Phosphalugel (Gel) Instructions for Use

Marketing Authorization Holder

Opella Healthcare France, SAS (France)

Manufactured By

Pharmatis (France)

Contact Information

OPELLA HEALTHCARE LLC (Russia)

ATC Code

A02AB03 (Aluminium phosphate)

Active Substance

Aluminium phosphate (DCF adopted for use in France)

Dosage Forms

	Phosphalugel	Oral gel 10.4 g/16 g: pkg. 6 or 20 pcs.
		Oral gel 12.38 g/20 g: pkg. 20 pcs.

Dosage Form, Packaging, and Composition

Oral gel white or almost white, homogeneous after stirring, with an orange odor.

Excipients : sorbitol solution 70% – 4.48 g, agar-agar 800 – 0.045 g, pectin – 0.087 g, calcium sulfate dihydrate – 0.012 g, potassium sorbate – 0.04 g, orange flavor – 0.08 g, purified water – up to 16 g.

16 g – multilayer heat-sealable sachets (sticks) (6) – cardboard packs.
16 g – multilayer heat-sealable sachets (20) – cardboard packs.

Oral gel white or almost white, homogeneous after stirring, with an orange odor.

Excipients : sorbitol solution 70% – 4.286 g, agar-agar 800 – 0.08 g, pectin – 0.1 g, calcium sulfate dihydrate – 0.01 g, potassium sorbate – 0.053 g, orange flavor – 0.032 g, purified water – up to 20 g.

20 g – multilayer heat-sealable sachets (20) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antacids; aluminum compounds

Pharmacological Action

Pharmacodynamics

It has acid-neutralizing, enveloping, adsorbing action.

It reduces the proteolytic activity of pepsin.

It does not cause alkalization of gastric juice, maintaining the acidity of gastric contents at a physiological level.

It does not lead to secondary hypersecretion of hydrochloric acid.

It forms a protective layer on the gastrointestinal mucosa.

It promotes the removal of toxins, gases, and microorganisms throughout the digestive tract, normalizing the passage of contents through the intestines.

Pharmacokinetics

Absorption

When taken orally, it has low absorption.

Most of the aluminium phosphate is insoluble, a small part is precipitated in the intestine in the form of oxides and insoluble carbonates.

Indications

In adults and children aged 0 to 18 years for

• Gastric and duodenal ulcer;
• Gastritis with normal or increased secretory function;
• Hiatal hernia;
• Reflux esophagitis, incl. accompanied by heartburn, sour belching;
• Gastroesophageal reflux,
• Non-ulcer dyspepsia syndrome;
• Functional diarrhea;
• Functional disorders of the colon;
• Gastric and intestinal disorders caused by intoxication, intake of medications, irritants (acids, alkalis), alcohol.

ICD codes

Dosage Regimen

For oral administration.

Adults and children over 6 years – 1-2 sachets 2-3 times/day.

The administration schedule depends on the nature of the disease

• gastroesophageal reflux, hiatal hernia – immediately after meals and at bedtime;
• gastric and duodenal ulcer – 1-2 hours after meals and immediately when pain occurs;
• gastritis, dyspepsia – before meals;
• functional disorders of the colon – in the morning on an empty stomach and at bedtime.

If pain recurs between doses of Phosphalugel, the drug can be repeated.

For children under 6 months – 1/4 sachet or 1 teaspoon (4 g) after each of 6 feedings; over 6 months – 1/2 sachet or 2 teaspoons after each of 4 feedings.

The drug can be taken neat or diluted in half a glass of water before administration.

Directions for use

It is necessary to thoroughly knead the contents of the sachet between the fingers to obtain a homogeneous gel.

Holding the sachet vertically, cut or tear off the corner at the point marked with a dotted line.

Squeeze the gel through the opening in the sachet with your fingers.

The gel can be taken neat or diluted in half a glass of water before administration.

Adverse Reactions

From the digestive system rarely – constipation (mainly in elderly patients and bedridden patients).

Contraindications

• Severe renal impairment;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

The drug can be used in therapeutic doses during pregnancy and lactation if indicated.

Use in Hepatic Impairment

The drug should be used with caution in liver cirrhosis.

Use in Renal Impairment

The drug should be used with caution in kidney diseases. Contraindicated in severe renal impairment.

Geriatric Use

In elderly patients, when using Phosphalugel in recommended doses, an increase in serum aluminum concentration is possible.

Special Precautions

The drug should not be taken for a long time without a doctor’s prescription.

Use with caution in kidney diseases, liver cirrhosis, severe heart failure.

In patients with impaired renal function and elderly patients, when using Phosphalugel in recommended doses, an increase in serum aluminum concentration is possible.

Tetracycline group antibiotics, iron preparations, cardiac glycosides should be taken no earlier than 2 hours after taking Phosphalugel.

For constipation, which occasionally occurs when taking Phosphalugel, it is recommended to increase the amount of water consumed daily.

The drug can be used in patients suffering from diabetes mellitus.

The drug can be used prophylactically to reduce the absorption of radioactive elements.

The use of the drug Phosphalugel does not affect the results of X-ray examination.

The drug Phosphalugel may have a mild laxative effect, as it contains sorbitol.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per 16 g or 20 g sachet.

Effect on ability to drive vehicles and operate machinery

No effect.

Overdose

Large amounts of aluminum ions suppress intestinal peristalsis.

Laxatives should be used to treat drug overdose.

Drug Interactions

When using Phosphalugel simultaneously with other drugs, you should consult a doctor, since Phosphalugel reduces the effectiveness of some drugs.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.