1) Trade Name: Glycodal
2) Generic Name: Calcium carbonate, Glycine, and Dimethicone
3) Composition:
(Active and Inactive ingredients):
Each chewable tablet contains:
Active ingredients:
Calcium carbonate 420 mg
Glycine 180 mg
Dimethicone 10 mg
Inactive ingredients:
Wheat starch, Saccharin sodium, Peppermint oil, Starch
1500, Gelatin powder, Magnesium stearate
4) Pharmaceutical Form: Round flat white chewable tablet
5) Pharmacological Actions:
Calcium carbonate: Calcium carbonate is antacid. It
acts by neutralising the hydrochloric acid produced by the
stomach and thus reducing gastric and duodenal irritation.
Dimethicone: As an antiflatulent, Dimethicone has been
shown in vitro to disperse and prevent the formation of
mucus-surrounded gas pockets in the Gl tract. Changing
the surface tension of the gas bubble prevents these
pockets. The gas bubbles coalesce and are more quickly
eliminated by flatus, belching, or absorption into the
bloodstream. These actions in vivo have not been clearly
established. Additionally, Dimethicone exhibits in vitro
activity against Helicobacter pylori.
Dimethicone also reduces gas bubbles that obstruct
visualization in various gastrointestinal procedures such
as radiography, gastroscopy, and colonoscopy.
Glycine: Is a non essential aliphatic amino acid it is used
as a dietary supplement, it is used as antacid in the
treatment of gastric hyperacidity.

6)Pharmacokinetics:
Calcium carbonate: Calcium carbonate is converted to
calcium chloride by gastric acid. Some of the calcium is
absorbed from the intestines but about 85% is reconverted
to insoluble calcium salts, such as the carbonate and is
excreted in the faeces.
Dimethicone: Dimethicone is administered orally.
Dimethicone is physiologically inert and not systemically
absorbed. A study in volunteers measuring silicon in the
blood (as the surrogate marker for Dimethicone) noted
that blood and urine levels of silicone were similar at
baseline and after receiving Glycodal. This suggests
minimal systemic absorption of Dimethicone. Similarly,
the body does not metabolize Dimethicone. Dimethicone
is excreted unchanged in the feces. Dimethicone is not
known to interfere with gastric secretion or nutrient absorption;
however, this medicine is usually taken after at least 4
hours of fasting. Glycodal may color the stool orange until
elimination is complete, typically 24 to 48 hours.
7) Indications:
For relief of the symptoms of gastric hyperacidity, heart-
burn, dyspepsia and flatulence.
For use as an aid in gastrointestinal or bowel prepara-
tion to reduce foaming and enhance visualization during
endoscopy, colonoscopy, gastrointestinal radiography, or
other Gl diagnostic procedures.
8) Dosage and Administration:
Adults, elderly and children over 12 years:
Chew or swallow 2 tablets every 2 to 3 hours as symptoms occur or as directed by a physician do not take more than
19 tablets in a 24-hour period or use maximum dosage for more than two weeks.
Children under 12 years: Not recommended.
9) Contraindications:
Hypersensitivity to the active ingredients or any of the excepients.
Calcium Carbonate: Hypophosphataemia, and avoid in
patients with heart failure or renal failure.
Dimethicone: Dimethicone is contraindicated in patients
with hypersensitivity to Dimethicone
10) Precautions & Warnings:
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Antacids may interfere with
certain prescription drugs
Stop use and ask a doctor if symptoms last for more
than 2 weeks
Calcium Carbonate
If symptoms persist, consult your doctor.
Not to be taken during the first three months of pregnancy.
Keep all medicines out of the reach of children.
11) Side Effects:
Calcium carbonate: Calcium salts can have a constipat-
ing effect. No side effects associated with sodium bicarbon-
ate except when taken in excess.
Rebound hyperacidity may occur with prolonged dosage.
Dimethicone: Mild eructation, flatulence
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation
of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any
suspected adverse reations via the Egyptian pharmaco
vigillance center at pv.followup@edaegypt.gov.eg

12) Drug Interactions:
Calcium carbonate
Antacids are known to reduce the absorption of certain
medicines including tetracyclines and iron salts.
Dimethicone
Levothyroxine ; Liothyronine (Porcine), Levothy-
roxine; Liothyronine (Synthetic), Liothyronine, and
Thyroid hormones: (Moderate) Oral thyroid hormones
should be administered at least 4 hours before or after
a dose of Dimethicone. Concurrent use may reduce
the efficacy of levothyroxine by binding and delaying
or preventing oral absorption, potentially resulting in
hypothyroidism. Dimethicone has been reported to chelate
oral levothyroxine within the Gl tract when administered
simultaneously, leading to decreased thyroid hormone
absorption.
13) Pregnancy and Lactation:
Caution should be exercised when prescribing to pregnant
women as calcium carbonate contraindicated in the first 3
months of pregnancy
14) Package & Storage:
Store at temperature not exceeding 30C in a dry place
Local: Carton box contains 3 (Al/ AI) strips, each of 10 tablets
and inner leaflet
Export and Tender: Carton box contains 100 (AI/ AI) strips,
each of 10 tablets and inner leaflet
Shelf life: 3 years