АЗИМИЛ 15 мг/2 мл Небулизируемая суспензия
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Инструкция по применению ATSIMIL
Содержание инструкции
Azimil 15 mg/2 ml solution for nebulization and oral use, 15 mg/5 ml single-dose syrup, 15 mg/5 ml multi-dose syrup
Ambroxol hydrochloride
Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after a short period of time.
Contents of this leaflet:
- 1. What Azimil is and what it is used for
- 2. What you need to know before you take Azimil
- 3. How to take Azimil
- 4. Possible side effects
- 5. How to store Azimil
- 6. Contents of the pack and other information
1. What is Azimil and what is it used for
Azimil contains ambroxol, an active ingredient belonging to a group of medicines called
mucolytics, which works by making mucus more fluid and therefore more easily eliminated from the
respiratory tract (bronchi and lungs).
Azimil is used in patients with acute and chronic respiratory diseases characterized by
thick and viscous mucus.
2. What you need to know before you take Azimil
Do not take Azimil if:
- you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
- you have severe liver and/or kidney disease;
Do not use Azimil in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Azimil if:
- you have stomach lesions (peptic ulcer);
- you have mild or moderate impairment of kidney function;
- during the first three months of pregnancy or if you are breastfeeding.
PAY ATTENTION:
Cases of severe skin reactions associated with the administration of Ambroxol have been reported.
- If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Azimil and consult your doctor immediately.
- If you experience coughing during inhalation, try to inhale and exhale normally. If you are particularly sensitive, you can pre-warm the solution to body temperature.
- If you suffer from asthma, it is recommended to take your usual medicines for asthma therapy (bronchodilators) before inhaling Azimil with a nebulizer. This will help to avoid possible breathing difficulties.
Children
Do not use Azimil in children under 2 years of age, as mucolytics can create obstruction
of the airways (bronchi).
Other medicines and Azimil
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Before taking Azimil, tell your doctor if you are taking antibiotics used to treat
infections caused by bacteria (e.g. amoxicillin, cefuroxime and erythromycin).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
In particular, during the first three months of pregnancy and during breastfeeding,
Azimil should only be used when absolutely necessary and under the direct supervision of your doctor.
Driving and operating machinery
Azimil does not impair the ability to drive and operate machinery.
Azimil syrup contains maltitol and hydroxybenzoates
Azimil syrup in single-dose container and multi-dose bottle contains maltitol.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking the
medicine.
Azimil syrup in multi-dose bottle contains para-hydroxybenzoates.
Para-hydroxybenzoates can cause allergic reactions (including delayed reactions).
Azimil solution for nebulization and oral use
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.
3. How to take Azimil
Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Solution for nebulization and oral use
Each single-dose container contains 2 ml and has a mark at a volume of 1 ml (half dose).
Solution for nebulization:
Adults
1 single-dose container, 2 times a day.
Children
Children from 2 to 5 years of age: half or 1 single-dose container, 1-2 times a day.
Children over 5 years: 1 single-dose container, 2 times a day.
Method of administration
This medicine must be nebulized (transformed into very small droplets) using an
“aerosol device” equipped with devices for oral and/or nasal administration.
Take the medicine by breathing normally through your mouth and/or nose.
To take half a dose, use the graduation on the container. The prescribed dose may
also be diluted by adding an equal amount of distilled water (1:1 ratio) to the solution
in the nebulizer ampoule.
Breathing too deeply may cause coughing; to reduce this risk, try to
inhale and exhale normally during inhalation. It may be helpful to warm the ampoule
containing the medicine to body temperature before nebulizing it.
Consult your doctor if the disorder recurs or if you notice any recent change
in your symptoms.
Oral solution:
Adults
2-4 ml (1-2 single-dose containers) 3 times a day.
Children
Children from 2 to 5 years of age: 1 ml (half single-dose container) 2-3 times a day.
Children over 5 years of age: 1-2 ml (half container – one single-dose container), 2-3
times a day.
Method of administration
Dilute the solution in a little water, tea, milk or fruit juices.
The medicine should be taken with meals.
Syrup
Adults
The initial dose is 10 ml of syrup (or two single-dose containers) 3 times a day, unless otherwise
indicated by your doctor; subsequently 5 ml (or one single-dose container) 3 times a day.
Children
Children from 2 to 5 years: the dose is 2.5 ml (or half single-dose container) of syrup, 2-3 times a
day, unless otherwise indicated by your doctor.
Children over 5 years: the dose is 5 ml (or one single-dose container) of syrup, 3 times a day,
unless otherwise indicated by your doctor.
The medicine should be taken with meals.
The package of the bottle also contains a measuring cup with markings at volumes of 2.5
ml, 5 ml and 10 ml.
If you use half a dose, close the single-dose container with pressure on the cap and store it
in the refrigerator (2-8 °C) for a maximum of 12 hours.
Do not exceed the recommended doses.
Do not use for prolonged treatments. After a short period of treatment without appreciable
results, consult your doctor.
If you take more Azimil than you should
The risk of side effects increases. In case of accidental ingestion/taking of an
excessive dose of Azimil, immediately inform your doctor or go to the nearest hospital.
If you forget to take Azimil
Do not take a double dose to make up for a missed dose.
If you stop taking Azimil
If you have any doubts about the use of Azimil, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Azimil immediately and contact your doctor if you experience any of the
following conditions: itching, skin rashes (urticaria, skin rash), swelling (angioedema)
of the face, eyes, lips and/or throat with difficulty breathing, due to allergy
(hypersensitivity).
Tell your doctor if you notice:
Common side effects(may affect up to 1 in 10 people):
- alteration or decrease in the sense of taste (dysgeusia);
- decreased sensitivity (hypoesthesia) of the mouth and pharynx (oral cavity);
- nausea. Uncommon side effects(may affect up to 1 in 100 people):
- vomiting;
- diarrhea;
- difficulty digesting (dyspepsia);
- abdominal pain;
- dry mouth.
Rare side effects(may affect up to 1 in 1000 people):
- headache;
- hypersensitivity reactions;
- rash, urticaria.
Side effects with unknown frequency:(frequency cannot be estimated based on the
available data)
- obstruction of the airways (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
- severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Azimil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
After opening the aluminium sachet containing the single-dose vials of syrup and
nebulizer and oral solution, the medicine must be used within three months; after this period, any unused medicine must be discarded. When using half a dose, the
vial must be stored at 2° - 8° C (in a refrigerator) for a maximum of 12 hours; after this period, any remaining medicine must be discarded.
After first opening the syrup bottle, the medicine must be used within one month;
after this period, any remaining medicine must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Azimil contains
The active ingredient is: Ambroxol.
Azimil 15 mg/2 ml solution for nebulisation and oral use.
- One single-dose container contains 15 mg of ambroxol hydrochloride.
- The other ingredients are: Sodium chloride, Water for injections.
Azimil 15 mg/5 ml syrup in single-dose container.
- One single-dose container contains 15 mg of ambroxol hydrochloride.
- The other ingredients are: Maltisorb ( Maltitol75%), Glycerol 98%, Citric acid monohydrate, Water for injections.
Azimil 15 mg/5 ml multi-dose syrup – 200 ml bottle.
- 5 ml of syrup contain 15 mg of ambroxol hydrochloride.
- The other ingredients are: Maltisorb ( Maltitol75%), Glycerol 98%, Citric acid monohydrate, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Water for injections.
Description of the appearance of Azimil and contents of the pack
Azimil Solution for nebulisation and oral use:
Pack of 15 or 30 single-dose containers of 2 ml divided into strips of 5 containers; each strip is
inserted in an aluminium pouch.
Azimil Syrup in single-dose container:
Pack of 20 single-dose containers of 5 ml. The single-dose containers are divided into strips of 5
containers; each strip is inserted in an aluminium pouch .
Azimil Syrup in multi-dose bottle:
200 ml bottle.
Marketing Authorisation Holder
GENETIC S.p.A., Via G. Della Monica 26, Castel San Giorgio (SA)
Manufacturer
GENETIC S.p.A., Contrada Canfora, Fisciano (SA)
This leaflet was last updated on:
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- Страна регистрации
- Форма выпускаNebulizable suspension, 15 MG/2 ML
- Код АТХR05CB06
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ATSIMILФорма выпуска: Solution for nebulization, 15 MG/2 MLДействующее вещество: АмброксолПроизводитель: EPIFARMA S.R.LОтпускается без рецептаФорма выпуска: Solution for nebulization, 15 MG/2 MLДействующее вещество: АмброксолПроизводитель: TECNIGEN S.R.L.Отпускается без рецептаФорма выпуска: Coated tablet, 30 MGДействующее вещество: АмброксолПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецепту
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Часто задаваемые вопросы
ATSIMIL не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ATSIMIL — Амброксол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ATSIMIL производится компанией GENETIC S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ATSIMIL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Другие лекарства с тем же действующим веществом (Амброксол) включают AMBROTUS, AMBROXOL TEKNIJEN, AMBROXOLO ABK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
