Otomize ear spray инструкция на русском

OTOMIZE® EAR SPRAY
(dexamethasone / neomycin sulphate / glacial acetic acid)
The medicine is known by the above name but will be referred to as Otomize
throughout this leaflet.

Patient Information Leaflet

Take special care with Otomize
• Excessive use (high doses or prolonged use) of this product on open
wounds or damaged skin may cause deafness. This is particularly
important to consider when used on children.
• Do not swallow any of the spray. If swallowed (especially by a child)
contact your doctor or casualty department immediately.

Pregnancy and breast feeding

Please read right through this leaflet before you start using this
medicine. This medicine is available on prescription only.
• Keep this leaflet you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

Talk to your doctor before using Otomize if you are pregnant, trying to
become pregnant, or breast feeding.

In this leaflet:

•
•
•
•
•

1.
2.
3.
4.
5.
6.

What Otomize does
Check before you use Otomize
How to use Otomize
Possible side effects
How to store Otomize
Further information

1. What Otomize does
Otomize is used to treat infection and inflammation of the outer ear.
Otomize contains three active ingredients.
Dexamethasone is a topical corticosteroid medicine which is used to control
inflammation.
Neomycin sulphate is a broad spectrum antibiotic to fight infections and acetic
acid is an antibacterial agent that also helps to clear infections.

2. Check before you use Otomize
Do not use Otomize:
• if you have ever had an allergic reaction to dexamethasone, neomycin
sulphate, acetic acid or to any of the other ingredients (listed in Section 6).

• anywhere other than in the ear. Do not inhale in the mouth or nose or
spray near the eyes.

• if you have a perforated ear drum or have a grommet fitted in the
affected ear.

• in children under 2 years of age.

3. How to use Otomize
Before using a new bottle of Otomize:
Shake well before use.
Press the pump down several times until you get a fine spray.
Make sure you do not point the nozzle at yourself or someone else.
Each time the pump is pressed down one measured dose will be delivered.
If you have not used Otomize for more than a week, press the pump a
few times until you get a fine spray again, and then follow the instructions
above.

For external use only.

Using Otomize:
Adults and children over the age of 2 years.
• Shake well before use.
• Place the nozzle tip gently into your ear.
• Press the pump once to deliver the correct dose.
• Spray one measured dose into each affected ear three times a day, or
as directed by your doctor.
• If you forget to use Otomize do not worry. Use it as soon as you
remember then go on as before.
• The nozzle tip must always be in place when you use the spray. You
can remove it for cleaning but always click it back into place afterwards.
• Continue using Otomize until two days after symptoms have gone.
• Stop using the product and consult a doctor if your condition
worsens or does not improve after 7 days treatment.
• Do not use more than the recommended dose.

4. Possible side effects
Like all medicines, Otomize can have side effects, but not everyone gets
them.
Stop using the medicine and tell your doctor if you experience:
• Sensitivity or allergic reactions (irritation or a rash).
The following side effects may also occur, but usually go away after the first
few days of treatment:
• Temporary stinging or a burning sensation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side
effects
directly
via
the
Yellow
Card
Scheme
at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Otomize
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Store the spray upright in the carton.
Do not use the spray after the expiry date printed on the carton or bottle label.
Use within one month of first use.
If the spray becomes discoloured or show any signs of deterioration you
should seek the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, please return any leftover
spray to the pharmacist for safe disposal. Only keep the spray if your doctor
tells you to.

6. Further information
What is in your medicine?
The name of your medicine is Otomize. Otomize is a milky liquid ear spray in
a glass bottle. It is an emulsion for application to the external ear canal. The
spray is non-pressurised and does not contain CFCs. This pack contains 5ml
as an aqueous suspension.
Each ml contains dexamethasone 0.1% w/w, neomycin sulphate 0.5% w/w
(3250 IU/ml) and glacial acetic acid 2% w/w.
Dexamethasone is an anti-inflammatory agent. Neomycin sulphate is a broad
spectrum antibiotic. Glacial acetic acid is an anti-bacterial agent and pH
adjuster.

Your medicine also contains the following inactive ingredients: macrogol (2)
stearyl ether, macrogol (20) stearyl ether, stearyl alcohol, methyl
parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) and
purified water.
Otomize is manufactured by Purna Pharmaceuticals, Belgium and is procured
from within the EU by the Product Licence Holder: Caseview (PL) Limited, 20
Alliance Court, Alliance Road, London W3 0RB and repackaged by O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1142

POM

Otomize® Ear Spray
Leaflet revision date (ref): 30/03/2016
Otomize is a registered trademark of Forest Laboratories UK Ltd, UK.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

OTOMIZE® EAR SPRAY
(dexamethasone / neomycin sulphate / glacial acetic acid)
The medicine is known by the above name but will be referred to as Otomize
throughout this leaflet.

Patient Information Leaflet

Take special care with Otomize
• Excessive use (high doses or prolonged use) of this product on open
wounds or damaged skin may cause deafness. This is particularly
important to consider when used on children.
• Do not swallow any of the spray. If swallowed (especially by a child)
contact your doctor or casualty department immediately.

Pregnancy and breast feeding

Please read right through this leaflet before you start using this
medicine. This medicine is available on prescription only.
• Keep this leaflet you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

Talk to your doctor before using Otomize if you are pregnant, trying to
become pregnant, or breast feeding.

In this leaflet:

•
•
•
•
•

1.
2.
3.
4.
5.
6.

What Otomize does
Check before you use Otomize
How to use Otomize
Possible side effects
How to store Otomize
Further information

1. What Otomize does
Otomize is used to treat infection and inflammation of the outer ear.
Otomize contains three active ingredients.
Dexamethasone is a topical corticosteroid medicine which is used to control
inflammation.
Neomycin sulphate is a broad spectrum antibiotic to fight infections and acetic
acid is an antibacterial agent that also helps to clear infections.

2. Check before you use Otomize
Do not use Otomize:
• if you have ever had an allergic reaction to dexamethasone, neomycin
sulphate, acetic acid or to any of the other ingredients (listed in Section 6).

• anywhere other than in the ear. Do not inhale in the mouth or nose or
spray near the eyes.

• if you have a perforated ear drum or have a grommet fitted in the
affected ear.

• in children under 2 years of age.

3. How to use Otomize
Before using a new bottle of Otomize:
Shake well before use.
Press the pump down several times until you get a fine spray.
Make sure you do not point the nozzle at yourself or someone else.
Each time the pump is pressed down one measured dose will be delivered.
If you have not used Otomize for more than a week, press the pump a
few times until you get a fine spray again, and then follow the instructions
above.

For external use only.

Using Otomize:
Adults and children over the age of 2 years.
• Shake well before use.
• Place the nozzle tip gently into your ear.
• Press the pump once to deliver the correct dose.
• Spray one measured dose into each affected ear three times a day, or
as directed by your doctor.
• If you forget to use Otomize do not worry. Use it as soon as you
remember then go on as before.
• The nozzle tip must always be in place when you use the spray. You
can remove it for cleaning but always click it back into place afterwards.
• Continue using Otomize until two days after symptoms have gone.
• Stop using the product and consult a doctor if your condition
worsens or does not improve after 7 days treatment.
• Do not use more than the recommended dose.

4. Possible side effects
Like all medicines, Otomize can have side effects, but not everyone gets
them.
Stop using the medicine and tell your doctor if you experience:
• Sensitivity or allergic reactions (irritation or a rash).
The following side effects may also occur, but usually go away after the first
few days of treatment:
• Temporary stinging or a burning sensation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side
effects
directly
via
the
Yellow
Card
Scheme
at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Otomize
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Store the spray upright in the carton.
Do not use the spray after the expiry date printed on the carton or bottle label.
Use within one month of first use.
If the spray becomes discoloured or show any signs of deterioration you
should seek the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, please return any leftover
spray to the pharmacist for safe disposal. Only keep the spray if your doctor
tells you to.

6. Further information
What is in your medicine?
The name of your medicine is Otomize. Otomize is a milky liquid ear spray in
a glass bottle. It is an emulsion for application to the external ear canal. The
spray is non-pressurised and does not contain CFCs. This pack contains 5ml
as an aqueous suspension.
Each ml contains dexamethasone 0.1% w/w, neomycin sulphate 0.5% w/w
(3250 IU/ml) and glacial acetic acid 2% w/w.
Dexamethasone is an anti-inflammatory agent. Neomycin sulphate is a broad
spectrum antibiotic. Glacial acetic acid is an anti-bacterial agent and pH
adjuster.

Your medicine also contains the following inactive ingredients: macrogol (2)
stearyl ether, macrogol (20) stearyl ether, stearyl alcohol, methyl
parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) and
purified water.
Otomize is manufactured by Stafford-Miller Ltd., Plymouth, United Kingdom
and is procured from within the EU by the Product Licence Holder: Caseview
(PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and
repackaged by O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
PL 13826/1142

POM

Otomize® Ear Spray
Leaflet revision date (ref): 30/03/2016
Otomize is a registered trademark of Forest Laboratories UK Ltd, UK.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

Excipient(s) with known effect

Includes methyl hydroxybenzoate, propyl hydroxybenzoate and stearyl alcohol (see section 4.4).

For the full list of excipients, see section 6.1.

Posology

Adults (including the elderly) and children 2 years of age and over:

Discontinue treatment if there is no clinical improvement after 7 days (see section 4.4).

One metered dose (60mg) to be administered directly into each affected ear three times daily.

Treatment should be continued until two days after symptoms have disappeared.

Infants and neonates (under 2 years of age):

Otomize ear spray is not suitable for infants and neonates (see section 4.3).

Method of administration

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.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

The product should not be used in patients where a perforated tympanic membrane has been diagnosed or is suspected or where a tympanostomy tube (grommet) is in situ.

The product should not be used in infants and neonates under 2 years of age.

Product use should be discontinued, and medical advice sought where appropriate, if irritation or rash occurs, or if the condition worsens or does not improve within 7 days.

When otitis externa is treated topically with preparations containing aminoglycosides, in patients who have a perforation of the tympanic membrane, there is an increased risk of drug induced deafness. It is therefore important to ensure that there is no perforation in such patients (see section 4.3).

It is important to exclude chronic alternate diagnoses, including chronic otitis media, before treatment is commenced.

Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.

In children there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression, with prolonged use increasing this risk of adrenal suppression in children.

Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Due to potentially immature renal function in children toxicity may develop, thus caution is warranted when administering neomycin in this age group.

Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment. This possibility should be considered when high doses or prolonged treatment is given to small children.

There have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, including cases where the patient’s aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. While no cases were identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin. These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids

Contains methyl and propyl hydroxybenzoates (E218 and E216) which may cause allergic reactions (possibly delayed).

Contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Pregnancy

There are no adequate data on the use of dexamethasone in pregnant women. Studies in animals have shown topical administration of corticosteroids to cause reproductive toxicity.

There is a risk of foetal ototoxicity if aminoglycoside antibiotics preparations are administrated during pregnancy.

Otomize is not recommended during pregnancy.

Lactation

No reports describing the use of neomycin or dexamethasone during human lactation are available and the effects on the nursing infant from exposure to the drug in milk are unknown. Maternal use of topical preparations generally carries less risk than a systemically administered drug.

A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Otomize therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Eye disorders

Blurred vision has been reported with corticosteroid use; for dexamethasone, the frequency is not known (see also section 4.4)

Skin and subcutaneous tissue disorders

Some patients may experience a transient stinging or burning sensation for the first few days of treatment.

Skin sensitisation / hypersensitivity reactions (immediate and delayed) leading to irritation, burning, stinging, itching and dermatitis.

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.

Pharmacotherapeutic group: dexamethasone and antiinfectives, S02CA06

Neomycin sulfate is an established antibiotic with a well characterised broad spectrum of activity. Dexamethasone is a well established topical anti-inflammatory steroid. Acetic acid functions to produce a low pH to assist in the control of bacterial infection.

Otomize ear spray is applied topically to the external auditory meatus and acts locally.

The spray provides excellent distribution and coverage of the surface.

Macrogol (2) Stearyl Ether

Macrogol (20) Stearyl Ether

Stearyl Alcohol

Methyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Purified Water

2 years

Shelf life after first opening of the container: use within one month of first use

Store upright in a carton. Do not store above 25°C. Do not freeze.

Teva UK Limited,

Ridings Point,

Whistler Drive,

Castleford,

WF10 5HX,

United Kingdom