Skip to Content

BROLENE ANTIBIOTIC 1.0 % W/W EYE OINTMENT

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Brolene® Antibiotic 1% w/w
Eye Ointment
chloramphenicol
Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
This medicine is available without prescription.
However, you still need to use Brolene Antibiotic Eye
Ointment carefully to get the best results from it.
• Always use this medicine exactly as described in this
leaflet or as your pharmacist or doctor has told you.
• Keep this leaflet. You may need to read it again.
• Ask your doctor or 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.
What is in this leaflet:
1. What Brolene Antibiotic Eye Ointment is and what it
is used for
2. What you need to know before you use Brolene
Antibiotic Eye Ointment
3. How to use Brolene Antibiotic Eye Ointment
4. Possible side effects
5. How to store Brolene Antibiotic Eye Ointment
6. Contents of the pack and other information
1.What Brolene Antibiotic Eye Ointment is and
what is it used for
Brolene Antibiotic Eye Ointment contains a medicine called

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 way some other medicines
work. Also some medicines can affect the way Brolene
Antibiotic Eye Ointment works.
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 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.

3. How to use Brolene Antibiotic Eye Ointment
Always use Brolene Antibiotic Eye Ointment exactly as
your doctor or pharmacist has told you. 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

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 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
followingsideeffectsgetseriousorlastslonger 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

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 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 ointment for 5 days even if your
symptoms improve

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

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.

Keep this medicine out of the sight and reach of children.
Do not use 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 25oC
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.

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. 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.

5. How to store Brolene Antibiotic Eye Ointment

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.
2. What you need to know before you use Brolene
Antibiotic Eye Ointment
Do not use 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 any of 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 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)
Youhavehadeyesurgeryorlasertreatmentinthe Turn
Over
last 6 months

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 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. Brolene Antibiotic Eye
Ointment is supplied in 4g aluminum collapsible tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi,OneOnslowStreet,Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email:uk-medicalinformation@sanofi.com
Manufacturer
Zentiva, k.s.
Prague 10, Dolní Mĕcholupy
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 revised in 01/2017
Sanofi, 1986 - 2017

ZV/575 40

Brolene antibiotic 1%, ointment 4g

PM TYPE:
ARTWORK VERSION
ARTWORK CREATION DATE:
REGION / TEXT:
REASON OF REVISION

LEAFLET
V3
6.2.2017
GB / EN
change of text

PLANT NAME:

PRAGUE

ARTWORK BY:

L.Preclíková

TECHNICAL INFORMATION

PM CODE:

11006850

1

K

(274) 10000101
LAETUS (optical code):
thick line - 1,5 mm; thin line - 0,5 mm; gap - 1 mm
LOOK CODE:

SAP ID:

NUMBER OF COLORS:

180 x 280 mm,
folded

FORMAT (size):

575 40

NO

CUTTING
FOLDING 1x

TECHNICAL DRAWING NUMBER:
MATERIAL:

KH Print Pharma 40 g/m2

MINIMAL SIZE OF TEXT:

8 pt

FONTS

Ocean Sans

9

9
12

12

KONEC TEXTU

ZAČÁTEK TEXTU
72,5

107 mm

8
2

2

2

177,8 mm - skutečný rozměr

smìr ètení kódu

GENERAL INFORMATION

PRODUCT NAME,
PHARM. FORM:

8

12

9

9

9

9

12

POKRAČOVÁNÍ TEXTU

POKRAČOVÁNÍ TEXTU

177,8 mm - skutečný rozměr

9

9

Vzor pro tisk příbalové informace
UNIVERSAL 180x280 mm - rolovaný (masti, čípky), překládaný - FALC 1
Rozmìr : 180/280 mm
Materiál: KH Print Pharma 40 g/m2
Optický kód : provedení a umístìní dle pøedlohy
text vysazen na obou stranách návodu

NÁHLEDOVÉ PDF KE KOREKTUŘE / PREVIEW TO PROOFREADING
Label design, a. s., Chrášťany 185, 252 19 Praha-západ, Czech Republic, tel.: +420 257 894 111, http: www.label-design.cz

Produkt:
Product:

F201701422x33

Typ produktu: Grafický návrh

Název:

575 40 BROLENE antib 1proc mast 4g GB falc 1

KPZ:

Name:

Type of product:

Zákazník: Zentiva, k.s.

Width (mm):

Výška etikety (mm): 140

Mezera na výšku (mm): 0

Poloměr rohů (mm): -

Max. DMJ na roli / průměr (mm): 5000

Height (mm):
Radius (mm):

Horní okraj (mm):
Upper edge (mm):
Dolní okraj (mm):
Bottom edge (mm):

0
0

Orientace užitků:
Winding position:
1. pozice:

2. pozice:

EAN
Description:

Popis:

1. position:

Popis:

2. position:

Description:

mezera
na výšku

Gap width (mm):

Gap height (mm):

Max. DMJ on role / diameter (mm):

Materiál:

Papírové nesamolepicí

/ 362

Material:
Dutinka (mm): 152x8 mm silnostěná VCELKU
Core (mm):

3
3.2.2017 12:18:19

DTP operátor:

Blanka Hájková

DPT operator:

Client number:

Mezera na šířku (mm): 0

Correction number:

Datum:
Date:

Číslo zákazníka: 7344

Client:

Šířka etikety (mm): 177.8

KPZ:

57540

Korektura číslo:

Měřítko (%):
radius

Scale (%):

mezera
na šířku

Barevnost:

pozice č. 1
pozice č. 2

šířka
etikety

směr
tisku

výška
etikety

UPOZORNĚNÍ: Vaše tisková data byla zpracována dle standardu PDF/X-4 v ESKO workflow. V případě, že tisková data obsahovala
technické nedostatky, věnujte laskavě pozornost, zda náhled odpovídá požadované podobě. V PDF náhledu je použito rozlišení
150 dpi, proto se bitmapové obrázky mohou zdát rozmazané. Pro tisk je standardně použito rozlišení 300 dpi. V případě CMYK
etikety Vám na vyžádání zašleme digitální nátisk jako vzor barevnosti. Přímé barvy budou doladěny k Pantone vzorníku, který je
součástí colormanagementu Label design, a.s.. Případné jiné ladění barevnosti přímých barev je nutné dohodnout předem.
Label design, a.s. neodpovídá za formální správnost provedení a obsah etiket, včetně čárových kódů.
WARNING: Your print data has been processed in ESKO workflow according to standard PDF/X-4. In case that the print data
contained technical defects, please pay attention to the preview, if it meets your requirements. In the preview PDF there is a
resolution of 150 dpi, so the bitmap images may appear blurred. We use standard resolution 300 dpi for printing. In case of CMYK
labels we can send you a digital proof on your request. Spot colors will be in accordance with Pantone Color Swatch, which is part of
colormanagement of Label design, a.s.. Other tuning of spot colors must be agreed in advance. Label Design, a. s. is not responsible
for the formal correctness of the design and content of the labels, including barcodes.

Colours:

Black
okraj

100%

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide