Earex Plus Ear Drops
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 not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast feeding:
Salicylates may be excreted in breast milk with possible risk of Reye’s syndrome in nursing infants. However, at therapeutic doses and with auricular route of administration of Earex plus ear drops, it is not known whether choline salicylate/ salicylic acid or glycerol is excreted in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from therapy taking into account the benefit of breast feeding for the child and the benefit of Earex plus ear drops therapy for the woman.
Fertility:
There is no information on the effects of auricular choline salicylate and/or glycerol on fertility.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Unknown frequency: allergic reactions (urticaria, angiodema, rhinitis, bronchospasm, dyspnoea, asthma) in people sensitive to NSAIDs, skin irritation.
4.9 Overdose
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L).
Each bottle of Earex Plus Ear Drops contains 1.6g of choline salicylate equivalent to 1.2g of aspirin. Accidental or deliberate ingestion of the contents of a bottle of Earex Plus Ear Drops is therefore only of concern in small infants.
In such cases, signs of intoxification may include dizziness, tinnitus, sweating, vomiting, confusion and hyperventilation. Gross overdose may lead to central nervous system depression.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code N02BA03
Choline Salicylate has actions similar to those of aspirin, i.e. analgesic, antiinflammatory and anti-pyretic actions considered to be due to inhibition of the biosynthesis of prostaglandins. Glycerol softens ear wax due to its water-retaining and emollient properties.
5.2 Pharmacokinetic properties
Not applicable as Earex Plus Ear Drops are applied topically.
5.3 Preclinical safety data
None stated.
6.1 List of excipients
Ethylene Oxide Polyoxypropylene Glycol Chlorbutol (hemihydrate) BP Hydrochloric Acid BP Propylene Glycol BP
6.2 Incompatibilities
None stated.
6.3 Shelf life
Three years unopened.
6.4 Special precautions for storage
Store at or below 25 °C.
6.5 Nature and contents of container
Cartoned amber glass bottle with screw cap and integral dropper containing 10ml of product.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
G R Lane Health Products Ltd.
SISSON ROAD GLOUCESTER GL2 0GR
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 01074/0243
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/05/2007
10
DATE OF REVISION OF THE TEXT
09/03/2015