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CERUMOL EAR DROPS

Active substance: CHLOROBUTANOL HEMIHYDRATE

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2.  efore you use Cerumol
B
Ear Drops

Cerumol Ear Drops Solution

Adults, the elderly and children:
•  repare a small pad of cotton wool, the size
P
of your thumb nail.
• Lie or sit down and tilt your head to the side.
•  se the dropper to put 5 drops into the ear
U
canal.
•  o not push the dropper into your ear.
D
•  s the liquid enters your ear you may
A
experience a harmless tingling sensation.
•  oisten the small pad of cotton wool with
M
Cerumol or smear with petroleum jelly.
•  lace the cotton wool pad in the ear but do
P
not push it too far into the ear canal. This
helps to keep the liquid in the ear canal.
•  emove the pad after one hour or the next
R
morning.
•  epeat twice a day for three days.
R
•  he loosened wax usually comes out on its
T
own, but if any wax remains, consult your
doctor for possible syringing.
•  o not use for longer than 3 days without
D
consulting your doctor.

 not use the medicine if you or
Do
your child have….

Arachis oil refined (peanut oil) 57.3% w/v
chlorobutanol hemihydrate 5% w/v

FRONT FACE TOP

3.  ow to use Cerumol Ear
H
Drops

•  n allergy to any of the ingredients listed in
A
section 6 including peanut oil or soya.
• A sore or inflamed ear canal.
• Dermatitis or eczema on the outer ear.
• A perforated ear drum.
ake special care with Cerumol Ear
T

PACKAGE LEAFLET: INFORMATION FOR
THE USER

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 Cerumol Ear
Drops carefully to get the best results from it.
•  eep this leaflet. You may need to read it
K
again.
•  sk your pharmacist if you need any more
A
information or advice.
•  ou must contact your doctor if your
Y
symptoms worsen or do not improve.
• f any of the side effects gets serious, or if
I
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. 
What Cerumol Ear Drops are and what they
are used for
2. Before you use Cerumol Ear Drops
3. How to use Cerumol Ear Drops
4. Possible side effects
5. How to store Cerumol Ear Drops
6. Further information

Drops….

•  o not use for more than three days without
D
talking to your doctor.
• Do not swallow the ear drops.
Pregnancy and breast-feeding….
Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding.

Driving and using machines

There are no known effects on driving and
using machines, but an ear wax plug may cause
temporary deafness.

For use in the ear.

1.  hat Cerumol Ear Drops
W
are and what they are
used for

Cerumol Ear Drops contains arachis oil refined
to help lubricate the ear wax and chlorobutanol
hemihydrate, an antibacterial agent, which also
helps to loosen the wax.
This product is used to soften and help remove
ear wax.

23892707

Approved by
Date

Suf fix

CRN

11704

Reason for
Change

Replace "refined arachis oil" with
"arachis oil refined" in line with EP.

C

Issued by
Date

MHRA/IMB
submission Yes
required

23892707

Helvetica

Helvetica Greek

1

Date

29.04.2015

Keyline (Does not print)

Proof No.

Helvetica Greek

210mm x 148mm flat (27mm x 148mm folded)

Keyline (Does not print)

Dimensions

Helvetica

23892707

Process Black

PCP Header Box

Artwork No 571470

Fonts Used

IG Code

Colours Used

11ml

If you get any side effects, talk to your doctor,
Title
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
Component
Leaflet
also report side effects directly via the following
Pack Size
national reporting 11ml
systems:
United Kingdom 23892707
IG Code
Yellow Card Scheme – www.mhra.gov.uk/yellowcard
210mm x 148mm flat (27mm x 148mm folded)
Dimensions
Malta
www.medicinesauthority.gov.mt/adrportal
Proof No.
Date
29.04.2015
1
By reporting side effects you can help provide
more information on the safety of this
medicine.

Leaflet

• Local irritation.
• Redness.
• Rash.
If any of the side effects gets serious or you
notice any side effect not included above, stop
use and tell your doctor or pharmacist. They
MHRA Header Box
will tell you what to do.

gill.kennedy

Fonts Used

Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
This leaflet was last revised in May 2015
Cerumol is a trade mark of Thornton and Ross
Ltd.

Possible side effects:

Operator

Marketing authorisation holder and
manufacturer

Pack Size

Like all medicines, Cerumol Ear Drops can
cause side effects, although not everybody gets
them.

Cerumol Ear Drops are a pale amber oily liquid
which smells of turpentine.
They are supplied in 11ml bottles.

Component

4. Possible side effects

What the medicine looks like

Process Black

Use the ear drops as soon as you remember.
You can then carry on the treatment at the
correct time.

MHRA Header Box

REVERSE FACE TOP

 you forget to use Cerumol Ear
If
Drops

What is in this medicine

The active ingredients are:
Arachis oil refined (peanut oil) 57.3% w/v,
chlorobutanol hemihydrate 5% w/v.
The other ingredients are:
turpentine oil, 3-methoxy butyl acetate,
σ-dichlorobenzene, p-dichlorobenzene.

Colours Used

• Keep out of the sight and reach of children.
•  o special storage precautions are necessary
N
for the unopened pack.
•  o not use after the expiry date shown on the
D
carton. The expiry date refers to the last day
of that month.
• Once opened, use within 6 months.
•  edicine should not be disposed of via
M
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information

Cerumol Ear Drops

See a doctor if you accidentally swallow some.
Take the pack with you to show which medicine
you have swallowed.

Product
Title

5.  ow to store Cerumol Ear
H
Drops

 you accidentally swallow Cerumol
If
Ear Drops

Reporting of side effects Drops
Cerumol Ear
Product

23892707

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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.

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