POLYGEL Chewable tablet Ref.[115716] Active ingredients: Aluminium hydroxide Magnesium hydroxide Magnesium silicate Simethicone

Source: Registered Drug Product Database (NG)  Revision Year: 2021  Publisher: M/s SHALINA HEALTHCARE DMCC Physical and Postal Address: 30 th Floor, Almas Towers, Jumeirah Lakes Towers Dubai-UAE, Country: Dubai Marketing authorisation in other countries: Registered in Congo, Zambia, Central African Republic

4.3. Contraindications

Polygel is not suitable in those patients who have shown prior history of hypersensitivity to any of the components of the drug. It is also contraindicated in patients with renal failure.

4.4. Special warnings and precautions for use

Aluminium may cause nausea, vomiting and constipation. Large doses can cause intestinal obstruction. Excessive or normal doses in patients with low phosphate diets may cause phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Magnesium may cause diarrhoea. Hypermagnesaemia may occur if renal function is impaired. Magnesium hydroxide and other magnesium salts, in the presence of renal insufficiency, may cause central nervous system depression.

Usage in pregnancy & lactation: Polygel is safe in pregnancy. Use in nursing mothers - Caution should be exercised when Polygel is administered to nursing mothers.

4.5. Interaction with other medicinal products and other forms of interaction

Aluminium and magnesium may alter the absorption of other medicines from the gastro-intestinal tract if administered concomitantly.

Polygel can reduce the activity of Fluoroquinolones, Isoniazid (oral), Iron, Indomethacin, Digoxin, Ketoconazole and Phenothiazines.

Mecamylamine: Polygel may potentiate the effects of Mecamylamine.

Tetracyclines: Polygel can reduce the effect of this medicine. In this case it should only be given after 3 to 4 hours of tetracycline.

4.6. Pregnancy and lactation

Usage in pregnancy & lactation: Polygel is safe in pregnancy.

Use in nursing mothers: Caution should be exercised when Polygel is administered to nursing mothers.

4.8. Undesirable effects

The adverse effects that may be encountered with Polygel are changes in bowel function, diarrhoea being the common symptom. A small reduction in dosage may often alleviate these symptoms. Polygel is a well-tolerated antacid. Constipation or stomach cramps, loss of appetite, vomiting, dizziness and headache may occur very rarely.

6.2. Incompatibilities

None.

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