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.

Dexamethasone with antibacterial ear spray

Otomize

In this article

• About dexamethasone with antibacterial ear spray
• Before using Otomize® ear spray
• How to use Otomize® ear spray
• Getting the most from your treatment
• Can this ear spray cause problems?
• How to store Otomize® ear spray
• Important information about all medicines

About dexamethasone with antibacterial ear spray

Otitis externa is a term used for inflammation in the ear when it is confined to the ear canal and does not go further than the eardrum. It is usually due to an infection. If you get things like water, shampoo or soap in an ear then it can cause itching. If you then scratch or poke your ear, this can damage the skin in the ear canal and cause inflammation. The inflamed skin can then quickly become infected.

The brand name for dexamethasone with antibacterial ear spray is Otomize®. It contains several ingredients — dexamethasone, neomycin and acetic acid. Together, these ingredients relieve inflammation, infection, itching and pain. Otomize® spray is only available on prescription. It can be prescribed for adults and for children over 2 years of age.

Before using Otomize® ear spray

To make sure that this is the right treatment for you, before you start using the spray please make sure that your doctor knows:

• If you are pregnant or breastfeeding.
• If you have a perforated eardrum, or if you have a grommet fitted in your ear.
• If you have ever had an allergic reaction to a medicine.

How to use Otomize® ear spray

• Before you start using the spray, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about the ingredients, and it will also provide you with more information on how to use the spray.
• Before you use the spray for the first time, shake the container gently and then press the pump down a number of times until you see a fine spray. Make sure that the nozzle is not directed at anyone and try not to inhale the spray as you do this.
• Use one spray three times a day into the affected ear. To do this, place the tip of the nozzle into your ear and press the pump down once. You should continue to use the spray for two days after your symptoms have gone. Do not use the spray for longer than seven days in total, unless your doctor has told you otherwise.
• If you forget to use the spray, don’t worry, use it as soon as you remember and then go on as before.
• If you feel there is no improvement in your symptoms after you have used the spray for a week, stop using it and make another appointment to see your doctor.

Getting the most from your treatment

• You can remove the nozzle in order to clean it. When you put it back on the container, make sure that it ‘clicks’ back into place correctly.
• To help stop further bouts of inflammation, try not to let soap or shampoo get into your ear canal when you wash. You can do this when you have a shower by gently placing a piece of cotton wool coated in soft white paraffin (eg, Vaseline®) into your ear. Do not poke your ear with cotton buds or use the corner of a towel to dry your ears, as this may cause further inflammation.
• Do not use olive oil or any other ear drops or sprays during treatment with Otomize®, unless told to by your doctor.
• Otitis externa is more common in regular swimmers compared with non-swimmers. This is due to the water which gets into your ear canal. If it is not possible for you to avoid swimming, try to protect your ears by not submerging them in water if possible.

Can this ear spray cause problems?

You may get a slight feeling of burning or stinging when you first start using the spray. This is usually mild and soon passes. If you get a rash or if you notice any other symptoms which you think may be due to the spray, please ask your doctor or pharmacist for advice. Occasionally people can have a mild allergic reaction to the preservative in the spray.

How to store Otomize® ear spray

• The spray has an expiry of four weeks once opened. Do not keep any spray remaining after your course of treatment has finished to use at a later time.
• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Peter DazeleyGetty Images

What is Otomize ear spray?

Otomize ear spray contains three active ingredients, dexamethasone, neomycin and acetic acid.

It is only available on prescription in the UK and there are no other ear drops or sprays containing this combination of active ingredients available in the UK.

What is Otomize ear spray used for?

▪️ Treating inflammation and infection of the outer part of the ear canal (otitis externa).

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How does Otomize ear spray work?

Otomize ear spray contains three active ingredients, dexamethasone, neomycin and acetic acid.

Dexamethasone belongs to a group of medicines known as corticosteroids, which are used for reducing inflammation. Inflammation in the ear may be a result of damage, irritation or infection of the skin inside the ear. It occurs because the immune system releases various substances that cause blood vessels to widen and result in the affected area becoming red, swollen and painful. Corticosteroids work by acting within cells to stop the release of these substances, thereby reducing swelling, redness and pain.

Neomycin is a type of antibiotic called an aminoglycoside. It is used to treat infections caused by a wide variety of bacteria. Neomycin works by interfering with the production of proteins that are essential for the bacteria’s survival. It binds to components in bacterial cells, making the bacteria produce abnormal proteins that can’t perform their normal function. The production of these abnormal proteins ultimately kills the bacteria and this clears up the infection.

Glacial acetic acid is included in this spray to produce an acid environment in the ear which is unfavourable for bacteria to survive in. This helps control any infection.

How do I use Otomize ear spray?

▪️ Otomize ear spray is administered directly into the ear opening to produce a local effect in the outer ear canal.

▪️ Shake the bottle well before each use.

▪️ Follow the instructions provided with the spray carefully. The spray should be primed before you use it for the first time by pressing the actuator down several times until a fine spray is produced. Make sure you point the spray away from yourself and other people while doing this. If you have not used the spray for longer than a week it will need to be reprimed in the same way before you use it again.

▪️ One spray should be administered into the affected ear(s) three times a day.

▪️ You should keep using this medicine for two days after your symptoms have cleared up to make sure that the infection is fully treated and thus minimise the chance of it coming back.

▪️ Otomize ear spray should disposed of four weeks after first opening it, because after this time the spray may be contaminated with germs. You may find it helpful to write the date of opening on the pack.

▪️ Consult your doctor if there is little or no improvement in your symptoms after seven days of treatment with this medicine.

Otomize ear spray should not be used in

▪️ People with a perforated eardrum (due to increased risk of hearing damage — however some specialists do use this medicine cautiously in people with a perforated eardrum if the infection has not cleared up using other medicines).

▪️ Babies under two years of age.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

Is it safe to use Otomize ear spray if pregnant or breastfeeding?

The safety of Otomize ear spray for use during pregnancy and breastfeeding has not been established. It should not be used during pregnancy and breastfeeding unless considered essential by your doctor, and only if the expected benefit to the mother is greater than any possible risk to the baby. Seek medical advice from your doctor.

Possible side effects of Otomize ear spray

Medicines and possible side-effects can affect individual people in different ways. The following are some of the side-effects which may be associated with this medicine. Just because a side-effect is listed here, this does not mean that everyone who uses this medicine will experience it, or any side-effect. If you are concerned about side-effects or experience an adverse reaction from your medicine, consult your GP.

▪️ Temporary burning or stinging sensation for the first few days of treatment.

You should read the patient information leaflet that is supplied with your medication for more information about side effects associated with it. You can find a copy of this here

If you think you have experienced side effects from this medicine you can report them using the yellow card scheme.

Can I use Otomize ear spray with other medicines?

The medicines in Otomize ear spray are not known to affect other medicines when administered into the ear. It is safe to use painkillers such as paracetamol, ibuprofen and co-codamol if using Otomize ear spray.

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Last updated 11/09/2019

Аргетт спрей

МНН: Диклофенак натрия

Производитель: Фарбил Вальтроп ГмбХ

Анатомо-терапевтическо-химическая классификация: Diclofenac

Номер регистрации в РК:
РК-ЛС-5№019395

Информация о регистрации в РК:
10.10.2017 — бессрочно

• Скачать инструкцию медикамента

Торговое название

Аргетт
спрей

Международное непатентованное название

Диклофенак

Лекарственная форма

Спрей для наружного применения, 4 %, 12.5 г или 25 г

Состав

1 г спрея содержит

активное вещество: натрия
диклофенак — 40 мг,

вспомогательные вещества:
пропиленгликоль, спирт изопропиловый, лецитин соевый 76 %, этанол,
натрия дигидрофосфат дигидрат, динатрия фосфат додекагидрат, динатрия
эдетат, масло мяты перечной,
аскорбилпальмитат, вода очищенная,
кислота хлороводородная, натрия гидроксид.

Описание

Прозрачный раствор золотисто-желтого цвета с запахом
спирта изопропилового и мяты перечной.

Фармакотерапевтическая группа

Нестероидные противовоспалительные препараты для
местного применения. Диклофенак.

Код АТХ М02АА15

Фармакологические свойства

Фармакокинетика

После распыления на кожу 1.5 г препарата, наблюдается
быстрое начало абсорбции диклофенака. Через 30 минут после нанесения
на кожу, плазменные уровни достигают значений около 1 нг/мл.
Максимальные уровни, составляющие около 3 нг/мл, наблюдаются
приблизительно через 24 часа. Системные концентрации диклофенака
приблизительно в 50 раз ниже концентраций, которые достигаются после
перорального приема эквивалентных количеств диклофенака.
Предполагается, что системные плазменные уровни не влияют на
эффективность препарата.

Диклофенак интенсивно связывается с белками плазмы
(приблизительно 99 %).

Фармакодинамика

Аргетт спрей
– нестероидный противовоспалительный препарат (НПВП). Оказывает
обезболивающее и противовоспалительное действие. Основным механизмом
действия диклофенака является подавление циклооксигеназы (ЦОГ) –
фермента, регулирующего превращение арахидоновой кислоты в
простагландины, участвующие в генезе воспаления, боли, лихорадки.

Показания к применению

— локальное симптоматическое облегчение легкой и
умеренной боли, а также воспаления при острой, тупой травме малых и
средних суставов и околосуставных структур.

Способ применения и дозы

Только для наружного применения.

Взрослые и подростки в возрасте 14 лет и старше

Следует нанести достаточное количество спрея на
пораженное место на коже. В зависимости от размера пораженного места,
необходимо обработать поверхность кожи 4-5 нажатиями (0.8-1.0 г
спрея, содержащего 32-40 мг натрия диклофенака) три раза в день с
регулярными интервалами. Не следует превышать максимальную разовую
дозу 1.0 г препарата. Максимальная суточная доза составляет 15
нажатий (3.0 г спрея, содержащего 120 мг натрия диклофенака).

У подростков в возрасте 14 лет и старше, если этот
препарат необходим для использованья более чем на 7 дней для
облегчения боли или если симптомы пациента ухудшаются, рекомендуется
проконсультироваться с врачом.

Препарат следует осторожно втирать в кожу, после чего
необходимо тщательно вымыть руки, кроме случаев, когда руки являются
обрабатываемым участком. После нанесения на кожу, препарат должен
высохнуть в течение нескольких минут.

Лечение препаратом может быть прекращено при уменьшении
симптомов (боли и отека). Лечение не должно продолжаться свыше 7 дней
без консультации врача. Следует проконсультироваться с врачом, если
улучшение не наступает после 3-х дней лечения.

Подростки от 14 лет и старше

В случае применения у подростков в возрасте 14 лет и
старше, более чем 7 дней для облегчения боли или если симптомы
пациента ухудшаются, рекомендуется проконсультироваться с врачом.

Пожилые пациенты

Способ применения и дозы у пожилых пациентов такие же,
как у взрослых пациентов.

Пациенты c
печеночной или почечной недостаточностью

У пациентов с нарушениями функций почек и печени
препарат следует применять с осторожностью.

Побочные действия

Часто

— сыпь, экзема, эритема, дерматит (в том числе
контактный дерматит), зуд

Редко

— дерматит буллезный

Очень редко

— астма, повышенная чувствительность
(в том числе крапивница), ангионевротический отек, гнойничковая сыпь,
реакции фоточувствительности

Неизвестны

— реакция на месте аппликации, сухая кожа, ощущение
жжения

Побочные реакции могут быть уменьшены с помощью
минимальной эффективной дозы до самой короткой продолжительности.
Общая разовая доза препарата не должна превышать 1,0 г (эквивалентно
5-ти нажатиям дозатора) спрея.

Во время длительного лечения до трёх недель или при
обработке больших областей (более 600 см² поверхности тела)
существует возможность системных побочных реакций таких как, боли в
животе, диспепсия, желудочные и почечные расстройства.

Противопоказания

— повышенная чувствительность
к действующему веществу, арахису, сое или любому из вспомогательных
веществ, к ацетилсалициловой кислоте или другим нестероидным
противовоспалительным препаратам (НПВП)

—
бронхиальная астма, крапивница или острый ринит, спровоцированные
приемом ацетилсалициловой кислоты или других нестероидных
противовоспалительных препаратов

— нанесение на область молочных желез

— третий
триместр
беременности и период
лактации

— детский и подростковый возраст до 14 лет

Лекарственные взаимодействия

Системная абсорбция диклофенака в данной лекарственной
форме очень низкая, поэтому риск взаимодействия с другими
лекарственными препаратами невелик.

Одновременный прием ацетилсалициловой кислоты или других
НПВП может привести к увеличению частоты побочных реакций.

Особые указания

Возможны системные побочные реакции после применения
спрея, если препарат применяется на больших участках кожи и в течение
длительного периода. Не следует допускать попадания препарата в глаза
и на слизистые оболочки. Необходимо наносить только на неповрежденную
кожу, избегая попадания на открытые раны или поврежденные участки
кожи.

Препарат нельзя применять с окклюзионной повязкой.

Необходимо избегать избыточного воздействия солнечного
света во время лечения препаратом для уменьшения риска появления
реакции фоточувствительности.

При возникновении сыпи, лечение следует прекратить.

Следует с осторожностью применять
препарат
в сочетании с другими пероральными НПВП, так как частота системных
побочных реакций
может увеличиться.

Препарат нельзя наносить на обширные участки кожи (более
600 см² поверхности тела) и использовать в течение
продолжительного периода времени (более четырех недель) из-за
возможности развития системных побочных реакций (повышенной
чувствительности, астматических реакций или побочных реакций со
стороны почек). У пациентов, страдающих от
бронхиальной астмы, или имеющих ее в анамнезе,
а также
аллергических реакций,
приступ бронхоспазма может быть ускорен.

Препарат следует применять с осторожностью у больных с
пептической язвой, печеночной или почечной недостаточностью, или
геморрагическим диатезом, а также воспалительными заболеваниями
кишечника.

Пропиленгликоль
может вызывать раздражение кожи, а масло
мяты перечной – аллергические реакции.

Беременность и лактация

Возможно применение
препарата во время первого и второго
триместра беременности с осторожностью, но доза должна быть как
можно ниже и продолжительность лечения как
можно короче.

Диклофенак противопоказан во время третьего триместра
беременности, так как ингибиторы синтеза простагландинов могут
привести к:

— сердечной токсичности (с преждевременным закрытием
артериального протока и легочной гипертензии);

— почечной дисфункции, которая может прогрессировать до
почечной недостаточности с недостаточностью околоплодных вод;

— возможно увеличение продолжительности кровотечения,
эффект анти-агрегирования, который может произойти даже при очень
низких дозах;

— торможение сократительной функции матки, в результате
задержки или затяжных родов.

Как и другие НПВП, диклофенак проникает в грудное молоко
в небольших количествах. Препарат в терапевтических дозах не влияет
отрицательно на плод. Из-за отсутствия контролируемых исследований у
кормящих женщин, препарат следует использовать в период лактации
только после консультации с врачом, поэтому препарат не должен
применяться ни в области груди кормящей, ни на больших участках кожи
в течение длительного периода времени.

Особенности влияния лекарственного средства на
способность управлять транспортом и другими потенциально опасными
механизмами

Не влияет

Передозировка

Симптомы: при наружном
применении диклофенака, системная абсорбция низкая, передозировка
маловероятна.

При случайном проглатывании содержимого флакона,
возможно появление системных нежелательных реакций, характерных для
НПВП.

Лечение: необходимо
промывание желудка, прием активированного угля, особенно в течение
короткого периода времени после случайного приема внутрь.

Форма выпуска и упаковка

По 12.5 г или 25 г препарата во флаконах из темного
стекла (тип III Евр.Фарм.) с номинальным объемом наполнения 15 мл или
30 мл, оснащенных распылителем и защитным колпачком из пластиковых
материалов.

По 1 флакону
вместе с инструкцией по медицинскому применению лекарственного
средства
на
государственном и русском языках помещают в картонную коробку.

Условия хранения

Хранить при температуре не выше 25 ºС, в
оригинальной упаковке.

Хранить в недоступном для детей месте!

Срок хранения

3 года

Период применения после первого вскрытия флакона — 6
месяцев.

Не использовать по истечении срока годности.

Условия отпуска из аптек

Без рецепта

Производитель

Фарбил Вальтроп ГмбХ, Им Вирриген
25, 45731, Вальтроп, Германия

Владелец регистрационного удостоверения

Дельта Медикел Промоушнз АГ,
Отенбахгассе 26, Цюрих 8001, Швейцария

Наименование
и адрес организации на территории Республики Казахстан, принимающей
претензии (предложения) по качеству лекарственных средства от
потребителей, ответственной за пострегистрационное наблюдение за
безопасностью лекарственного средства

Представительство АО «Дельта Медикел Промоушнз АГ»
(Швейцария), 050040, г. Алматы, Бостандыкский район, ул. Байзакова,
д. 280, тел./факс: +7 (727) 332 20 79, электронная почта:
DrugSafety@deltaswiss.eu

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