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1. Drug name
Phalugel
2. Drug formula ingredients
Each package contains:
Aluminum phosphate gel 20%…………12.38g.
Excipients: Sorbitol, xanthan gum, vanilla flavor, disodium hydrophosphate, ethanol, sodium benzoate, sufficient water.
3. Dosage form
Oral suspension.
4. Route of administration
Oral route.
5. Indications
- Gastric and duodenal ulcers.
- Gastritis with high acidity.
- Heartburn; chronic colitis.
- Prevent and treat digestive disorders caused by using many drugs.
- Poisoning.
6. Administration, dosage
Dosage
1-2 packs/day.
Administration
Use directly orally.
Drink between meals or when feeling uncomfortable.
7. Contraindications
Patients who are allergic or sensitive to any ingredient of the drug.
8. Warnings and precautions when using medicine
Do not use high doses for long periods in patients with chronic kidney failure.
9. Use medicine for pregnant and lactating women
Pregnant
Aluminum phosphate can be used by pregnant women but avoid using high doses for long periods of time.
Breastfeeding women
The amount of aluminum phosphate distributed into breast milk is very small and not enough to cause harm to the nursing infant.
10. Effects of drugs on the ability to drive and operate machinery
The drug does not affect the ability to drive and operate machinery.
11. Drug interactions and incompatibilities
Aluminum phosphate may increase or decrease the rate and extent of absorption of concomitantly administered drugs, by altering gastrointestinal transit time, or by binding or complexing with drugs. Tetracycline forms a complex with aluminum phosphate, so when using tetracycline it must be 1-2 hours before or after taking the drug.
Aluminum phosphate reduces the absorption of digoxin, indomethacin, iron salts, isoniazid, clodiazepoxide, naproxen.
Aluminum phosphate increases the absorption of dicoumarol, pseudoephedrine, diazepam.
Aluminum phosphate increases urine pH, thereby reducing the excretion of weak alkaline drugs (amphetamine, quinidine) and increasing the excretion of weak acid drugs (aspirin).
The absorption of aluminum through the gastrointestinal tract may increase if taken with citrates or ascorbic acid.
12. Unwanted effects of the drug
During use of the product, it may cause some unwanted side effects such as:
Aluminum phosphate is an astringent and may cause constipation.
High doses can cause intestinal obstruction.
Report unwanted effects
It is important to report unwanted effects after a drug is approved. It allows continued monitoring of the benefit/risk assessment of the drug. Healthcare professionals are asked to report any unwanted effects to:
13. Overdose and treatment
There is currently no information about drug overdose. However, while using the drug, if the patient experiences any serious symptoms, they should immediately notify the doctor and go to the nearest medical center for timely treatment.
14. Pharmacodynamic properties
Pharmacological group: Antacids
ATC code: A02AB03
Aluminum phosphate is used as an antacid in the form of aluminum phosphate gel. Aluminum phosphate reduces excess gastric acid but does not neutralize it. Colloidal gel creates a mucus-like protective film that covers a large area of the digestive tract mucosa. The protective film consists of finely dispersed aluminum phosphate, which quickly heals inflammation and ulcers, protects the stomach lining against external influences and makes the patient immediately comfortable.
15. Pharmacokinetic properties
Normally the drug is not absorbed into the body and does not affect the body's acid-alkaline balance. Aluminum phosphate dissolves slowly in the stomach and reacts with hydrochloric acid to form aluminum chloride and water. In addition to creating aluminum chloride, aluminum phosphate also creates phosphoric acid. About 17 - 30% of the aluminum chloride formed is absorbed and quickly eliminated by the kidneys in people with normal kidney function. Unabsorbed aluminum phosphate is excreted in the stool.
16. Packaging specifications
Box of 26 packs x 20g with instructions for use.
17. Storage conditions, expiration date, and quality standards of the drug
Storage conditions: Cool and dry place, protected from light, temperature not exceeding 30 o C.
Expiry date: 36 monthsfrom the date of manufacture.
Quality standards of drugs: TCCS
18. Name and address of the drug manufacturing facility
Euro Santé Pharmaceutical Joint Stock Company
Song Cung industrial site, Dong Thap commune, Dan Phuong district, Hanoi city, Vietnam.
