Instructions for use Phosphalugel oral gel, package No. 20
Composition
active ingredient: aluminum phosphate;
1 packet contains 12.38 g of aluminum phosphate 20% gel;
excipients: sorbitol non-crystallizing solution (E 420), agar, pectin, calcium sulfate, potassium sorbate, orange flavoring, purified water.
Dosage form
Oral gel.
Main physicochemical properties: creamy-white gel with a sweet orange smell and taste.
Pharmacotherapeutic group
Preparations for the treatment of acid-dependent diseases. Antacids. Aluminum phosphate. ATX code A02A B03.
Pharmacological properties
Pharmacodynamics.
The drug is a balanced aluminum phosphate gel. It has an antacid, enveloping, adsorbing effect. It reduces the proteolytic activity of pepsin, binds bile acids and lysolecithin.
Aluminum phosphate, due to its buffering properties, neutralizes only excess hydrochloric acid, maintains physiological conditions of digestion and does not lead to secondary hypersecretion of gastric juice. The antacid effect of the drug manifests itself quickly.
Aluminum phosphate micelles have a larger contact surface, envelop the mucous membrane with a uniform layer, protect it from the action of aggressive factors and promote regeneration. The cytoprotective effect of the drug is also due to the ability to activate the synthesis of prostaglandins, which stimulate the secretion of mucus and bicarbonates in the gastric mucosa.
The use of the drug does not lead to electrolyte balance disorders, does not cause the development of alkalosis and the formation of stones in the urinary tract.
Pharmacokinetics.
Aluminum phosphate neutralizes hydrochloric acid with the formation of aluminum chloride. Under the influence of the alkaline environment of the intestine, the latter is converted into alkaline aluminum salts, which are poorly absorbed and excreted in the feces. Phosphalugel does not bind food phosphates, does not lead to disorders of phosphorus-calcium metabolism, osteoporosis and osteomalacia.
It belongs to the group of non-absorbable antacids.
Indication
The drug is used both in monotherapy and as part of complex therapy for disorders in the upper parts of the gastrointestinal tract:
gastric and duodenal ulcer; acute gastritis, chronic gastritis with normal or increased gastric secretory function; hiatal hernia, gastroesophageal reflux disease (including reflux esophagitis), duodenogastric reflux; functional dyspepsia.
Contraindication
Hypersensitivity to aluminum phosphate or to other excipients of the drug. Severe abdominal pain of unspecified origin, habitual constipation, chronic diarrhea. Alzheimer's disease.
Interaction with other medicinal products and other types of interactions
Antacids interact with some other drugs that are absorbed in the gastrointestinal tract. There is a decrease in the absorption in the gastrointestinal tract of drugs that are used simultaneously with antacids: furosemide, bumetanide, fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin, perfloxacin).
It is recommended to use Phosphalugel 2 hours before or after taking other medications.
Application features
It is not recommended for use in chronic renal failure, as aluminum phosphate does not reduce serum phosphorus levels.
If the symptoms of diseases/conditions for which Fosfalugel is prescribed do not disappear within 7 days, you should consult a doctor. If abdominal pain occurs, accompanied by fever, vomiting, you should consult a doctor immediately.
The medicinal product contains 4.3 g of sorbitol (1 sachet). Patients with hereditary fructose intolerance should not take this medicinal product. Due to the presence of sorbitol, this medicinal product may cause gastrointestinal discomfort and a mild laxative effect.
The medicinal product contains 13.0 to 14.6 mg of potassium/packet (20 g of gel). Caution should be exercised when used in patients with reduced renal function or those on a controlled potassium diet.
Use during pregnancy or breastfeeding
The safety profile of the use of Phosphalugel in women during pregnancy and breastfeeding has not been established. The data obtained in clinical trials on the use of aluminum phosphate by women in the third trimester of pregnancy allow periodic (short-term) use of Phosphalugel in therapeutic doses according to indications.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect the ability to drive vehicles and other mechanisms.
Method of administration and doses
Mix the contents of the sachet between your fingers until a smooth gel is obtained. Holding the sachet vertically, cut or tear off one of the corners at the marked point. Squeeze the gel out of the sachet with your fingers.
The drug can be used in its pure form or diluted before use in half a glass of water.
Adult doses:
If the pain recurs between uses of Phosphalugel, the drug should be repeated.
The maximum daily dose is 6 packets.
Children
The safety of using Phosphalugel in children has not been studied (in clinical trials).
Overdose
Constipation up to intestinal obstruction may occur when using high doses. The consequences of overdose are more serious in patients with renal insufficiency.
Side effects
Sometimes constipation occurs, especially in bedridden patients and the elderly. In these cases, it is recommended to consume sufficient fluids. Phosphalugel contains sorbitol, which can cause diarrhea.
In individuals with hypersensitivity to the components of the drug, allergic reactions may develop.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
20 g of gel in bags, 20 bags in a cardboard box.
Vacation category
Without a prescription.
Producer
Pharmatis, France.
Location of the manufacturer and its business address
Zone d'Activites Est n° 1 60190 Estrees-Saint-Denis, France / Zone d'Activites Est n° 1 60190 Estrees-Saint-Denis, France.
Applicant
LLC "Sanofi-Aventis Ukraine".
Applicant's location
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
