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
POLYGEL (Antacid Chewable Tablets).
| Pharmaceutical Form |
|---|
|
Chewable tablet. |
| Chemical Name | Approved Name (if any) | Quantity per Tablet in mg | Active / Non-active |
|---|---|---|---|
| Active Ingredients | |||
| --- | Dried Aluminium Hydroxide Gel BP | 300.00 | Antacid |
| --- | Magnesium Aluminium Silicate Hydrate BP | 50.00 | Antacid |
| --- | Magnesium Hydroxide BP | 25.00 | Antacid |
| poly (dimethylsiloxane) | Simethicone BP | 25.00 | Antifoaming Agent / Antiflatulent |
| Excipients | |||
| b-D-fructofuranosyl-a-D- glucopyranoside | Sucrose (Pharma Grade) BP | 384.50 | Sweetening agent |
| D-Mannitol | Mannitol BP | 267.00 | Diluent |
| 1-Ethenyl-2-pyrrolidinone homopolymer | PVP K-30 BP | 12.00 | Suspending Agent |
| Methyl-4-hydroxybenzoate | Methyl Hydroxy Benzoate BP | 1.00 | Antimicrobial Preservative |
| Propyl 4-hydroxybenzoate | Propyl Hydroxy Benzoate BP | 0.500 | Antimicrobial Preservative |
| --- | Colour Erythrosine Supra IH | 0.200 | Colourant |
| 1,2-Benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt | Saccharin Sodium BP | 2.00 | Sweetening agent |
| Propan-2-ol | Isopropyl Alcohol BP* | 32.00 | Solvent |
| Talc | Purified Talc BP | 17.80 | Glidant |
| Octadecanoic acid magnesium salt | Magnesium Stearate BP | 13.00 | Lubricant |
| --- | Flavour Trusil Peppermint Dry Mix Powder IH | 17.00 | Flavouring Agent |
Definitions:
* Does not appear in final product.
BP: British Pharmacopoeia, IH: In-house Specification
| Active Ingredient |
|---|
|
Aluminium hydroxide is a slow-acting antacid. It is used to provide symptomatic relief in gastric hyperacidity. In addition, the antipeptic and demulcent activity of aluminium hydroxide helps to protect inflamed gastric mucosa against further irritation by gastric secretions. |
|
Magnesium hydroxide is practically insoluble in water and solution is not effected until the hydroxide reacts with hydrochloric acid in the stomach to form magnesium chloride. Its neutralising action is almost equal to that of sodium bicarbonate. When the dose is in excess of that required to neutralise the acid the intragastric pH may reach pH 8 or 9. Acid rebound following magnesium hydroxide is clinically insignificant. Magnesium hydroxide has an indirect cathartic effect resulting from water retention in the intestinal lumen. |
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Simethicone is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus. |
| List of Excipients |
|---|
|
Sucrose BP |
POLYGEL is available as blister of 10 tablets, Such 20 blisters are packed in the carton along with leaflet.
M/s SHALINA HEALTHCARE DMCC
Physical and Postal Address: 30th Floor, Almas Towers, Jumeirah Lakes Towers Dubai-UAE, Country: Dubai
Marketing authorisation in other countries: Registered in Congo, Zambia, Central African Republic
| Drug | Countries | |
|---|---|---|
| POLYGEL | Nigeria |
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