Biogaran Conseil Esomeprazole 20 mg 14 Gastroresistant capsules

Description Biogaran Conseil Esomeprazole 20 mg 14 Gastro-resistant capsules

Indicated for the short-term treatment of symptoms of gastroesophageal reflux disease (e.g. pyrosis and acid regurgitation) in adults.

Directions for use Biogaran Conseil Esomeprazole 20 mg 14 Gastroresistant capsules

Dosage

The recommended dose is 20 mg of esomeprazole (one capsule) per day.

It may be necessary to take the capsules for 2 or 3 consecutive days to obtain an improvement in symptoms. Treatment may last up to 2 weeks. Once symptoms have disappeared, treatment should be discontinued.

If symptoms persist after 2 weeks of continuous treatment, the patient should be advised to consult a doctor

Special populations

Patients with renal impairment

No dosage adjustment is necessary in patients with renal impairment. Patients with severe renal impairment should be treated with caution due to limited experience in these patients (see Pharmacokinetics).

Patients with hepatic impairment

No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. However, patients with severe hepatic impairment should be advised by a physician before taking ESOMEPRAZOLE BIOGARAN CONSEIL (see Warnings and Precautions and Pharmacokinetics).

Elderly (> 65 years of age)

No dosage adjustment is necessary in the elderly.

Pediatric population

There is no justified use of ESOMEPRAZOLE BIOGARAN CONSEIL in the pediatric population under 18 years of age for the indication "short-term treatment of symptoms of gastroesophageal reflux disease (e.g. pyrosis and acid regurgitation)".

Method of administration

Capsules should be swallowed whole with a glass of water. Capsules should not be chewed or crunched.

For patients with swallowing difficulties:

Capsules may also be opened and contents dispersed in half a glass of non-carbonated water. No other liquid should be used, as the enteric coating may be dissolved. Stir and drink the liquid with the granules immediately or within 30 minutes. Rinse glass with half a glass of water and drink. Gastro-resistant granules must not be chewed.

Composition Biogaran Conseil Esomeprazole 20 mg 14 Gastro-resistant capsules

Gastroresistant capsule (opaque yellow head, opaque white body, 20 mg engraved in black on head and body. Capsule contains off-white to grayish spherical microgranules): esomeprazole magnesium dihydrate, i.e. esomeprazole 20 mg.

Excipients: Sugar spheres (sucrose and corn starch), Hypromellose, Dimeticone emulsion 35%, (Dimeticone, Propyl parahydroxybenzoate (E 216), Methyl parahydroxybenzoate (E 218), Sorbic acid, Sodium benzoate, Polyethylene glycol sorbitan monolaurate, Octylphenoxy-polyethoxy-ethanol, Propylene glycol), Polysorbate 80, Mannitol, Diacetylated monoglycerides, Talc, 30% methacrylic acid/ethyl acrylate copolymer dispersion (1:1), (Copolymer of methacrylic acid and ethyl acrylate, Sodium lauryl sulfate, Polysorbate 80), Triethyl citrate, Stearic macroglycerides, Black iron oxide (E 172), Shellac, Yellow iron oxide (E 172), Titanium dioxide (E 171), Gelatin, qsp 1 gastroresistant capsule.

Excipient: sucrose (8.05 mg per capsule), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium benzoate.

This drug contains less than 1 mmol (23 mg) sodium per capsule, i.e. it is essentially "sodium-free".