Product Description
Espumisan is a medicinal product containing simethicone as the active ingredient. It is used to alleviate gastrointestinal discomfort and may also be employed as an adjunct in diagnostic procedures.
Ingredients
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Active substance: Simethicone 40 mg per capsule
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Excipients: Methylparaben (E218), glycerol, colorants – Quinoline Yellow (E104), Sunset Yellow FCF (E110)
Dosage and Administration
Espumisan should be taken exactly as described in the patient information leaflet or as directed by a physician or pharmacist. In case of doubt, consult a healthcare professional.
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For gastrointestinal discomfort due to excessive gas, e.g., bloating:
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Children ≥6 years, adolescents, and adults: 2 capsules (80 mg simethicone) 3–4 times daily.
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For preparation for diagnostic procedures (e.g., abdominal radiology, ultrasound, gastroscopy):
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Day before procedure: 2 capsules, 3 times daily (240 mg simethicone total)
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Morning of procedure: 2 capsules (80 mg simethicone)
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Espumisan may be taken before, during, or after meals, and if needed, before bedtime. It is also suitable for postoperative use.
Mechanism of Action
Simethicone reduces gas-related discomfort by breaking down gas bubbles in the gastrointestinal tract. The released gas can then be absorbed or expelled naturally. Simethicone acts only physically and does not participate in chemical reactions. It is pharmacologically and physiologically inert, not absorbed from the gastrointestinal tract, and is excreted unchanged.
Indications
Espumisan is indicated for:
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Symptomatic treatment of gastrointestinal discomfort associated with excessive gas, such as bloating, fullness, belching, and intestinal rumbling
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Postoperative bloating
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Preparation for abdominal radiological or ultrasonographic examinations and gastroscopy
Espumisan may be used in children ≥6 years, adolescents, and adults.
Contraindications
Do not use Espumisan if the patient is hypersensitive to:
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Simethicone
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Sunset Yellow FCF (E110)
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Methylparaben (E218)
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Any other excipient in the product
Adverse Reactions
Hypersensitivity reactions have been reported with simethicone-containing products, including urticaria, rash, redness, pruritus, allergic dermatitis, and other skin reactions. Frequency is unknown.
Warnings and Precautions
Read the patient information leaflet carefully. Consult a physician or pharmacist if new or persistent abdominal symptoms occur, to exclude underlying conditions requiring treatment.
Espumisan contains Sunset Yellow (E110) and methylparaben, which may cause allergic reactions, possibly delayed in the case of methylparaben.
Interactions
No known drug interactions.
Pregnancy and Lactation
Simethicone is not absorbed from the gastrointestinal tract, and harmful effects on pregnancy or lactation are not expected. Clinical data on Espumisan use in pregnant women are limited. Consult a physician before use.
Use in Children and Adolescents
Not recommended for children under 6 years or infants. Other formulations are available for younger children.
Driving and Operating Machinery
Espumisan has no or negligible effect on the ability to drive and operate machinery.
