NEXIAM 2,5 mg SACHETS GRANULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

AstraZeneca Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

GRANULES

Composition:

EACH SACHET CONTAINS ESOMEPRAZOLE 2,5 mg

Authorization status:

Registered

Authorization date:

2013-05-12

Patient Information leaflet

AstraZeneca Pharmaceuticals (Pty) Ltd
Date: 20 May 2021
Nexiam
®
5 mg Sachets; Nexiam
®
2,5 mg Sachets (Granules)
Module 1.3.2
Page 1 of 10
1.3.2 PATIENT INFORMATION LEAFLET (CURRENT APPROVED)
1.3.2 Page 2 of 10
FINAL PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
NEXIAM
® 2,5 SACHETS (ESOMEPRAZOLE 2,5 MG) (GRANULES)
NEXIAM
® 5 SACHETS (ESOMEPRAZOLE 5 MG) (GRANULES)
NEXIAM 2,5 and 5 mg Sachets are referred to as NEXIAM throughout this
leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE NEXIAM.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
NEXIAM has been prescribed for your child personally and should not be
shared with other people. It may harm them, even if their symptoms are
the same as your child.
1.
WHAT NEXIAM CONTAINS:
Each sachet of NEXIAM 2,5 mg contains 2,5 mg esomeprazole (as
magnesium trihydrate).
1.3.2 Page 3 of 10
Each sachet of NEXIAM 5 mg contains 5 mg esomeprazole (as
magnesium trihydrate).
_The other ingredients in NEXIAM 2,5 and 5 mg Sachets are:_
glycerol monostearate, hyprolose, hypromellose, magnesium stearate,
methacrylic acid copolymer, polysorbate 80, sugar spheres, talc,
triethyl
citrate, dextrose, xanthan gum, crospovidone, citric acid, iron oxide
(yellow)
(E 172), hyprolose. Contains sugar (sucrose).
2.
WHAT NEXIAM IS USED FOR:
NEXIAM is a type of medicine called a “proton pump inhibitor”
(medicines
used to treat ulcers). It reduces the production of acid in your
stomach.
NEXIAM is used for treating the following conditions:
•
the decrease in acidity in the food pipe by reducing the acidity of
the return flow fluid
from the stomach in neonates and infants.
•
the treatment of Gastro Oesophageal Reflux Disease (GORD) i.e. a
condition caused by
a return flow of fluid from the stomach into the food pipe confirmed
by special a test
(pH probe or endoscopy).
3.
BEFORE YOU GIVE NEXIAM:
DO NOT GIVE NEXIAM

Summary of Product characteristics

AstraZeneca Pharmaceuticals (Pty) Ltd
Date: 20 May 2021
Nexiam
®
5 mg Sachets; Nexiam
®
2,5 mg Sachets (Granules)
Module 1.3.1.1
Page 1 of 22
1.3.1.1 PROFESSIONAL INFORMATION (CURRENT APPROVED)
1.3.1.1 Page 2 of 22
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
NEXIAM
® 5 MG SACHETS; NEXIAM
®
2,5 MG SACHETS (GRANULES)
COMPOSITION:
_NEXIAM 5 mg Sachets: _
Each sachet contains esomeprazole 5 mg (as magnesium trihydrate) in
the form of gastro-
resistant granules for oral suspension.
_NEXIAM 2,5 mg Sachets: _
Each sachet contains esomeprazole 2,5 mg (as magnesium trihydrate) in
the form of gastro-
resistant granules for oral suspension.
Contains sugar (sucrose).
_List of excipients:_
glycerol monostearate 40-55, hyprolose, hypromellose, magnesium
stearate, methacrylic acid copolymer type C, polysorbate 80, sugar
spheres, talc, triethyl
citrate, dextrose, xanthan gum, crospovidone, citric acid, iron oxide,
hyprolose.
1.3.1.1 Page 3 of 22
PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3 Medicines acting on gastro-intestinal tract. Other.
PHARMACOLOGICAL ACTION:
_Pharmacodynamic properties: _
Esomeprazole, the S-isomer of omeprazole, reduces gastric acid
secretion through specific
inhibition of the acid pump in the parietal cell, where it is
concentrated and converted to the
active form in the acidic environment of the secretory canaliculi and
inhibits the enzyme
H
+
K
+
-ATPase – the acid pump. This effect on the final step of the
gastric acid secretion is
dose-dependent and provides for effective inhibition of both basal and
stimulated acid
secretion.
_Effect on gastric acid secretion: _
After oral dosing with esomeprazole 20 mg and 40 mg the onset of
effect occurs within 1
hour. After repeated administration with 20 mg esomeprazole once daily
for 5 days, mean
peak acid output after pentagastrin stimulation is decreased by 90 %
when measured 6-7
hours after dosing on day 5.
After 5 days of oral dosing with 20 mg and 40 mg of esomeprazole,
intragastric pH above 4
was maintained for a mean time of 13 hours and 17