Cerumol ear drops

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Chlorobutanol; Arachis oil

Disponible desde:

Thornton & Ross Ltd

Código ATC:

n/a

Designación común internacional (DCI):

Chlorobutanol; Arachis oil

Dosis:

50mg/1ml ; 573mg/1ml

formulario farmacéutico:

Ear drops

Vía de administración:

Auricular

clase:

No Controlled Drug Status

tipo de receta:

Never Valid To Prescribe As A VMP

Resumen del producto:

BNF: 12010300; GTIN: 5011309010619

Información para el usuario

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

Ficha técnica

OBJECT 1
CERUMOL EAR DROPS
Summary of Product Characteristics Updated 23-Dec-2015 | Thornton &
Ross Ltd
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 amoun