ACETILCISTEINA 600 mg Эффервесцентная Таблетка
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Инструкция по применению AKETILKISTEINA AUROBINDO
Содержание инструкции
Acetilcisteina Aurobindo 600 mg effervescent tablets
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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Acetilcisteina Aurobindo is and what it is used for
- 2. What you need to know before you take Acetilcisteina Aurobindo
- 3. How to take Acetilcisteina Aurobindo
- 4. Possible side effects
- 5. How to store Acetilcisteina Aurobindo
- 6. Contents of the pack and other information
1. What is Acetilcisteina Aurobindo and what is it used for
Acetilcisteina Aurobindo contains the active ingredient acetylcysteine, which liquefies viscous mucus in the
airways.
Acetilcisteina Aurobindo 600 mg effervescent tablets is used in adults to dissolvemucus and
to facilitate its eliminationin cases of bronchitis induced by a cold.
2. What you need to know before you take Acetilcisteina Aurobindo
Do not take Acetilcisteina Aurobindo:
- If you are allergicto acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
- Children under the age of 2 years should not use this medicine;
- Children and pregnant women with phenylketonuria (phenylketonuria is a particular congenital metabolic disorder) should not use this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acetilcisteina Aurobindo if you have:
- bronchial asthma. If you suffer from bronchial asthma, Acetilcisteina Aurobindo should be taken under close medical supervision because it can cause narrowing of the airways (bronchospasm). If you experience such symptoms, stop using acetylcysteine immediately.
- a history of stomach or intestinal ulcers, or are currently suffering from them. If you have or have had a peptic ulcer, as Acetilcisteina Aurobindo can irritate the gastric wall. Especially if you are using other medicines known to cause irritation of the gastric wall.
- skin and mucous membrane disorders. Very rarely, the onset of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has been reported in connection with the use of acetylcysteine. If new skin and mucous membrane disorders occur, you should consult a doctor immediately and stop using acetylcysteine.
- As the mucus becomes denser and more fluid, its volume will increase, especially at the beginning of treatment. If you are unable to effectively expel this liquid mucus, you should consult a doctor so that appropriate measures can be taken to remove it.
- hypersensitivity to histamine. Long-term therapy should be avoided in these patients, as Acetilcisteina Aurobindo influences histamine metabolism and can lead to symptoms of intolerance (e.g. headache, runny nose, itching).
- inability to expel mucus. Mucolytics can cause obstruction of the airways in children under 2 years of age, due to the characteristics of their airways and the limited ability to eliminate sputum. Therefore, mucolytics should not be used in children under 2 years of age.
Other medicines and Acetilcisteina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This applies in particular to:
- cough-relieving agentsThe combined use of Acetilcisteina Aurobindo with cough-relieving agents may cause a dangerous congestion of the secretion, due to the reduced cough reflex. A particularly careful diagnosis is required for this combined treatment. You should consult your 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 with acetylcysteine at the same time.
- activated charcoal
- glycerol trinitrate:a medicine also known as nitroglycerin, used to widen blood vessels. Your doctor will monitor you for lowered blood pressure, which may be severe and may be reported by the onset of headache.
- carbamazepineIf used simultaneously with carbamazepine, the effects of carbamazepine may be reduced due to decreased plasma levels.
Laboratory tests
Tell your doctor that you are taking Acetilcisteina Aurobindo if you need 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 are pregnant, are planning a pregnancy or are breastfeeding with breast
milk ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Because there is insufficient experience with the use of acetylcysteine in pregnant women,
Acetilcisteina Aurobindo should be used during pregnancy only if the doctor considers it
absolutely necessary.
Breastfeeding
There is no information on the excretion of acetylcysteine into breast milk. Therefore
Acetilcisteina Aurobindo should be used during breastfeeding only if the doctor considers it
absolutely necessary.
Driving and using machines
Acetilcisteina Aurobindo is not known to affect the ability to drive vehicles or use
machinery.
Acetilcisteina Aurobindo contains lactose monohydrate
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.
Acetilcisteina Aurobindo contains aspartame
Each 600 mg effervescent tablet contains 15 mg of aspartame.
Aspartame (E951) is a source of phenylalanine. It may be harmful if you have phenylketonuria,
a rare genetic disorder that causes phenylalanine to accumulate because the body cannot dispose of it
correctly.
Acetilcisteina Aurobindo contains sodium
This medicine contains 65.714 mg of sodium (the main component of table salt) per
effervescent tablet. This is equivalent to 3.29% of the recommended daily maximum intake
of salt with the diet of an adult.
3. How to take Acetilcisteina Aurobindo
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 aged 18 years and over: 1 effervescent tablet once a day.
Method of administration
Dissolve the effervescent tablet in half a glass of water and drink the solution immediately.
For patients who have difficulty expectorating mucus (elderly and debilitated patients), it is recommended to
take the effervescent tablet in the morning.
Duration of use
Do not use this medicine for more than 14 days without consulting your doctor.
If symptoms worsen or do not improve after 4-5 days, consult your doctor.
If you take more Acetilcisteina Aurobindo than you should
In case of overdose, irritation of the stomach and intestinal tract may occur, such as abdominal pain, nausea, vomiting, diarrhea.
So far, no serious side effects or symptoms of intoxication have been observed, even in cases of
high overdose. However, if you suspect an overdose with Acetilcisteina Aurobindo, inform your
doctor.
If you forget to take Acetilcisteina Aurobindo
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.
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 can cause side effects, although not everybody gets them.
Stop taking Acetilcisteina Aurobindo and contact your doctorif you experience signs of an allergic skin reaction or severe reaction.
Uncommon(may affect up to 1 in 100 people)
- Allergic reactions
Very rare(may affect up to 1 in 10,000 people)
- Severe allergic reactions, including shock.
- Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Other possible side effects may occur with the following frequencies:
Uncommon(may affect up to 1 in 100 people)
- Headache
- Fever
- Inflammation of the lining of the mouth
- Abdominal pain
- Nausea, vomiting
- Diarrhoea
- Whistling or ringing in the ears
- Fast heartbeat
- Decreased blood pressure
- Itching, blistering, rash
- Widespread 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 - predominantly in patients with a hyper-reactive bronchial system in the presence of bronchial asthma
- Indigestion
Very rare(may affect up to 1 in 10,000 people)
- Bleeding
Not known(frequency cannot be estimated from available data)
- Swelling of the facial tissues caused by excess fluid
- Reduced platelet aggregation
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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
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 blister and the package after
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Store in the original package to protect from light.
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. Package contents and other information
What Acetilcisteina Aurobindo contains
- The active ingredient is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
- The other ingredients are: Ascorbic acid, citric acid, sodium bicarbonate, crospovidone (type B), lactose monohydrate, orange aroma (contains flavouring preparations, flavourings, natural flavouring substances, maltodextrin, gum arabic (E 414), butylated hydroxyanisole (E320)), peppermint aroma (contains flavouring preparations, natural flavouring substances, maltodextrin, gum arabic (E 414)), aspartame (E951), leucine.
Description of the appearance of Acetilcisteina Aurobindo and package contents
Effervescent tablet.
White, flat, rounded tablets with beveled edges.
Acetilcisteina Aurobindo 600 mg effervescent tablets are available in blister packs (blister
packs with composite film in Paper/Al/PE).
Packs:
Blister packs: 10, 20, 30 and 60 effervescent tablets.
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:
Belgium: Acetylcysteine AB 200 mg/600 mg effervescent tablets/comprimés effervescents/
brausetabletten
Italy: Acetilcisteina Aurobindo
Netherlands: Acetylcysteine Auro 200 mg/600 mg, effervescent tablets
Poland: Aceflucil
Portugal: Acetilcisteína Generis
Spain: Acetilcisteína Aurovitas 200 mg/600mg effervescent tablets EFG
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- Страна регистрации
- Форма выпускаEffervescent tablet, 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 AUROBINDOФорма 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
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AKETILKISTEINA AUROBINDO производится компанией AUROBINDO PHARMA (ITALIA) S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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