Descrizione Clinica
RELEFAST
Description
Class IIb invasive medical device that is presented in the form of a liquid solution on an oily basis, of yellow colour and with a characteristic odor. The product is presented in a glass bottle with a pumped dropper screwed on the bottle itself.
Oleous solution indicated in the treatment in case of: dyspeptic disorders, gastroenteric meteorism, aerophagia and gaseous colics in infants, children and adults.
The above device is a valid aid in alleviating those harassed symptoms, such as cramps and abdominal pains, recorded in children, infants and adults with gaseous colics. The product contributes to reducing the surface tension of excess gases that accumulate at gastro-enteric level by exploiting the anti-foam power of the symeticons contained in it.
Mode of use
Single dose: 20 drops of product contain 40 mg of Simeticone.
Adults (from 12 years on): 20-40 drops, possibly to be diluted in a liquid, 2-4 times a day preferably after meals or according to medical advice.
Children (2-12 years): 20 drops preferably after meals and possibly to dilute in a liquid 1-3 times a day or according to medical advice.
Milk quotations (0-2 years): 20 drops preferably after meals and possibly to dilute in a liquid 1-2 times a day or according to medical advice.
Shake before use. Close the bottle well after use.
Components
Symeticons in oleous emulsion, vitamin E, coenzyme Q10, silica.
Without gluten.
Warnings
Do not use in case of hypersensitivity known to the product components.
The device is not subject to particular precautions of use, it is warned, however:
- do not use the product for more than 30 days.
- the product could come with two separate steps. As a result of agitation, the same must be presented as a homogeneous emulsion.
- Keep out of the 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 properly preserved product.
- Do not use the product if the packaging does not appear integral.
- 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 suspend the use of the product and consult the doctor in order to establish suitable therapy.
- During use, if an accidental pollution of the dropper is suspected, wash it well before reinserting it in the appropriate bottle to prevent possible contamination.
- Do not use in case of suspected intestinal or ileo perforation.
In the event of a serious accident occurred in relation to the medical device, report the episode to the manufacturer and the Competente Authority.
Compliance with the instructions contained in the package leaflet reduces the risk of unwanted effects.
It is important to report to the doctor or pharmacist the appearance of unwanted effects not described in this leaflet.
In case of therapies with drugs based on levotiroxine or carbamazepine, use Rilefast CE only after medical advice.
We do not recommend the concomitant use of SIMETICONE with:
- laxatives based on mineral oils (paraffin), since the combination of these two products reduces its effectiveness;
- products based on Cefradina, Gliclazide, Cimetidina, Ranitidina, Chinidina, Cefuroxima, Fenitoin as the interaction potentially limits the absorption of these products;
- pyastrinic or anticoagulant anti-aggregant drugs, such as warfarine or acetylsalicylic acid, as it can increase the risk of bleeding, especially in conjunction with a low intake of vitamin K.
Pregnancy: there is no adequate data on the use of the product in pregnant women; therefore, it should not be used unless a real need and after evaluation by the doctor.
Breasting: it is not known if Simeticone is excreted in breast milk; therefore, it should not be used unless a real need and after evaluation by the doctor.
Guide: there are no effects on the ability to drive and the use of machines.
Undesirable effects
Like all products based on symeticons, this medical device can cause unwanted effects although not all people manifest them.
Tell your doctor if, during use of the device, note the following side effects:
- vomiting, diarrhea, abdominal pain, ileo, nausea;
- rashes on the skin;
- swelling of the face, eyes, lips, tongue, throat with difficulty breathing (angioedema).
Such effects occur very rarely.
Conservation
Store at room temperature. Store the package well closed and sheltered from heat sources.
Validity of whole packaging: 36 months.
Post-opening validation: 1 month.
Format
20 ml bottle.
Class IIb invasive medical device that is presented in the form of a liquid solution on an oily basis, of yellow colour and with a characteristic odor. The product is presented in a glass bottle with a pumped dropper screwed on the bottle itself.
Oleous solution indicated in the treatment in case of: dyspeptic disorders, gastroenteric meteorism, aerophagia and gaseous colics in infants, children and adults.
The above device is a valid aid in alleviating those harassed symptoms, such as cramps and abdominal pains, recorded in children, infants and adults with gaseous colics. The product contributes to reducing the surface tension of excess gases that accumulate at gastro-enteric level by exploiting the anti-foam power of the symeticons contained in it.
Mode of use
Single dose: 20 drops of product contain 40 mg of Simeticone.
Adults (from 12 years on): 20-40 drops, possibly to be diluted in a liquid, 2-4 times a day preferably after meals or according to medical advice.
Children (2-12 years): 20 drops preferably after meals and possibly to dilute in a liquid 1-3 times a day or according to medical advice.
Milk quotations (0-2 years): 20 drops preferably after meals and possibly to dilute in a liquid 1-2 times a day or according to medical advice.
Shake before use. Close the bottle well after use.
Components
Symeticons in oleous emulsion, vitamin E, coenzyme Q10, silica.
Without gluten.
Warnings
Do not use in case of hypersensitivity known to the product components.
The device is not subject to particular precautions of use, it is warned, however:
- do not use the product for more than 30 days.
- the product could come with two separate steps. As a result of agitation, the same must be presented as a homogeneous emulsion.
- Keep out of the 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 properly preserved product.
- Do not use the product if the packaging does not appear integral.
- 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 suspend the use of the product and consult the doctor in order to establish suitable therapy.
- During use, if an accidental pollution of the dropper is suspected, wash it well before reinserting it in the appropriate bottle to prevent possible contamination.
- Do not use in case of suspected intestinal or ileo perforation.
In the event of a serious accident occurred in relation to the medical device, report the episode to the manufacturer and the Competente Authority.
Compliance with the instructions contained in the package leaflet reduces the risk of unwanted effects.
It is important to report to the doctor or pharmacist the appearance of unwanted effects not described in this leaflet.
In case of therapies with drugs based on levotiroxine or carbamazepine, use Rilefast CE only after medical advice.
We do not recommend the concomitant use of SIMETICONE with:
- laxatives based on mineral oils (paraffin), since the combination of these two products reduces its effectiveness;
- products based on Cefradina, Gliclazide, Cimetidina, Ranitidina, Chinidina, Cefuroxima, Fenitoin as the interaction potentially limits the absorption of these products;
- pyastrinic or anticoagulant anti-aggregant drugs, such as warfarine or acetylsalicylic acid, as it can increase the risk of bleeding, especially in conjunction with a low intake of vitamin K.
Pregnancy: there is no adequate data on the use of the product in pregnant women; therefore, it should not be used unless a real need and after evaluation by the doctor.
Breasting: it is not known if Simeticone is excreted in breast milk; therefore, it should not be used unless a real need and after evaluation by the doctor.
Guide: there are no effects on the ability to drive and the use of machines.
Undesirable effects
Like all products based on symeticons, this medical device can cause unwanted effects although not all people manifest them.
Tell your doctor if, during use of the device, note the following side effects:
- vomiting, diarrhea, abdominal pain, ileo, nausea;
- rashes on the skin;
- swelling of the face, eyes, lips, tongue, throat with difficulty breathing (angioedema).
Such effects occur very rarely.
Conservation
Store at room temperature. Store the package well closed and sheltered from heat sources.
Validity of whole packaging: 36 months.
Post-opening validation: 1 month.
Format
20 ml bottle.
