Fluimucil Special Precautions

Effervescent tab/Powd for oral soln: Effervescent tablets, granules and tablets containing 600mg acetylcysteine cannot be used in children under 12 years (and in children with cystic fibrosis under 6 years).
The simultaneous administration of an antitussive drug is not reasonable from a medical point of view (see as follows).
Caution is recommended in patients with a risk for gastrointestinal haemorrhage (for example, in latent peptic ulcer or oesophageal varices), as orally administered acetylcysteine can induce vomiting.
Due to the risk of bronchospasm, caution is also recommended in patients with bronchial asthma and a hyper-reactive bronchial system.
When hypersensitivity reactions or bronchospasm occur, the medicine should be discontinued immediately, and if necessary appropriate measures must be taken.
The use of acetylcysteine might, mainly at treatment start, fluidify bronchial secretions and promote expectoration. If the patient is not able to effectively expectorate, it can be supported with postural drainage and broncho-aspiration.
Acetylcysteine leads in vitro to an inhibition of diamine oxidase (DAO) by 20-50%.
Therefore, caution should be used in patients with histamine intolerance.
The simultaneous administration of antitussive drugs may, by suppressing the cough reflex and the physiological self-cleaning of the respiratory tract, result in congestion of the mucus with a risk of bronchospasm and respiratory tract infection.
Mucolytic agents may cause respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, the physiological self-cleaning ability may be limited. Therefore, mucolytic agents should not be used in children under 2 years of age (see "Contraindications").
Excipients of particular interest: Fluimucil granules (100 mg and 200 mg) contains 25 mg of aspartame for each sachet. In case of patients suffering from phenylketonuria, it should be considered that aspartame is a source of phenylalanine.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product, as the pharmaceutical form granules contain glucose and lactose.
Patients with rare hereditary problems of fructose intolerance, e.g. hereditary deficiency of fructose-1,6-diphosphatase, should not take this medicinal product, as the pharmaceutical form granules contain sorbitol (that will be metabolized into fructose).
Fluimucil, effervescent tablets contain 20 mg of aspartame. In case of patients suffering from phenylketonuria, it should be considered that aspartame is a source of phenylalanine. Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicinal product,as the pharmaceutical form effervescent tablets contain glucose.
Fluimucil 600 mg effervescent tablets contain 156,9 mg sodium per effervescent tablet, equivalent to 7,8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
The maximum daily dose of Fluimucil 200 mg effervescent tablets (e.g. 600 mg) corresponds to 23, 5% of the WHO recommended maximum daily sodium intake and has to be considered high in sodium. This should be considered in patients following a low sodium diet.
In such cases, the use of Fluimucil granules or tablets, which are sodium-free, or an alternative salt-free acetylcysteine preparation is advisable.
Syrup: A productive cough must not be suppressed since this is a fundamental part of the bronchopulmonary defense mechanism.
The combination of a mucolytic with a cough suppressant medicine and/or a substance that dries out secretions (atropinic drug) is not rational.
Mucolytic agents can cause excessive bronchial congestion in infants. This is because their bronchial mucus drainage capacities are limited by the specific physiological characteristics of their airways. These agents must not be used in infants therefore (see Contraindications).
Caution is advised when the product is used in patients with a peptic ulcer or a history of peptic ulcer disease, especially when used concomitantly with other medicinal products known to irritate the mucous membrane of the gastrointestinal tract.
Patients with bronchial asthma must be closely monitored during treatment. In the event of bronchospasm, acetylcysteine must be stopped immediately and appropriate treatment initiated.
Bronchial secretions may become more fluid and increase in volume, particularly at the start of treatment with acetylcysteine. If a patient is unable to cough up the secretions effectively, postural drainage and broncho-aspiration should be performed.
Acetylcysteine may have a moderate effect on histamine metabolism; consequently, caution is required if this medicinal product is given as long-term treatment in patients with histamine intolerance due to the potential development of intolerance symptoms (headaches, vasomotor rhinitis, pruritus).
A mild sulfur odour does not indicate a change in the medicinal product but is a property of the active substance itself.
This medicinal product contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).
This medicinal product contains 38.21 mg sodium per 10-mL measuring cup, equivalent to 1.9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicinal product contains 15 mg of sodium benzoate per 10-mL measuring cup.
This medicinal product contains 4.88 mg of alcohol (ethanol) per 10-mL measuring cup. The quantity per 10-mL measuring cup of this medicinal product is equivalent to at least 1 mL of beer or 1 mL of wine.
The small quantity of alcohol in this medicinal product is not likely to cause any noteworthy effects.
This medicinal product contains 23.4 mg of propylene glycol per 10-mL measuring cup.
Treatment must be re-assessed if the symptoms or condition persist or worsen.
Effects on ability to drive and use machines: N-acetylcysteine has no effect on the ability to drive vehicles or use machines.