EarCalm Spray: Indications, Dosage, Precautions, Adverse Effects
Россия
  • Россия
  • Украина

EarCalm Spray - Product Information

Manufacture: Forest Laboratories, Inc.
Country: Belgium
Condition: Ear Infection, acute outer (Acute Otitis Externa), Ear infection, chronic outer (Otitis Externa), Otitis Externa
Class: Otic anti-infectives
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

EarCalm Spray.

Qualitative and Quantitative Composition

Acetic Acid (Glacial) Ph. Eur., 2.0% w/w

Pharmaceutical Form

Ear spray for auricular use.

Clinical Particulars

Therapeutic Indications

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.

Contraindications

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

None known

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

Undesirable Effects

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.

Overdose

Overdosage by this route is extremely unlikely.

If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.

Pharmacological Properties

Pharmacodynamic Properties

Acetic acid possesses antibacterial activity. It is reported to be active against: Haemophilus and Pseudomonas species, Candida and Trichomonas.

Pharmacokinetic Properties

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.

Pharmaceutical Particulars

List of Excipients

Macrogol (2) stearyl ether

Macrogol (20) stearyl ether

Stearyl alcohol

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Purified water

Incompatibilities

None known.

Shelf Life

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,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

Marketing Authorisation Number(s)

PL 00108/0334

Date of First Authorisation/Renewal of the Authorisation

21/05/2008

Date of Revision of the Text

14/07/2015

Company Contact Details

Forest Laboratories UK Limited (a subsidiary of Actavis PLC)

http://www.actavis.co.uk

Address

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346106

Medical Information e-mail

medinfo@actavis.co.uk

Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44(0)1271 385 257