Earex Plus ear drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glycerol; Choline salicylate

Available from:

G.R. Lane Health Products Ltd

ATC code:

n/a

INN (International Name):

Glycerol; Choline salicylate

Dosage:

126.2mg/1ml ; 160mg/1ml

Pharmaceutical form:

Ear drops

Administration route:

Auricular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12010100; GTIN: 5012509330507

Patient Information leaflet

Common Technical Document
Earex Plus Ear Drops
Module 1 – Administrative and Prescribing Information
Module 1.3 – Product Information
Text to appear on the Patient Information Leaflet
EAREX PLUS
Ear drops
Choline salicylate solution 43.22% w/v
and Glycerol 12.62% w/v
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before using Earex Plus Ear Drops.
• Keep this leaflet, you may wish to read it again.
• Ask your pharmacist if you need more information or advice.
IN THIS LEAFLET:
1. What Earex Plus Ear Drops are and what they are used for?
2. Before you use Earex Plus Ear Drops
3. How to use Earex Plus Ear Drops
4. Possible side effects
5. How to store Earex Plus Ear Drops
6. Further information
1. WHAT EAREX PLUS EAR DROPS ARE AND WHAT THEY ARE USED FOR?
These drops should be used for the relief of
EAR PAIN
in acute and chronic internal and external
earache.
IF YOU HAVE EAR PAIN YOU SHOULD ALWAYS SPEAK TO YOUR DOCTOR OR
PHARMACIST.
They are also used for the
SOFTENING OF EAR WAX
as an aid to ear wax removal.
2. BEFORE YOU USE EAREX PLUS EAR DROPS
DO NOT USE EAREX PLUS EAR DROPS
• If you are allergic to active ingredient choline salicylate or
glycerol or any of the other ingredients
in this product. See 'What these drops contain' for the full list
of ingredients.
• If you have a perforated or bleeding ear drum.
• If you are pregnant or think you may be pregnant or are planning
to have a baby
• On children under 1 year of age, unless advised by your doctor.
TAKE SPECIAL CARE...
• Make sure Earex Plus Ear Drops are suitable for you to use - ask
your doctor
or pharmacist.
PREGNANCY AND BREASTFEEDING....
If you are breast-feeding, ask your doctor or pharmacist for advice
before taking this medicine.
Speak to your doctor…
• If symptoms persist beyond 4 days or get worse, talk to your
doctor or pharmacist.
• Please speak with your doctor if you are taking aspirin or other
salicylates.
Earex Plus ear drops contains propylene glycol this may cause skin
irritation
January 2015 - LB
Comm

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Earex Plus Ear Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Choline Salicylate Solution BP 43.22% w/v
Glycerol BP 12.62% w/v
Also contains Propylene glycol. For a full list of excipients, see
section 6.1.
3
PHARMACEUTICAL FORM
Solution for topical administration to the ear.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of ear pain in acute and chronic otitis
media and
externia. Patients with ear pain should always seek medical advice.
Softening
of ear wax as an aid to ear wax removal.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Auricular use.
_Adults, the Elderly and Children not younger than 1 year of age: _
_For Pain Relief:_
With the head tilted to one side, the external ear canal is filled
completely with
Earex Plus Ear Drops using the dropper provided. The ear should be
plugged
with cotton wool soaked with the ear drops. A wick may be inserted, if
preferred, using the ear drops to keep it moist. Earex Plus Ear Drops
should
be instilled every three to four hours.
_For the Softening of Ear Wax:_
Apply as described above, twice daily, for four days.
4.3
CONTRAINDICATIONS
Not to be used in children under one year of age without medical
advice being
sought.
Perforated ear drum.
Hypersensitivity to choline salicylate (or any other NSAID’s),
glycerol or any
of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep out of the sight and reach of children.
Do not exceed the stated dose.
Contains propylene glycol and esters which may cause skin irritation.
If there is no improvement after 4 days or there is aggravation of the
condition, the
doctor should be consulted.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy:
There is no data from the use of Choline salicylate and glycerol in
pregnant
women. Also there is insufficient data from animal studies with
respect to
reproductive toxicity.
Hence Earex plus ear drops are