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Symptomatic relief of gases in adults, children and infants.
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1. What is Entero-Silicona and what it is used.
The active ingredient of Entero-Silicona is simethicone, which belongs to a group of medicines that act in the intestine destroying gas bubbles, facilitating their elimination and relieving the discomfort.
It is indicated for the symptomatic relief of gases in adults, children and infants.
You should consult a doctor if worsens or does not improve after 10 days.
2. What you need to know before you start taking Enterococcus Silicone.
Do not take Entero-Silicona if:
- If you are allergic to simethicone or any of the other ingredients of this medicine (listed in section 6).
- Drilling or intestinal obstruction.
Warnings and Precautions:
Consult your doctor or pharmacist before you start taking Entero-Silicona if symptoms worsen or persist, or in case of prolonged constipation, consult your doctor.
Taking Full-Silicone with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Use of Entero-Silicona with food and drink:
It has no known effects of interaction with food or drink. Use preferably after meals.
Pregnancy and lactation:
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
Driving and using machines:
Entero-Silicona has no known effects on the ability to drive or operate machinery.
Entero-Silicona contains methyl parahydroxybenzoate and 96 percent ethanol:
It can produce (possibly delayed) allergic reactions because it contains methyl parahydroxybenzoate.
This product contains 0.04% (v / v) ethanol 96 percent (alcohol), this small amount corresponds to 0.3 mg / ml.
3. Taking Full-Silicone.
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt ask your doctor or pharmacist.
The recommended dose in adults and children over 12 years old dose is 10 ml or 1 tablespoon (90 mg simethicone) 3 times a day. Do not administer more than 55 ml or 5 tablespoons and a half large (495 mg simethicone) per day.
Use in children:
Children from 0 to 2 years old:
The recommended dose is 2.5 ml or ½ teaspoon (22.5 mg simethicone) administered 3 times a day with a bottle or other food or liquid. Do not administer more than 25 ml or 5 teaspoons (225 mg simethicone) per day.
Children 2 to 12 years old:
The recommended dose is 5 ml or 1 teaspoon (45 mg simethicone) 3 times a day.
Do not administer more than 25 ml or 5 teaspoons (225 mg simethicone) per day.
Entero-Silicona is administered orally after meals. Shake the bottle before utilitzación.
If you take more Entero-Silicona should:
No cases of overdose are known.
Even if an amount much higher than indicated ingested, is unlikely to produce adverse effects due to the lack of digestive absorption of the medicine. In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call poison control center, phone: (+34) 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Entero-Silicona:
Do not take a double dose to make up for missed doses.
4. Possible side effects.
Like all medicines, Entero-Silicona can cause side effects, although not everybody gets them.
They have reported the following adverse reactions with a frequency not known (can not be estimated from available data):
- Nausea and constipation.
- Hypersensitivity reactions such as rash, itching, swelling of the face or tongue, difficulty breathing.
Communication adverse effects:
If you experience any side effects, talk to your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet. You can also communicate directly through the Spanish Pharmacovigilance System for Medicinal Products for Human Use Web page: http.//www.notificaram.es.
By communicating adverse effects you can help provide more information on the safety of this medicine.
5. Entero-Silicona Conservation.
Keep this medicine out of the sight and reach of children.
It does not require any special storage conditions.
Do not use Entero-Silicona after the expiration date on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. Contents of the pack and other information.
- The active ingredient is simethicone. Each ml of oral emulsion contains 9 mg of simethicone.
- The other ingredients are: carmellose sodium (E-466), sodium saccharin (E-954), methyl parahydroxybenzoate (E 218), polyvinyl alcohol, aniseed (96 percent ethanol and propylene glycol) and purified water. See section 2 "Full Silicone contains methyl parahydroxybenzoate and 96 percent ethanol."
Looks like and contents of the pack:
Entero-Silicona is available in bottles of 250 ml and 150 ml of oral emulsion.
Oral emulsion is an opaque white liquid which may have phase separation but homogenized by stirring.
Authorization holder responsible for marketing and manufacturing:
LABORATORY ESTEDI S.L.
Leopoldo Alas 7-Montseny 41 08012 Barcelona (Spain)
ALDO-UNION LABORATORY S.A
Baronne de Malda, 73
08950 Esplugues de Llobregat Barcelona (Spain)
Source: Spanish Agency for Medicines and Health Products