- Approval Id
- 985c7bb410c66c7b
- Drug Approval Emc Name
- EarCalm Spray
- Drug Name
- EarCalm Spray
- Company Name
- Dexcel Pharma Ltd
- Company Address
- 7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
- Company Website
- http://www.dexcelpharma.com
- Company Telephone
- +44 (0)1327 312 266
- Company Medical Info Direct Line
- +44 (0) 1748 828 784
- Company Medical Info Email
- Dexcel@EU.ProPharmaGroup.com
- Legal Category
- Pharmacy
- Authorisation Holder
- Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton fields, Daventry,
Northamptonshire NN11 8PB,
UK
- Authorisation Number
- PL 14017/0310
- Authorisation Date
- 21/05/2008
- Instruction Authorisation Holder
- Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton fields, Daventry,
Northamptonshire NN11 8PB,
UK
- Instruction Authorisation Number
- PL 14017/0310
- Instruction Authorisation Date
- 21/05/2008
- Instruction Composition
- Acetic Acid (Glacial) Ph. Eur., 2.0% w/w
- Instruction Dosage Form
- Ear spray for auricular use.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.4.2 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.4.3 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.4.4 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.4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
There are no known restrictions to the use of the product in pregnancy and lactation4.7 Effects on ability to drive and use machines
Unresolved ear problems could themselves effect driving ability4.8 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdosage by this route is extremely unlikely.
If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Acetic acid possesses antibacterial activity. It is reported to be active against: Haemophilus and Pseudomonas species, Candida and Trichomonas.5.2 Pharmacokinetic properties
EarCalm Spray is applied topically to the external auditory meatus and acts locally.5.3 Preclinical safety data
Acetic acid is widely available and toxicity problems at this concentration are unlikely.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Macrogol (2) stearyl ether
Macrogol (20) stearyl ether
Stearyl alcohol
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Purified water6.2 Incompatibilities
None known.6.3 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 use6.4 Special precautions for storage
Do not store above 25°C. Keep container upright in the outer carton.6.5 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.6.6 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.
- Instruction Content
- ## Composition
Acetic Acid (Glacial) Ph. Eur., 2.0% w/w
## Pharmaceutical Form
Ear spray for auricular use.
## Clinical Particulars
4.1 Therapeutic indications
EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.4.2 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.4.3 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.4.4 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.4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
There are no known restrictions to the use of the product in pregnancy and lactation4.7 Effects on ability to drive and use machines
Unresolved ear problems could themselves effect driving ability4.8 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdosage by this route is extremely unlikely.
If EarCalm should be accidentally swallowed, neutralisation with milk or water may be required.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Acetic acid possesses antibacterial activity. It is reported to be active against: Haemophilus and Pseudomonas species, Candida and Trichomonas.5.2 Pharmacokinetic properties
EarCalm Spray is applied topically to the external auditory meatus and acts locally.5.3 Preclinical safety data
Acetic acid is widely available and toxicity problems at this concentration are unlikely.
## Pharmaceutical Particulars
6.1 List of excipients
Macrogol (2) stearyl ether
Macrogol (20) stearyl ether
Stearyl alcohol
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Purified water6.2 Incompatibilities
None known.6.3 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 use6.4 Special precautions for storage
Do not store above 25°C. Keep container upright in the outer carton.6.5 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.6.6 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.
