NEXAZOLE Hard gastro-resistant capsule Ref.[49867] Active ingredients: Esomeprazole

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
• Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers

20mg Nexazole 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 i.v. induced prevention of rebleeding of peptic ulcers

40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

Treatment of Zollinger Ellison Syndrome

The recommended initial dosage is Nexazole 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

Patients with 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 (see section 5.2).

Patients with 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 Nexazole should not be exceeded (see section 5.2).

Elderly

Dose adjustment is not required in the elderly.

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:

Children below the age of 12 years

Nexazole should not be used in children younger than 12 years since no data is available.

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 (see section 6.6).

Do not eat the desiccant capsule provided in the container.

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.

2 years.

Blister pack consisting of OPA/Alu/PE + DES film/Alu + PE foil:

Store in the original package in order to protect from moisture.

Blister pack consisting of OPA/Alu/PVC/Alu foil:

Do not store above 30°C.

Store in the original package in order to protect from moisture.

HDPE tablet container:

Keep the container tightly closed in order to protect from moisture.

Blister pack (OPA/Alu/PE + DES film/Alu + PE foil): 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 hard gastro-resistant capsules, in a box.

Blister pack (OPA/Alu/PVC/Alu foil): 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 hard gastro-resistant capsules, in a box.

HDPE tablet container with PP closure with desiccant: 98 hard gastro-resistant capsules, and a desiccant capsule, in a box. Do not eat the desiccant capsule provided in the container.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.

Administration through gastric tube:

1. Openthecapsuleand empty the pellets 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 to evenly distribute the granules throughout the suspension.

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 (the syringe must be held with the tip pointing up to avoid clogging of the tip).

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 of water and 5 ml of air and repeat step 5 if necessary to wash down any sediment left in the syringe.

For some tubes, 50 ml water is needed.