Инструкция по применению AKETILKISTEINA AUROBINDO ITALIA
Содержание инструкции
Acetilcisteina Aurobindo Italia 600 mg granules for oral solution in sachet
Generic medicine
Read this leaflet carefully before taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What is Acetilcisteina Aurobindo Italia and what it is used for
- 2. What you need to know before you take Acetilcisteina Aurobindo Italia
- 3. How to take Acetilcisteina Aurobindo Italia
- 4. Possible side effects
- 5. How to store Acetilcisteina Aurobindo Italia
- 6. Contents of the pack and other information
1. What is Acetilcisteina Aurobindo Italia and what is it used for
Acetilcisteina Aurobindo Italia contains the active substance acetylcysteine, which liquefies viscous mucus
in the airways.
Acetilcisteina Aurobindo Italia 600 mg granules for oral solution is indicated in adults as
an adjunct in the treatment of acute respiratory conditions associated with excessive mucus in the
lungs and airways, when the mucus is too thick and viscous to be easily expectorated with
coughing.
2. What you need to know before taking Acetilcisteina Aurobindo Italia
Do not take Acetilcisteina Aurobindo Italia:
- If you are allergicto acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
- Children under 2 years of age should not use this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acetilcisteina Aurobindo Italia if you have:
- Skin and mucous membrane changes. If new changes to the skin and mucous membranes occur, you should immediately consult a doctor and stop using acetylcysteine.
- Bronchial asthma.
- A history of stomach or intestinal ulcers, or if you currently suffer from them.
- Hypersensitivity to histamine. Long-term therapy should be avoided in these patients, as Acetilcisteina Aurobindo Italia influences histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
- Inability to expel mucus.
- Acetylcysteine may increase the intensity of vomiting.
Children and adolescents
Acetilcisteina Aurobindo Italia should not be used by children under 2 years of age (see
section “Do not take Acetilcisteina Aurobindo Italia”).
Acetilcisteina Aurobindo Italia is not recommended in children and adolescents (due to
the high active ingredient content). Other medicines with a lower amount of active ingredient are available for them.
Other medicines and Acetilcisteina Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This applies particularly to:
- cough-relieving agentsThe combined use of Acetilcisteina Aurobindo Italia with cough-relieving agents may cause a dangerous congestion of secretions, due to the reduced cough reflex. A particularly careful diagnosis is required for this combined treatment. Consult a doctor before using this combination.
- antibioticsExperimental studies show evidence of a weakening of the effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and at an interval of at least 2 hours. This does not apply to medicines with the active ingredients cefixime or loracarbef. These can be taken simultaneously with acetylcysteine.
- activated charcoal
- glycerol trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels. Your doctor will monitor you with reference to the reduction in blood pressure, which may be severe and which may be indicated by the onset of headache.
- carbamazepine: the combination of acetylcysteine and carbamazepine (medicine for epilepsy) may reduce the effects of carbamazepine.
- Acetilcisteina Aurobindo Italia may interfere with heavy metal salts, such as gold and iron salts, and with calcium salts. Therefore, it is best to separate the intake of acetylcysteine and these salts, or choose another route of administration.
Laboratory tests
Tell your doctor that you are taking Acetilcisteina Aurobindo Italia if you are to undergo any of the
following tests; it may affect the determination of:
- salicylates: medicines for the treatment of pain, inflammation or rheumatism;
- ketone bodies in urine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.,
The administration of acetylcysteine during pregnancy and breastfeeding should only occur after
a careful assessment of the risk/benefit ratio.
Pregnancy
There is insufficient data on the use of acetylcysteine in pregnant women. It has not
been shown to have a harmful effect on the fetus, however, as a precaution, it is recommended not to use Acetilcisteina Aurobindo Italia during pregnancy. Acetilcisteina
Aurobindo Italia should only be used during pregnancy if your doctor considers it absolutely
necessary.
Breastfeeding
There is no information on the excretion of acetylcysteine in breast milk. A potential risk to the newborn/infant cannot be
excluded. Therefore, Acetilcisteina Aurobindo Italia should only be used during breastfeeding if your doctor considers it absolutely necessary.
Fertility
There are limited data on the influence of acetylcysteine use on fertility in men. Studies on
animals have not shown harmful effects on fertility in humans at recommended doses.
Driving and using machines
Acetilcisteina Aurobindo Italia is not known to affect the ability to drive or operate
machinery.
Acetilcisteina Aurobindo Italia contains sucrose
Acetilcisteina Aurobindo Italia 600 mg granules for oral solution contains 1.98 g of sucrose per
dose (1.98 g/1 sachet).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
Acetilcisteina Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is essentially
‘sodium-free’.
3. How to take Acetilcisteina Aurobindo Italia
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults: Take 1 sachet of 600 mg of Acetilcisteina Aurobindo Italia once a day. Do not take
more than one sachet a day.
Use in children and adolescents:
Do not use in children and adolescents. Other formulations more suitable for this
population are available.
Method of administration
Acetilcisteina Aurobindo Italia 600 mg granules for oral solution can be taken during or
away from meals.
Dissolve the granules of one sachet in half a glass of water, or other liquid, and stir until the
solution becomes homogeneous. Use a glass or plastic container (never use rubber or metal
containers). The reconstituted solution must be administered immediately after
preparation. Partially used sachets can be stored until the next dose
(it is recommended to use the other half within 24 hours).
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Upon opening the package, you may notice a slight sulfurous (rotten egg) odor. This is a
normal characteristic of this medicine and does not mean that its use is unsafe.
Duration of use
The duration of treatment will be determined by the doctor based on the symptoms.
If you take more Acetilcisteina Aurobindo Italia than you should
In case of overdose, irritation of the stomach and intestinal tract may occur, such as abdominal
pain, nausea, vomiting, diarrhea.
Serious side effects or symptoms of intoxication have not been observed so far, even in cases of
high overdose. However, if you suspect an overdose with Acetilcisteina Aurobindo Italia,
inform your doctor.
If you forget to take Acetilcisteina Aurobindo Italia
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.
If you stop taking Acetilcisteina Aurobindo Italia
Do not stop taking Acetilcisteina Aurobindo Italia prescribed by your doctor without his
advice, as this could reduce the success of therapy.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Acetilcisteina Aurobindo Italia can cause side effects, although not everyone
will experience them.
Stop taking Acetilcisteina Aurobindo Italia and contact your doctor if you experience signs of an
allergic reaction or a serious skin reaction.
Uncommon(may affect up to 1 in 100 people)
- Allergic reactions.
Very rare(may affect up to 1 in 10,000 people)
- Serious allergic reactions, such as skin rash, itching, fluid retention (edema), difficulty breathing and loss of consciousness.
Other possible side effects may occur with the following frequencies:
Uncommon(may affect up to 1 in 100 people)
- Headache
- Fever
- Inflammation of the inner lining of the mouth
- Abdominal pain
- Nausea, vomiting
- Diarrhea
- Whistling or ringing in the ears
- Fast heartbeat
- Decreased blood pressure
- Itching, blistering, skin rash
- Severe swelling, mostly painful, of the deep layers of the skin, mainly of the face.
Rare(may affect up to 1 in 1,000 people)
- Shortness of breath
- Bronchospasm
- Indigestion.
Very rare(may affect up to 1 in 10,000 people)
- Bleeding
- Dizziness.
Not known(frequency cannot be estimated based on available data)
- Swelling of facial tissues caused by excess fluid
- Reduced platelet aggregation.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Acetilcisteina Aurobindo Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the sachet and on the package after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Acetilcisteina Aurobindo Italia contains
- The active ingredient is acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
- The other ingredients are: Sucrose, sodium saccharin, orange flavour (corn syrup, natural and artificial flavouring substances, gum arabic).
Description of the appearance of Acetilcisteina Aurobindo Italia and contents of the pack
Granules for oral solution.
Granular powder from white to off-white in sachets.
Acetilcisteina Aurobindo Italia 600 mg granules for oral solution is available in packs
containing 20 and 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
- 21047 - Saronno (VA) Italy
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus, 19, Venda Nova,
- 2700- 487 Amadora Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Acetilcisteina Aurobindo Italia
Portugal: Acetilcisteína Generis Phar
- Страна регистрации
- Форма выпускаGranules for oral solution in sachet, 600 MG
- Код АТХR05CB01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги AKETILKISTEINA AUROBINDO ITALIAФорма выпуска: Injectable solution, 300 MG/3 MLДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Powder for oral solution, 100 MGДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается без рецептаФорма выпуска: Oral solution powder, 600 MGДействующее вещество: АцетилцистеинПроизводитель: HEXAL A/SОтпускается по рецепту
Аналоги AKETILKISTEINA AUROBINDO ITALIA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог AKETILKISTEINA AUROBINDO ITALIA в Испания
Аналог AKETILKISTEINA AUROBINDO ITALIA в Польша
Аналог AKETILKISTEINA AUROBINDO ITALIA в Украина
Врачи онлайн по AKETILKISTEINA AUROBINDO ITALIA
Обсудите применение AKETILKISTEINA AUROBINDO ITALIA и возможные следующие шаги — по оценке врача.
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Часто задаваемые вопросы
AKETILKISTEINA AUROBINDO ITALIA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество AKETILKISTEINA AUROBINDO ITALIA — Ацетилцистеин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
AKETILKISTEINA AUROBINDO ITALIA производится компанией AUROBINDO PHARMA (ITALIA) S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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Вы можете купить AKETILKISTEINA AUROBINDO ITALIA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (Ацетилцистеин) включают AKK FLUIDIFIKANTE E ANTIDOTO, AKK, AKKFLUBUST. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















