ESTOHALT 10mg or 40mg Hard Gelatin Capsules Contains Enteric Coated Pellets

Therapeutic Indications

Both Estohalt 10mg & 40mg are used for:

  1. Treatment of oesophageal reflux disease including reflux oesophagitis
  2. Treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy.
  3. Zollinger-Ellison syndrome
  4. Helicobacter eradication: Omeprazole should be given in combination with antibiotics for eradication of Helicobacter pylori (Hp) in peptic ulcer disease.
  5.  Prophylaxis of acid aspiration

Estohalt 10mg is also used for:

  • Relief of reflux-like symptoms (e.g. heartburn) and/or ulcer-like symptoms (e.g. epigastric pain) associated with acid-related dyspepsia.
  • Treatment and prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and gastroduodenal erosions in patients with a previous history of gastroduodenal lesions that require continued NSAID treatment.
  • Relief of associated dyspeptic symptoms.

Posology

Oesophageal reflux disease including reflux oesophagitis:

The usual dosage is 20mg Omeprazole once daily. The majority of patients are healed after 4 weeks. Symptom relief is rapid. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment.

Omeprazole has also been administered in a dose of 40mg once daily in patients with reflux oesophagitis refractory to other therapy. Healing usually occurred within 8 weeks. Patients can continue at a dosage of 20mg once daily.

Acid reflux disease:

For long-term management 10mg Omeprazole once daily is recommended, increasing to 20mg if symptoms return.

Duodenal and benign gastric ulcers:

The usual dose is 20mg Omeprazole once daily.

The majority of patients with duodenal ulcer are healed after 4 weeks.

The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40mg Omeprazole daily. A dosage of 20mg Omeprazole once daily is recommended for a long-term therapy in patients with a history of recurrent duodenal ulcer. For prevention of relapse in patients with duodenal ulcer the recommended dose is 10mg Omeprazole once daily is increasing to 20mg once daily,it symptoms return.

The following groups are at risk from recurrent ulcer relapse: younger patients (< 60 years), those whose symptoms persist for more than 1 year and smokers, those with increased Helicobacter pylori infection. These patients will require initial long-term therapy with 20mg Omeprazole once daily, reducing to 10mg once daily, if necessary.

Acid-related dyspepsia:

The usual dosage is Omeprazole 10mg or 20mg once daily for 2-4 weeks depending on the severity and persistence of symptoms.

For the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions:

the recommended dosage of Omeprazole is 20mg once daily. Symptom resolution is rapid and in most patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment.
For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment: the only recommended dosage of Omeprazole is 20mg once daily.

Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease:

Omeprazole is recommended at a dose of 40mg once daily or 20mg twice daily in association with antimicrobial agents.

Prophylaxis of acid aspiration:

For patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is 40mg on the evening before surgery followed by 40mg 2-6 hours prior to surgery.

Zollinger-Ellison syndrome:

The recommended initial dosage is 60 mg Omeprazole once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120mg daily. With doses above 80mg daily, the dose should be divided and given twice daily. A limited duration of the Omeprazole intake is not foreseen for the treatment of the Zollinger-Ellison syndrome.

Treatment should be continued under specialist supervision as long as clinically indicated.

Undesirable effects

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

Pregnancy

The analysis of the results from three prospective epidemiological studies (more than 1000 exposed outcomes) has revealed no evidence of adverse events of Omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can be used during pregnancy.

Breast-feeding

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Composition

Estohalt 10mg Hard Gelatin Capsules Contains enteric coated pellets

Each hard gelatin capsule contains: Enteric coated readymade pellets (6.5%) 153.846mg. Each 153.846mg pellets containing:

Active ingredient: Omeprazole 10mg

Inactive ingredients: Mannitol, pharma grade sugar, pharma grade sugar special grade, disodium hydrogen phosphate, calcium carbonate, sodium lauryl sulfate, hydroxy propyl methyl cellulose-E,, methyacrylic acid copolymer type C (L300), diethyl phthalate, titanium dioxide, talc, tween 80, sodium hydroxide, DM water.

Composition of capsule shell:

  • Cap: gelatin, titanium dioxide, sunset yellow, brilliant blue, Erythrosine, carmoisine.
  • Body: gelatin, titanium dioxide, sunset yellow, brilliant blue, Erythrosine, carmoisine.

Estohalt 40mg Hard Gelatin Capsules Contains enteric coated pellets

Each hard gelatin capsule contains: Enteric coated readymade pellets (12%) 333.333mg. Each 333.333mg pellets containing:

Active ingredient: Omeprazole 40mg

Inactive ingredients: Mannitol, sucrose, sucrose special grade, disodium hydrogen phosphate, calcium carbonate, sodium lauryl sulfate, hydroxy propyl methyl cellulose-E,. methyacrylic acid copolymer type C (L300), diethyl phthalate, titanium dioxide, talc, tween 80, sodium hydroxide.

Composition of capsule shell size one:

Cap: gelatin, titanium dioxide, sunset yellow, brilliant blue, carmoisine.

Body: gelatin, titanium dioxide, brilliant blue, ponceau, quinoline.

استوهالت كبسولات جيلاتينية صلبة 10 مجم أو 40 مجم تحتوي على كريات مغلفة معوية

Pharmaceutical Form

Hard Gelatin Capsules Contains Enteric Coated Pellets.

ESTOHALT Leaflet

Product code: A02BC01