SimetiCarbon
CE 0426 Class IIa medical device.
Medical device able to effectively relieve symptoms related to bloating of both the stomach (aerophagia) and the intestine (meteorism) due to gas build-up. Eases associated cramps and pain and prevents flatulence and belching.
Components | | per 1 bilayer tablet |
| Simethicone | 50 mg |
| Charcoal | 300 mg |
| Excipients: maltodextrins; sucrose; microcrystalline cellulose; hydroxypropyl methylcellulose; polyvinylpyrrolidone; colloidal silica; croscarmellose sodium; polyvinylpolypyrrolidone; glyceryl behenate; silicon dioxide; vegetable magnesium stearate. |
Mechanism of action The effectiveness of the device is due to the antifoaming action of simethicone, combined with the adsorbent action of activated charcoal on intestinal gases: the action is therefore based exclusively on mechanical phenomena. The bilayer structure of the tablet releases about 50% of the ingredients in the gastric environment within 15 minutes of taking the device, while complete disintegration of the tablet takes place in the intestinal environment within 1 hour. The components are not absorbed in the gastrointestinal tract and do not interfere with the absorption of nutrients.
Directions for use Adults - take 1 or 2 tablets at the end of each main meal, up to a maximum of 4 tablets a day.
Young people aged 14 to 18 - 1 tablet at the end of each main meal, up to a maximum of 2 tablets a day.
Remove the tablet from the blister taking care not to break it and swallow it with a glass of water.
Known side effects At the recommended doses, brown colouring of the stools may be observed due to the presence of charcoal. This is completely normal and has no pathological significance. No known medium/long-term side effects are reported. The device does not adversely affect sensory abilities (level of attention, ability to drive or carry out activities.
Warnings and precautions Do not use under 14 years of age.
Do not exceed the recommended daily dose.
Keep the device out of the reach of children.
For people with swallowing difficulties, it is advisable to take the medical device with plenty of water.
Do not use the device after the expiry date shown on the pack and blister.
Do not use if the pack is damaged.
Each tablet is single-use and should be removed from the pack only immediately before taking it; do not attempt to reuse partially used tablets (crushed or broken) or tablets removed from the blister at unknown times, as this could involve a risk of contamination of the product.
Do not use in the presence of known gastric or intestinal lesions.
Do not use in case of intestinal obstruction.
Do not take the medical device at the same time as other oral devices or medicinal products: the adsorbent power of activated charcoal and simethicone could reduce their effectiveness. Consult your doctor if you are undergoing drug therapy.
Simethicone may interfere with the effect of some reagents used in diagnostics, such as guaiac gum.
Contraindications and limitations of useTaking the device is not recommended in case of known hypersensitivity of the user to any of the components.
As there are insufficient data to support use during pregnancy or breastfeeding, in these cases use the device only when truly necessary and only after consulting your doctor.
Storage Store the tablets in the blister in a dry place away from direct light or heat sources: remove the tablets only at the time of use. Store the device below 25 °C.
Pack size Pack of 40 single-use bilayer tablets in blister.
