Description

Calpol Six Plus Suspension Sugar Free is a paracetamol-based oral suspension designed for children aged 6 years and older. Here are the key details about the product:

Product Overview

• Active Ingredient: Each 5 ml of the suspension contains 250 mg of paracetamol.
• Formulation: It is sugar-free and flavored with strawberry, making it more palatable for children.
• Volume: Available in an 80 ml bottle.

Indications

Calpol Six Plus is indicated for:

• Relief of mild to moderate pain (e.g., headaches, toothaches, earaches).
• Fever reduction, including post-immunization fever and symptoms associated with colds and flu

Dosage Guidelines

The recommended dosages are as follows:

• Children aged 6 to 8 years: 5 ml up to 4 times a day.
• Children aged 8 to 10 years: 7.5 ml up to 4 times a day.
• Children aged 10 to 12 years: 10 ml up to 4 times a day.
• Children aged 12 to 16 years: 10-15 ml up to 4 times a day.

It is crucial to leave at least 4 hours between doses and not exceed 4 doses in any 24-hour period. The medicine should not be administered for more than 3 consecutive days without consulting a healthcare professional

Key Benefits

• Pain Relief: Provides effective relief for mild to moderate pain, including headaches, toothaches, and earaches.
• Fever Reduction: Acts as an antipyretic, helping to lower fever associated with colds, flu, and post-immunization reactions.
• Sugar-Free Formula: Suitable for children who require sugar-free medications, minimizing the risk of dental issues and accommodating dietary restrictions.
• Palatable Flavor: The strawberry flavor enhances acceptance among children, making it easier to administer.

Key Ingredients

• Active Ingredient:
  • Paracetamol: Each 5 ml of suspension contains 250 mg of paracetamol, which is the primary ingredient responsible for pain relief and fever reduction.
• Excipients:
  • Maltitol Liquid (E965): A sugar substitute that provides sweetness without calories from sugar.
  • Sorbitol Liquid (E420): Another sugar substitute that has a mild laxative effect in higher doses.
  • Glycerol: Used as a sweetener and to maintain moisture.
  • Propylene Glycol (E1520): A solvent and humectant that helps dissolve other ingredients.
  • Methyl Parahydroxybenzoate (E218) and Propyl Parahydroxybenzoate (E216): Preservatives that help prevent microbial growth.
  • Benzyl Alcohol: A preservative that may cause allergic reactions in sensitive individuals.

  • Mechanism of Action

    Paracetamol (Acetaminophen)

    • Analgesic Effect: Paracetamol works by inhibiting the synthesis of prostaglandins in the brain. Prostaglandins are chemicals that promote inflammation, pain, and fever. By reducing their production, paracetamol alleviates pain and discomfort associated with various conditions such as headaches, toothaches, and muscle aches
    • Antipyretic Effect: Paracetamol acts on the hypothalamus, the part of the brain that regulates body temperature. It helps to lower fever by promoting heat loss through vasodilation (widening of blood vessels) and sweating, effectively helping to bring down elevated body temperatures associated with infections or other illnesses

    Absorption and Distribution

    • After oral administration, paracetamol is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations are typically reached within 30 minutes to 2 hours post-dosing Its distribution throughout the body allows it to exert its effects on pain and fever efficiently.

    Metabolism

    • Paracetamol is metabolized primarily in the liver through conjugation with glucuronic acid and sulfate. A small fraction is converted to a toxic metabolite (N-acetyl-p-benzoquinone imine, or NAPQI), but this is usually detoxified by glutathione. In cases of overdose or in individuals with compromised liver function, this detoxification pathway can be overwhelmed, leading to potential toxicity

    Safety Profile

    • Paracetamol is generally well-tolerated when used at recommended doses. However, it is crucial to adhere to dosing guidelines to avoid liver damage due to overdose
    • 

    • Key Precautions

      • Age Restrictions: Calpol Six Plus is not recommended for children under 6 years of age. Alternative formulations should be sought for younger children
      • Allergic Reactions: Do not give this medication if your child is allergic to paracetamol or any other ingredients in the suspension. Signs of an allergic reaction may include skin rashes, swelling, or difficulty breathing
      • Pre-existing Conditions: Consult a healthcare professional if your child has:
        • Severe liver or kidney disease: This can affect how the body processes paracetamol, increasing the risk of toxicity
        • Fructose intolerance: The product contains maltitol and sorbitol, which could cause gastrointestinal discomfort in those with this condition
        • Metabolic acidosis risk: If your child has a severe infection, they may be at increased risk for metabolic acidosis, which requires immediate medical attention if symptoms arise (e.g., rapid breathing, nausea, vomiting)
      • Medication Interactions: Avoid giving Calpol Six Plus if your child is taking other medications that contain paracetamol or certain anticoagulants (e.g., warfarin). Always consult a doctor or pharmacist before combining medications

      • Dietary Restrictions and Precautions

        • Fructose Intolerance: Children with hereditary fructose intolerance should avoid this product. It contains both sorbitol and maltitol, which can cause gastrointestinal discomfort in these individuals
        • Sodium Content: Calpol Six Plus Suspension contains less than 1 mmol of sodium (23 mg) per 5 ml, making it essentially sodium-free. However, parents should still be cautious if their child is on a strict sodium-restricted diet
        • Sugar-Free Consideration: While the suspension is sugar-free, it does contain sweeteners like maltitol and sorbitol, which may have a mild laxative effect. Diabetics should also consider the carbohydrate content of these ingredients
        • Allergic Reactions: The suspension contains preservatives such as methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions in sensitive individuals. If your child has known allergies, consult a healthcare professional before administration
        • Other Health Conditions: Consult a doctor if your child has:
          • Severe liver or kidney disease
          • Is underweight or malnourished
          • A history of gastrointestinal issues
          • Chronic alcoholism or dehydration

          • Key Interactions

            • Paracetamol Overdose Risk: Avoid administering any other products that contain paracetamol while giving Calpol Six Plus. This is crucial to prevent overdose, which can lead to severe liver damage
            • Anticoagulants: Prolonged use of paracetamol may enhance the anticoagulant effect of warfarin and other coumarins, increasing the risk of bleeding. Occasional doses typically do not have a significant effect, but caution is advised with regular use
            • Drugs Inducing Hepatic Enzymes: Medications such as carbamazepine, phenytoin, and phenobarbital may accelerate the metabolism of paracetamol, potentially increasing the risk of hepatotoxicity if overdoses occur
            • Gastrointestinal Motility Agents: The absorption of paracetamol can be increased by metoclopramide or domperidone, while cholestyramine may reduce its absorption
            • Flucloxacillin: Caution is advised when using paracetamol concurrently with flucloxacillin due to an increased risk of high anion gap metabolic acidosis, particularly in patients with renal impairment or other risk factors
            • Alcohol: Chronic alcohol consumption can increase the risk of hepatotoxicity associated with paracetamol overdose. Acute alcohol intake may also impair the metabolism of paracetamol, prolonging its plasma half-life and increasing toxicity risk
              • Store Calpol Six Plus Suspension in a cool, dry place, away from direct sunlight.
              • Keep the bottle tightly closed and out of reach of children to prevent accidental ingestion.
              • The suspension should not be used after the expiration date indicated on the packaging

                Dosage

                The recommended dosage of Calpol Six Plus varies based on the child’s age:

                • Children aged 6 to 8 years: 5 ml (one teaspoon) up to four times a day.
                • Children aged 8 to 10 years: 7.5 ml (one and a half teaspoons) up to four times a day.
                • Children aged 10 to 12 years: 10 ml (two teaspoons) up to four times a day.
                • Children aged 12 to 16 years: 10 to 15 ml (two to three teaspoons) up to four times a day.
                • Adults and children over 16 years: 10 to 20 ml (two to four teaspoons) up to four times a day.

                Important Guidelines

                • Do not exceed four doses in any 24-hour period.
                • Ensure at least 4 hours between doses.
                • Do not use for more than 3 consecutive days without consulting a healthcare professional

                Storage

                • Store Calpol Six Plus Suspension in a cool, dry place, away from direct sunlight.
                • Keep the bottle tightly closed and out of reach of children to prevent accidental ingestion.
                • The suspension should not be used after the expiration date indicated on the packaging

                Reviews

                While specific user reviews were not included in the search results, Calpol products generally receive positive feedback from parents for their effectiveness in relieving pain and fever in children. Many appreciate the sugar-free formulation, which is suitable for children with dietary restrictions. Users often highlight its palatable taste, making it easier for children to take.