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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

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Summary of Product Characteristics last updated on the eMC: 21/05/2012
SPC Nexium 10 mg gastro-resistant granules for oral suspension, sachet

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 21/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4

 

Addition of information about slightly increase risk of gastrointestinal infections of treatment with proton pump inhibitors.

 

 

Section 4.5

 

Addition of information about about esomeprazole interaction with cilostazol.

 

 

Section 5.1

 

Addition of information about risk of Clostridium difficile infection in hospitalised patients.

 

 

Section 10

 

Date of revision changed to 11th May 2012.

 

 
Updated on 05/10/2011 and displayed until 21/05/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Information added re about ‘Interference with laboratory tests’

 

Section 4.5 - Information added about interaction with St John’s wort, rifampicin and digoxin

 

Section 5.1 - Information added about the increased levels of Chromogranin A

 
Updated on 21/07/2011 and displayed until 05/10/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

 

Paediatric population


Following text removed

For a 10 mg dose empty the contents of a 10 mg sachet into a glass containing 15 ml of water. For a 20 mg dose empty the contents of two 10 mg sachets into a glass containing 30 ml of 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 of 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.

 

Following text removed

 

Adults and adolescent 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.

 

Following text replaced

 

Children below the age of 1 year or <10 kg

Nexium should not be used in children younger than 1 year or in children <10 kg since no data is available.

 

Replacement Text

 

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

 

New text added

 

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 gastroresistant tablet SmPC.

 

Special populations

 

New text added

 

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.

 

Section 5.1

 

New Text Added

 

GORD – 0 to 11 months of age

In a placebo-controlled study (98 patients aged 1-11 months) efficacy and safety in patients with signs and symptoms of GORD were evaluated. Esomeprazole 1 mg/kg once daily was given for 2 weeks (open-label phase) and 80 patients were included for an additional 4 weeks (doubleblind, treatment-withdrawal phase). There was no significant difference between esomeprazole and placebo for the primary endpoint time to discontinuation due to symptom worsening.

 

In a placebo-controlled study (52 patients aged < 1 month) efficacy and safety in patients with symptoms of GORD were evaluated. Esomeprazole 0.5 mg/kg once daily was given for a minimum of 10 days. There was no significant difference between esomeprazole and placebo in the primary endpoint, change from baseline of number of occurrences of symptoms of GORD.

 

Results from the paediatric studies further show that 0.5 mg/kg and 1.0 mg/kg esomeprazole in < 1 month old and 1 to 11 month old infants, respectively, reduced the mean percentage of time with intra-oesophageal pH < 4.

 

The safety profile appeared to be similar to that seen in adults.

 

Section 10

Change to date of Revision: 30th May 2011
Updated on 22/06/2011 and displayed until 21/07/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1     

 

Text amened to read:  Children 1-11years old

 

Additional Text:         Children over 4 years of age

In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori.

 

Section 4.2

 

New Text and table added

 

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: 

Weight

Posology

< 30 kg

Combination with two antibiotics: Nexium 10 mg, amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administered together twice daily for one week.

30 - 40 kg

Combination with two antibiotics: Nexium 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: Nexium 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administered together twice daily for one week.

 

Section 4.5     

 

New text added:         Interaction studies have only been performed in adults.

 

Section 10

Change of revision date of text

 
Updated on 22/10/2009 and displayed until 22/06/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3

Replacement of last sentence in section with:

Esomeprazole should not be used concomitantly with nelfinavir (See section 4.5)

Section 4.4

Addition of last paragraph:

Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.


Section 4.5

Addition of paragraph under heading 'Medicinal products with pH dependent absorption'

Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP2C19. For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended. Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax and Cmin). Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg qd) with atazanavir .400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared with the exposure observed with atazanavir 300 mg/ritonavir 100 mg qd without omeprazole 20 mg qd. Co-administration of omeprazole (40 mg qd) reduced mean nelfinavir AUC, Cmax and Cmin by 36–39 % and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92%. For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg qd). Treatment with omeprazole 20 mg qd had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with concomitant ritonavir). Treatment with esomeprazole 20 mg qd had no effect on the exposure of amprenavir (with and without concomitant ritonavir). Treatment with omeprazole 40 mg qd had no effect on the exposure of lopinavir (with concomitant ritonavir). Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended and concomitant administration with esomeprazole and nelfinavir is contraindicated.

Section 10

Change of date to: 

21st September 2009
Updated on 02/10/2009 and displayed until 22/10/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  esomeprazole magnesium trihydrate