BROCETIL 600 mg Эффервесцентная Таблетка
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Инструкция по применению BROKETIL
Содержание инструкции
BROCETIL 600 mg effervescent tablets
PHARMACOTHERAPEUTIC CATEGORY
Mucolytic and fluidifying agent.
Antidote as an antioxidant and precursor of Glutathione
THERAPEUTIC INDICATIONS
Treatment of respiratory conditions characterized by dense and viscous hypersecretion:
acute bronchitis, chronic bronchitis and its exacerbations, pulmonary emphysema, cystic fibrosis and
bronchiectasis.
Antidote treatment
Accidental or intentional paracetamol poisoning.
Iso and cyclophosphamide uropathy
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Due to the presence of sorbitol, the product is contraindicated in hereditary fructose
intolerance.
Generally contraindicated in pregnancy and breastfeeding (see “Special Warnings”).
PRECAUTIONS FOR USE
Patients with bronchial asthma must be closely monitored during
therapy; if bronchospasm occurs, treatment should be discontinued immediately.
Careful use is required in patients with peptic ulcer or
with a history of peptic ulcer, especially when taking
other drugs with a known gastrolesive effect.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines,
including those without a prescription.
Drug-drug interaction
Drug-drug interaction studies have only been conducted on adult patients.
Antitussive drugs and N-acetylcysteine should not be taken at the same time
because a reduction in the cough reflex could lead to an accumulation of bronchial
secretions.
Activated charcoal may reduce the effect of N-acetylcysteine
It is advisable not to mix other drugs with the BROCETIL 600 mg solution.
The available information regarding the antibiotic-N-acetylcysteine interaction refers
to in vitro tests, in which the two substances were mixed, which showed a
decreased activity of the antibiotic. However, as a precaution, it is recommended to take
oral antibiotics at least two hours after administering N-
acetylcysteine.
It has been shown that the simultaneous administration of nitroglycerin and N-acetylcysteine
causes significant hypotension and results in dilation of the temporal artery with
possible onset of headache.
If the simultaneous administration of nitroglycerin and N-
acetylcysteine is necessary, patients should be monitored for hypotension, which may also
be severe, and warned about the possible onset of headache.
Drug-laboratory test interactions
N-acetylcysteine can cause interference with the colorimetric dosage method for the
determination of salicylates.
N-acetylcysteine can interfere with the test for determining ketones in urine.
SPECIAL WARNINGS
The possible presence of a sulfurous odor does not indicate alteration of the preparation but is a property
of the active ingredient contained therein.
The administration of BROCETIL 600 mg, especially at the beginning of treatment, may fluidify
bronchial secretions and increase their volume at the same time. If the patient is unable
to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid
retention of secretions.
Pregnancy and breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Although teratological studies conducted with N-Acetylcysteine in animals have not
shown any teratogenic effects, however, as with other drugs, its
administration during pregnancy and during breastfeeding should be
carried out only when absolutely necessary under the direct control of the doctor.
Effects on ability to drive and operate machinery
There is no reason or evidence that BROCETIL 600 mg may alter the ability
to attention and reaction times.
Important information about some excipients
Due to the presence of sorbitol, the product may cause stomach upset and diarrhea.
Patients with rare hereditary fructose intolerance should not take
this medicine (see Contraindications section)
In diabetic patients, it should be taken into account that each tablet contains 20 mg of
sodium saccharin and that the acceptable daily dose of 2.8 mg/kg should not be exceeded.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
ADULTS
Treatment of respiratory conditions
One effervescent tablet of BROCETIL 600 mg per day (preferably in the evening).
Any adjustments to the dosage may concern the frequency of
administrations or the fractionation of the dose but must still be within the
maximum daily dose of 600 mg.
The duration of therapy is 5 to 10 days in acute forms and in chronic forms should
be continued, at the doctor's discretion, for several months.
Accidental or intentional paracetamol poisoning
Orally, initial dose of 140 mg/kg of body weight to be administered as soon as possible,
within 10 hours of taking the toxic agent, followed every 4 hours and for 1-3 days by single doses of 70 mg/kg of weight.
Iso and cyclophosphamide uropathy
In a typical chemotherapy cycle with iso and cyclophosphamide of 1,200 mg/m of surface
area per day for 5 days every 28 days, Acetylcysteine can be administered orally at a dose of 4 g/day on the days of chemotherapeutic treatment distributed in 4 doses of 1 g.
Method of use:dissolve one tablet in a glass containing a little water. The
preparation should be taken once the solution is prepared.
OVERDOSE
Symptoms
Overdose may cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.
In case of accidental/intentional ingestion of an excessive dose of Germed Acetylcysteine
immediately notify your doctor or go to the nearest hospital.
If you have any doubts about the use of BROCETIL 600 mg, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, BROCETIL 600 mg can cause side effects, although not
everyone experiences them.
The following table shows the frequency of adverse reactions
following the administration of N-acetylcysteine orally:
| g Organ-system classification A | Adverse reactions | |||
| Uncommon (>1/1.000; <1/100) | Rare (>1/10.000; <1/1.000) | Very rare (<1/10.000) | Not known (frequency cannot be defined based on available data) | |
| Immune system disorders | Hypersensitivity | c Anaphylactic shock, reaction m anaphylactic/ anaphylactoid | ||
| Nervous system disorders | Headache | r | ||
| Ear and labyrinth disorders | Tinnitus | a | ||
| Cardiac disorders | Tachycardia | F | ||
| Vascular disorders | Hemorrhage | |||
| Respiratory, thoracic and mediastinal disorders | l e Bronchospasm, dyspnea | |||
| Gastrointestinal disorders | Vomiting, diarrhea, stomatitis, abdominal pain nausea | D Dyspepsia a | ||
| Skin and subcutaneous tissue disorders | Urticaria, rash, angioedema, pruritus | |||
| Systemic disorders and conditions related to the site of administration | F Fever i | Facial edema | ||
| Laboratory examinations | a t Reduced blood pressure |
In very rare cases, the appearance of severe skin reactions has been reported in temporal connection
with the intake of N-acetylcysteine, such as Stevens-Johnson syndrome and
Lyell's syndrome.
Although in most cases at least one other suspect drug has been identified
more likely involved in the genesis of the aforementioned mucocutaneous syndromes, in case of
mucocutaneous alterations it is appropriate to consult your doctor and the intake of N-
acetylcysteine should be immediately stopped.
Some studies have confirmed a reduction in platelet aggregation during
taking N-acetylcysteine. The clinical significance of this evidence has not yet been
defined.
undesirable effects.
Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet
consult your doctor or pharmacist. Adverse reactions can also be reported
directly through the national reporting system at the address:
www.agenziafarmaco.gov.it/it/responsabili.Reporting adverse reactions
helps provide 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
Warning: do not use the medicine after the expiry date printed on the
packaging
Do not store above 30°C. Keep the container tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Keep the medicine out of the sight and reach of children
Composition
One tablet contains:
Active ingredient
N-Acetylcysteine 600 mg
Excipients :
Anhydrous citric acid - sodium bicarbonate - sorbitol - L-Leucine - Macrogol 6000 - sodium saccharin
sodica - orange aroma
PHARMACEUTICAL FORM AND CONTENT
Effervescent tablets.
Pack of 20 tablets
MARKETING AUTHORISATION HOLDER
S.F. GROUP S.R.L.
VIA TIBURTINA, 1143
00156 ROME
PRODUCER:
E-Pharma Trento S.p.A. - Via Provina, 2 – 38040 Ravina (TN)
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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 BROKETILФорма 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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Действующее вещество BROKETIL — Ацетилцистеин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BROKETIL производится компанией S.F. GROUP S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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