ESPICOL BABY

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESPICOL BABY

Composition:

Active substance: simethicone;

1 ml of drops contains simethicone emulsion equivalent to simethicone 40 mg. Approximately 20 drops in 1 ml;

Excipients: caraway oil; fennel oil; sugar; methylparahydroxybenzoate (E 218); propylparahydroxybenzoate (E 216); disodium edetate; propylene glycol; sorbitol non-crystallizing solution; sodium hydroxide; purified water.

Pharmaceutical form. Oral drops.

White to almost white thick suspension.

Pharmacotherapeutic group.

Agents affecting the digestive tract and metabolism. Agents used in functional gastrointestinal disorders.

ATC Code A03A X13.

Pharmacological Properties

Pharmacodynamics

Simethicone reduces gas accumulation by eliminating it from the gastrointestinal tract. By reducing surface tension at the phase interface, it hinders the formation and promotes the breakdown of gas bubbles in the alimentary suspension and gastrointestinal mucus. The released gases can then be absorbed through the intestinal walls or expelled via peristalsis. This prevents the formation of large gas-mucus conglomerates that cause painful bloating.

Pharmacokinetics

Simethicone is not absorbed from the gastrointestinal tract following oral administration and is excreted in the feces unchanged. Due to its chemical inertness, it does not affect microorganisms or enzymes present in the gastrointestinal tract. It does not impair nutrient absorption, nor does it alter the reaction or volume of gastric juice.

Clinical characteristics.

Indications.

For symptomatic treatment of gastrointestinal disturbances associated with gas accumulation, such as in meteorism and infant colic. As an antifoaming agent in intoxications with surface-active substances (laundry detergents or other cleaning agents).

Contraindications.

Hypersensitivity to simethicone or to any of the excipients; complete intestinal obstruction.

Interaction with other medicinal products and other forms of interactions.

There are no reports indicating that simethicone affects the action of other medicinal products.

The antifoaming effect of simethicone may be reduced by antacids such as aluminium hydroxide and magnesium carbonate, which absorb silicon. Possible interference with the absorption of oral anticoagulants may occur.

Special precautions for use

Espicol Baby should be used with caution in patients with obstructive gastrointestinal disorders.

If gastrointestinal disturbances do not resolve or recur, a physician should be consulted.

The medicinal product contains sugar, which should be taken into account when prescribing it to patients with diabetes mellitus. Since the formulation contains sorbitol, this medicinal product should not be administered to patients with rare hereditary fructose intolerance. The medicinal product also contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (see section "Side effects*").

Use during pregnancy or breastfeeding.

Used in pediatric practice.

Ability to affect reaction speed while driving or operating machinery.

Used in pediatric practice.

Dosage and Administration.

Espicol Baby is intended for oral use.

The medication should be taken during or after meals, and if necessary, before bedtime.

The duration of treatment depends on the presence of symptoms and is determined individually by a physician.

For gastrointestinal disturbances caused by excessive gas accumulation:

• For infants, add 20 drops to the bottle with infant food at each feeding, or administer 20 drops from a spoon before or after breastfeeding;
• For children aged 1 to 6 years, administer 20 drops 3 to 5 times daily;
• For children aged 6 to 14 years, administer 20–40 drops 3–5 times daily;
• For children aged 14 years and older, administer 40 drops 3–5 times daily.

As an antidote in poisoning with surfactants:

For children, administer 52 drops or 2.5–10 mL depending on the severity of the condition.

Children.

The medication is used in pediatric practice.

Overdose.

There have been no reports of overdose cases to date. Since simethicone is chemically and physiologically inert, intoxication is practically impossible. Even large amounts of Espicol Baby are well tolerated without causing any symptoms of intoxication. In case of doses exceeding the recommended amounts, medical advice should be sought.

Side effects.

No adverse effects have been reported when the drug is used at the recommended doses.

Possible skin hypersensitivity reactions, including itching, rash, and urticaria.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate contained in the drops may cause allergic reactions (possibly delayed), and in individual cases – bronchospasm.

Shelf life. 2 years.

Storage conditions. Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 ml in a bottle; 1 bottle in a cardboard box together with a measuring pipette in an individual package.

Release category. Over-the-counter.

Manufacturer. Indoco Remedies Limited.

Manufacturer's address.

L-14, Verna Industrial Area, Verna, Goa IN-403 722, India