Emanera 40 mg gastro-resistant capsules
Keep out of reach of children. Read the manual carefully before use
If need more information please consult with your doctor
COMPOSITION:
Each gastro-resistant capsule, contains 40 mg esomeprazole (as esomeprazole magnesium)
CLINICAL PARTICULARS:
Therapeutic indications
Emanera capsules are indicated in adults for:
Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent relapse
- symptomatic treatment of gastroesophageal reflux disease (GERD)
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and
- healing of Helicobacter pylori associated duodenal ulcer and
- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers
Patients requiring continued NSAID therapy
- healing of gastric ulcers associated with NSAID therapy - prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk
Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers
Treatment of Zollinger Ellison Syndrome
Emanera capsules are indicated in adolescents from the age of 12 years for:
Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent relapse
- symptomatic treatment of gastroesophageal reflux disease (GERD)
In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori
Posology and method of administration:
Posology Adults Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis 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.
- long-term management of patients with healed esophagitis to prevent relapse 20 mg once daily.
- symptomatic treatment of gastroesophageal reflux disease (GERD) 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. 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.
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and
- healing of Helicobacter pylori associated duodenal ulcer and
- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers. 20 mg Emanera with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
Patients requiring continued NSAID therapy
- Healing of gastric ulcers associated with NSAID therapy The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.
- Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk 20 mg once daily
Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers
40 mg once daily for 4 weeks after IV induced prevention of rebleeding of peptic ulcers.
Treatment of Zollinger Ellison Syndrome
The recommended initial dosage is Emanera 40 mg 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 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily
Special Populations Paediatric
population Adolescents from the age of 12 years
Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis
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.
- long-term management of patients with healed esophagitis to prevent relapse 20 mg once daily.
- symptomatic treatment of gastroesophageal reflux disease (GERD)
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
Treatment of duodenal ulcer caused by Helicobacter pylori
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: Emanera 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: Emanera 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
Emanera should not be used in children younger than 12 years since no data is available.
Impaired renal function
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
Impaired hepatic function
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 Emanera should not be exceeded
Elderly
Dose adjustment is not required in the elderly
Method of administration
The capsules should be swallowed whole with some water. The capsules should not be chewed or crushed.
For patients who have difficulty in swallowing, the capsules can also be opened and the pellets mixed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Drink the water with the pellets immediately or within 30 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 capsules can be opened and pellets mixed 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 before use
OTHER INFORMATION: Please refer to the Instruction sheet included in the package
MANUFACTURED BY: KRKA, D.D., NOVO MESTO (SLOVENIA)
DISTRIBUTOR: GLOBAL PHARMACEUTICAL JOINT-STOCK COMPANY
