ACCFLUBUST 600 mg Oral Solution Powder
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Инструкция по применению AKKFLUBUST
Содержание инструкции
- What is Acetilcisteina Hexal A/S and what is it used for?
- What you need to know before you take Acetilcisteina Hexal A/S
- How to take Acetilcisteina Hexal A/S
- Possible side effects
- How to store Acetilcisteina Hexal A/S
- Package Contents and Other Information
Acetylcysteine Hexal A/S 600 mg powder for oral solution
For adults and adolescents over 14 years of age
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 they have the same symptoms as you, as it may 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 is Acetylcysteine Hexal A/S and what it is used for
- 2. What you need to know before you take Acetylcysteine Hexal A/S
- 3. How to take Acetylcysteine Hexal A/S
- 4. Possible side effects
- 5. How to store Acetylcysteine Hexal A/S
- 6. Contents of the pack and other information
1. What is Acetilcisteina Hexal A/S and what is it used for?
Acetilcisteina Hexal A/S contains the active ingredient acetylcysteine, which liquefies viscous mucus in the
airways.
Acetilcisteina Hexal A/S 600 mg powder for oral solution is used to liquefymucus
and facilitate coughingin cases of respiratory diseases with viscous mucusin adolescents starting from 14
years of age and in adults.
2. What you need to know before you take Acetilcisteina Hexal A/S
Do not take Acetilcisteina Hexal A/S:
- If you are allergicto the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
- If you are a child under 2 years of age
- If you are a child or adolescent under 14 years of age
Warnings and precautions
Talk to your doctor or pharmacist before taking Acetilcisteina Hexal A/S if you have:
- skin and mucous membrane changesVery rarely, the occurrence of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, has been reported in association with the use of acetylcysteine. If skin and mucosal changes occur, consult a doctor immediately and stop using acetylcysteine
- bronchial asthma
- previous or ongoing gastric or intestinal ulcers
- hypersensitivity to histamine
In these patients, long-term therapy should be avoided, as Acetilcisteina Hexal A/S
affects histamine metabolism and can cause symptoms of intolerance (such as headache, runny
nose, itching).
- inability to expectorate mucus
Dissolving acetylcysteine formulations with other medicines is not recommended.
Children
Acetilcisteina Hexal A/S 600 mg powder for oral solution is not recommended in adolescents
under 14 years of age (due to the high active ingredient content). Other
medicines with a lower active ingredient content are available for these patients.
Other medicines and Acetilcisteina Hexal A/S
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is particularly relevant for:
- Cough sedativesThe combined use of acetylcysteine with substances that relieve cough can cause dangerous secretory congestion due to a reduction in the cough reflex. Therefore, a particularly careful diagnosis is required for this combination treatment. It is mandatory to consult a doctor before using this combination.
- AntibioticsExperimental studies show evidence of a weakening effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and at least 2 hours apart. This does not apply to medicines containing the active ingredients cefixime or loracarbef, which can be taken concurrently with acetylcysteine.
- Activated charcoal
- Trinitroglycerin:a medicine also known as nitroglycerin, used to widen blood vessels. Your doctor will monitor you for any reduction in blood pressure, which may be severe and indicated by headache.
Laboratory tests
Tell your doctor that you are taking Acetilcisteina Hexal A/S if you are to undergo any of the
following blood tests, as this medicine can affect the determination of:
- salicylates:medicines used to treat 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.
Since adequate experience with the use of acetylcysteine during pregnancy and
breastfeeding is not available, Acetilcisteina Hexal A/S should only be used during pregnancy and
breastfeeding if the treating doctor considers it absolutely necessary.
Driving and using machines
It is not known whether Acetilcisteina Hexal A/S impairs the ability to drive or operate machinery.
Acetilcisteina Hexal A/S contains sucrose and sodium
This medicine contains less than 2.0 g of sucrose per sachet. Patients with rare
inherited problems of fructose intolerance, glucose-galactose malabsorption, or
sucrase-isomaltase insufficiency should not take this medicine
This medicine contains less than mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
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3. How to take Acetilcisteina Hexal A/S
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose, unless otherwise prescribed by your doctor, is:
Adults and adolescents aged 14 years and over: one sachet once a day.
Method of administration
After a meal, dissolve Acetilcisteina Hexal A/S in at least half a glass of cold water, then
fill the glass with warm, but not boiling water. Mix the solution and drink as soon as the
temperature is acceptable. Caution: always add the warm water to the cold water, not the
other way around. The reconstituted solution must be taken immediately after preparation.
Duration of use
If symptoms worsen or do not improve after 4-5 days, consult your doctor.
Note:
The possible presence of a sulfurous odor does not indicate a deterioration of the product, but is a characteristic
of the active ingredient contained in this preparation.
If you take more Acetilcisteina Hexal A/S than you should
In case of overdose, irritation may occur in the gastrointestinal tract, such as abdominal
pain, nausea, vomiting, diarrhea.
So far, no serious adverse effects or symptoms of intoxication have been observed, even in the case
of massive overdose. However, if you suspect an overdose with Acetilcisteina Hexal A/S, it is
necessary to inform your doctor.
If you forget to take Acetilcisteina Hexal A/S
Do not take a double dose to compensate for a missed dose. Simply take the
next dose at the usual time.
If you stop taking Acetilcisteina Hexal A/S
Do not interrupt the intake of Acetilcisteina Hexal A/S prescribed by your doctor unless
indicated by the latter, as this may reduce the effectiveness of the 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 Hexal A/S can cause side effects, although not everybody gets them.
The following side effects may occur:
Uncommon side effects, may affect up to 1 in 100 people
Hypersensitivity reactions indicated by:
- Headache
- Fever
- Inflammation of the inner lining of the mouth
- Tinnitus or ringing in the ears
- Fast heartbeat
- Decreased blood pressure
- Itching, hives, skin rashes
- Widespread skin rash
- Severe and predominantly painful swelling of the deep layers of the skin, mainly in the face
- Abdominal pain
- Nausea, vomiting
- Diarrhea
Rare, may affect up to 1 in 1,000 people
- Shortness of breath
- Bronchospasm, predominantly in patients with bronchial hyperreactivity in the presence of bronchial asthma
- Indigestion: the main symptom is generally pain or discomfort in the upper part of the abdomen
Very rare, may affect up to 1 in 10,000 people
- Bleeding
- Sudden skin rash, difficulty breathing and fainting (within minutes or hours) due to hypersensitivity (severe allergic reaction including anaphylactic shock). This can be life-threatening.
- Stevens-Johnson Syndrome or Lyell's Syndrome: severe skin reaction (only mucosal lesions or mucosal and skin lesions including blister formation) in temporal association with the use of acetylcysteine. If skin or mucous membrane abnormalities develop, it is therefore advisable to consult a doctor immediately and stop using acetylcysteine, Not known: the frequency cannot be estimated based on available data
- Swelling of the facial tissues, caused by excess fluid
- Reduced platelet aggregation in the blood
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system network 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
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5. How to store Acetilcisteina Hexal A/S
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 sachet and the pack after
Exp.. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The reconstituted solution must be used immediately after preparation.
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 Hexal A/S contains
The active ingredient is acetylcysteine.
Each sachet contains 600 mg of acetylcysteine.
The other ingredients are sucrose, ascorbic acid (E 300), sodium saccharin, lemon flavour, honey
flavour.
Description of the appearance of Acetilcisteina Hexal A/S and package contents
Homogeneous white powder with a lemon/honey odour
The powder for oral solution is packaged in polyethylene-aluminium-paper sachets and inserted into a
cardboard box.
The sachets contain 3 g of powder
Package sizes: 6, 10, 20, 30, 60, 90 sachets.
Not all package sizes may be marketed.
Marketing Authorisation Holder
Hexal A/S, EdvardThomsensVej 14, DK-2300 København S, Denmark
Representative for Italy: Sandoz S.p.A. ,L.go U. Boccioni 1, 21040 Origgio (VA)
Manufacturer responsible for batch release
SalutasPharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany Acetylcystein HEXAL 600mg Pulver zur Herstellung einer Lösung zum
Einnehmen
Austria Husten ACC Hexal akut 600 mg - Pulver zur Herstellung einer Lösung zum
Einnehmen
Belgium Acetylcysteïn Sandoz 600 mg powder for drink
Estonia ACC
Greece ACC 600 mg κόνις για πόσιμο διάλυμα
Italy Acetilcisteina Hexal A/S
Lithuania ACC 600 mg milteliai geriamajam tirpalui
Slovenia Fluimukan 600 mg prašek za peroralno raztopino z okusom medu in limone
- Страна регистрации
- Форма выпускаOral solution powder, 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 AKKFLUBUSTФорма 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: Effervescent tablet, <100 mgДействующее вещество: АцетилцистеинПроизводитель: HEXAL AGОтпускается без рецепта
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Действующее вещество AKKFLUBUST — Ацетилцистеин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
AKKFLUBUST производится компанией HEXAL A/S. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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