Colludol 1 mg - 2 mg oromucos. spray emuls. spray cont. 30 ml

Colludol 30 spr

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Indications:

Symptomatic supportive treatment of painful conditions in the oro-pharynx, namely angina, pharyngitis, mouth ulcers, the effects of surgery on the tonsils.

Composition:

Hexamidine. diisethionas 1 mg - lidocaine. hydrochlorid. 2 mg - Glycerol. - Sacchar. - Fructus flavor passii synth. (derog. 42/960) - Persic. synth flavor. (derog. 42/961) - Menthol. - Aethanol. - Aqua Purif. q.s. ad 1 ml - Nitrogen. q.s. to 1 spray.

Posology and method of use:

Adults and children over 6 years: usually, 3 to 6 ; sprays per day, according to the state, to divide the day.
remove the protective cap on the valve and the spray bottle of places. The opening of the spray in the mouth and press. The solution is not swallowed. Ensure that the spray is not infected.

This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.

Contraindications:

Known hypersensitivity to diamidinederivaten, local anesthetics of the amide group of one or another component of the solution. Infection or serious injuries in the oro-pharynx. - Porphyria. - Do not use in infants and small children younger than 6 years, because the risk of rapid absorption of lidocaine and because of the risk of laryngeal spasm reflex and croup.

Special precautions:

Colludol is a symptomatic therapeutic agent. Without precise diagnosis of the responsible disease treatment should be limited to 1 week.
1.) For hexamidine. When prolonged or improper use (too frequent sprays) can hexamidine systemic effects.
2.) for lidocaine. - A prolonged or inappropriate use (too frequent sprays) may lead to an increased intake of lidocaine. This increases the risk of adverse effects and are more severe (see 'Undesirable effects'). - Lidocaine is metabolised in the liver. In hepatic must therefore reduced the dosage. - The dosage should also be reduced in patients with heart disease. - Careful use in children (over 6 years) and patients with a damaged mucosa, because of the risk of the absorption of excessive doses toxic symptoms occur (see 'Undesirable effects').

Pregnancy and lactation:

It is not advisable to use this medicine during pregnancy or lactation, because they have too few concrete facts in this connection and because of the risk of resorption a significant amount of lidocaine.

Undesirable effects:

1.) Caused by hexamidine.
So far, no human any systemic effect caused by hexamidine, observed (see 'special precautions'). Hexamidine sensitization may, in the form of a trigger contact dermatitis. The frequency depends on the severity of the damage and the number epidermisbarrière sprays. This contact dermatitis differs from the classical clinical area and contact dermatitis is characterized by skin rash, often with infiltration. The lesions with papules or papulovesiculeuze and hemispheric lesions are individually or grouped to have numerous and flow together at the application site and they also come insulated. The regression is often slow. This probably makes contact dermatitis using humoral immunological mechanisms.
2.) Caused by lidocaine.
Toxic reactions when applied externally are exceptions and are caused by an accidental transfer into the bloodstream (wound) after an overdose or too frequent use. Following phenomena were observed: - Central nervous system: agitation, yawning, tremor, anxiety, nystagmus, headache, nausea, tinnitus. These symptoms often evolve into seizures and a suppression of the central nervous system. - Respiratory System: then dyspnea and tachypnea. - Cardio-vascular: tachycardia and hypertension, then bradycardia and hypotension may, exceptionally evolve into cardiac arrest.
Lidocaine causes extremely rare hypersensitivity reactions.

Overdose:

when properly used the product, one should not fear overdose. If misused (often to squirt, to make an infected wound or mucous membranes, used in young children or infants, ...) can occur with an overdose of these are symptoms of a toxic reaction caused by lidocaine (see 'Undesirable effects' ).
Consideration of a possible overdose: oxygen therapy and assisted ventilation if necessary. For convulsions, as soon as possible an anticonvulsant (a benzodiazepine, a short-acting barbiturate) IV administration with simultaneous monitoring of cardiac and respiratory functions.

Interactions:

The concomitant or sequential use of various antiseptics should be avoided: drug interactions can occur (inactivation, antagonism).