Patient leaflet - EAREX PLUS EAR DROPS
5. how to store earex pain relief ear drops
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton.
Do not store above 25°C and protect from sunlight.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationwhat earex pain relief ear drops containthe active substances are:
- choline salicylate 43.22% w/v (equivalent to choline salicylate 20% by volume) and
- glycerol 12.62% w/v
The other ingredients are: ethylene oxide polyoxypropylene glycol, chlorbutol (hemihydrate), hydrochloric acid and propylene glycol.
What Earex Pain Relief Ear Drops look like and the contents of the pack
Earex Pain Relief Ear Drops are a clear, odourless, very pale yellow liquid contained in an amber glass bottle with a screw cap and integral dropper. The bottle contains 10 ml. UK Marketing Authorisation Holder:
G. R. Lane Health Products Ltd., Sisson Road, Gloucester, GL2 0GR, United Kingdom.
Tel +44 (0)1452 524012
Email: PL 17905/0018
Irish Product Authorisation Holder:
LanesHealth (Ireland) Ltd., Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, D18 NW62 Ireland. Marketing Authorisation number: PA 22702/003/001 Manufacturer: Huddersfield Pharmacy Specials, Gate 2 Acre Mill, School Street West, Huddersfield HD3 3ET Manufacturer (EU Batch Release for Ireland):
Elara Pharmaservices Europe Limited 239 Blanchardstown Corporate Park, Ballycoolin, Dublin, D15 KV21, Ireland Earex is a trade mark of G. R. Lane Health Products Ltd.
This leaflet was last revised September 2020
Other sources of information
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For a large print, braille or audio version of this leaflet please telephone +44 (0)1452 524012 3027–01
Earex
PAIN RELIEF
EAR DROPS
choline salicylate 20% w/v and glycerol 12.62% w/v
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. See section 4.
- You must talk to your doctor if you do not feel better or if you feel worse after 4 days.
What is in this leaflet:
-
1. What Earex Pain Relief Ear Drops are and what they are used for
-
2. What you need to know before you use Earex Pain Relief Ear Drops
-
3. How to use Earex Pain Relief Ear Drops
-
4. Possible side effects
-
5. How to store Earex Pain Relief Ear Drops
-
6. Contents of the pack and other information
-
1. What Earex Pain Relief Ear Drops are and what they are used for
Earex Pain Relief Ear Drops should be used for the relief of earache in the external ear canal and the middle ear. 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. You must talk to a doctor if you do not feel better or if you feel worse after 4 days.
2. what you need to know before you use earex pain relief ear drops
Do not use Earex Pain Relief Ear Drops:
- If you are allergic to choline salicylate, or any other non-steroidal anti-inflammatory drug (NSAIDs) or glycerol, or any of the other ingredients of this medicine (listed in section 6).
- If you have a perforated or bleeding ear drum.
- In children under 1 year of age, unless advised by your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Earex Pain Relief Ear Drops.
Children
Do not use this medicine in children under 1 year of age, unless advised by your doctor or pharmacist.
Other medicines and Earex Pain Relief Ear Drops
Tell your doctor or pharmacist if you are taking aspirin or other salicylates.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant, think you may be pregnant, or are planning to have a baby. If you are breast-feeding, ask your doctor or pharmacist for advice before using this medicine.
3. how to use earex pain relief ear drops
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults, the elderly and children over 1 year old: For pain relief
- With the head tilted to one side, completely fill the external ear canal with Earex Pain Relief Ear Drops using the dropper provided.
- Following this the ear should be plugged with cotton wool soaked with the ear drops. Alternatively, you may wish to insert a wick, using the ear drops to keep it moist. Earex Pain Relief Ear Drops should be used every three to four hours.
For softening of ear wax
- Apply as described for pain relief, twice daily, for four days.
If you use more Earex Pain Relief Ear Drops than you should:
If you use more than you should, rinse your ear thoroughly and consult a qualified healthcare practitioner.
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, talk to your doctor or pharmacist. Swallowing the drops is of particular concern in small children, where signs of overdose may include dizziness, ringing in the ears, sweating, vomiting, confusion and increased rate of breathing.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you do get any of these serious side effects, stop taking the medicine and see a doctor at once:
- Skin irritation.
- Allergic reactions like skin rash, swelling of the skin, irritation and inflammation inside the nose, difficulty in breathing and asthma have been reported in patients sensitive to NSAIDs.
Reporting side effects
If you do get any side effects, talk to your doctor or pharmacist. This includes possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.
United Kingdom: Yellow Card Scheme, Vigilance and Intelligence research Group, Vigilance and Risk Management of Medicines, MHRA, 10 South Colonnade, London E14 4PU
Tel: +44 (0) 800 731 6789 Website: E-mail:. Alternatively, search for “MHRA yellowcard” in the Google Play or Apple App Store. Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: E-mail: By reporting side effects you can help provide more information on the safety of this medicine.
Earex
PLUS
EAR DROPS
choline salicylate 20% w/v and glycerol 12.62% w/v
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. See section 4.
- You must talk to your doctor if you do not feel better or if you feel worse after 4 days.
-
1. What Earex Plus Ear Drops are and what they are used for
-
2. What you need to know 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. Contents of the pack and other information
-
1. What Earex Plus Ear Drops are and what they are used for
Earex Plus Ear Drops should be used for the relief of earache in the external ear canal and the middle ear. 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. You must talk to a doctor if you do not feel better or if you feel worse after 4 days.
2. what you need to know before you use earex plus ear drops
Do not use Earex Plus Ear Drops:
- If you are allergic to choline salicylate, or any other non-steroidal anti-inflammatory drug (NSAIDs) or glycerol, or any of the other ingredients of this medicine (listed in section 6).
- If you have a perforated or bleeding ear drum.
- In children under 1 year of age, unless advised by your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Earex Plus Ear Drops.
Children
Do not use this medicine in children under 1 year of age, unless advised by your doctor or pharmacist.
Other medicines and Earex Plus Ear Drops
Tell your doctor or pharmacist if you are taking aspirin or other salicylates.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant, think you may be pregnant, or are planning to have a baby. If you are breast-feeding, ask your doctor or pharmacist for advice before using this medicine.
3. how to use earex plus ear drops
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults, the elderly and children 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. Alternatively, you may wish to insert a wick, using the ear drops to keep it moist. Earex Plus Ear Drops should be used every three to four hours.
For softening of ear wax
- Apply as described for pain relief, twice daily, for four days.
If you use more Earex Plus Ear Drops than you should: If you use more than you should, rinse your ear thoroughly and consult a qualified healthcare practitioner.
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, talk to your doctor or pharmacist. Swallowing the drops is of particular concern in small children, where signs of overdose may include dizziness, ringing in the ears, sweating, vomiting, confusion and increased rate of breathing.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you do get any of these serious side effects, stop taking the medicine and see a doctor at once:
- Skin irritation.
- Allergic reactions like skin rash, swelling of the skin, irritation and inflammation inside the nose, difficulty in breathing and asthma have been reported in patients sensitive to NSAIDs.
Reporting side effects
If you do get any side effects, talk to your doctor or pharmacist. This includes possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.
United Kingdom: Yellow Card Scheme, Vigilance and Intelligence research Group, Vigilance and Risk Management of Medicines, MHRA, 10 South Colonnade, London E14 4PU
Tel: +44 (0) 800 731 6789 Website: E-mail:. Alternatively, search for “MHRA yellowcard” in the Google Play or Apple App Store. Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: E-mail:
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store earex plus ear drops
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton.
Do not store above 25°C and protect from sunlight.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information what earex plus ear drops contain
The active substances are:
- choline salicylate 20% w/v and
- glycerol 12.62% w/v
What Earex Plus Ear Drops look like and the contents of the pack
Earex Plus Ear Drops are a clear, odourless, very pale yellow liquid contained in an amber glass bottle with a screw cap and integral dropper. The bottle contains 10 ml. UK Marketing Authorisation Holder:
G. R. Lane Health Products Ltd., Sisson Road, Gloucester, GL2 0GR, United Kingdom.
Tel +44 (0)1452 524012
Email: PL 17905/0018
Irish Product Authorisation Holder:
LanesHealth (Ireland) Ltd., Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, D18 NW62 Ireland. Marketing Authorisation number: PA 22702/003/001 Manufacturer: Huddersfield Pharmacy Specials, Gate 2 Acre Mill, School Street West, Huddersfield HD3 3ET Manufacturer (EU Batch Release for Ireland):
Elara Pharmaservices Europe Limited 239 Blanchardstown Corporate Park, Ballycoolin, Dublin, D15 KV21, Ireland Earex is a trade mark of G. R. Lane Health Products Ltd.
This leaflet was last revised April 2021. ,
Other sources of information
For a large print, braille or audio version of this leaflet please telephone +44 (0)1452 524012 3027–01
3027–01 Earex PLUS PIL.indd 1
13/08/2021 08:59