Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Almond oil; Arachis oil; Camphor oil rectified
G.R. Lane Health Products Ltd
Almond oil; Arachis oil; Camphor oil rectified
333.3microlitre/1ml ; 333.3microlitre/1ml ; 333.3microlitre/1ml
Ear drops
Auricular
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 12010300; GTIN: 5012509330286
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 Read the complete document
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 Read the complete document