ACC 100 mg Proszek Do Sporządzania Roztworu Doustnego
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BRONCOHEXAL 100 mg powder for oral solution
BRONCOHEXAL 200 mg powder for oral solution
acetylcysteine
WHAT IT IS
Broncohexal contains acetylcysteine. Acetylcysteine belongs to a group of medicines called
mucolytics. These medicines work by thinning bronchial secretions (mucus).
WHY IT IS USED
Broncohexal is used for the treatment of acute respiratory conditions characterized by
dense and viscous (mucus) hypersecretion.
WHEN IT MUST NOT BE USED
Hypersensitivity to the active ingredient or to any of the excipients.
Active peptic ulcer
Broncohexal is contraindicated in children under the age of 2 years.
PRECAUTIONS FOR USE
Mucolytics can induce bronchial obstruction in children under the age of 2 years. In fact, the
ability to drain bronchial mucus is limited in this age group, due to the
physiological characteristics of the respiratory tract. They should therefore not be used in children
under 2 years of age.
Much care must be taken during use in patients with bronchial asthma and in
patients with a history of ulcers; if bronchospasm occurs, treatment should be
immediately discontinued.
The administration of acetylcysteine, at the beginning of treatment, can thin the secretions
bronchial and increase the volume at the same time; if the patient is unable to expectorate in
effectively, to avoid retention of secretions, postural drainage and
bronchoaspiration should be used.
Very rarely, the onset 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.
The possible presence of a sulfurous odor does not indicate alteration of the preparation, but is its own
active ingredient contained therein.
WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE MEDICINE
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicine, including those available over the counter.
The combined use of acetylcysteine with antitussives (cough suppressants) can cause a dangerous
secretory congestion due to the reduction of the cough reflex, to the point that, for this
combination treatment, a particularly accurate diagnosis is necessary.
To date, reports of inactivation of antibiotics (tetracyclines, aminoglycosides,
penicillins) due to acetylcysteine refer exclusively to in vitro experiments, in which the
substances in question were mixed directly. However, for safety reasons, the
oral antibiotics must be administered separately and at least 2 hours apart. This
does not apply to cefixime and loracarbef.
The co-administration of acetylcysteine can result in an increase in the vasodilating effects of
nitroglycerin. Caution is advised.
IT IS IMPORTANT TO KNOW THAT
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Since adequate experience on the use of acetylcysteine in pregnant women is not available,
Broncohexal should be used during pregnancy only if the doctor deems it
absolutely necessary.
Breastfeeding
No information is available regarding the excretion of acetylcysteine in breast milk.
Broncohexal should be used during breastfeeding only if the doctor deems it absolutely
necessary..
Consult your doctor if you suspect you are pregnant or plan to become
pregnant.
Effects on the ability to drive vehicles and operate machinery
Broncohexal does not impair the ability to drive vehicles or operate machinery
Important information on some excipients of Broncohexal powder for oral solution
The medicine contains sucrose: if your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.
Furthermore, in the case of diabetic patients or those following hypocaloric diets, it should be noted
that the sachet contains sugar in an amount corresponding to approximately ½ teaspoonful of
coffee per sachet.
HOW TO USE THIS MEDICINE
HOW MUCH
Adults:
1 sachet of BRONCOHEXAL 200 mg or 2 sachets of BRONCOHEXAL 100 mg, 2-3 times a day.
Children from 2 years of age:
1 sachet of BRONCOHEXAL 100 mg 2 to 4 times a day.
Caution: do not exceed the indicated doses.
WHEN AND FOR HOW LONG
Do not use for more than 5-10 days.
Consult your doctor if the disorder occurs repeatedly or if you notice any change
recent of its characteristics.
HOW
Dissolve the contents of the sachet in a glass containing a little water, stirring at
need with a teaspoon.
The powder can also be dissolved in fruit juice or cold tea.
The mucolytic effect of acetylcysteine is favored by the intake of liquids.
WHAT TO DO IF YOU HAVE TAKEN TOO MUCH MEDICINE
In case of accidental ingestion/intake of an excessive dose of Broncohexal, immediately warn
the doctor or go to the nearest hospital.
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.
UNDESIRABLE EFFECTS
Like all medicines, Broncohexal can cause side effects, although not everyone
manifest them.
The assessment of undesirable effects is based on the following information regarding frequencies:
Very common (≥ 1/10)
Common (from ≥ 1/100 to <1/10)
Uncommon (from ≥1/1000 to <1/100)
Rare (from ≥1/10,000 to <1/1000)
Very rare (<1/10,000)
Not known (the frequency cannot be defined based on available data).
Immune system disorders
Uncommon: hypersensitivity reactions
Very rare: anaphylactic shock, anaphylactic/anaphylactoid reactions
Nervous system disorders
Uncommon: headache
Ear and labyrinth disorders
Uncommon: tinnitus
Cardiac disorders
Uncommon: tachycardia
Vascular disorders
Uncommon: hypotension
Very rare: bleeding
Respiratory, thoracic and mediastinal disorders
Rare: dyspnea, bronchospasm
Gastrointestinal disorders
Uncommon: stomatitis, abdominal pain, nausea, vomiting, diarrhea
Rare: dyspepsia
Skin and subcutaneous tissue disorders
Uncommon: urticaria, rash, angioedema, pruritus, exanthems
Systemic disorders and conditions related to the site of administration
Uncommon: fever
Not known: facial edema
Several studies have confirmed a decrease in platelet aggregation in the presence of
acetylcysteine. The clinical relevance of this data has not yet been clarified.
Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, tell
your doctor or pharmacist.
You can also report side effects directly through the national reporting system
at the address www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can contribute to providing more information on the safety
of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
The expiry date refers to the last day of the month.
Caution: do not use the medicine after the expiry date printed on the packaging:
Store in the original container and in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. Ask the
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
KEEP BRONCOHEXAL OUT OF THE SIGHT AND REACH OF CHILDREN.
It is important to always have the information on the medicine available, therefore keep both
COMPOSITION
Broncohexal 100 mg powder for oral solution
One sachet of 3 g contains:
Active ingredient: acetylcysteine 100 mg
Excipients: sucrose, ascorbic acid, saccharin, orange aroma
Broncohexal 200 mg powder for oral solution
One sachet of 3 g contains:
Active ingredient: acetylcysteine 200 mg
Excipients: sucrose, ascorbic acid, saccharin, orange aroma
HOW IT IS PRESENTED
Broncohexal 100 mg is presented in the form of powder for oral solution.
The packaging contains 30 sachets.
Broncohexal 200 mg is presented in the form of powder for oral solution.
The packaging contains 30 sachets.
MARKETING AUTHORISATION HOLDER
SANDOZ S.p.A. - Largo U. Boccioni 1 – 21040 Origgio (VA)
MANUFACTURER
Salutas Pharma GmbH - Otto-Von-Guericke-Allee 1 - 39179 Barleben (Germany)
DRUG:
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- Kraj rejestracji
- Postać farmaceutycznaPowder for oral solution, 100 MG
- Kod ATCR05CB01
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki AKKPostać farmaceutyczna: Injectable solution, 300 MG/3 MLSubstancja czynna: acetylcysteineProducent: SANDOZ S.P.A.Wymaga receptyPostać farmaceutyczna: Oral solution powder, 600 MGSubstancja czynna: acetylcysteineProducent: HEXAL A/SWymaga receptyPostać farmaceutyczna: Effervescent tablet, <100 mgSubstancja czynna: acetylcysteineProducent: HEXAL AGBez recepty
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AKK nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w AKK jest acetylcysteine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
AKK jest produkowany przez SANDOZ S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie AKK jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić AKK w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (acetylcysteine) to m.in. AKK FLUIDIFIKANTE E ANTIDOTO, AKKFLUBUST, AKKFLUEFF. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
