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Flucoldstad
OTC

Flucoldstad is fixed-combination of paracetamol, caffeine and phenylephrine that is indicated for the relief of sinus pain and the symptoms of colds and influenza, including fatigue and drowsiness.

Pack size Box of 100 tablets
Shelf-life 36 months
Composition Paracetamol, Caffeine, Phenylephrine hydrochloride
Dosage forms and strengths Film-coated tablet:
Paracetamol: 500 mg; Caffeine: 25 mg; Phenylephrine hydrochloride: 5 mg
Product code :

PRESCRIBING INFORMATION

Indications

  • For the relief of sinus pain and the symptoms of colds and influenza, including fatigue and drowsiness.

Dosage

  • Adults, children aged 16 years and over and the elderly: 2 tablets every 4 – 6 hours as required. Do not take more than 8 tablets in 24 hours.
  • These doses should not be repeated more frequently than every 4 hours.
  • Do not take continuously for more than 7 days without medical advice.
  • Do not exceed the stated dose.
  • Use the lowest amount needed to achieve benefit for the shortest duration of treatment.
  • Not recommended for children under the age of 16 years.

Usage

  • Flucoldstad is orally administered.
  • Hypersensitivity to any of the ingredients.
  • Concomitant use of other sympathomimetic decongestants.
  • Phaeochromocytoma.
  • Closed angle glaucoma.
  • Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease.
  • Patients taking tricyclic antidepressants or beta-blocking drugs.
  • Patients who are taking or who have taken IMAO within the last two weeks.

Paracetamol

  • Adeverse reactions of paracetamol are rare and usually mild.
  • Thrombocytopenia, agranulocytosis.
  • Anaphylaxis, cutaneous hypersensitivity reactions including skin rashes, angiodema. Very rare cases of serious skin reactions have been reported.
  • Bronchospasm.
  • Hepatic dysfunction.

Caffeine

  • Excitability, dizziness and headache.
  • Nervousness, insomnia, restlessness, anxiety and irritability.
  • Palpitations.
  • Gastrointestinal disturbances.

Phenylephrine

  • Increased blood pressure.
  • Nervousness.
  • Headache, dizziness, insomnia.
  • Nausea, vomiting.

When experiencing adverse reactions of the drug, it is advised to stop using the drug and notify the physicians or go to the nearest medical facility for timely treatment.

  • When detecting first signs of skin rash or any other hypersensitivity reactions, patients should stop using the drug. Who have already had serious skin reactions caused by paracetamol shouldn’t use the medicine again and should inform the medical staff to know about this issue.
  • Patients should be advised not to take other paracetamol-containing products concurrently. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
  • Concomitant use of other decongestants or cold and flu medicines should be avoided.
  • The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Underlying liver disease increases the risk of paracetamol-related liver damage.
  • This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
  • Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
  • Do not exceed the stated dose.
  • If symptoms persist consult your doctor.
  • Consult your doctor if you are taking warfarin.
  • Flucoldstad contains azo colouring agents (sunset yellow, tartrazine) which may cause allergic reactions.
  • This drug is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy.
  • This product should not be used while breast-feeding without medical advice because caffeine in breast milk may have a stimulating effect on breast-fed infants and phenylephrine may be excreted in breast milk.
  • Patients should be advised not to drive or operate machinery if affected by dizziness.