Cerumol Ear Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Arachis oil; Chlorobutanol

Available from:

Thornton & Ross Limited

ATC code:

S02DC

INN (International Name):

Arachis oil; Chlorobutanol

Dosage:

57.3%w/w +5.0 percent weight/weight

Pharmaceutical form:

Ear drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Indifferent preparations

Authorization status:

Not marketed

Authorization date:

1991-08-26

Patient Information leaflet

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 plug may cause
temporary deafness.
3. HOW TO USE CERUMOL EAR
DROPS
For use in the ear.
ADULTS, THE ELDERLY AND CHILDREN:
• Prepare a small pad of cotton wool, the size

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cerumol Ear Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear Drops, solution
Oily Solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in softening and mobilising wax collection in 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
Contraindicated in hypersensitivity to arachis (peanut) oil, soya, or
any of the other ingredients.
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.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
Arachis Oil (Peanut Oil)
57.3
% w/v
Chlorobutanol (Chlorbutol)
5.0
% w/v
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