% w/w - 2016-09-16 - Brolene/Brochlor RFI 0.1