Source: Medicines Authority (MT) Revision Year: 2023 Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Daleron COLD3 relieves signs and symptoms of cold and flu in adults and children over 12 years of age:
The recommended dose for adults and children over 12 years of age is 2 tablets. The dose can be repeated up to 4 times daily. The dosing interval should be at least 4 hours. The maximum daily dose of paracetamol is 4 g.
The recommended doses should not be exceeded.
The drug is contraindicated in children under 12 years of age (see section 4.3).
The drug should be given with caution to patients with renal insufficiency (see section 4.4).
The drug is contraindicated in patients with severe renal impairment (see section 4.3).
The drug should be given with caution to patients with hepatic dysfunction (see section 4.4).
The drug is contraindicated in patients with severe hepatic impairment (see section 4.3).
Caution is required in the elderly.
Oral use.
The tablet should be swallowed with liquid.
Doses much higher than the recommended ones (>7.5 g in adults) may cause severe hepatic and renal impairment. In children, signs of acute overdose become evident at doses exceeding 150 mg/kg body weight. Signs of acute overdose are manifested within the first 24 hours as nausea, vomiting, increased sweating and abdominal pain. Signs of hepatic impairment occur only 2 to 4 days after the intake of an overdose. Treatment is symptomatic. The specific antidote in paracetamol overdose is N-acetylcysteine, which should be administered within the first 12 hours following the overdose.
After the intake of an overdose, the undesirable effects are exacerbated, especially restlessness, irritability, tremor, hallucinations, cramps, hypertension, cardiac arrhythmias, nausea and vomiting. Symptoms usually occur 4 to 8 hours after the ingestion of an overdose, are transient and no treatment is usually necessary. Gastric lavage is a measure in acute overdosage that has to be carried out within 4 hours following the overdose. Activated charcoal is effective only if it is taken within 1 hour following the overdose. If the kidneys are not affected, an increase in the diuresis may promote the elimination of the active substance from the body. If there are signs of cardiac toxicity, intravenous propranolol may be given and diazepam in the event of delirium or cramps.
Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, insomnia, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG, including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In the event of massive overdose, the following symptoms may be observed: coma, respiratory depression, convulsions.
Gastric lavage is required if doses higher than 10 mg/kg body weight have been taken. Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of dextromethorphan within the preceding hour. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses for treatment of opioid overdose, can be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome can be used.
5 years.
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
Blister (Al foil, PVC/PVDC foil): 12 film-coated tablets (1 blister of 12 tablets), in a box.
Blister (Al foil, PVC/PVDC foil): 24 film-coated tablets (2 blisters of 12 tablets), in a box.
Not all pack sizes may be marketed.
No special requirements.
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