Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Rowex Ltd, Bantry, Co. Cork
Emazole 20 mg gastro-resistant tablets are indicated for:
Gastro-Oesophageal Reflux Disease (GORD)
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and
Patients requiring continued NSAID therapy
Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers
Treatment of Zollinger Ellison Syndrome
Gastroesophageal Reflux Disease (GORD)
In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori.
40 mg once daily for 4 weeks.
An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.
20 mg once daily.
20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. An on demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on demand regimen is not recommended.
20 mg Emazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.
20 mg once daily.
40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.
The recommended initial dosage is 40 mg Emazole twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 mg to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2).
Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg esomeprazole should not be exceeded (see section 5.2).
Dose adjustment is not required in the elderly.
Adolescents from the age of 12 years
40 mg once daily for 4 weeks.
An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.
20 mg once daily.
20 mg once daily in patients without esophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily.
When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents. The treatment should be supervised by a specialist.
The posology recommendation is:
| Weight | Posology |
|---|---|
| 30-40 kg | Combination with two antibiotics: Emazole 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administered together twice daily for one week. |
| >40 kg | Combination with two antibiotics: Emazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administered together twice daily for one week. |
Children below the age of 12 years
Emazole should not be used in children younger than 12 years since no data is available.
The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 15 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested. For preparation and administration instructions see section 6.6.
There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were uneventful.
No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
Aclar/aluminium blisters: 18 months.
Aluminium/aluminium blister: 24 months.
HDPE bottles: 24 months.
Shelf life after first opening: 6 months.
Do not store above 30°C. Keep the container tightly closed in order to protect from moisture.
Aluminium/aluminium blisters and aclar/aluminium blisters: Do not store above 25°C.
HDPE bottles:
Storage conditions before opening of the HDPE bottle: Do not store above 30°C.
For storage conditions after first opening of the HDPE bottle, see section 6.3.
Aluminium/aluminium blisters and aclar/aluminium blisters with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 100 × 1 gastro-resistant tablets.
HDPE bottles with PP cap and desiccant with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 250 gastro-resistant tablets.
Not all pack sizes may be marketed.
Administration via a stomach tube:
1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water is needed to prevent the pellets from clogging the tube.
2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip has not clogged.
4. Attach the syringe to the tube whilst maintaining the above position.
5. Shake the syringe and position it with the tip pointing down. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake it. Keep the syringe tip pointed upward as it will avoid clogging.
6. Turn the syringe with the tip down and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
7. Fill the syringe with 25 ml water and 5 ml air and repeat step 5 if necessary to wash down any sediment left in the syringe. Some tubes will require 50 ml water.
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