NEXIUM Gastro-resistant granules Ref.[6797] Active ingredients: Esomeprazole

Posology

Paediatric population

Children 1–11 years with a bodyweight of ≥10 kg

Gastroesophageal Reflux Disease (GERD):

• Treatment of endoscopically proven erosive reflux esophagitis:
  • Weight ≥10 - <20 kg: 10 mg once daily for 8 weeks.
  • Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks.
• Symptomatic treatment of gastroesophageal reflux disease (GERD):
  • 10 mg once daily for up to 8 weeks.

Doses over 1 mg/kg/day have not been studied.

Children over 4 years of age

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 1 year

The experience of treatment with esomeprazole in infants <1 year is limited and treatment is therefore not recommended (see section 5.1).

Adults and adolescents from the age of 12 years

For posology in patients from the age of 12 years reference is made to the Nexium gastro-resistant tablet SmPC.

Special populations

Renal impairment

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).

Hepatic impairment

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients ≥12 years with severe liver impairment, a maximum dose of 20 mg Nexium should not be exceeded. For children 1-11 years with severe liver impairment, a maximum dose of 10 mg should not be exceeded (see section 5.2).

Elderly

Dose adjustment is not required in the elderly.

Method of administration

For a 10 mg dose empty the contents of a 10 mg sachet into a glass containing 15 ml water. For a 20 mg dose empty the contents of two 10 mg sachets into a glass containing 30 ml water. Do not use carbonated water. Stir the contents until the granulate has been dispersed and leave for a few minutes to thicken. Stir again and drink within 30 minutes. The granules must not be chewed or crushed. Rinse with 15 ml water to obtain all granules.

For patients who have a nasogastric or gastric tube in place: see section 6.6 for preparation and administration instructions.

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.

3 years.

To be used within 30 minutes after reconstitution.

This medicinal product does not require any special storage conditions.

Carton containing 28 or 30 sachets. Not all pack sizes may be marketed.

Sachets (containing granules): Laminate consisting of three layers: polyethylene terephthalate (PET), aluminium, low density polyethylene (LDPE) which protects the granules against moisture.

No special requirements for disposal.

For patients who have a nasogastric or gastric tube in place

1. For a 10 mg dose, add the contents of a 10 mg sachet into 15 ml of water.
2. For a 20 mg dose add the contents of two 10 mg sachets into 30 ml of water.
3. Stir.
4. Leave for a few minutes to thicken.
5. Stir again.
6. Draw the suspension into a syringe.
7. Inject through the enteric tube, French size 6 or larger, into the stomach within 30 minutes after reconstitution.
8. Refill the syringe with 15 ml water for a 10 mg dose and 30 ml for a 20 mg dose.
9. Shake and flush any remaining contents from the enteric tube into the stomach.

Any unused suspension should be discarded.