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Drug Details

Lemsip Max Cold and Flu Capsules

• Drug Class Description
  analgesic and antipyretic / stimulant
• Generic Name
  Paracetamol, caffeine, phenylephrine hydrochloride
• Presentation
  Red/yellow hard gelatine capsules
• Description
  Paracetamol : 500 mg/capsule Caffeine : 25 mg/capsule Phenylephrine hydrochloride : 6.1 mg/capsule
• Indications
  

  For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion, and lowering of temperature.

• Adult Dosage
  

  Adults and children 12 years and over:

  Two capsules every 4-6 hours to a maximum of 4 doses in any 24 hours.

  Do not exceed 8 capsules in any 24 hours.

  Swallow whole with water. Do not chew.

• Child Dosage
  

  Do not give to children under 12 years.

• Contra Indications
  

  Paracetamol: Hypersensitivity to paracetamol or any of the other constituents.

  Caffeine: Should be given with care to patients with a history of peptic ulcer.

  Phenylephrine hydrochloride: Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

• Special Precautions
  

  Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

  Use with caution in patients with Raynaud's Phenomenon and diabetes mellitus.

  Phenylephrine

  Phenylephrine should be used with care in patients with cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.

• Interactions
  

  Paracetamol

  The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

  The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

  Medicinal products which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose.

  Phenylephrine hydrochloride

  Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors.

  Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

  Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The risk of hypertension and other cardiovascular side effects may be increased.

  Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects with phenylephrine.

  Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.

  Caffeine

  Caffeine undergoes extensive metabolism by hepatic microsomal cytochrome P450, factors known to alter the activity of this enzyme system may influence caffeine clearance. Thus, caffeine elimination is enhanced in cigarette smokers and inhibited by cimetidine, disulfiram, and oral contraceptive steroids.

• Adverse Drug Reactions
  

  Paracetamol

  Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

  Acute pancreatitis after ingestion of above normal amounts.

  Phenylephrine hydrochloride

  High blood pressure with headache and vomiting, probably only in overdose. Rarely, palpitations. Also, rare reports of allergic reactions and occasionally urinary retention in males.

  Caffeine

  The most commonly reported adverse events following dosing with caffeine are GI irritation and CNS stimulation. Adverse CNS effects include insomnia, restlessness, nervousness and mild delirium; adverse GI effects include nausea, vomiting and gastric irritation