Acc 600 mg Effervescent tablets

ACC On The Go or effervescent tablets are used as a mucolytic in acute respiratory conditions.

Posology: ACC 600 (effervescent tablets): Adults and adolescents from 14 years of age: u03a9 effervescent tablet twice daily or 1 effervescent tablet once daily (equivalent to 600 mg acetylcysteine per day). ACC On The Go: For adults only: 1 sachet once daily (equivalent to 600 mg acetylcysteine per day). ACC On The Go is not suitable for use in adolescents and children.

Method of administration: ACC 600 (effervescent tablets): The effervescent tablets are taken dissolved in a glass of water after meals. Duration of use: ACC 600 effervescent tablets should not be taken for more than 14 days without medical advice. ACC On The Go: The oral powder of one sachet should be placed directly on the tongue. The oral powder stimulates salivation so the oral powder can be swallowed easily. The oral powder should not be chewed before swallowing. Can be taken without water. Elderly and weakened patients: Patients with a reduced cough reflex (elderly and weakened patients) should take the oral powder preferably in the morning. Duration of use: ACC On The Go should not be taken for more than 14 days without medical advice. Paediatric patients: Due to the high content of active substance, acetylcysteine 600 mg should not be used in children less than 14 years of age.

Hypersensitivity to acetylcysteine and/or any of the other ingredients of ACC 600. Safety in pregnancy has not been established. ACC 600 should not be used during pregnancy (see section 4.6). Active peptic ulceration.

ACC 600 should be used with caution in asthmatic patients. If bronchospasm occurs, the use of acetylcysteine must be stopped immediately and appropriate treatment initiated. ACC 600 should be used with caution in patients with a history of peptic ulcer disease, both because drug-induced nausea and vomiting may increase the risk of gastrointestinal haemorrhage in patients predisposed to the condition, and because of a theoretical risk that mucolytics may disrupt the gastric mucosal barrier. The use of acetylcysteine, especially in early treatment can lead to liquefaction and thus to an increase in volume of bronchial secretions. If the patient is unable to sufficiently expectorate, appropriate measures (such as drainage and aspiration) should be performed. The occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyellu00eds syndrome has very rarely been reported in temporal connection with the use of acetylcysteine. If cutaneous and mucosal changes occur, consult your health care provider without delay and use of acetylcysteine be terminated (see section 4.8).

Intolerance: Caution is advised in patients with histamine intolerance. Treatment with acetylcysteine for longer periods should be avoided in such patients, as acetylcysteine affects histamine metabolism and can result in symptoms of intolerance (e.g. headache, runny nose, itching). ACC 600 effervescent tablets contains lactose anhydrous. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take ACC 600 effervescent tablets. ACC 600 effervescent tablets contains lactose anhydrous, which may have an effect on the glycaemic control of patients with diabetes mellitus.

ACC On The Go contains aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Combined administration of ACC 600 with antitussives may cause a dangerous secretory congestion due to the reduced cough reflex, so that an especially careful diagnosis is required for this combination treatment. Tetracycline hydrochloride (with the exception of doxycycline) and other oral antibiotics must be administered separately from ACC 600 and with an interval of at least 2 hours. The concomitant administration of acetylcysteine can potentially result in an intensification of the vasodilatory and inhibition of platelet aggregation effects of glyceryl trinitrate (nitroglycerine). If concomitant treatment with glyceryl trinitrate and acetylcysteine is considered necessary, patients should be monitored for the possible development of hypotension, which can be serious, and advised of the possibility of headaches. Activated charcoal in high doses (as an antidote) can reduce the effectiveness of acetylcysteine. Acetylcysteine can affect the colorimetric determination of salicylates. In urine tests, acetylcysteine can affect the results of determinations of ketone bodies. The dissolution of ACC 600 together with other medicines is not recommended.

Safety and efficacy of acetylcysteine in pregnancy and lactation have not been established (see section 4.3).

Fertility: Data concerning effects of acetylcysteine on human fertility are not available. In animal studies, no harmful effects on fertility were observed for therapy-relevant doses of acetylcysteine.

Pregnancy: There are no adequate clinical data from the use of acetylcysteine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. ACC 600 should not be used during pregnancy.

Breastfeeding: No information is available regarding excretion of acetylcysteine or its metabolites into breast milk. A risk for the breast-fed child cannot be excluded. The use of acetylcysteine during breastfeeding is not recommended.

ACC 600 has no known effect on the ability to drive and use machines.

Immune system disorders: Less frequent: Hypersensitivity reactions. Frequency unknown: Anaphylactic shock, anaphylactic / anaphylactoid reactions.

Nervous system disorders: Less frequent: Headache, convulsions, syncope.

Eye disorders: Less frequent: Blurred vision.

Ear and labyrinth disorders: Less frequent: Tinnitus.

Cardiac disorders: Less frequent: Tachycardia.

Vascular disorders: Less frequent: Haemorrhage, hypertension.

Respiratory, thoracic and mediastinal disorders: Less frequent: Dyspnoea, bronchospasm - predominantly in patients with hyperactive reactive bronchial system in association with bronchial asthma.

Gastrointestinal disorders: Less frequent: Nausea, vomiting, diarrhoea, abdominal pain, stomatitis. Frequency unknown: Dyspepsia.

Hepato-biliary disorders: Less frequent: Disturbances of the liver function, acidosis.

Skin and subcutaneous tissue disorders: Less frequent: *Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, rash, angioedema, itching, exanthema, pruritus, flushing.

Musculoskeletal, connective tissue and bone disorders: Less frequent: Arthralgia.

General disorders and administration site conditions: Less frequent: Fever, hypotension. Frequency unknown: Facial oedema. *Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine. If skin or mucous membrane abnormalities develop, the use of acetylcysteine must be discontinued immediately. A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by different studies. The clinical relevance has not yet been clarified to date.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are requested to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Suspected adverse reactions may also be reported directed to the Holder of Certificate of Registration (HCR) via the link: https://pvi1j.solutions.iqvia.com or the e-mail address, [email protected].

Overdoses may lead to gastrointestinal symptoms, such as nausea, vomiting and diarrhoea. Infants are at risk of hypersecretion. Treatment of overdose is supportive and symptomatic.