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Analgesics & Antipyretics

Flucoldstad

 

Pack size:

Box of 10 blisters x 10 tablets.

 

Composition:

Each film-coated tablet contains paracetamol 500 mg, caffeine 25 mg

and phenylephedrine hydrochloride 5 mg.

 

Shelf-life:       

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • For the relief of sinus pain and the symptoms of colds and influenza, including fatigue and drowsiness.
  • Administered orally.
  • Adults, children aged 12 years:
    1-2 tablets, twice a day, up to 4 times a day. (Not more than 8 tablets a day).
  • These doses should not be repeated more frequently than every four hours.
  • Do not take continuously for more than 7 days without medical advice.


Or as advised by physicians.

 

  • Hypersensitivity to any ingredient of the drug.
  • 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.
  • Who are taking or who have taken IMAO within the last two weeks.

     

Paracetamol

  • Adverse effects of paracetamol are rare and usually mild, although haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Skin rashes and other hypersensitivity reactions occur occasionally.

Caffeine

  • Adverse CNS effects of caffeine include insomnia, restlessness, nervousness, and mild delirium.

Phenylephrine

  • Cause a prolonged rise in blood pressure.
  • It induces tachycardia or reflex bradycardia.

     

  • Impaired kidney or liver function, alcohol dependence.
  • History of peptic ulcer.
  • Symptomatic cardiac arrhythmias, palpitation.
  • Prostatic hypertrophy.
  • Bradycardia.
  • Severe arteriosclerosis.
  • Peripheral or mesenteric vascular thrombosis.
  • Patients should be advised to discontinue the drug and consult a clinician if symptoms persist more than 7 days or are accompanied by fever, or if nervousness, dizziness, or insomnia develops during therapy.
  • Use drug containing phenylephrine with caution in children and the elderly.
  • The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell's syndrome, acute generalized exanthematous pustulosis (AGEP).
  • Pregnancy: 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.
  • Lactation: 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.
  • Effects on ability to drive and use machines: Patients should be advised not to drive or operate machinery if affected by dizziness.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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