Description
RILEFAST
Description
Class IIb invasive medical device that comes in the form of a liquid solution on an oily basis, yellow in color and with a characteristic odor. The product is presented in a glass bottle equipped with a pump dropper screwed onto the bottle itself.
Oily solution indicated in the treatment of: dyspeptic disorders, gastrointestinal meteorism, aerophagia and gas colic in infants, children and adults.
The above device is a valid aid in alleviating those annoying symptoms, such as cramps and abdominal pain, recorded in children, infants and adults suffering from gas colic. The product helps reduce the surface tension of excess gases that accumulate at the gastrointestinal level by exploiting the anti-foaming power of the simethicone contained in it.
How to use
Single dose: 20 drops of product contain 40 mg of Simethicone.
Adults (12 years and older): 20-40 drops, possibly diluted in liquid, 2-4 times a day, preferably after meals or as advised by your doctor.
Children (2-12 years): 20 drops preferably after meals and possibly diluted in a liquid 1-3 times a day or according to the doctor's advice.
Infants (0-2 years): 20 drops preferably after meals and possibly diluted in a liquid 1-2 times a day or according to the doctor's advice.
Shake before use. Close the bottle tightly after use.
Components
Simethicone in oily emulsion, vitamin E, coenzyme Q10, silica.
Gluten free.
Warnings
Do not use in case of known hypersensitivity to any component of the product.
The device is not subject to any particular precautions for use, however, we warn you:
- do not use the product for more than 30 days.
- the product may present itself with two separate phases. After shaking it should present itself 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 intact and correctly stored product.
- Do not use the product if the packaging is not intact.
- All components that make up the product including the dropper must be intact.
- After a short period of treatment (7 days) without appreciable results, consult your doctor.
- In case of adverse reactions, discontinue use of the product and consult your doctor in order to establish appropriate therapy.
- During use, if you suspect accidental contamination of the dropper, wash it thoroughly before reinserting it into the appropriate bottle to prevent possible contamination.
- Do not use if intestinal or ileal perforation is suspected.
In the event of a serious incident involving the medical device, report the incident to the Manufacturer and the Competent Authority.
Following the instructions in the package leaflet reduces the risk of side effects.
It is important to report to your doctor or pharmacist the appearance of side effects not described in this leaflet.
In case of therapy with drugs based on levothyroxine or carbamazepine, use Rilefast CE only after consulting a doctor.
The concomitant use of SIMETICONE with:
- laxatives based on mineral oils (paraffin), as the combination of these two products reduces their effectiveness;
- products based on Cefradine, Gliclazide, Cimetidine, Ranitidine, Quinidine, Cefuroxime, Phenytoin as the interaction potentially limits the absorption of these products;
- antiplatelet or anticoagulant drugs, such as warfarin or acetylsalicylic acid, as they may increase the risk of bleeding, especially in conjunction with low vitamin K intake.
Pregnancy: There are no adequate data on the use of the product in pregnant women; therefore, it should not be used unless really necessary and after evaluation by the doctor.
Breastfeeding: It is not known whether Simethicone is excreted in breast milk; therefore, it should not be used unless really necessary and after evaluation by the doctor.
Driving: No effects on the ability to drive or use machines have been reported.
Side effects
Like all simethicone products, this medical device can cause side effects, although not everybody gets them.
Inform your doctor if you notice the following side effects while using the device:
- vomiting, diarrhea, abdominal pain, ileus, nausea;
- skin rashes;
- swelling of the face, eyes, lips, tongue, throat with difficulty breathing (angioedema).
Such effects occur very rarely.
Conservation
Store at room temperature. Keep the package tightly closed and away from heat sources.
Validity with intact packaging: 36 months.
Validity after opening: 1 month.
Format
20 ml bottle.
Class IIb invasive medical device that comes in the form of a liquid solution on an oily basis, yellow in color and with a characteristic odor. The product is presented in a glass bottle equipped with a pump dropper screwed onto the bottle itself.
Oily solution indicated in the treatment of: dyspeptic disorders, gastrointestinal meteorism, aerophagia and gas colic in infants, children and adults.
The above device is a valid aid in alleviating those annoying symptoms, such as cramps and abdominal pain, recorded in children, infants and adults suffering from gas colic. The product helps reduce the surface tension of excess gases that accumulate at the gastrointestinal level by exploiting the anti-foaming power of the simethicone contained in it.
How to use
Single dose: 20 drops of product contain 40 mg of Simethicone.
Adults (12 years and older): 20-40 drops, possibly diluted in liquid, 2-4 times a day, preferably after meals or as advised by your doctor.
Children (2-12 years): 20 drops preferably after meals and possibly diluted in a liquid 1-3 times a day or according to the doctor's advice.
Infants (0-2 years): 20 drops preferably after meals and possibly diluted in a liquid 1-2 times a day or according to the doctor's advice.
Shake before use. Close the bottle tightly after use.
Components
Simethicone in oily emulsion, vitamin E, coenzyme Q10, silica.
Gluten free.
Warnings
Do not use in case of known hypersensitivity to any component of the product.
The device is not subject to any particular precautions for use, however, we warn you:
- do not use the product for more than 30 days.
- the product may present itself with two separate phases. After shaking it should present itself 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 intact and correctly stored product.
- Do not use the product if the packaging is not intact.
- All components that make up the product including the dropper must be intact.
- After a short period of treatment (7 days) without appreciable results, consult your doctor.
- In case of adverse reactions, discontinue use of the product and consult your doctor in order to establish appropriate therapy.
- During use, if you suspect accidental contamination of the dropper, wash it thoroughly before reinserting it into the appropriate bottle to prevent possible contamination.
- Do not use if intestinal or ileal perforation is suspected.
In the event of a serious incident involving the medical device, report the incident to the Manufacturer and the Competent Authority.
Following the instructions in the package leaflet reduces the risk of side effects.
It is important to report to your doctor or pharmacist the appearance of side effects not described in this leaflet.
In case of therapy with drugs based on levothyroxine or carbamazepine, use Rilefast CE only after consulting a doctor.
The concomitant use of SIMETICONE with:
- laxatives based on mineral oils (paraffin), as the combination of these two products reduces their effectiveness;
- products based on Cefradine, Gliclazide, Cimetidine, Ranitidine, Quinidine, Cefuroxime, Phenytoin as the interaction potentially limits the absorption of these products;
- antiplatelet or anticoagulant drugs, such as warfarin or acetylsalicylic acid, as they may increase the risk of bleeding, especially in conjunction with low vitamin K intake.
Pregnancy: There are no adequate data on the use of the product in pregnant women; therefore, it should not be used unless really necessary and after evaluation by the doctor.
Breastfeeding: It is not known whether Simethicone is excreted in breast milk; therefore, it should not be used unless really necessary and after evaluation by the doctor.
Driving: No effects on the ability to drive or use machines have been reported.
Side effects
Like all simethicone products, this medical device can cause side effects, although not everybody gets them.
Inform your doctor if you notice the following side effects while using the device:
- vomiting, diarrhea, abdominal pain, ileus, nausea;
- skin rashes;
- swelling of the face, eyes, lips, tongue, throat with difficulty breathing (angioedema).
Such effects occur very rarely.
Conservation
Store at room temperature. Keep the package tightly closed and away from heat sources.
Validity with intact packaging: 36 months.
Validity after opening: 1 month.
Format
20 ml bottle.
