Acetylcysteine Teva 200mg Granules for Oral Solution 30 Sachets

Therapeutic indications

Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

Dosage

Adults: 1 sachet of ACETYLCYSTEINE TEVA 200 mg granules for oral solution 2-3 times a day. The duration of therapy is from 5 to 10 days in the acute forms and in the chronic forms it will be continued, in the opinion of the doctor, for periods of a few months. The use of the product is reserved for adults. How to use Dissolve the contents of a sachet in a glass containing a little water, mixing as needed with a teaspoon. The solution should be taken as soon as it is ready.

Overdose

No cases of overdose have been reported with respect to oral administration of N-acetylcysteine. Healthy volunteers, who for three months took a daily dose of N-acetylcysteine equal to 11.6 g, did not show any serious adverse reactions. Doses up to 500 mg NAC / kg body weight, administered orally, were tolerated without any symptoms of intoxication. Symptoms Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. Treatment There are no specific antidotic treatments; overdose therapy is based on symptomatic treatment.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Contraindicated in pregnancy and lactation (see section 4.6). Children under the age of 12.

Side effects

The following are the undesirable effects (and their frequency) that occurred after taking oral N-acetylcysteine, organized according to the MedDRA system organ class.

Organ-systemic classification	Adverse reactions
	Uncommon (≥1 / 1,000; <1/100)	Rare (≥1 / 10,000; <1 / 1,000)	Very rare (<1 / 10,000)	Not known
Disorders of the immune system	Hypersensitivity		Anaphylactic shock, anaphylactic / anaphylactoid reaction
Nervous system disorders	Headache
Ear and labyrinth disorders	Tinnitus
Cardiac pathologies	Tachycardia
Vascular pathologies			Hemorrhage
Respiratory, thoracic and mediastinal disorders		Bronchospasm, dyspnoea		Bronchial obstruction
Gastrointestinal disorders	Vomiting, diarrhea, stomatitis, abdominal pain, nausea	Dyspepsia
Skin and subcutaneous tissue disorders	Urticaria, rash, angioedema, pruritus
General disorders and administration site conditions	Pyrexia			Face edema
Diagnostic tests	Reduced blood pressure

In very rare cases, there has been the appearance of severe skin reactions 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 suspected drug more likely involved in the genesis of the aforementioned mucocutaneous syndromes has been identified, in case of mucocutaneous alterations it is advisable to discontinue the intake of N-acetylcysteine. Some studies have confirmed a reduction in platelet aggregation when taking N-Acetylcysteine. The clinical significance of these findings has not yet been defined. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

The administration of acetylcysteine during pregnancy and during the lactation period, should be carried out only in case of real need under the direct supervision of the doctor.

Special warnings

Patients with bronchial asthma must be closely monitored during therapy, if bronchospasm occurs, the treatment must be stopped immediately. Administer the medicinal product with particular care to patients with peptic ulcer or with a history of peptic ulcer, especially in case of concomitant use of other drugs with a known gastric-damaging effect. The administration of acetylcysteine, especially at the beginning of the treatment, by thinning the bronchial secretions, can increase the volume at the same time. If the patient is unable to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid secretion retention. The possible presence of a sulphurous odor does not indicate alteration of the preparation but is typical of the active ingredient contained therein. Important information about some of the excipients The medicine contains sucrose ( each dose of ACETYLCYSTEINE TEVA provides 2.24 g of sucrose ): therefore, this medicine should be taken with caution in subjects with rare hereditary fructose intolerance problems, glucose-galactose malabsorption and by insufficiency of sucrase – isomaltase. Furthermore, this sugar intake must be considered for administration in diabetic subjects or those following low-calorie diets.

Expiry and Retention

Store in the original package to protect the medicine from moisture.

Active principles

One sachet contains: Active substance: Acetylcysteine 200 mg Excipients with known effects : sucrose 2.24 g and sunset yellow (E110) For the full list of excipients, see section 6.1

Excipients

Granular orange juice; Orange flavor; Saccharin; Sunset yellow (E 110); Sucrose