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EAREX PLUS EAR DROPS

Active substance: GLYCEROL

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Common Technical Document
Module 1 – Administrative and Prescribing Information
Module 1.3 – Product Information

Earex Plus Ear Drops

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

Common Technical Document
Module 1 – Administrative and Prescribing Information
Module 1.3 – Product Information

Earex Plus Ear Drops

3. How to use Earex Plus Ear Drops
Adults, the elderly and infants over 1 year old:
For Pain Relief
• With the head tilted to one side, completely fill the external ear canal
with Earex Plus Ear Drops using the dropper provided.
• Following this the ear should be plugged with cotton wool soaked with the
ear drops.
• A wick may then 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 Softening of Ear Wax
• Apply as described for pain relief, twice daily, for four days.
If you accidentally swallow the drops...
These drops are for use in the ear only. Do not put them in your mouth or
swallow them. If you do accidentally swallow them, speak to your doctor
or pharmacist.
Swallowing the drops is of particular concern in small infants, where signs
of overdose may include dizziness, ringing in the ears, sweating, vomiting,
confusion and increased rate of breathing.
4. Possible side effects
Skin irritation and allergic reactions like skin rash, swelling of the skin, irritation & inflammation
inside the nose, difficulty in breathing and asthma have been reported in patients sensitive to
NSAIDs. If you feel you are reacting badly to this medicine in any way, then stop using the drops
and speak to your doctor or pharmacist.
5. How to store Earex Plus Ear Drops
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not use after the expiry date shown on the label and carton.
• If you find that you still have this medicine after its expiry date, return it to
your local pharmacist who will dispose of it properly.
6. Further information
What Earex Plus Ear Drops contain
Earex Plus Ear Drops contain 43.22% by volume of the active ingredient choline salicylate solution
(equivalent to choline salicylate 20% by volume) and 12.62% by volume of the active ingredient
glycerol. Choline salicylate possesses analgesic, anti-inflammatory and anti-pyretic properties and
glycerol softens ear wax due to its water retaining and emollient properties.
They also contain ethylene oxide polyoxypropylene glycol, chlorbutol
(hemihydrate), hydrochloric acid and propylene glycol.
The drops are a clear, odourless, very pale yellow liquid contained in cartoned amber glass bottles
incorporating a screw cap and integral dropper of 10ml.
Marketing Authorisation Holder: G R Lane Health Products Ltd.

January 2015 - LB

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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