NAME OF PHARMACEUTICAL PRODUCT: VISCOTEINA®, Carbocysteine (I.N.N.)
PHARMACEUTICAL FORM: VISCOTEINA® is presented in the form of an aqueous oral solution.
COMPOSITION: One ml contains:
Carbocysteine (I.N.N.) …………………………………............………………………………… 50 mg
Excipients: Water, saccharose 0.3 g, sodium hydroxide 15 mg (8.625 mg of sodium), sodium methylparaben (E219) (0.2378 mg of sodium), caramel aroma, sodium propylparaben (E217) (0.0455 mg of sodium), sodium saccharine (0.0239 mg of sodium), caramel colouring (E150), s.q.
PHARMACOLOGICAL ACTION: VISCOTEINA® contains as its only active ingredient, carbocysteine (S-carboxymethyl-L-cysteine), a mucous regulator with expectorant properties and certain local anti-inflammatory properties.
The normalisation of the rheological properties of bronchial mucous after treatment with carbocysteine is very favourable to contribute to the easy drainage of the mucous by the combined action of the mucociliary system and the coughing mechanism. On the other hand, there are some indications that suggest that carbocysteine could have a beneficial effect on the mucociliary funtion itself when it is at a reduced level.
By these mechanisms, VISCOTEINA® achieves a change in the characteristics of the mucous, increases the volume and fluidity of expectoration and other mucous secretions, un-blocks the airways to reduce difficulties in breathing and the frequency of coughing attacks.
INDICATIONS: VISCOTEINA® is a drug indicated in the treatment of diseases that imply an increase of the volume and viscosity of the secretion of mucous in the upper air ways, bronchial arbour and middle ear.
These diseases include: sinusitis, rhinitis, pharyngitis, laryngitis, tracheitis, bronchorrhea, acute bronchitis, exacerbations of chronic bronchitis, bronchiectasia, emphysema, cystic fibrosis, effusive otitis of the middle ear and ototubaritis.
The possibility should be considered that the disease being treated is of an infectious nature, since in cases of concomitant bacterial infection the relevant antibiotic treatment should be established.
INTERACTIONS WITH OTHER MEDICINES: Cimetidine inhibits one of the metabolic methods (sulphoxidation) of carbocysteine, and a small increase in the seric levels of carbocysteine is possible, although it has no clinical impact.
It is not advisable to administer VISCOTEINA® together with antitussive products and/or drugs that dry secretions (atropinic drugs, for example), since its effect would be reduced.
Do not associate with excessively acid or alkaline media nor with heavy metals.
- Hypersensitivity to the drug or any of its components.
- Active peptic ulcer.
- First term of pregnancy
PRECAUTIONS: Should be used with caution in patients with a background of having suffered from gastro-duodenal ulcer.
SECONDARY EFFECTS: Generally, this drug is well tolerated and does not produce important systemic effects. Very occasionally digestive disorders, stomach-ache, nausea, diarrhoea, headache and rashes may appear, which are generally of minor importance and short duration. They disappear when medication is suspended.
IMPORTANT FOR WOMEN
If you are pregnant or suspect that you may be, consult your doctor before taking this medicine. The use of this medicine during pregnancy could be dangerous for the embryo or the foetus and should be watched by your doctor.
Warning about excipients
This medicine contains 4.5 g of saccharose for each 15ml dose; 1.5 g for each 5 ml dose; 0.750 g for each 2.5 ml dose; which should be taken into consideration by patients suffering hereditary fructose intolerance, problems associated with glucose/galactose absorption, saccharase- isomaltase deficiency and diabetic patients.
Since this medicine contains 133.983 mg of sodium for each 15 ml dose; 44.661 mg for each 5 ml dose; 22.3305 mg for each 2.5 ml dose; it can harmful in patients with diets poor in sodium.
DOSAGE AND METHOD OF ADMINISTRATION
Adults and children over 12 years: 15 ml (750 mg), three times a day.
Children 5-12 years: 5 ml (250 mg), three times a day.
Children 2-5 years: 2.5 ml (125 mg), three times a day
Children below 2 years: it is not recommended the administration
TREATMENT IN CASE OF AN OVERDOSE: The high level of tolerance of VISCOTEINA® means that the possibility of intoxication is practically nil. The intake of large amounts of carbocysteine could produce stomach-ache, nausea, vomiting and diarrhoea. Be alert to the possible appearance of lesions to the gastrointestinal mucous.
In case of an overdose or accidental intake, consult the Toxicological Information Service.
EXPIRY: This medicine should not be used after the date of expiry indicated on the box.
CONSERVATION: Protect from direct light.
PRESENTATION: Bottle contains 200 ml oral solution.
WITHOUT MEDICAL PRESCRIPTION
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