Nexium Control 20 Mg Esomeprazole Antacid 14 Gastro-resistant Tablets

Gastro-resistant tablets based on esomeprazole.

Therapeutic indications

Nexium Control is indicated in adults for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation).

Dosage and Posology

Nexium Control is given as follows: the recommended dose is 20 mg of esomeprazole (one tablet) per day.

It may be necessary to take the tablets for 2-3 consecutive days to improve symptoms. The duration of treatment is up to 2 weeks. Once symptoms have completely disappeared, treatment should be stopped. If resolution of symptoms is not achieved within 2 weeks of continuous treatment, the patient should consult a physician.

The tablets should be swallowed whole with half a glass of water. The tablets should not be chewed or crushed. Alternatively, the tablet can be dispersed in half a glass of still water. Other liquids should not be used as the gastro-resistant coating may dissolve. The water should be mixed until the tablet disperses. The liquid with the granules should be drunk immediately or within 30 minutes. The glass should be rinsed with half a glass of water and the water drunk. The granules must not be chewed or crushed.

Overdose

There is currently very limited experience with intentional overdose. The symptoms described in connection with the intake of 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg of esomeprazole caused no consequences. A specific antidote is not known.
Esomeprazole is extensively bound to plasma proteins and therefore is not readily dialysable. Treatment should be symptomatic and supportive measures should generally be used.

Contraindications

• Hypersensitivity to the components of the product or to other related substances from a chemical point of view.
• Esomeprazole should not be used concomitantly with nelfinavir.

Side effects

Headache, abdominal pain, diarrhea and nausea are among the most commonly reported adverse reactions in clinical trials (and also from post-marketing use). Furthermore, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose related adverse reactions were identified.

Special warnings

Patients should be instructed to consult a physician if:

• Have significant unintended weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, the malignant nature of the ulcer should be excluded as esomeprazole therapy may alleviate symptoms. and delay the diagnosis.
• Have had a previous stomach ulcer or gastrointestinal surgery.
• They have been on continuous symptomatic treatment of dyspepsia or heartburn for 4 or more weeks.
• Have jaundice or severe liver disease.
• They are over the age of 55 with new or recently changed symptoms.
• Patients with long-term recurring symptoms of dyspepsia or heartburn should see their doctor at regular intervals. In particular, patients over the age of 55 who are taking daily non-prescription treatment for dyspepsia and heartburn should inform their doctor or pharmacist.

Patients should not take Nexium Control as a long-term preventative drug. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter, and possibly also Clostridium difficile in hospitalized patients. Patients should consult their doctor before taking this medicine if they are to undergo an endoscopy or urea breath test

Pregnancy and breastfeeding

A modest amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformation or fetus / neonatal toxicity of esomeprazole. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy.

It is unknown whether esomeprazole / its metabolites are excreted in human milk. There is insufficient information on the effects of esomeprazole in newborns / infants. Esomeprazole should not be used during breastfeeding.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One Nexium Control tablet contains:

Active principle:

20 mg of esomeprazole

Excipients

Glycerol monostearate 40-55, hyprolose, hypromellose, iron oxide (red-brown) (E 172), iron oxide (yellow) (E 172) magnesium stearate, copolymerized methacrylic acid ethyl acrylate (1: 1) 30% dispersion, microcrystalline cellulose , synthetic paraffin, macrogol 6000, polysorbate 80, crospovidone (Type A), sodium stearyl fumarate, sugar spheres (sucrose), talc, titanium dioxide (E 171), triethyl citrate.