Reflunorm^® (Gel) Instructions for Use

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

ATC Code

A02AB03 (Aluminium phosphate)

Active Substance

Aluminium phosphate (DCF adopted for use in France)

Dosage Form

Reflunorm®

Gel for oral administration: sachets 16 g 5, 6, 10, 15, or 20 pcs.

Dosage Form, Packaging, and Composition

Gel for oral administration white or almost white, homogeneous after stirring, with an orange odor.

Excipients : calcium sulfate dihydrate – 12 mg, pectin – 87 mg, agar-agar 900 – 45 mg, orange flavor – 80 mg, potassium sorbate – 40 mg, sorbitol 70% – 4480 mg, purified water – up to 16 g.

16 g – sachets (5) – cardboard packs.
16 g – sachets (6) – cardboard packs.
16 g – sachets (10) – cardboard packs.
16 g – sachets (15) – cardboard packs.
16 g – sachets (20) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

Antacid agent. Neutralizes hydrochloric acid of gastric juice and reduces the proteolytic activity of pepsin.

It is practically not absorbed from the gastrointestinal tract and does not cause alkalosis.

Adsorbed on the gastric mucosa in the form of hydrophilic colloidal micelles, Aluminium phosphate creates a protective mucoid layer that protects the mucosa from the effects of hydrochloric acid, pepsin, endogenous and exogenous toxic substances.

It does not cause phosphate deficiency in the body.

Pharmacokinetics

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

Peptic ulcer of the stomach and duodenum in the acute phase, chronic gastritis with increased and normal secretory function of the stomach in the acute phase, acute gastritis, acute duodenitis, symptomatic ulcer of various origins, erosion of the gastrointestinal mucosa, reflux esophagitis, hiatal hernia, enterocolitis, sigmoiditis, proctitis, diverticulitis, diarrhea in patients after gastrectomy, dyspeptic phenomena (including those of neurotic origin, after dietary errors, taking medications, chemotherapy), acute pancreatitis, chronic pancreatitis in the acute phase, poisoning and intoxication.

For the purpose of prevention to reduce the absorption of radioactive elements.

ICD codes

Dosage Regimen

Administer orally. Shake the sachet thoroughly before opening.

For adults and children over 12 years, take 1-2 sachets, 3-4 times daily.

For children aged 6 to 12 years, take 1 sachet, 3 times daily.

For infants under 6 years, administer 1-2 teaspoons (5-10 ml) of gel, 3-4 times daily after meals and at bedtime.

For gastroesophageal reflux disease, take the dose 30-60 minutes after meals and at bedtime.

For peptic ulcer disease, take the dose 1-2 hours after meals and as needed for pain.

For acute gastritis or dyspepsia, take the dose immediately after symptoms appear.

The maximum daily dose for adults is 6 sachets.

The maximum daily dose for children aged 6-12 years is 3 sachets.

Do not use for more than 14 consecutive days without medical consultation.

For long-term therapy, ensure adequate dietary phosphate intake to prevent hypophosphatemia.

Adverse Reactions

From the digestive system constipation (especially in elderly and bedridden patients), nausea, vomiting, change in taste sensations.

From laboratory parameters with long-term use in high doses – hypophosphatemia, hypocalcemia, increased aluminium content in the blood.

From the musculoskeletal system osteomalacia, osteoporosis.

From the CNS encephalopathy.

From the urinary system hypercalciuria, nephrocalcinosis, renal failure.

Contraindications

Renal failure, Alzheimer’s disease, hypophosphatemia, hypersensitivity to aluminium phosphate.

Use in Pregnancy and Lactation

If necessary, it can be used during pregnancy and during lactation (breastfeeding).

Use in Renal Impairment

Use with caution in high doses in patients with impaired renal function (due to the possible risk of accumulation of aluminium phosphate, leading to constipation). In patients with concomitant renal failure, thirst, decreased blood pressure, and decreased reflexes are possible.

Geriatric Use

Use with caution in high doses in elderly patients (due to the possible risk of accumulation of aluminium phosphate, leading to constipation).

Special Precautions

Use with caution in high doses in elderly patients and in patients with impaired renal function (due to the possible risk of accumulation of aluminium phosphate, leading to constipation).

In patients with concomitant renal failure, thirst, decreased blood pressure, and decreased reflexes are possible.

Drug Interactions

Aluminium preparations used as antacids interact with most oral medications both by changing the pH of gastric juice and rapid gastric emptying, and by adsorption with the formation of complexes that are not absorbed.

With simultaneous use, citrates and ascorbic acid increase the absorption of aluminium from the gastrointestinal tract.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.