Cerumol Ear Drops

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

CHLOROBUTANOL, ARACHIS OIL

から入手可能:

Thornton & Ross Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATCコード:

S02DC

INN（国際名）:

CHLOROBUTANOL 5 % (W/V) ARACHIS OIL 57.3 % (W/V)

医薬品形態:

EAR DROPS, SOLUTION

構図:

CHLOROBUTANOL 5 % (W/V) ARACHIS OIL 57.3 % (W/V)

処方タイプ:

OTC

治療領域:

OTOLOGICALS

認証ステータス:

Withdrawn

承認日:

2005-11-02

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR 
THE USER
CERUMOL EAR DROPS SOLUTION
arachis oil (peanut oil) 57.3% w/v
chlorobutanol 5% w/v
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.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• You must contact your doctor if your
symptoms worsen or do not improve.
• If any of the side effects gets serious, or if
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
1.  WHAT CERUMOL EAR DROPS 
ARE AND WHAT THEY ARE  
USED FOR
Cerumol Ear Drops contains arachis oil to help 
lubricate the ear wax and chlorobutanol, an 
antibacterial agent, which also helps to loosen 
the wax.
This product is used to soften and help remove 
ear wax.
2.  BEFORE YOU USE CERUMOL 
EAR DROPS
         DO NOT USE THE MEDICINE IF YOU OR 
YOUR CHILD HAVE….
• An
ALLERGY  to  any  of  the  ingredients  listed  in    

section 6 including PEANUT OIL or SOYA.
• A SORE or INFLAMED EAR CANAL.
• DERMATITIS or ECZEMA on the OUTER EAR.
• A PERFORATED EAR DRUM.

TAKE SPECIAL CARE WITH CERUMOL EAR 
DROPS….
• Do not use for more than three days without
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

製品の特徴

1 
NAME OF THE MEDICINAL PRODUCT 

Cerumol Ear Drops 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active Drug Substances 

Arachis oil (Peanut oil) 
BP 
57.3% 
Chlorobutanol (Chlorbutol) 
BP 
5.0% 
3 PHARMACEUTICAL 
FORM 

Ear drops solution. 
Oily drops for topical application 
4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 

To loosen wax causing occlusion or partial occlusion of the external
auditory 
meatus. 
(Either a collection of soft wax or a harder wax plug.) 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
At home: With the head inclined, 5 drops are put into the ear. This
may cause 
a harmless tingling sensation. A plug of cotton wool moistened
with Cerumol 
or smeared with petroleum jelly should then be applied to retain the
liquid. 
One hour later, or the next morning, the plug is removed. The
procedure is 
repeated twice a day for three days; the loosened wax may then
come out on 
its own making syringing unnecessary. If any wax remains the doctor
should 
be consulted so that syringing of the softened residue may be carried
out. 

At the surgery: If there has been no prior treatment with Cerumol, 5
drops are 
instilled as described above and left for at least 20 minutes. Then
syringing or 
a probe tipped with cotton wool may be employed. 
4.3 CONTRAINDICATIONS 

Otitis externa, seborrhoeic dermatitis and eczema affecting the outer
ear. 
Perforated ear drums. 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Not to be taken internally. Do not use for more than three days
without 
consulting your doctor. Cerumol contains Arachis oil (peanut oil)
and should 
not be taken by patients known to be allergic to peanut. As there is a
possible 
relationship between allergy to peanut and allergy to soya, patients
with soya 
allergy should also avoid Cerumol. 

4.5 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 

None known. 
4.6 
FERTILITY, PREGNANCY AND LACTATION 

No side effects have been r