Phosphalugel

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHOSPHALUGEL

Composition:

active substance: aluminium phosphate;

1 sachet contains 12.38 g of 20% gel of aluminium phosphate;

excipients: sorbitol solution non-crystallizing (E 420), agar, pectin, calcium sulfate, potassium sorbate, orange flavor, purified water.

Pharmaceutical form. Oral gel.

Main physicochemical characteristics: creamy white gel with the odor and taste of sweet orange.

Pharmacotherapeutic group. Drugs for the treatment of acid-related disorders. Antacids. Aluminium phosphate. ATC code A02A B03.

Pharmacological properties.

Pharmacodynamics.

The drug is a balanced aluminum phosphate gel. It exerts acid-neutralizing, coating, and adsorbing effects. It reduces the proteolytic activity of pepsin, binds bile acids and lysophosphatidylcholine.

Due to its buffering properties, aluminum phosphate neutralizes only excess hydrochloric acid, maintains physiological conditions for digestion, and does not lead to secondary hypersecretion of gastric juice. The antacid effect of the drug develops rapidly.

Micelles of aluminum phosphate have a large contact surface, coat the mucous membrane with a uniform layer, protect it from aggressive factors, and promote regeneration. The cytoprotective effect of the drug is also due to its ability to stimulate the synthesis of prostaglandins, which enhance the secretion of mucus and bicarbonate in the gastric mucosa.

The use of the drug does not cause electrolyte imbalance, does not lead to alkalosis, or formation of kidney stones.

Pharmacokinetics.

Aluminum phosphate neutralizes hydrochloric acid, forming aluminum chloride. Under the influence of the alkaline environment of the intestine, aluminum chloride is converted into insoluble aluminum salts, which are poorly absorbed and are excreted in feces. Phosphalugel does not bind dietary phosphates, does not cause disturbances in phosphorus-calcium metabolism, osteoporosis, or osteomalacia.

Belongs to the group of non-absorbable antacids.

Clinical characteristics.

Indications.

The drug is used both as monotherapy and as part of combination therapy for gastrointestinal disorders in the upper regions:

• gastric and duodenal ulcers;
• acute gastritis, chronic gastritis with normal or increased gastric secretory function;
• hiatal hernia, gastroesophageal reflux disease (including reflux esophagitis), duodenogastric reflux;
• functional dyspepsia.

Contraindications.

Hypersensitivity to aluminium phosphate or to any of the excipients of the drug. Severe abdominal pain of unknown origin, habitual constipation, chronic diarrhea. Alzheimer's disease.

Interaction with other medicinal products and other forms of interaction.

Antacids interact with certain other medicinal products absorbed in the gastrointestinal tract. Decreased gastrointestinal absorption may occur with concomitantly administered drugs: furosemide, bumetanide, fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin, perfloxacin).

Phosphalugel is recommended to be administered 2 hours before or after other medicinal products.

Special precautions for use

The use of this medication is not recommended in patients with chronic renal insufficiency, as aluminum phosphate does not reduce serum phosphorus levels.

If symptoms of diseases or conditions for which Phosphalugel is prescribed do not resolve within 7 days, medical advice must be sought. In case of abdominal pain accompanied by fever or vomiting, immediate medical attention is required.

The medicinal product contains 4.3 g of sorbitol per sachet (1 sachet). This product should not be used by patients with hereditary fructose intolerance. Due to the presence of sorbitol, this medicinal product may cause gastrointestinal discomfort and mild laxative effect.

The medicinal product contains potassium in the amount of 13.0 to 14.6 mg per sachet (20 g of gel). Caution is advised when administering to patients with impaired renal function or those on a potassium-controlled diet.

Use during pregnancy or breastfeeding

The safety profile of Phosphalugel in women during pregnancy and breastfeeding has not been established. Clinical trial data on the use of aluminum phosphate in women during the third trimester of pregnancy support the intermittent (short-term) use of Phosphalugel at therapeutic doses when clinically indicated.

Effect on the ability to drive vehicles or operate machinery

Phosphalugel does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

Mix the contents of the sachet between fingers until a homogeneous gel is obtained. Holding the sachet vertically, cut or tear off one of the corners at the marked spot. Squeeze the gel out through the opening with fingers.

The medication can be used undiluted or diluted before administration in half a glass of water.

Dosage for adults:

Phosphalugel should be administered orally, 1 or 2 sachets 2–3 times daily.

If pain recurs between doses of Phosphalugel, the medication should be administered again.

Maximum daily dose – 6 sachets.

Children.

The safety of using Phosphalugel in children has not been studied (in clinical trials).

Overdose.

When high doses are used, constipation up to intestinal obstruction may occur. Consequences of overdose are more severe in patients with renal insufficiency.

Side effects.

Constipation may occasionally occur, particularly in bedridden patients and elderly individuals. In such cases, it is recommended to consume an adequate amount of fluids. Phosphalugel contains sorbitol, which may cause diarrhea.

Allergic reactions are possible in individuals with hypersensitivity to the components of the drug.

Shelf life. 3 years.

Do not use the medication after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 20 g of gel in sachets, 20 sachets in a cardboard box.

Availability. Over-the-counter.

Manufacturer. Pharmatis, France / Pharmatis, France.

Manufacturer's address.

Zone d'Activites Est n° 1 60190 Estrees-Saint-Denis, France / Zone d'Activites Est n° 1 60190 Estrees-Saint-Denis, France.

Marketing Authorization Holder. Opella HealthCare Ukraine LLC.

Address of the Marketing Authorization Holder.

48-50A Zhylianska St., Kyiv, Ukraine, 01033.