Acetylcysteine Angeneric 200mg Powder For Oral Solution

Sachets based on N-acetylcysteine.

Therapeutic indications

Acetylcysteine Angenerico is used in:

• Treatment of respiratory diseases characterized by thick and viscous hypersecretion: acute bronchitis, chronic bronchitis and its exacerbations, pulmonary emphysema, mucoviscidosis and bronchiectasis.
• Antidotic treatment: Accidental or voluntary intoxication with paracetamol. Uropathy due to iso- and cyclophosphamide.

Dosage and Posology

The drug should be taken according to the following doses and methods:

• Adults: 1 sachet of Angeneric Acetylcysteine 2-3 times a day

For the prevention of exacerbations it is recommended to use the sachets of Acetylcysteine Angenerico 200 mg powder for oral solution. The duration of the therapy is 5-10 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.

Accidental or deliberate intoxication with paracetamol: orally, initial dose, 140 mg / kg body weight to be administered as soon as possible, within 10 hours of taking the toxic agent, followed every 4 hours and for 1 to 3 days by single doses of 70 mg / kg of weight. Iso- and Cyclophosphamide Uropathy In a typical course of iso- and cyclophosphamide chemotherapy of 1,200 mg / m2 body surface area per day for 5 days every 28 days, acetylcysteine can be administered orally at a dose of 4 g / day in the days of chemotherapy treatment, distributed in 4 doses of 1 g.

Dissolve the contents of the sachet in a glass containing a little water, mixing as needed with a teaspoon. The powder can also be dissolved in fruit juice or iced tea. The mucolytic effect of acetylcysteine is favored by the intake of liquids.

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 product components and other closely related substances from a chemical point of view.
• Generally contraindicated in pregnancy and breastfeeding
• The drug is contraindicated in children under 2 years of age, with the exception of antidotic treatment

Side effects

Below is a table relating to the frequency of adverse reactions that occurred after taking N-acetylcysteine by mouth:

- Disorders of the immune system

• Common: hypersensitivity
• Very rare: Anaphylactic shock, anaphylactic / anaphylactoid reaction

- Nervous system disorders

• Common: Headache

- Ear and labyrinth disorders

• Common: Tinnitus

- Cardiac pathologies

• Common: Tachycardia

- Vascular pathologies

• Very rare: Hemorrhage

- Respiratory, thoracic and mediastinal disorders:

• Rare: Bronchospasm, dyspnoea
• Not known: Bronchial obstruction

- Gastrointestinal disorders

• Uncommon: Vomiting, diarrhea, stomatitis, abdominal pain, nausea
• Rare: Dyspepsia

- Skin and subcutaneous tissue disorders

• Uncommon: Urticaria, rash, angioedema, pruritus

- General disorders and administration site conditions

• Uncommon: Pyrexia
• Very rare: Edema of the face

- Diagnostic tests

• Uncommon: Reduced blood pressure

In very rare cases, severe skin reactions have occurred in temporal connection with the intake of N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell 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 consult your doctor and the intake of N-acetylcysteine must be stopped immediately. Some studies have confirmed a reduction in platelet aggregation when taking N-acetylcysteine. The clinical significance of these findings has not yet been defined.

Pregnancy and breastfeeding

Even if the teratological studies conducted with Mucolytic Angeneric Acetylcysteine on animals did not show any teratogenic effect, however, as for other drugs, its administration during pregnancy and during the lactation period, should be carried out only in case of actual need under the direct medical supervision.

Special warnings

Patients with bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, treatment should be stopped immediately. The use of the medicinal product in patients with peptic ulcer or with a history of peptic ulcer requires particular attention, especially in the case of concomitant use of other drugs with a known gastric-damaging effect. The administration of acetylcysteine, especially at the beginning of the treatment, can thin the bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid secretion retention. Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the 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. The possible presence of a sulphurous odor does not indicate alteration of the preparation, but is typical of the active ingredient contained therein.

In the case of diabetic subjects or those who follow low-calorie diets, it should be borne in mind that the preparation in sachets contains sugar in an amount corresponding to about ½ teaspoonful of each sachet. Angeneric Acetylcysteine Powder for oral solution contains Sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store in the original carton and outer carton.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One sachet of Angeneric Acetylcysteine contains:

Active principle

N-acetylcysteine 200 mg

Excipients

Sucrose - ascorbic acid - saccharin - orange flavor