Cerumol ear drops

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Chlorobutanol; Arachis oil

Commercializzato da:

Mawdsley-Brooks & Company Ltd

Codice ATC:

n/a

INN (Nome Internazionale):

Chlorobutanol; Arachis oil

Dosaggio:

50mg/1ml ; 573mg/1ml

Forma farmaceutica:

Ear drops

Via di somministrazione:

Auricular

Classe:

No Controlled Drug Status

Tipo di ricetta:

Never Valid To Prescribe As A VMP

Dettagli prodotto:

BNF: 12010300

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR
THE USER
CERUMOL EAR DROPS SOLUTION
Arachis oil refined (peanut oil) 57.3% w/v
chlorobutanol hemihydrate 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 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.
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:
• Prep

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cerumol Ear Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Arachis Oil, Refined (Peanut Oil)
57.3%
Chlorobutanol Hemihydrate
5.0%
For the full list of excipients, see section 6.1.
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
Pregnancy
There are no or limited amount of data from the use of Arachis Oil
and/or
Chlorobutanol in pregnant wo