COLDREX Tablet Ref.[115926] Active ingredients: Caffeine Paracetamol Phenylephrine Vitamin C

Adults and children older than 12 years

1-2 tablets taken every 4-6 hours, if required.

Intervals between administrations – not less than 4 hours.

Do not exceed 8 tablets in 24 hours.

Children

Not recommended for children under 12 years.

Method of administration

Coldrex Tablets are for oral administration only.

This product is not recommended to be used during more than five days as an analgesic and three days as an antipyretic without a consultation with doctor. Increasing of daily dose or prolongation of a treatment is possible only under medical supervision.

Consult a doctor if symptoms persist.

Do not exceed the stated dose. In case of overdosing immediately seek for medical help, even if you feel well.

Symptoms of overdosing by this medicine are often caused by paracetamol.

Paracetamol

Overdosing with paracetamol may result in liver damage. Immediate medical help is required in case of overdosing, even if sings of overdosing are absent.

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors:

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, hypoglycemia, bleeding, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Symptoms may be limited with nausea or vomiting and may not indicate the severity of overdosing or risk of damage of other organs.

Administration of activated charcoal may be beneficial when performed within one hour of the overdose but can be considered for up to four hours after the overdose. Paracetamol concentration in plasma should be assessed in 4 hours and later post ingestion (earlier measures of concentration are unreliable).

Antidotes such as N-acetylcysteine (NAC) and methionine protect the liver if administered within 24 hours of overdose, however the maximum treatment effect is reached when NAC is administered until 8 hours passed after paracetamol administration. NAC should be administered intravenous in accordance with stated dosing schedule. If vomiting is an option, then administration of methionine is an alternative for distant areas. Treatment of patients with liver dysfunction must be carried out at specialized units.

Treatment: if treatment is started within 10 hours after paracetamol administration, then gastric lavage can be used. If more than 10 hours passed, then hemoperfusion may be required. Symptomatic treatment.

Phenylephrine hydrochloride

Symptoms of overdosing with phenylephrine hydrochloride: hypertension, palpitation, arrhythmia, irritability, anxiety, convulsions, difficulty with excretory, urine retention, hallucination and difficulty with breathing.

Treatment: symptomatic. Treatment is directed to recover breathing and control of arterial pressure. Evident hypertension may require the use of adrenoblockers such as phetolamine. In convulsions anti-consulsives must be administered.

Caffeine

Symptoms: epigastric pain, vomiting, increased diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

Treatment: there is no specific antidote, but supportive therapy must be used, such as antagonists of beta-blockers may relief cardiotoxic effect.

Symptoms of overdosing with ascorbic acid: nausea, abdominal discomfort, diarrhea (when more than 3000 mg is taken).

Four years. Should not be used after expiry date stated on a pack.

Store below 25°C.

Tablets. 12 tablets in blister (PVC/aluminum foil). One blister is packed in one cardboard cartons with patient information leaflet.

None stated.