Justeen Pharmaceauticals Limited

COL-COL TABLETS

Paracetamol, Phenylephrine HCI, Chlorpheniramine Maleate & Caffeine Tablets

• QUALITATIVE AND QUANTITATIVE COMPOSITION

  Each uncoated tablet contains:
  Paracetamol BP: 500mg
  Phenylephrine Hydrochloride BP: 5mg
  Chlorpheniramine Maleate USP: 2mg
  Caffeine Anhydrous BP: 15mg
  Excipients: QS
  Approved Colors used
  

• PHARMACEUTICAL DOSAGE FORM

  For oral administration.

• CLINICAL PARTICULARS

  Therapeutic indications

  COL-COL is indicated for the relief of symptoms associated with colds and flu such as fever, nasal decongestants, headache and minor aches and pains.

  Posology and method of administration

  Adults: Maximum Recommended 4 tablets per a Day

  Children (6-12 Years): Maximum Recommended 2 tablets per day.

  Not recommended for children under 6 years of age.

  Repeat three times daily. Do not use continuously for more than ten (10) days without consulting your doctor.

  Contraindications

  Patients hypersensitive to any of the ingredients. Severe liver disease.

  Phenylephrine HCl: Contra-indicated in most types of cardiovascular disease, including angina and hypertension, and also in hyperthyroidism and closed angle glaucoma

  Chlorpheniramine Maleate: Stenosing. peptic ulcer; symptomatic porostatic hypertrophy; asthmatic attack; bladder neck obstruction; pyloroduodenal obstruction.

  Caffeine: Contraindicated to patients with porphyria.

  Special warnings and precautions for use

  WARNINGS:
  Severe hypertensive episodes leading to intracranial haemorrhage have followed phenylephrine ingestion. Do not drive a motor vehicle, operate dangerous machinery or perform potentially dangerous tasks.

  PRECAUTION:
  COL-COL Tablet contains Paracetamol and therefore should not be used in conjunction with other after taking COL-COL medication. Paracetamol containing products.

  COL-COL Tablet should be used with caution in patients with renal or hepatic dysfunction, diabetes mellitus.

  Interaction with other medicinal products and other forms of interaction

  Clinically significant drug interactions may occur on concomitant administration of COL-COL Tablet with Monoamine Oxidase inhibitors, Tricyclic antidepressants, Beta-adrenergic agents, Methyldopa, Reserpine and Veratrum alkaloids.

  Pregnancy and lactation

  Not recommended in pregnancy and lactating mothers.

  Undesirable effects

  Prolonged excessive use may cause irreversible kidney damage, anxiety, fear, restlessness, tremor, irritability, confusion, weakness, headache, sedation varying from slight drowsiness to deep sleep.

  Overdose

  Paracetamol:
  Symptoms of over dosage include nausea and vomiting, Liver damage, which may be foetal. It may only appear after a few days. Kidney failure has been described following acute intoxication.

  Phenylephrine HCL:
  Psychotic states, cardiac arrest. Overdose may be fatal especially in children in whom the main symptoms are central nervous system stimulation, ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia.

  Chlorpheniramine Maleate:
  Symptoms of over dosage may include convulsions and hyperpyrexia. : over dosage may lead to maniacal behaviour, diuresis and repeated vomiting with extreme thirst, tremor, delirium.

  Caffeine:
  An acute overdose of Caffeine, usually in excess dose, dependent on body weight and level of Caffeine tolerance, can result in a state of Central Nervous System over-stimulation called Caffeine intoxication. It may include restlessness, nervousness, excitement, insomnia, flushing of the face, and psychomotor agitation.

• PHARMACOLOGICAL PROPERTIES

  Pharmacodynamic properties

  Paracetamol is an analgesic and antipyretic compound. Phenylephrine HCI is a decongestant of the mucous membrane of the respiratory tract. Chlorpheniramine is an antihistamine for cases in which allergic symptoms are a factor may due to inhibition of nasal discharge.

  Caffeine is a bitter, white crystalline Xanthine alkaloid that is a CNS stimulant drug.

  Pharmacokinetic properties

  Paracetamol is metabolised by the hepatic microsomal enzymes. It is rapidly and completely absorbed from the gastro-intestinal tract. The plasma half-life is one to three hours and It is uniformly distributed throughout the body.

  Phenylephrine hydrochloride is irregularly absorbed from the gastro-intestinal tract. When injected intramuscularly it takes 10- 15 minutes to act and subcutaneous and intramuscular injections are effective for about one hour.

  Chlorpheniramine Maleate is well absorbed when administered orally. Maximum concentration to the plasma is seen about 2 hours from the intake.

  Caffeine is readily absorbed from the gastro-intestinal tract.

• PHARMACEUTICAL PARTICULARS

  Special precaution for storage

  Store below 25 ?C in a well closed container protected from light.
  KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.