EarCalm Spray - Product Information
|Manufacture:||Forest Laboratories, Inc.|
|Condition:||Ear Infection, acute outer (Acute Otitis Externa), Ear infection, chronic outer (Otitis Externa), Otitis Externa|
|Form:||Ear drops (otic), Spray|
|Ingredients:||acetic acid, macrogol stearyl alcohol, stearyl alcohol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water|
Name of the Medicinal Product
Qualitative and Quantitative Composition
Acetic Acid (Glacial) Ph. Eur., 2.0% w/w
Ear spray for auricular use.
EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.
Posology and Method of Administration
Route of administration: Topical. For external aural use to the external auditory canal only.
Adults, children, aged 12 years and above, and the elderly.
For treatment of superficial infections of the outer ear: one metered dose (60 milligrams) to be administered directly into each affected ear at least three times daily (morning, evening and after swimming, showering or bathing). Maximum dosage frequency one spray every 2 - 3 hours.
Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.
Before using the product for the first time, prime the pump by depressing actuator 6 - 10 times until a fine spray is obtained. Use within 1 month of first actuation. If more than one week has elapsed since the last use, dispose of the contents of the pump chamber by 1 or 2 depressions of the actuator.
The product should not be used in patients with a known sensitivity to any of the ingredients.
Not recommended for children under 12 years of age without medical advice.
Special Warnings and Precautions for Use
Do not use for more than 7 days. Avoid spraying near the eyes.
If pain occurs during use, or if symptoms worsen or do not improve within 48 hours, or if your hearing becomes impaired, stop treatment and consult your doctor.
Patients who are known to have a perforated ear drum should only use the product under medical supervision.
Interaction with Other Medicinal Products and Other Forms of Interaction
Fertility, Pregnancy and Lactation
There are no known restrictions to the use of the product in pregnancy and lactation
Effects on Ability to Drive and Use Machines
Unresolved ear problems could themselves effect driving ability
Some patients may experience a transient stinging or burning sensation after dosing for the first few days of treatment.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Overdosage by this route is extremely unlikely.
If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.
Acetic acid possesses antibacterial activity. It is reported to be active against: Haemophilus and Pseudomonas species, Candida and Trichomonas.
EarCalm Spray is applied topically to the external auditory meatus and acts locally.
Preclinical Safety Data
Acetic acid is widely available and toxicity problems at this concentration are unlikely.
List of Excipients
Macrogol (2) stearyl ether
Macrogol (20) stearyl ether
Shelf life of the product as packaged for sale: 24 months from the date of manufacture
Shelf life after first opening of the container: Use within one month of first use
Special precautions for storage
Do not store above 25°C. Keep container upright in the outer carton.
Nature and Contents of Container
5 ml of the product is supplied in a 8.5ml capacity amber glass bottle fitted with a spray device.
Special Precautions for Disposal and Other Handling
Shake the bottle well before use. Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray. Administer spray directly by gently placing nozzle tip into ear opening and pressing down once on the actuator.
Use within one month of first use. If there is a period of more than one week since last use, press actuator down a few times before using again.
Marketing Authorisation Holder
Forest Laboratories UK Limited,
Marketing Authorisation Number(s)
Date of First Authorisation/Renewal of the Authorisation
Date of Revision of the Text
Company Contact Details
Forest Laboratories UK Limited (a subsidiary of Actavis PLC)
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346106
Medical Information e-mail
+44 (0)1271 311 200
Medical Information Direct Line
+44(0)1271 385 257