Brocetil

PACKAGE LEAFLET

BROCETIL 600 mg effervescent tablets

PHARMACOTHERAPEUTIC CATEGORY
Mucolytic expectorant.
Antidote due to antioxidant properties and glutathione precursor.

THERAPEUTIC INDICATIONS
Treatment of respiratory conditions characterized by thick and viscous hypersecretion:
acute bronchitis, chronic bronchitis and its exacerbations, pulmonary emphysema, cystic fibrosis, and bronchiectasis.

Antidotal treatment
Accidental or intentional paracetamol poisoning.

Uropathy due to ifosfamide and cyclophosphamide.

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 during pregnancy and breastfeeding (see "Special Warnings").

PRECAUTIONS FOR USE
Patients affected by bronchial asthma must be closely monitored during treatment; if bronchospasm occurs, treatment must be immediately discontinued.
Particular caution is required when using this medicine in patients with peptic ulcer or a history of peptic ulcer, especially if other drugs known to have gastrotoxic effects are taken concomitantly.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.

Drug-drug interactions
Drug interaction studies have been conducted only in adult patients.
Antitussive agents and N-acetylcysteine should not be taken simultaneously, as suppression of the cough reflex may lead to accumulation of bronchial secretions.
Activated charcoal may reduce the effect of N-acetylcysteine.
It is advised not to mix other medicines with the BROCETIL 600 mg solution.
Available data regarding antibiotic-N-acetylcysteine interactions come from in vitro studies where both substances were mixed, showing reduced antibiotic activity. However, as a precaution, oral antibiotics should be taken at least two hours apart from administration of N-acetylcysteine.
Concomitant administration of nitroglycerin and N-acetylcysteine has been shown to cause significant hypotension and dilation of the temporal artery, possibly leading to headache.
If concomitant administration of nitroglycerin and N-acetylcysteine is necessary, patients should be monitored for signs of hypotension, which may be severe, and warned about the possible onset of headache.

Drug-laboratory test interactions
N-acetylcysteine may interfere with colorimetric assay methods for salicylate determination.
N-acetylcysteine may interfere with urine ketone testing.

SPECIAL WARNINGS
The possible presence of a sulfurous odor does not indicate degradation of the product but is characteristic of the active substance contained in it.
Administration of BROCETIL 600 mg, particularly at the beginning of treatment, may liquefy bronchial secretions while simultaneously increasing their volume. If the patient is unable to effectively expectorate, postural drainage and bronchial aspiration should be performed to prevent retention of secretions.

Pregnancy and breastfeeding
Seek advice from your doctor or pharmacist before taking any medicine.
Although teratogenicity studies conducted with N-acetylcysteine in animals have not shown teratogenic effects, as with other drugs, administration during pregnancy and breastfeeding should only occur when clearly necessary and under direct medical supervision.

Effects on the ability to drive and use machines
There are no grounds or evidence that BROCETIL 600 mg may affect attention or reaction times.

Important information about certain excipients
Due to the presence of sorbitol, the product may cause gastrointestinal disturbances and diarrhea.
Patients with rare hereditary fructose intolerance must not take this medicine (see section "Contraindications").
In diabetic patients, it should be noted that each tablet contains 20 mg of sodium saccharin and that the acceptable daily intake of 2.8 mg/kg body weight must not be exceeded.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION

ADULTS

Treatment of respiratory disorders
One effervescent tablet of BROCETIL 600 mg daily (preferably in the evening).
Adjustments in dosage may involve frequency of administration or dose fractionation, but must not exceed the maximum daily dose of 600 mg.
Treatment duration is 5 to 10 days for acute conditions; for chronic conditions, treatment may continue, at the physician's discretion, for several months.

Accidental or intentional paracetamol poisoning
Oral administration: initial dose of 140 mg/kg body weight, administered as soon as possible within 10 hours of ingestion of the toxic agent, followed by single doses of 70 mg/kg body weight every 4 hours for 1 to 3 days.

Uropathy due to ifosfamide and cyclophosphamide
In a typical chemotherapy cycle with ifosfamide and cyclophosphamide at 1,200 mg/m² body surface area per day for 5 days every 28 days, acetylcysteine may be administered orally at a dose of 4 g/day during chemotherapy days, divided into 4 doses of 1 g each.

Method of administration: Dissolve one tablet in a glass containing a small amount of water. The solution should be taken immediately after preparation.

OVERDOSE

Symptoms
Overdose may cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea.
In case of accidental ingestion or overdose of Acetylcysteine Germed, contact your doctor immediately 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 adverse effects, although not everybody experiences them.

Below is a table listing the frequency of adverse reactions following oral administration of N-acetylcysteine:

In very rare cases, serious skin reactions have occurred temporally related to the administration of N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell's syndrome.
Although in most cases at least one other suspected drug more likely involved in the development of these mucocutaneous syndromes has been identified, if mucocutaneous changes occur, it is advisable to consult a physician and treatment with N-acetylcysteine must be immediately discontinued.
Some studies have confirmed a reduction in platelet aggregation during treatment with N-acetylcysteine. The clinical significance of these findings has not yet been established.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide further information on the safety of this medicinal product.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under recommended storage conditions.
Warning: do not use the medicinal product after the expiry date stated on the packaging
Do not store above 30°C. Keep the container tightly closed.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep this medicinal product out of the sight and reach of children
Composition
One tablet contains:
Active substance
N-Acetylcysteine 600 mg
Excipients:
Anhydrous citric acid - sodium bicarbonate - sorbitol - L-leucine - Macrogol 6000 - sodium saccharin - orange flavor
PHARMACEUTICAL FORM AND CONTENT
Effervescent tablets.
Box containing 20 tablets
MARKETING AUTHORISATION HOLDER
S.F. GROUP S.R.L.
VIA TIBURTINA, 1143
00156 ROMA
MANUFACTURER:
E-Pharma Trento S.p.A. - Via Provina, 2 – 38040 Ravina (TN)