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OTC - Other products - Baby Gaz

Keep out of the reach of children.
Read carefully the enclosed insert before use.
In case of any unexpected reaction consult your doctor or pharmacist.


COMPOSITION: Each 30 ml oral suspension contains:

Active ingredients: Simethicone ………………….  2000 mg

Excipients: Deionised water, polydimethylsiloxane, sorbitan monostearate, polyoxyethylene 20 sorbitan, silicon dioxide (Amorphous silica), xanthan gum, benzoic acid, sorbic acid, potassium hydroxide, hydrogen chloride, microcrystalline cellulose & carboxymethyl cellulose sodium, carboxymethyl cellulose sodium, citric acid anhydrous, sodium citrate, methyl paraben, propyl paraben, sorbitol 70%, strawberry flavor liquid, allura red, aspartame, purified water.


DESCRIPTION OF PACKAGING:

Bottle of 30 ml per box.2


Part 2

INFORMATION LEAFLET FOR HEALTHCARE PROFESSIONALS

Part 2


1. PHARMACODYNAMICS:

Pharmacotherapeutic group: Anti-flatulence
Simethicone lowers surface tension and facilitates gas dispersion by causing coalescence of gas bubbles in the GI tract, thus reduces the feeling of bloating or distention.


2. PHARMACOKINETICS:

Simethicone is physiologically inert; it does not appear to be absorbed from the GI tract or to interfere with gastric secretion or absorption of nutrients, following oral administration, the drug is excreted unchanged in the feces..


3. INDICATIONS:

Relief of the symptoms of excess gas in the digestive tract.


4. DOSAGE AND ADMINISTRATION:

Administration: Shake well before using.
Babygaz should be taken after meals and at bedtime, or as directed by a physician.
Product is presented as a bottle and a dropper with divided line. When using, squeeze the dropper to withdraw the directed doses. Reseal bottle with dropper.
Dosage:
Infants (under 2 years): 0.3 ml/time, four times daily. The dosage can also be mixed with 30 ml of cool water, infant formula or other suitable liquids to ease administration.
Children 2 – 12 years: 0.6 ml/time, four times daily.
Adults and children 12 years and over: 0.6 ml – 1.8 ml/time, four times daily.
Patients with liver and kidney failure: No dose adjustment is required in patients with liver and kidney failure due to simethicone does not be absorbed from the GI tract into the blood.


5. CONTRAINDICATIONS:

It is contraindicated in the patients known to be hypersensitivity to simethicone and other components.
Patients with known or suspected intestinal perforation and obstruction.


6. WARNINGS AND PRECAUTIONS:

Do not exceed 12 doses per day, unless directed by a physician.
Cautious use of this drug in cases of gastroesophageal esophageal reflux, nausea, vomiting, patients with fluid restriction.
This drug contains:
– Methyl paraben and propyl paraben which may cause allergic reactions (possibly delayed).
– Sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this drug.
– Aspartame: Patients with phenylketonuria and patients who have to limit phenylalanine intake should not use this drug.
– Allura red which may cause allergic reactions.
– 1.33 mg of benzoic acid per 30 ml of suspension. Benzoic acid increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
Pregnancy: Babygaz should be used in pregnancy only if essential.
Lactation: Since simethicone is not absorbed by the gastrointestinal tract, Babygaz may be taken during lactation.
Effects on ability to work: The product may cause dizziness. Patients should be cautious when driving, operating machinery, working at height and other activities.


7. INTERACTIONS:

Levothyroxine may bind to simethicone. Absorption of levothyroxine may be impaired if Babygaz is given concurrently to infants treated for thyroid disorders.


8. SIDE EFFECTS

Common, 1/100 < ADR < 1/10
Body as a whole: Abdominal pain, headache.
Digestive: Diarrhea, nausea, vomiting.
Uncommon, 1/1000 < ADR < 1/100
Body as a whole: Back pain, chest pain, chills, asthenia, fever, malaise, neck pain, pelvic pain.
Cardiovascular: Bradycardia, hematoma, hypertension, pallor, palpitations, tachycardia.
Digestive: Eructation, dyspepsia, flatulence, dysphagia, dry mouth, melena.
Hemic: Ecchymosis, lymphadenopathy.
Metabolic: Hypoglycemia.
Nervous: Hypertonia, somnolence.
Respiratory: Pharyngitis, rhinitis, epistaxis, pneumothorax.
Skin: Rash
Urogential: Dysuria.


9. OVERDOSE AND TREATMENT:

Symptoms:
None reported.
Treatment:
If overdosage is suspected, the use should be discontinued. Come to the nearest hospital.
Monitor carefully to provide timely treatment if needed.


10. SIGNS SHOULD BE NOTED AND RECOMMENDATIONS:

Shake well before use.
Do not exceed recommended dosage.