BBcolic

Information

The device is not subject to any special precautions for use; however, the following warnings apply:

• The product may appear as two separate phases; after shaking, it should appear as a homogeneous emulsion.
• Keep out of reach of children.
• Do not exceed the recommended doses.
• Do not use the product after the expiry date; the expiry date refers to the unopened and properly stored product.
• Do not use the product if the packaging is damaged.
• All components of the product, including the dropper, must be intact.
• Do not use the product for more than 30 days after opening.
• If no improvement is observed after 7 days of treatment, consult a doctor.
• In the event of adverse reactions, discontinue use of the product and consult a doctor in order to establish appropriate therapy.
• During use, if accidental contamination of the dropper is suspected, wash it thoroughly before reinserting it into the bottle to prevent possible contamination.
• Compliance with the instructions provided in the package leaflet reduces the risk of undesirable effects.
• It is important to inform your doctor or pharmacist of any undesirable effects not described in this leaflet.
• Do not use in cases of suspected intestinal perforation or ileus.
• Do not use in cases of known hypersensitivity to one or more components of the product.
• Keep the bottle tightly closed, away from heat sources, and store at room temperature. Do not use if improperly stored.

Like all simethicone-based products, this medical device may cause side effects, although not everybody experiences them.

It is recommended to inform your doctor if, during the use of BBcolic, the following side effects occur:

• vomiting, diarrhea, abdominal pain or ileus, nausea;
• skin rash;
• swelling of the face, eyes, lips, tongue, or throat with difficulty breathing (angioedema).

These effects occur very rarely.

No cases of overdose have been reported.

No interactions with other drugs or incompatibilities with other pharmaceutical products are known or have been reported. However, the literature reports one case of interaction between simethicone and levothyroxine; therefore, in the case of therapy with levothyroxine-based medicines, BBcolic should only be used following medical advice.

Pregnancy: there are no adequate data on the use of the product in pregnant women; therefore, it should not be used unless clearly necessary and after medical evaluation.

Breastfeeding: it is not known whether simethicone is excreted in breast milk; therefore, it should not be used unless clearly necessary and after medical evaluation.