Nexium Control

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

Nexium Control 20 mg gastro-resistant tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate)

Excipient(s) with known effect
Each gastro-resistant tablet contains 28 mg sucrose.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Gastro-resistant tablet.

A light pink, oblong, biconvex, film-coated, gastro-resistant tablet of 14 mm x 7 mm engraved with 
‘20 mG’ on one side and ‘A/EH’ on the other side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid 
regurgitation) in adults.

4.2 Posology and method of administration

Posology
The recommended dose is 20 mg esomeprazole (one tablet) per day.

It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of 
symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has 
occurred, treatment should be discontinued.

If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be 
instructed to consult a doctor.

Special populations
Patients with 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).

Patients with hepatic impairment
Dose adjustment is not required in patients with mild to moderate liver impairment. However, patients 
with severe liver impairment should be advised by a doctor before taking Nexium Control (see 
sections 4.4 and 5.2).

Elderly patients (≥65 years old)
Dose adjustment is not required in elderly patients.



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Paediatric population
There is no relevant use of Nexium Control in the paediatric population below 18 years of age for the 
indication of “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”.

Method of administration 
The tablets should be swallowed whole with half a glass of water. The tablets must not be chewed or 
crushed.

Alternatively, the tablet can be dispersed in half a glass of non-carbonated water. No other liquids 
should be used as the enteric coating may be dissolved. The water should be stirred until the tablet 
disintegrates. The liquid with the pellets should be drunk immediately or within 30 minutes. The glass 
should be rinsed with half a glass of water and the water drunk. The pellets should not be chewed or 
crushed.

4.3 Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed 
in section 6.1.
Esomeprazole must not be used concomitantly with nelfinavir (see section 4.5).

4.4 Special warnings and precautions for use

General
Patients should be instructed to consult a doctor if:

 They have significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis 
or melaena and when gastric ulcer is suspected or present, malignancy should be excluded as 
treatment with esomeprazole may alleviate symptoms and delay diagnosis.

 They have had previous gastric ulcer or gastrointestinal surgery.

 They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more 
weeks.

 They have jaundice or severe liver disease.

 They are aged over 55 years with new or recently changed symptoms.

Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at 
regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy 
on a daily basis should inform their pharmacist or doctor.

Patients should not take Nexium Control as a long term preventive medicinal product.

Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal 
infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly 
Clostridium difficile (see section 5.1).

Patients should consult their doctor before taking this medicinal product if they are due to have an 
endoscopy or urea breath test.

Combination with other medicinal products
Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the 
combination of atazanavir with a PPI 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.



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Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the 
potential for interactions with medicinal products metabolised through CYP2C19 should be 
considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance 
of this interaction is uncertain. The use of esomeprazole with clopidogrel should be discouraged (see 
section 4.5).

Patients should not take another PPI or H2 antagonist concomitantly.

Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 
To avoid this interference, Nexium Control treatment should be stopped for at least 5 days before CgA 
measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after 
initial measurement, measurements should be repeated 14 days after cessation of proton pump 
inhibitor treatment.

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially
in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical
help promptly and the health care professional should consider stopping Nexium Control. SCLE after
previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton
pump inhibitors.

Sucrose
This medicinal product contains sugar spheres (sucrose). Patients with rare hereditary problems of 
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not 
take this medicinal product.

4.5 Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults.

Effects of esomeprazole on the pharmacokinetics of other medicinal products
As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions 
reported with omeprazole.

Protease inhibitors
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 once a day) 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 once a day without omeprazole 20 mg once a day. Co-administration of omeprazole 
(40 mg once a day) 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%. 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 (see section 4.3 and 4.4).



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For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported 
during concomitant omeprazole treatment (40 mg once a day). Treatment with omeprazole 20 mg once 
a day had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with 
concomitant ritonavir). 

Treatment with esomeprazole 20 mg once a day had no effect on the exposure of amprenavir (with and 
without concomitant ritonavir). Treatment with omeprazole 40 mg once a day had no effect on the 
exposure of lopinavir (with concomitant ritonavir). 

Methotrexate
When given together with PPIs, methotrexate levels have been reported to increase in some patients. 
In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be 
considered.

Tacrolimus
Concomitant administration of esomeprazole has been reported to increase the serum levels of 
tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine 
clearance) should be performed, and the dose of tacrolimus adjusted if needed.

Medicinal products with pH dependent absorption
Gastric acid suppression during treatment with esomeprazole and other PPIs might decrease or 
increase the absorption of medicinal products with a gastric pH dependent absorption. The absorption 
of medicinal products taken orally such as ketoconazole, itraconazole and erlotinib can decrease 
during treatment with esomeprazole and the absorption of digoxin can increase during treatment with 
esomeprazole. 

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the 
bioavailability of digoxin by 10% (up to 30% in two out of ten subjects). Digoxin toxicity has been 
rarely reported. However, caution should be exercised when esomeprazole is given at high doses in 
elderly patients. Therapeutic monitoring of digoxin should then be reinforced.

Medicinal products metabolised by CYP2C19
Esomeprazole inhibits CYP2C19, the major esomeprazole metabolising enzyme. Thus, when 
esomeprazole is combined with medicinal products metabolised by CYP2C19, such as warfarin, 
phenytoin, citalopram, imipramine, clomipramine, diazepam, etc., the plasma concentrations of these 
medicinal products may be increased and a dose reduction could be needed. In case of clopidogrel, a 
prodrug which is transformed into its active metabolite via CYP2C19, the plasma concentrations of 
the active metabolite may be decreased.

Warfarin
Concomitant administration of 40 mg esomeprazole to warfarin-treated patients in a clinical study
showed that coagulation times were within the accepted range. However, post-marketing, a few 
isolated cases of elevated INR of clinical significance have been reported during concomitant 
treatment. Monitoring is recommended when initiating and ending concomitant esomeprazole 
treatment during treatment with warfarin or other coumarine derivatives.

Clopidogrel
Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) 
interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and 
esomeprazole (40 mg orally daily) resulting in decreased exposure to the active metabolite of 
clopidogrel by an average of 40%, and resulting in decreased maximum inhibition of (ADP induced) 
platelet aggregation by an average of 14%.

In a study in healthy subjects, there was a decreased exposure by almost 40% of the active metabolite 
of clopidogrel when a fixed dose combination of esomeprazole 20 mg + acetylsalicylic acid 81 mg 
was given with clopidogrel compared to clopidogrel alone. However, the maximum levels of 
inhibition of (ADP induced) platelet aggregation in these subjects were the same in both groups.



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Inconsistent data on the clinical implications of this PK/PD interaction in terms of major 
cardiovascular events have been reported from both observational and clinical studies. As a 
precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.

Phenytoin
Concomitant administration of 40 mg esomeprazole resulted in a 13% increase in trough plasma levels 
of phenytoin in epileptic patients. It is recommended to monitor the plasma concentrations of 
phenytoin when treatment with esomeprazole is introduced or withdrawn. 

Voriconazole
Omeprazole (40 mg once daily) increased voriconazole (a CYP2C19 substrate) Cmax and AUCτ by 
15% and 41%, respectively.

Cilostazol
Omeprazole as well as esomeprazole act as inhibitors of CYP2C19. Omeprazole, given in doses of 
40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 
26% respectively, and one of its active metabolites by 29% and 69% respectively.

Cisapride
In healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in a 32% increase 
in area under the plasma concentration-time curve (AUC) and a 31% prolongation of elimination 
half-life(t1/2) but no significant increase in peak plasma levels of cisapride. The slightly prolonged QTc 
interval observed after administration of cisapride alone, was not further prolonged when cisapride 
was given in combination with esomeprazole.

Diazepam
Concomitant administration of 30 mg esomeprazole resulted in a 45% decrease in clearance of the 
CYP2C19 substrate diazepam.

Investigated medicinal products with no clinically relevant interaction
Amoxicillin and quinidine
Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of 
amoxicillin and quinidine. 

Naproxen or rofecoxib
Studies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did 
not identify any clinically relevant pharmacokinetic interactions during short-term studies.

Effects of other medicinal products on the pharmacokinetics of esomeprazole
Medicinal products which inhibit CYP2C19 and/or CYP3A4
Esomeprazole is metabolised by CYP2C19 and CYP3A4. Concomitant administration of 
esomeprazole and a CYP3A4 inhibitor, clarithromycin (500 mg twice a day (b.i.d.)), resulted in a 
doubling of the exposure (AUC) to esomeprazole. Concomitant administration of esomeprazole and a 
combined inhibitor of CYP2C19 and CYP 3A4 may result in more than doubling of the esomeprazole 
exposure. The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUCt by 280%. 
A dose adjustment of esomeprazole is not regularly required in either of these situations. However, 
dose adjustment should be considered in patients with severe hepatic impairment and if long-term 
treatment is indicated.

Medicinal products which induce CYP2C19 and/or CYP3A4
Medicinal products known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s 
wort (Hypericum perforatum)) may lead to decreased esomeprazole serum levels by increasing the 
esomeprazole metabolism.



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4.6 Fertility, pregnancy and lactation

Pregnancy
A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no 
malformative or feto/ neonatal toxicity of esomeprazole.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3). 
As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy.

Breast-feeding
It is unknown whether esomeprazole/metabolites are excreted in human milk. There is insufficient 
information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used 
during breast-feeding.

Fertility
Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate 
effects with respect to fertility.

4.7 Effects on ability to drive and use machines

Esomeprazole has minor influence on the ability to drive or use machines. Adverse reactions such as 
dizziness and visual disturbances are uncommon (see section 4.8). If affected, patients should not 
drive or use machines.

4.8 Undesirable effects

Summary of the safety profile
Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been 
most commonly reported in clinical studies (and also from post-marketing use). In addition, the safety 
profile is similar for different formulations, treatment indications, age groups and patient populations. 
No dose-related adverse reactions have been identified.

Tabulated list of adverse reactions
The following adverse reactions have been identified or suspected in the clinical studies programme 
for esomeprazole and post-marketing. The reactions are classified according to MedDRA frequency 
convention: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available 
data).

Common Uncommon Rare Very rare Not known
Blood and 
lymphatic system 
disorders

leukopenia,
thrombocytope-
nia

agranulocytosis,
pancytopenia

Immune system 
disorders

hypersensitivity 
reactions e.g. 
fever, 
angioedema and 
anaphylactic 
reaction/shock



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Common Uncommon Rare Very rare Not known
Metabolism and 
nutrition 
disorders

peripheral 
oedema 

hyponatraemia hypomagne-
saemia; 
severe 
hypomagne-
saemia can 
correlate 
with 
hypocalcae-
mia; 
hypomagne-
saemia may 
also result in 
hypokalaem-
ia

Psychiatric 
disorders

insomnia agitation,
confusion,
depression

aggression,
hallucinations

Nervous system 
disorders

headache dizziness,
paraesthesia,
somnolence

taste 
disturbance

Eye disorders blurred vision
Ear and labyrinth 
disorders

vertigo

Respiratory, 
thoracic and 
mediastinal 
disorders

bronchospasm

Gastrointestinal 
disorders

abdominal 
pain, 
constipa-
tion,
diarrhoea,
flatulence,
nausea/ 
vomiting, 
fundic 
gland 
polyps 
(benign)

dry mouth stomatitis,
gastrointestinal 
candidiasis

microscopic 
colitis

Hepatobiliary 
disorders

increased 
liver 
enzymes

hepatitis with or 
without 
jaundice

hepatic failure,
hepatic 
encephalopathy 
in patients with 
pre-existing 
liver disease

Skin and 
subcutaneous 
tissue disorders

dermatitis,
pruritus, rash 
urticaria

alopecia,
photosensitivity

erythema 
multiforme,
Stevens-
Johnson 
syndrome,
toxic epidermal 
necrolysis 
(TEN)

Subacute
cutaneous
lupus 
erythematosu
s (see section 
4.4).



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Common Uncommon Rare Very rare Not known
Musculoskeletal 
and connective 
tissue disorders

arthralgia,
myalgia

muscular 
weakness

Renal and 
urinary disorders

Interstitial 
nephritis

Reproductive 
system and 
breast disorders

gynaecomastia

General disorders 
and 
administration 
site disorders

malaise,
increased 
sweating

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

There is very limited experience to date with deliberate overdose. The symptoms described in 
connection with 280 mg esomeprazole 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 dialysable. Treatment should be symptomatic and 
general supportive measures should be utilised.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders, proton pump inhibitors,
ATC code: A02BC05.

Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific 
targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R-
and S-isomer of omeprazole have similar pharmacodynamic activity.

Mechanism of action
Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic 
environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+K+-ATPase 
(the acid pump) and inhibits both basal and stimulated acid secretion.

Pharmacodynamic effects
After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour. 
After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid 
output after pentagastrin stimulation is decreased 90% when measured 6-7 hours after dosing on day 
five.

After five 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 hours, respectively over 24 hours in symptomatic 
gastroesophageal reflux disease (GERD) patients. The proportion of patients maintaining an 
intragastric pH above 4 for at least 8, 12 and 16 hours respectively were for esomeprazole 20 mg 76%, 
54% and 24%. Corresponding proportions for esomeprazole 40 mg were 97%, 92% and 56%.



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Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of 
acid secretion and exposure has been shown.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the 
decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA 
level may interfere with investigations for neuroendocrine tumours.

Available published evidence suggests that proton pump inhibitors should be discontinued between 
5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously 
elevated following PPI treatment to return to reference range.

An increased number of ECL cells possibly related to the increased serum gastrin levels, have been 
observed in some patients during long-term treatment with esomeprazole.

Decreased gastric acidity due to any means including PPIs, increases gastric counts of bacteria 
normally present in the gastrointestinal tract. Treatment with PPIs may lead to slightly increased risk 
of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also 
possibly Clostridium difficile.

Clinical efficacy
Esomeprazole 20 mg has been demonstrated to effectively treat frequent heartburn in subjects 
receiving one dose per 24 hours over 2 weeks. In two multicenter, randomized, double-blind, 
placebo-controlled pivotal studies 234 subjects with a recent history of frequent heartburn were treated 
with 20 mg esomeprazole for 4 weeks. Symptoms associated with acid reflux (such as heartburn and 
acid regurgitation) were evaluated retrospectively over a 24 hour period. In both studies esomeprazole 
20 mg was significantly better compared to placebo for the primary endpoint, complete resolution of 
heartburn, defined as no heartburn episodes during the last 7 days prior to the final visit 
(33.9% - 41.6% vs. placebo 11.9 – 13.7%, (p<0.001). The secondary endpoint of complete resolution 
of heartburn, defined as no heartburn on the patient’s diary card for 7 consecutive days, was 
statistically significant at both week 1 (10.0% - 15.2% vs placebo 0.9% - 2.4%, p = 0.014, p<0.001) 
and week 2 (25.2% - 35.7% vs placebo 3.4% - 9.0%, p<0.001).

Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at 
week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean 
heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over 
a 24 hour period and during the night compared to placebo. Approximately 78% of the subjects on
20 mg esomeprazole reported first resolution of heartburn within the first week of treatment compared 
to 52 – 58% for placebo. Time to sustained resolution of heartburn, defined as when 7 consecutive 
days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group 
(39.7% - 48.7% by day 14 vs placebo 11.0% - 20.2%). The median time to first resolution of 
night-time heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) 
and approaching significance in the other (p=0.069). About 80% of nights were heartburn free during 
all time periods and 90% of nights were heartburn free by week 2 of each clinical study, compared to 
72.4 – 78.3% for placebo. The investigators’ assessments of heartburn resolution were consistent with 
the subjects’ assessments, showing statistically significant differences between esomeprazole 
(34.7% - 41.8%) compared to placebo (8.0% - 11.4%). The investigators also found esomeprazole to 
be significantly more effective than placebo in resolving acid regurgitation (58.5% - 63.6% vs placebo 
28.3% - 37.4%) during the week 2 evaluation. 

Following Overall Treatment Evaluation (OTE) of patients at week 2, 78.0-80.7% of patients on 
esomeprazole 20 mg, compared to 72.4 – 78.3% for placebo, reported their condition as improved. 
The majority of these rated the importance of this change to be Important to Extremely Important in 
performing their activities of daily living (79 - 86% at week 2).



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5.2 Pharmacokinetic properties

Absorption
Esomeprazole is acid labile and is administered orally as enteric-coated granules. In vivo conversion to 
the R-isomer is negligible. Absorption of esomeprazole is rapid, with peak plasma levels occurring 
approximately 1-2 hours after dose. The absolute bioavailability is 64% after a single dose of 40 mg 
and increases to 89% after repeated once-daily administration. For 20 mg esomeprazole the 
corresponding values are 50% and 68% respectively. Food intake both delays and decreases the 
absorption of esomeprazole although this has no significant influence on the effect of esomeprazole on 
intragastric acidity.

Distribution
The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body 
weight. Esomeprazole is 97% plasma protein bound.

Biotransformation 
Esomeprazole is completely metabolised by the cytochrome P450 system (CYP). The major part of 
the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the 
formation of the hydroxy- and desmethyl metabolites of esomeprazole. The remaining part is 
dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole 
sulphone, the main metabolite in plasma.

Elimination
The parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 
enzyme, extensive metabolisers. 

Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration. 
The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing. Esomeprazole is 
completely eliminated from plasma between doses with no tendency for accumulation during 
once-daily administration. The major metabolites of esomeprazole have no effect on gastric acid 
secretion. Almost 80% of an oral dose of esomeprazole is excreted as metabolites in the urine, the 
remainder in the faeces. Less than 1% of the parent compound is found in urine.

Linearity/non-linearity
The pharmacokinetics of esomeprazole has been studied in doses up to 40 mg b.i.d. The area under the 
plasma concentration-time curve increases with repeated administration of esomeprazole. This 
increase is dose-dependent and results in a more than dose proportional increase in AUC after repeated 
administration. This time and dose-dependency is due to a decrease of first pass metabolism and 
systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by esomeprazole and/or 
its sulphone metabolite. 

Special patient populations
Poor metabolisers
Approximately 2.9±1.5% of the population lack a functional CYP2C19 enzyme and are called poor 
metabolisers. In these individuals the metabolism of esomeprazole is probably mainly catalysed by 
CYP3A4. After repeated once-daily administration of 40 mg esomeprazole, the mean area under the 
plasma concentration-time curve was approximately 100% higher in poor metabolisers than in subjects 
having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations 
were 60% higher.
These findings have no implications for the posology of esomeprazole.

Gender
Following a single dose of 40 mg esomeprazole the mean are under the plasma concentration-time 
curve is approximately 30% higher in females than in males. No gender difference is seen after 
repeated once-daily administration. These findings have no implications for the posology of 
esomeprazole.



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Hepatic impairment
The metabolism of esomeprazole in patients with mild to moderate liver dysfunction may be impaired. 
The metabolic rate is decreased in patients with severe liver dysfunction resulting in a doubling of the 
area under the plasma concentration-time curve of esomeprazole. Therefore, a maximum of 20 mg 
should not be exceeded in patients with severe dysfunction. Esomeprazole or its major metabolites do 
not show any tendency to accumulate with once-daily dosing.

Renal impairment
No studies have been performed in patients with decreased renal function. Since the kidney is 
responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the 
parent compound, the metabolism of esomeprazole is not expected to be changed in patients with 
impaired renal function.

Elderly patients (≥65 years old)
The metabolism of esomeprazole is not significantly changed in elderly patients (71-80 years of age).

5.3 Preclinical safety data

Non-clinical data reveal no particular hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development. 
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to 
clinical exposure levels and with possible relevance to clinical use were as follows:
Carcinogenicity studies in the rat with the racemic mixture have shown gastric ECL-cell hyperplasia 
and carcinoids. These gastric effects in the rat are the result of sustained, pronounced 
hypergastrinaemia secondary to reduced production of gastric acid and are observed after long-term 
treatment in the rat with inhibitors of gastric acid secretion.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol monostearate 40-55
Hydroxypropylcellulose
Hypromellose 2910 (6 mPa·s)
Reddish-brown iron oxide (E172)
Yellow iron oxide (E172)
Magnesium stearate 
Methacrylic acid ethylacrylate copolymer (1:1) dispersion 30 per cent 
Cellulose microcrystalline 
Synthetic Paraffin 
Macrogol 6000 
Polysorbate 80 
Crospovidone (Type A)
Sodium stearyl fumarate 
Sugar spheres (sucrose and maize starch) 
Talc 
Titanium dioxide (E171) 
Triethyl citrate

6.2 Incompatibilities

Not applicable.



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6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30°C
Store in the original package in order to protect from moisture.

6.5 Nature and contents of container 

Aluminium blister. Pack sizes of 7, 14 and 28 gastro-resistant tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal 

No special requirements.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Dungarvan Limited, 
Knockbrack, 
Dungarvan, 
Co. Waterford,
Ireland

8. MARKETING AUTHORISATION NUMBER(S) 

EU/1/13/860/001
EU/1/13/860/002
EU/1/13/860/004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26 August 2013
Date of latest renewal: 25 June 2018

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.



14

1. NAME OF THE MEDICINAL PRODUCT

Nexium Control 20 mg gastro-resistant hard capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gastro-resistant hard capsule contains 20 mg esomeprazole (as magnesium trihydrate)

Excipient(s) with known effect
Each gastro-resistant hard capsule contains 11.5 mg sucrose.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Gastro-resistant hard capsule. (Gasto-resistant capsule).

Capsule approximately 11 x 5 mm, with a clear body, and an amethyst cap imprinted with “NEXIUM 
20 MG” in white. The capsule has a yellow centre band, and contains yellow and purple enteric coated 
pellets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid 
regurgitation) in adults.

4.2 Posology and method of administration

Posology
The recommended dose is 20 mg esomeprazole (one capsule) per day.

It might be necessary to take the capsules for 2-3 consecutive days to achieve improvement of 
symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has 
occurred, treatment should be discontinued.

If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be 
instructed to consult a doctor.

Special populations
Patients with 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).

Patients with hepatic impairment
Dose adjustment is not required in patients with mild to moderate liver impairment. However, patients 
with severe liver impairment should be advised by a doctor before taking Nexium Control (see 
sections 4.4 and 5.2).

Elderly patients (≥65 years old)
Dose adjustment is not required in elderly patients.



15

Paediatric population
There is no relevant use of Nexium Control in the paediatric population below 18 years of age for the 
indication of “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”.

Method of administration 
The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed, 
crushed or opened.

4.3 Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed 
in section 6.1.

Esomeprazole must not be used concomitantly with nelfinavir (see section 4.5).

4.4 Special warnings and precautions for use

General
Patients should be instructed to consult a doctor if:

 They have significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis 
or melaena and when gastric ulcer is suspected or present, malignancy should be excluded as 
treatment with esomeprazole may alleviate symptoms and delay diagnosis.

 They have had previous gastric ulcer or gastrointestinal surgery.

 They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more 
weeks.

 They have jaundice or severe liver disease.

 They are aged over 55 years with new or recently changed symptoms.

Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at 
regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy 
on a daily basis should inform their pharmacist or doctor.

Patients should not take Nexium Control as a long term preventive medicinal product.

Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal 
infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly 
Clostridium difficile (see section 5.1).

Patients should consult their doctor before taking this medicinal product if they are due to have an 
endoscopy or urea breath test.

Combination with other medicinal products
Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the 
combination of atazanavir with a PPI 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.

Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the 
potential for interactions with medicinal products metabolised through CYP2C19 should be 
considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance 



16

of this interaction is uncertain. The use of esomeprazole with clopidogrel should be discouraged (see
section 4.5).

Patients should not take another PPI or H2 antagonist concomitantly.

Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 
To avoid this interference, Nexium Control treatment should be stopped for at least 5 days before CgA 
measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after 
initial measurement, measurements should be repeated 14 days after cessation of proton pump 
inhibitor treatment.

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially
in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical
help promptly and the health care professional should consider stopping Nexium Control. SCLE after
previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton
pump inhibitors.

Sucrose
This medicinal product contains sugar spheres (sucrose). Patients with rare hereditary problems of 
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not 
take this medicinal product.

4.5 Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults.

Effects of esomeprazole on the pharmacokinetics of other medicinal products
As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions 
reported with omeprazole.

Protease inhibitors
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 once a day) 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 once a day without omeprazole 20 mg once a day. Co-administration of omeprazole 
(40 mg once a day) 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%. 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 (see section 4.3 and 4.4).

For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported 
during concomitant omeprazole treatment (40 mg once a day). Treatment with omeprazole 20 mg once 
a day had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with 
concomitant ritonavir). 



17

Treatment with esomeprazole 20 mg once a day had no effect on the exposure of amprenavir (with and 
without concomitant ritonavir). Treatment with omeprazole 40 mg once a day had no effect on the 
exposure of lopinavir (with concomitant ritonavir). 

Methotrexate
When given together with PPIs, methotrexate levels have been reported to increase in some patients. 
In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be 
considered.

Tacrolimus
Concomitant administration of esomeprazole has been reported to increase the serum levels of 
tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine 
clearance) should be performed, and the dose of tacrolimus adjusted if needed.

Medicinal products with pH dependent absorption
Gastric acid suppression during treatment with esomeprazole and other PPIs might decrease or 
increase the absorption of medicinal products with a gastric pH dependent absorption. The absorption 
of medicinal products taken orally such as ketoconazole, itraconazole and erlotinib can decrease 
during treatment with esomeprazole and the absorption of digoxin can increase during treatment with 
esomeprazole.

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the 
bioavailability of digoxin by 10% (up to 30% in two out of ten subjects). Digoxin toxicity has been 
rarely reported. However, caution should be exercised when esomeprazole is given at high doses in 
elderly patients. Therapeutic monitoring of digoxin should then be reinforced.

Medicinal products metabolised by CYP2C19
Esomeprazole inhibits CYP2C19, the major esomeprazole metabolising enzyme. Thus, when 
esomeprazole is combined with medicinal products metabolised by CYP2C19, such as warfarin, 
phenytoin, citalopram, imipramine, clomipramine, diazepam, etc., the plasma concentrations of these 
medicinal products may be increased and a dose reduction could be needed. In case of clopidogrel, a 
prodrug which is transformed into its active metabolite via CYP2C19, the plasma concentrations of 
the active metabolite may be decreased.

Warfarin
Concomitant administration of 40 mg esomeprazole to warfarin-treated patients in a clinical study
showed that coagulation times were within the accepted range. However, post-marketing, a few 
isolated cases of elevated INR of clinical significance have been reported during concomitant 
treatment. Monitoring is recommended when initiating and ending concomitant esomeprazole 
treatment during treatment with warfarin or other coumarine derivatives.

Clopidogrel
Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) 
interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and 
esomeprazole (40 mg orally daily) resulting in decreased exposure to the active metabolite of 
clopidogrel by an average of 40%, and resulting in decreased maximum inhibition of (ADP induced) 
platelet aggregation by an average of 14%.

In a study in healthy subjects, there was a decreased exposure by almost 40% of the active metabolite 
of clopidogrel when a fixed dose combination of esomeprazole 20 mg + acetylsalicylic acid 81 mg 
was given with clopidogrel compared to clopidogrel alone. However, the maximum levels of 
inhibition of (ADP induced) platelet aggregation in these subjects were the same in both groups.

Inconsistent data on the clinical implications of this PK/PD interaction in terms of major 
cardiovascular events have been reported from both observational and clinical studies. As a 
precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.



18

Phenytoin
Concomitant administration of 40 mg esomeprazole resulted in a 13% increase in trough plasma levels 
of phenytoin in epileptic patients. It is recommended to monitor the plasma concentrations of 
phenytoin when treatment with esomeprazole is introduced or withdrawn. 

Voriconazole
Omeprazole (40 mg once daily) increased voriconazole (a CYP2C19 substrate) Cmax and AUCτ by 
15% and 41%, respectively.

Cilostazol
Omeprazole as well as esomeprazole act as inhibitors of CYP2C19. Omeprazole, given in doses of 
40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 
26% respectively, and one of its active metabolites by 29% and 69% respectively.

Cisapride
In healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in a 32% increase 
in area under the plasma concentration-time curve (AUC) and a 31% prolongation of elimination 
half-life(t1/2) but no significant increase in peak plasma levels of cisapride. The slightly prolonged QTc 
interval observed after administration of cisapride alone, was not further prolonged when cisapride
was given in combination with esomeprazole.

Diazepam
Concomitant administration of 30 mg esomeprazole resulted in a 45% decrease in clearance of the 
CYP2C19 substrate diazepam.

Investigated medicinal products with no clinically relevant interaction
Amoxicillin and quinidine
Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of 
amoxicillin and quinidine. 

Naproxen or rofecoxib
Studies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did 
not identify any clinically relevant pharmacokinetic interactions during short-term studies.

Effects of other medicinal products on the pharmacokinetics of esomeprazole
Medicinal products which inhibit CYP2C19 and/or CYP3A4
Esomeprazole is metabolised by CYP2C19 and CYP3A4. Concomitant administration of 
esomeprazole and a CYP3A4 inhibitor, clarithromycin (500 mg twice a day (b.i.d.)), resulted in a 
doubling of the exposure (AUC) to esomeprazole. Concomitant administration of esomeprazole and a 
combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole 
exposure. The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUCt by 280%. 
A dose adjustment of esomeprazole is not regularly required in either of these situations. However, 
dose adjustment should be considered in patients with severe hepatic impairment and if long-term 
treatment is indicated.

Medicinal products which induce CYP2C19 and/or CYP3A4
Medicinal products known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s 
wort (Hypericum perforatum)) may lead to decreased esomeprazole serum levels by increasing the 
esomeprazole metabolism.

4.6 Fertility, pregnancy and lactation

Pregnancy
A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no 
malformative or feto/ neonatal toxicity of esomeprazole.



19

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3). 
As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy.

Breast-feeding
It is unknown whether esomeprazole/metabolites are excreted in human milk. There is insufficient 
information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used 
during breast-feeding.

Fertility
Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate 
effects with respect to fertility.

4.7 Effects on ability to drive and use machines

Esomeprazole has minor influence on the ability to drive or use machines. Adverse reactions such as 
dizziness and visual disturbances are uncommon (see section 4.8). If affected, patients should not 
drive or use machines.

4.8 Undesirable effects

Summary of the safety profile
Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been 
most commonly reported in clinical studies (and also from post-marketing use). In addition, the safety 
profile is similar for different formulations, treatment indications, age groups and patient populations. 
No dose-related adverse reactions have been identified.

Tabulated list of adverse reactions
The following adverse reactions have been identified or suspected in the clinical studies programme 
for esomeprazole and post-marketing. The reactions are classified according to MedDRA frequency 
convention: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available 
data).

Common Uncommon Rare Very rare Not known
Blood and 
lymphatic system 
disorders

leukopenia,
thrombocytope-
nia

agranulocytosis,
pancytopenia

Immune system 
disorders

hypersensitivity 
reactions e.g. 
fever, 
angioedema and 
anaphylactic 
reaction/shock



20

Common Uncommon Rare Very rare Not known
Metabolism and 
nutrition 
disorders

peripheral 
oedema 

hyponatraemia hypomagne-
saemia; 
severe 
hypomagne-
saemia can 
correlate 
with 
hypocalcae-
mia; 
hypomagne-
saemia may 
also result in 
hypokalaem-
ia

Psychiatric 
disorders

insomnia agitation,
confusion,
depression

aggression,
hallucinations

Nervous system 
disorders

headache dizziness,
paraesthesia,
somnolence

taste 
disturbance

Eye disorders blurred vision
Ear and labyrinth 
disorders

vertigo

Respiratory, 
thoracic and 
mediastinal 
disorders

bronchospasm

Gastrointestinal 
disorders

abdominal 
pain, 
constipa-
tion,
diarrhoea,
flatulence,
nausea/ 
vomiting, 
fundic 
gland 
polyps 
(benign)

dry mouth stomatitis,
gastrointestinal 
candidiasis

microscopic 
colitis

Hepatobiliary 
disorders

increased 
liver 
enzymes

hepatitis with or 
without 
jaundice

hepatic failure,
hepatic 
encephalopathy 
in patients with 
pre-existing 
liver disease

Skin and 
subcutaneous 
tissue disorders

dermatitis,
pruritus, rash 
urticaria

alopecia,
photosensitivity

erythema 
multiforme,
Stevens-
Johnson 
syndrome,
toxic epidermal 
necrolysis 
(TEN)

Subacute
cutaneous
lupus 
erythematosu
s (see section 
4.4).



21

Common Uncommon Rare Very rare Not known
Musculoskeletal 
and connective 
tissue disorders

arthralgia,
myalgia

muscular 
weakness

Renal and 
urinary disorders

Interstitial 
nephritis

Reproductive 
system and 
breast disorders

gynaecomastia

General disorders 
and 
administration 
site disorders

malaise,
increased 
sweating

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

There is very limited experience to date with deliberate overdose. The symptoms described in 
connection with 280 mg esomeprazole 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 dialysable. Treatment should be symptomatic and 
general supportive measures should be utilised.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders, proton pump inhibitors,
ATC code: A02BC05.

Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific 
targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R-
and S-isomer of omeprazole have similar pharmacodynamic activity.

Mechanism of action
Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic 
environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+K+-ATPase 
(the acid pump) and inhibits both basal and stimulated acid secretion.

Pharmacodynamic effects
After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour. 
After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid 
output after pentagastrin stimulation is decreased 90% when measured 6-7 hours after dosing on day 
five.

After five 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 hours, respectively over 24 hours in symptomatic 
gastroesophageal reflux disease (GERD) patients. The proportion of patients maintaining an 
intragastric pH above 4 for at least 8, 12 and 16 hours respectively were for esomeprazole 20 mg 76%, 
54%, and 24%. Corresponding proportions for esomeprazole 40 mg were 97%, 92%, and 56%.



22

Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of 
acid secretion and exposure has been shown.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the 
decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA 
level may interfere with investigations for neuroendocrine tumours.

Available published evidence suggests that proton pump inhibitors should be discontinued between 
5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously 
elevated following PPI treatment to return to reference range.

An increased number of ECL cells possibly related to the increased serum gastrin levels, have been 
observed in some patients during long-term treatment with esomeprazole.

Decreased gastric acidity due to any means including PPIs, increases gastric counts of bacteria 
normally present in the gastrointestinal tract. Treatment with PPIs may lead to slightly increased risk 
of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also 
possibly Clostridium difficile.

Clinical efficacy
Esomeprazole 20 mg has been demonstrated to effectively treat frequent heartburn in subjects 
receiving one dose per 24 hours over 2 weeks. In two multicentre, randomised, double-blind, 
placebo-controlled pivotal studies 234 subjects with a recent history of frequent heartburn were treated 
with 20 mg esomeprazole for 4 weeks. Symptoms associated with acid reflux (such as heartburn and 
acid regurgitation) were evaluated retrospectively over a 24 hour period. In both studies esomeprazole 
20 mg was significantly better compared to placebo for the primary endpoint, complete resolution of 
heartburn, defined as no heartburn episodes during the last 7 days prior to the final visit 
(33.9% - 41.6% vs. placebo 11.9 - 13.7%, (p<0.001). The secondary endpoint of complete resolution 
of heartburn, defined as no heartburn on the patient’s diary card for 7 consecutive days, was 
statistically significant at both week 1 (10.0% - 15.2% vs. placebo 0.9% - 2.4%, p = 0.014, p<0.001) 
and week 2 (25.2% - 35.7% vs. placebo 3.4% - 9.0%, p<0.001).

Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at 
week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean 
heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over 
a 24 hour period and during the night compared to placebo. Approximately 78% of the subjects on 
20 mg esomeprazole reported first resolution of heartburn within the first week of treatment compared 
to 52 - 58% for placebo. Time to sustained resolution of heartburn, defined as when 7 consecutive 
days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group 
(39.7% - 48.7% by day 14 vs. placebo 11.0% - 20.2%). The median time to first resolution of 
night-time heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) 
and approaching significance in the other (p=0.069). About 80% of nights were heartburn free during 
all time periods and 90% of nights were heartburn free by week 2 of each clinical study, compared to 
72.4 - 78.3% for placebo. The investigators’ assessments of heartburn resolution were consistent with 
the subjects’ assessments, showing statistically significant differences between esomeprazole 
(34.7% - 41.8%) compared to placebo (8.0% - 11.4%). The investigators also found esomeprazole to 
be significantly more effective than placebo in resolving acid regurgitation (58.5% - 63.6% vs.
placebo 28.3% - 37.4%) during the week 2 evaluation. 

Following Overall Treatment Evaluation (OTE) of patients at week 2, 78.0 - 80.7% of patients on 
esomeprazole 20 mg, compared to 72.4 - 78.3% for placebo, reported their condition as improved. The 
majority of these rated the importance of this change to be Important to Extremely Important in 
performing their activities of daily living (79 - 86% at week 2).



23

5.2 Pharmacokinetic properties

Absorption
Esomeprazole is acid labile and is administered orally as enteric-coated granules. In vivo conversion to 
the R-isomer is negligible. Absorption of esomeprazole is rapid, with peak plasma levels occurring 
approximately 1-2 hours after dose. The absolute bioavailability is 64% after a single dose of 40 mg 
and increases to 89% after repeated once-daily administration. For 20 mg esomeprazole the 
corresponding values are 50% and 68% respectively. Food intake both delays and decreases the 
absorption of esomeprazole although this has no significant influence on the effect of esomeprazole on 
intragastric acidity. 

Distribution
The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body 
weight. Esomeprazole is 97% plasma protein bound.

Biotransformation 
Esomeprazole is completely metabolised by the cytochrome P450 system (CYP). The major part of 
the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the 
formation of the hydroxy- and desmethyl metabolites of esomeprazole. The remaining part is 
dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole 
sulphone, the main metabolite in plasma.

Elimination
The parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 
enzyme, extensive metabolisers.

Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration. 
The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing. Esomeprazole is 
completely eliminated from plasma between doses with no tendency for accumulation during 
once-daily administration. The major metabolites of esomeprazole have no effect on gastric acid 
secretion. Almost 80% of an oral dose of esomeprazole is excreted as metabolites in the urine, the 
remainder in the faeces. Less than 1% of the parent compound is found in urine.

Linearity/non-linearity
The pharmacokinetics of esomeprazole has been studied in doses up to 40 mg b.i.d. The area under the 
plasma concentration-time curve increases with repeated administration of esomeprazole. This 
increase is dose-dependent and results in a more than dose proportional increase in AUC after repeated 
administration. This time and dose-dependency is due to a decrease of first pass metabolism and 
systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by esomeprazole and/or 
its sulphone metabolite. 

Special patient populations
Poor metabolisers
Approximately 2.9±1.5% of the population lack a functional CYP2C19 enzyme and are called poor 
metabolisers. In these individuals the metabolism of esomeprazole is probably mainly catalysed by 
CYP3A4. After repeated once-daily administration of 40 mg esomeprazole, the mean area under the 
plasma concentration-time curve was approximately 100% higher in poor metabolisers than in subjects 
having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations 
were 60% higher.
These findings have no implications for the posology of esomeprazole.

Gender
Following a single dose of 40 mg esomeprazole the mean are under the plasma concentration-time 
curve is approximately 30% higher in females than in males. No gender difference is seen after 
repeated once-daily administration. These findings have no implications for the posology of 
esomeprazole.



24

Hepatic impairment
The metabolism of esomeprazole in patients with mild to moderate liver dysfunction may be impaired. 
The metabolic rate is decreased in patients with severe liver dysfunction resulting in a doubling of the 
area under the plasma concentration-time curve of esomeprazole. Therefore, a maximum of 20 mg 
should not be exceeded in patients with severe dysfunction. Esomeprazole or its major metabolites do
not show any tendency to accumulate with once-daily dosing.

Renal impairment
No studies have been performed in patients with decreased renal function. Since the kidney is 
responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the 
parent compound, the metabolism of esomeprazole is not expected to be changed in patients with 
impaired renal function.

Elderly patients (≥65 years old)
The metabolism of esomeprazole is not significantly changed in elderly patients (71-80 years of age).

5.3 Preclinical safety data

Non-clinical data reveal no particular hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development. 
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to 
clinical exposure levels and with possible relevance to clinical use were as follows:
Carcinogenicity studies in the rat with the racemic mixture have shown gastric ECL-cell hyperplasia 
and carcinoids. These gastric effects in the rat are the result of sustained, pronounced 
hypergastrinaemia secondary to reduced production of gastric acid and are observed after long-term 
treatment in the rat with inhibitors of gastric acid secretion.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule content
Glycerol monostearate 40-55
Hydroxypropylcellulose 
Hypromellose 2910 (6 mPa·s)
Magnesium stearate
Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent
Polysorbate 80
Sugar spheres (sucrose and maize starch)
Talc
Triethyl citrate
Carmine (E120)
Indigo carmine (E132)
Titanium dioxide (E171)
Yellow iron oxide (E172)

Capsule shell
Gelatin
Indigo carmine (E132)
Erythrosine (E127)
Allura red AC (E129)

Printing ink
Povidone K-17
Propylene glycol
Shellac



25

Sodium hydroxide
Titanium dioxide (E171)

Band
Gelatin
Yellow iron oxide (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 30°C
Store in the original package in order to protect from moisture.

6.5 Nature and contents of container 

High-density polyethylene (HDPE) bottle with an induction seal closure and child resistant closure
containing 14 gastro-resistant capsules. The bottle also contains a sealed container with silica gel 
desiccant.

Nexium Control capsules are available in pack sizes of 14 and 28 capsules. Not all pack sizes may be 
marketed.

6.6 Special precautions for disposal 

No special requirements.

7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Dungarvan Limited, 
Knockbrack, 
Dungarvan, 
Co. Waterford,
Ireland

8. MARKETING AUTHORISATION NUMBER(S) 

EU/1/13/860/003
EU/1/13/860/005

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26 August 2013
Date of latest renewal: 25 June 2018



26

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.



27

ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT



28

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Pfizer Consumer Manufacturing Italy S.r.l. 
Via Nettunense, 90 
04011 Aprilia (LT) 
Italy

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product not subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT  

 Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 

updates of the RMP.

An updated RMP should be submitted:

 At the request of the European Medicines Agency;

 Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 

as the result of an important (pharmacovigilance or risk minimisation) milestone being 

reached. 



29

ANNEX III

LABELLING AND PACKAGE LEAFLET



30

A. LABELLING



31

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Nexium Control 20 mg gastro-resistant tablets

esomeprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate).

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 gastro-resistant tablets
14 gastro-resistant tablets
2 x 14 gastro-resistant tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

The tablets should be swallowed whole. Do not chew or crush the tablets.
Read the package leaflet before use.
Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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



32

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Dungarvan Limited, 
Knockbrack, 
Dungarvan, 
Co. Waterford, 
Ireland

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/13/860/001 7 gastro-resistant tablets
EU/1/13/860/002 14 gastro-resistant tablets
EU/1/13/860/004 2 x 14 gastro-resistant tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

For short–term treatment of reflux symptoms (heartburn, acid regurgitation) in adults, aged 18 or over.
Do not use if you are allergic to esomeprazole or any of the other ingredients of this medicine. 
Talk to your pharmacist or doctor if:
You are taking any medicines listed in the package leaflet
You are over 55 and have new or recently changed reflux symptoms.
How to use
Take one tablet once a day. Do not exceed this dose.
May take 2-3 days for full effect.
If your symptoms worsen or do not improve after taking this medicine for 14 days in a row, contact 
your doctor. 

Treats Heartburn & Acid Reflux

One tablet daily
Lasts 24 hours

<www.xxx.xxx>



33

16. INFORMATION IN BRAILLE

Nexium Control 20 mg Tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable.



34

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Nexium Control 20 mg gastro-resistant tablets

esomeprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Dungarvan Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



35

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Nexium Control 20 mg gastro-resistant hard capsules

esomeprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each gastro-resistant hard capsule contains 20 mg esomeprazole (as magnesium trihydrate).

3. LIST OF EXCIPIENTS

Contains sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 gastro-resistant hard capsules
2 x 14 gastro-resistant hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

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



36

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Dungarvan Limited, 
Knockbrack, 
Dungarvan, 
Co. Waterford, 
Ireland

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/13/860/003 14 gastro-resistant hard capsules
EU/1/13/860/005 2 x 14 gastro-resistant hard capsules

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

For short–term treatment of reflux symptoms (heartburn, acid regurgitation) in adults, aged 18 or over.

Do not use if you are allergic to esomeprazole or any of the other ingredients of this medicine. 

Talk to your pharmacist or doctor if:
 You are taking any medicines listed in the package leaflet. 
 You are over 55 and have new or recently changed reflux symptoms.

How to use
Take one capsule once a day. Do not exceed this dose.
The capsules should be swallowed whole. Do not chew, crush or open capsule.
May take 2-3 days for full effect.
If your symptoms worsen or do not improve after taking this medicine for 14 days in a row, contact 
your doctor. 

Treats Heartburn & Acid Reflux

Capsules

One capsule daily
Lasts 24 hours
<www.xxx.xxx>



37

16. INFORMATION IN BRAILLE

Nexium Control 20 mg Capsules

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable.



38

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Nexium Control 20 mg gastro-resistant capsules

esomeprazole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each gastro-resistant capsule contains 20 mg esomeprazole (as magnesium trihydrate).

3. LIST OF EXCIPIENTS

Contains sucrose.

4. PHARMACEUTICAL FORM AND CONTENTS

14 gastro-resistant capsules.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Keep the container tightly closed to protect from moisture.



39

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Dungarvan Limited, 
Knockbrack, 
Dungarvan, 
Co. Waterford, 
Ireland

12. MARKETING AUTHORISATION NUMBER(S) 

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

Treats Heartburn &Acid Reflux 

Take one capsule once a day. Do not exceed this dose.
Swallow whole. Do not chew, crush or open capsule.

Capsules

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA



40

B. PACKAGE LEAFLET



41

Package leaflet: Information for the user

Nexium Control 20 mg gastro-resistant tablets
esomeprazole

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you.
Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. 
- Keep this leaflet. You may need to read it again. 
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 14 days

What is in this leaflet

1. What Nexium Control is and what it is used for 
2. What you need to know before you take Nexium Control
3. How to take Nexium Control
4. Possible side effects 
5. How to store Nexium Control
6. Contents of the pack and other information

- Further helpful information

1. What Nexium Control is and what it is used for

Nexium Control contains the active substance esomeprazole. It belongs to a group of medicines called 
‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

This medicine is used in adults for the short-term treatment of reflux symptoms (for example, 
heartburn and acid regurgitation).

Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”) which may become 
inflamed and painful. This may cause you symptoms such as a painful sensation in the chest rising up 
to your throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Nexium Control is not meant to bring immediate relief. You may need to take the tablets for 2-3 days 
in a row before you feel better. You must talk to a doctor if you do not feel better or if you feel worse 
after 14 days.

2. What you need to know before you take Nexium Control

Do not take Nexium Control
- If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in 

section 6). 
- If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, 

lansoprazole, rabeprazole or omeprazole).
- If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or 
pharmacist before taking this medicine.

Warnings and precautions 
Talk to your doctor before taking Nexium Control if:
 You have had a stomach ulcer or stomach surgery in the past.



42

 You have been taking treatment continuously for reflux or heartburn for 4 or more weeks.
 You have jaundice (yellowing of skin or eyes) or severe liver problems.
 You have severe kidney problems.
 You are aged over 55 years and have new or recently changed reflux symptoms or need to take 

a non-prescription indigestion or heartburn remedy treatment every day.
 You have ever had a skin reaction after treatment with a medicine similar to Nexium Control that

reduces stomach acid. 
 You are due to have an endoscopy or a urea breath test.
 You are due to have a specific blood test (Chromogranin A).

Tell your doctor immediately before or after taking this medicine, if you notice any of the following 
symptoms, which could be a sign of another, more serious, disease.
 You lose a lot of weight for no reason. 
 You have problems or pain when swallowing.
 You get stomach pain or signs of indigestion such as nausea, fullness, bloating especially after 

food intake.
 You begin to vomit food or blood, which may appear as dark coffee grounds in your vomit.
 You pass black stools (blood-stained faeces).
 You have severe or persistent diarrhoea; esomeprazole has been associated with a small 

increased risk of infectious diarrhoea.
 You get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as

you can, as you may need to stop your treatment with Nexium Control. Remember to also 
mention any other ill-effects like pain in your joints.

Seek urgent medical attention if you experience chest pain with light-headedness, sweating, dizziness 
or shoulder pain with shortness of breath. This could be a sign of a serious condition with your heart.

If any of the above apply to you (or you are not sure), talk to your doctor straight away.

Children and adolescents
This medicine should not be used by children and adolescents under 18 years of age.

Other medicines and Nexium Control
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is because this medicine can affect the way some medicines work and some medicines 
can have an effect on it.

Do not take this medicine if you are also taking a medicine containing nelfinavir (used to treat HIV 
infection).

You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent 
blood clots).

Do not take this medicine with other medicines that limit the amount of acid produced in your stomach 
such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or an H2

antagonist (e.g. ranitidine or famotidine).

You may take this medicine with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, 
aluminium hydroxide, magnesium carbonate or combinations of these) if needed.

Tell your doctor or pharmacist if you are taking any of the following medicines:
 Ketoconazole and itraconazole (used to treat infections caused by a fungus)
 Voriconazole (used to treat infections caused by a fungus) and clarithromycin (used to treat 

infections). Your doctor may adjust your dose of Nexium Control if you also have severe liver 
problems and are treated for a long period of time.



43

 Erlotinib (used to treat cancer)
 Methotrexate (used to treat cancer and rheumatic disorders)
 Digoxin (used for heart problems)
 Atazanavir, saquinavir (used to treat HIV infection)
 Citalopram, imipramine or clomipramine (used to treat depression)
 Diazepam (used to treat anxiety, relax muscles or in epilepsy)
 Phenytoin (used to treat epilepsy)
 Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor 

you when you start or stop taking Nexium Control
 Cilostazol (used to treat intermittent claudication – a condition where poor blood supply to the 

leg muscles causes pain and difficulty in walking)
 Cisapride (used for indigestion and heartburn)
 Rifampicin (used to treat tuberculosis)
 Tacrolimus (in cases of organ transplantation)
 St. John’s wort (Hypericum perforatum) (used to treat depression)

Pregnancy and breast-feeding
As a precautionary measure, you should preferably avoid the use of Nexium Control during 
pregnancy. You should not use this medicine during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Nexium Control has a low likelihood of affecting your ability to drive or use machines. However, side 
effects such as dizziness and visual disturbances may uncommonly occur (see section 4). If affected, 
you should not drive or use machines.

Nexium Control contains sucrose
Nexium Control contains sugar spheres, which contain sucrose, a type of sugar. If you have been told 
by your doctor that you have an intolerance to some sugars, contact your doctor before taking this 
medicine.

3. How to take Nexium Control

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told 
you. Check with your doctor or pharmacist if you are not sure.

How much to take
 The recommended dose is one tablet a day. 
 Do not take more than this recommended dose of one tablet (20 mg) a day, even if you don’t 

feel an improvement immediately. 
 You may need to take the tablets for 2 or 3 days in a row before your reflux symptoms (for 

example, heartburn and acid regurgitation) get better.
 The treatment length is up to 14 days.
 When your reflux symptoms have completely gone you should stop taking this medicine.
 If your reflux symptoms get worse or do not improve after taking this medicine for 14 days in a 

row, you should consult a doctor.

If you have persistent or longstanding, frequently recurring symptoms even after treatment with this 
medicine, you should contact your doctor.

Taking this medicine
 You can take your tablet at any time of the day either with food or on an empty stomach.



44

 Swallow your tablet whole with half a glass of water. Do not chew or crush the tablet. This is 
because the tablet contains coated pellets, which stop the medicine from being broken down by 
the acid in your stomach. It is important not to damage the pellets.

Alternative method of taking this medicine
 Put the tablet in a glass of still (non-fizzy) water. Do not use any other liquids.
 Stir until the tablet breaks up (the mixture will not be clear) then drink the mixture straight away 

or within 30 minutes. Always stir the mixture just before drinking it.
 To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass 

of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

If you take more Nexium Control than you should
If you take more Nexium Control than recommended, talk to your doctor or pharmacist straight away.
You may experience symptoms such as diarrhoea, stomach ache, constipation, feeling or being sick 
and weakness.  

If you forget to take Nexium Control
If you forget to take a dose, take it as soon as you remember it, on the same day. Do not take a double 
dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 
If you notice any of the following serious side effects, stop taking Nexium Control and contact a 
doctor immediately:
 Sudden wheezing, swelling of your lips, tongue and throat, rash, fainting or difficulties in 

swallowing (severe allergic reaction, seen rarely)
 Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in 

the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic 
epidermal necrolysis’, seen very rarely.

 Yellow skin, dark urine and tiredness, which can be symptoms of liver problems, seen rarely.

Talk to your doctor as soon as possible if you experience any of the following signs of infection:
This medicine may in very rare cases affect the white blood cells leading to immune deficiency. If you 
have an infection with symptoms such as fever with a severely reduced general condition or fever with 
symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you 
must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can 
be ruled out by a blood test. It is important for you to give information about your medicine at this 
time.

Other side effects include:

Common (may affect up to 1 in 10 people)
 Headache.
 Effects on your stomach or gut: diarrhoea, stomach ache, constipation, wind (flatulence).
 Feeling sick (nausea) or being sick (vomiting).
 Benign growths (polyps) in the stomach.

Uncommon (may affect up to 1 in 100 people)
 Swelling of the feet and ankles.
 Disturbed sleep (insomnia), feeling sleepy.
 Dizziness, tingling feelings such as “pins and needles”.
 Spinning feeling (vertigo).



45

 Dry mouth.
 Increased liver enzymes shown in blood tests that check how the liver is working.
 Skin rash, lumpy rash (hives) and itchy skin.

Rare (may affect up to 1 in 1,000 people)
 Blood problems such as a reduced number of white blood cells or platelets. This can cause 

weakness, bruising or make infections more likely.
 Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps
 Feeling agitated, confused or depressed.
 Taste changes.
 Eyesight problems such as blurred vision.
 Suddenly feeling wheezy or short of breath (bronchospasm).
 An inflammation on the inside of the mouth.
 An infection called “thrush” which can affect the gut and is caused by a fungus.
 Hair loss (alopecia).
 Skin rash on exposure to sunshine.
 Joint pain (arthralgia) or muscle pain (myalgia).
 Generally feeling unwell and lacking energy.
 Increased sweating.

Very rare (may affect up to 1 in 10,000 people)
 Low numbers of red blood cells, white blood cells, and platelets (a condition called 

pancytopenia)
 Aggression
 Seeing, feeling or hearing things that are not there (hallucinations)
 Severe liver problems leading to liver failure and inflammation of the brain.
 Muscle weakness
 Severe kidney problems
 Enlarged breasts in men

Not known (frequency cannot be estimated from the available data)
 Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), 

cramps, tremor and changes in heart rhythm (arrhythmias). If you have very low levels of 
magnesium, you may also have low levels of calcium and/or potassium in your blood.

 Inflammation of the gut (leading to diarrhoea).
 Rash, possibly with pain in the joints.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine.

5. How to store Nexium Control

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. 
The expiry date refers to the last day of that month.

Do not store above 30°C.

Keep this medicine in the original package in order to protect from moisture.



46

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nexium Control contains 
- The active substance is esomeprazole. Each gastro-resistant tablet contains 20 mg esomeprazole 

(as magnesium trihydrate).
- The other ingredients are glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, 

reddish-brown iron oxide (E172), yellow iron oxide  (E172), magnesium stearate, methacrylic 
acid ethylacrylate copolymer (1:1) dispersion 30 per cent, cellulose microcrystalline, synthetic 
paraffin, macrogol 6000, polysorbate 80, crospovidone (Type A), sodium stearyl fumarate, 
sugar spheres (sucrose and maize starch), talc, titanium dioxide (E171) and triethyl citrate (see 
section 2, “Nexium Control contains sucrose”).

What Nexium Control looks like and contents of the pack
Nexium Control 20 mg gastro-resistant tablets are light pink, oblong, biconvex, 14 mm x 7 mm, film-
coated, engraved with ‘20 mG’ on one side and A/EH on the other side.

Nexium Control is available in pack sizes of 7, 14 and 28 gastro-resistant tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, 
Ireland 

Manufacturer 
Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italy.

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien,Luxembourg/
Luxemburg
GlaxoSmithKline Consumer Healthcare s.a./n.v.
Tél/Tel: + 32 10858600

Latvija
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
lv-epasts@gsk.com

България
ГлаксоСмитКлайн Консюмър Хелткеър
Teл.: + 359 2 953 10 34

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00
info.lt@gsk.com

Česká republika
GlaxoSmithKline Consumer Healthcare Czech
Republic s.r.o. 
Tel.: + 420  222 001 111
cz.info@gsk.com

Magyarország
GlaxoSmithKline – Consumer Kft.
Tel.: + 36 1 225 5800

Danmark
GlaxoSmithKline Consumer Healthcare ApS
Tel.: + 45 80 25 16 27
scanda.consumer-relations@gsk.com

Nederland
GlaxoSmithKline Consumer Healthcare BV
Tel: 800 4090005
Info.nlch@gsk.com



47

Deutschland
GlaxoSmithKline Consumer Healthcare GmbH
& Co.KG. 
Tel.: + 49 (0) 800 6645626

Österreich
GSK-Gebro Consumer Healthcare GmbH
Tel: +43 (0) 5354 563350

Eesti
GlaxoSmithKline Eesti OÜ
Tel: + 372 6676 900
estonia@gsk.com

Norge
GlaxoSmithKline Consumer Healthcare
Tlf:  + 47 80 05 86 30
scanda.consumer-relations@gsk.com

Ελλάδα
GSK CH Ελλάς Μονοπρόσωπη Α.Ε.

Λεωφ. Κηφισίας 274, 152 32, Χαλάνδρι
Τηλ.: 210 6882100

Polska
GlaxoSmithKline Consumer Healthcare Sp.z.o.o.
Tel: + 48 (0)22 576 96 00

España
GlaxoSmithKline Consumer Healthcare, S.A.
Tel: + 34 900 816 705

Portugal
GlaxoSmithKline Consumer Healthcare –
Produtos para a Saúde e Higiene, Lda. 
Tel: 800 784 695 
apoio.consumidor@gsk.com

France
GlaxoSmithKline Santé Grand Public
Tél. : + 33 (0)1 39 17 60 07

România
GlaxoSmithKline Consumer Healthcare S.R.L
Tel: + 40 21 302 8 208

Hrvatsk
GlaxoSmithKline d.o.o.
Tel:+385 1 6051 999

Slovenija
GSK d.o.o., Ljubljana
Tel: + 386 (0)1 280 25 00

Ireland, Malta
GlaxoSmithKline Consumer Healthcare
(Ireland) Limited 
Tel.: 800 441 442

Slovenská republika
GlaxoSmithKline Consumer Healthcare Slovakia 
s.r.o. 
Tel: + 421 248 261 111
cz.info@gsk.com

Ísland
Vistor hf. GlaxoSmithKline ehf.
Sími: + 354 535 700

Suomi/Finland
GlaxoSmithKline Oy
Consumer Healthcare
Puh/Tel: 080 077 40 80
scanda.consumer-relations @gsk.com

Italia
GlaxoSmithKline Consumer Healthcare S.r.l.
Tel.: + 39 02 38062020

Sverige
GlaxoSmithKline Consumer Healthcare
Tel: 020-100579
scanda.consumer-relations @gsk.com

Κύπρος
C. A. Papaellinas Ltd,
Τ.Θ. 24018, 1700 Λευκωσία
Tηλ. +357 22 741 741

United Kingdom
GlaxoSmithKline Consumer Healthcare (UK) 
Trading Limited 
Tel.: 0800 783 8881 



48

This leaflet was last revised in 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

FURTHER HELPFUL INFORMATION

What are the symptoms of heartburn? 
The normal symptoms of reflux are a painful sensation in the chest rising up to your throat (heartburn) 
and a sour taste in the mouth (acid regurgitation). 

Why do you get these symptoms?
Heartburn can be a result of eating too much, eating high fat food, eating too quickly and drinking lots 
of alcohol. You may also notice that when you lie down, that your heartburn gets worse. If you are 
overweight or smoke you increase the probability of suffering from heartburn.

What can I do to help relieve my symptoms?
 Eat healthier food and try to avoid spicy and fatty foods and large meals late before bedtime. 
 Avoid fizzy drinks, coffee, chocolate and alcohol.
 Eat slowly and eat smaller portions.
 Try to lose weight.
 Stop smoking.

When should I seek advice or help?
 You should seek urgent medical advice if you experience chest pain with light-headedness, 

sweating, dizziness or shoulder pain with shortness of breath.
 If you experience any of the symptoms detailed in Section 2 of this leaflet and it advises you 

to talk to your doctor or pharmacist.
 If you are suffering from any of the side effects detailed in Section 4 which require medical 

attention.



49

Package leaflet: Information for the user

Nexium Control 20 mg gastro-resistant hard capsules
esomeprazole

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you.
Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. 
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is in this leaflet

1. What Nexium Control is and what it is used for 
2. What you need to know before you take Nexium Control
3. How to take Nexium Control
4. Possible side effects 
5. How to store Nexium Control
6. Contents of the pack and other information

- Further helpful information

1. What Nexium Control is and what it is used for

Nexium Control contains the active substance esomeprazole. It belongs to a group of medicines called 
‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

This medicine is used in adults for the short-term treatment of reflux symptoms (for example, 
heartburn and acid regurgitation).

Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”) which may become 
inflamed and painful. This may cause you symptoms such as a painful sensation in the chest rising up 
to your throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Nexium Control is not meant to bring immediate relief. You may need to take the capsules for 2-3 
days in a row before you feel better. You must talk to a doctor if you do not feel better or if you feel 
worse after 14 days.

2. What you need to know before you take Nexium Control

Do not take Nexium Control
 If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in

section 6). 
 If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, 

lansoprazole, rabeprazole or omeprazole).
 If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or 
pharmacist before taking this medicine.

Warnings and precautions 
Talk to your doctor before taking Nexium Control if:
 You have had a stomach ulcer or stomach surgery in the past.



50

 You have been taking treatment continuously for reflux or heartburn for 4 or more weeks.
 You have jaundice (yellowing of skin or eyes) or severe liver problems.
 You have severe kidney problems.
 You are aged over 55 years and have new or recently changed reflux symptoms or need to take 

a non-prescription indigestion or heartburn remedy treatment every day.
 You have ever had a skin reaction after treatment with a medicine similar to Nexium Control that

reduces stomach acid. 
 You are due to have an endoscopy or a urea breath test.
 You are due to have a specific blood test (Chromogranin A).

Tell your doctor immediately before or after taking this medicine, if you notice any of the following 
symptoms, which could be a sign of another, more serious, disease.
 You lose a lot of weight for no reason. 
 You have problems or pain when swallowing.
 You get stomach pain or signs of indigestion such as nausea, fullness, bloating especially after 

food intake.
 You begin to vomit food or blood, which may appear as dark coffee grounds in your vomit.
 You pass black stools (blood-stained faeces).
 You have severe or persistent diarrhoea; esomeprazole has been associated with a small 

increased risk of infectious diarrhoea.
 You get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as

you can, as you may need to stop your treatment with Nexium Control. Remember to also 
mention any other ill-effects like pain in your joints.

Seek urgent medical attention if you experience chest pain with light-headedness, sweating, dizziness 
or shoulder pain with shortness of breath. This could be a sign of a serious condition with your heart.

If any of the above apply to you (or you are not sure), talk to your doctor straight away.

Children and adolescents
This medicine should not be used by children and adolescents under 18 years of age.

Other medicines and Nexium Control
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is because this medicine can affect the way some medicines work and some medicines 
can have an effect on it.

Do not take this medicine if you are also taking a medicine containing nelfinavir (used to treat HIV 
infection).

You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent 
blood clots).

Do not take this medicine with other medicines that limit the amount of acid produced in your stomach 
such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or an H2

antagonist (e.g. ranitidine or famotidine).

You may take this medicine with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, 
aluminium hydroxide, magnesium carbonate or combinations of these) if needed.

Tell your doctor or pharmacist if you are taking any of the following medicines:
 Ketoconazole and itraconazole (used to treat infections caused by a fungus).
 Voriconazole (used to treat infections caused by a fungus) and clarithromycin (used to treat 

infections). Your doctor may adjust your dose of Nexium Control if you also have severe liver 
problems and are treated for a long period of time.

 Erlotinib (used to treat cancer).



51

 Methotrexate (used to treat cancer and rheumatic disorders).
 Digoxin (used for heart problems).
 Atazanavir, saquinavir (used to treat HIV infection).
 Citalopram, imipramine or clomipramine (used to treat depression).
 Diazepam (used to treat anxiety, relax muscles or in epilepsy).
 Phenytoin (used to treat epilepsy).
 Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor 

you when you start or stop taking Nexium Control.
 Cilostazol (used to treat intermittent claudication – a condition where poor blood supply to the 

leg muscles causes pain and difficulty in walking).
 Cisapride (used for indigestion and heartburn).
 Rifampicin (used to treat tuberculosis).
 Tacrolimus (in cases of organ transplantation).
 St. John’s wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breast-feeding
As a precautionary measure, you should preferably avoid the use of Nexium Control during 
pregnancy. You should not use this medicine during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Nexium Control has a low likelihood of affecting your ability to drive or use machines. However, side 
effects such as dizziness and visual disturbances may uncommonly occur (see section 4). If affected, 
you should not drive or use machines.

Nexium Control contains sucrose
Nexium Control contains sugar spheres, which contain sucrose, a type of sugar. If you have been told 
by your doctor that you have an intolerance to some sugars, contact your doctor before taking this 
medicine.

3. How to take Nexium Control

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told 
you. Check with your doctor or pharmacist if you are not sure.

How much to take
 The recommended dose is one capsule a day. 
 Do not take more than this recommended dose of one capsule (20 mg) a day, even if you don’t

feel an improvement immediately. 
 You may need to take the capsules for 2 or 3 days in a row before your reflux symptoms (for 

example, heartburn and acid regurgitation) get better.
 The treatment length is up to 14 days.
 When your reflux symptoms have completely gone you should stop taking this medicine.
 If your reflux symptoms get worse or do not improve after taking this medicine for 14 days in a 

row, you should consult a doctor.

If you have persistent or longstanding, frequently recurring symptoms even after treatment with this 
medicine, you should contact your doctor.

Taking this medicine
 You can take your capsule at any time of the day either with food or on an empty stomach.
 Swallow your capsule whole with half a glass of water. Do not chew, crush or open the capsule. 

This is because the capsule contains coated pellets, which stop the medicine from being broken 
down by the acid in your stomach. It is important not to damage the pellets.



52

If you take more Nexium Control than you should
If you take more Nexium Control than recommended, talk to your doctor or pharmacist straight away.
You may experience symptoms such as diarrhoea, stomach ache, constipation, feeling or being sick 
and weakness.  

If you forget to take Nexium Control
If you forget to take a dose, take it as soon as you remember it, on the same day. Do not take a double 
dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 
If you notice any of the following serious side effects, stop taking Nexium Control and contact a 
doctor immediately:
 Sudden wheezing, swelling of your lips, tongue and throat, rash, fainting, or difficulties in 

swallowing (severe allergic reaction, seen rarely).
 Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in 

the lips, eyes, mouth, nose, and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic 
epidermal necrolysis’, seen very rarely.

 Yellow skin, dark urine and tiredness, which can be symptoms of liver problems, seen rarely.

Talk to your doctor as soon as possible if you experience any of the following signs of infection:
This medicine may in very rare cases affect the white blood cells leading to immune deficiency. If you 
have an infection with symptoms such as fever with a severely reduced general condition or fever with 
symptoms of a local infection such as pain in the neck, throat or mouth, or difficulties in urinating, you 
must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can 
be ruled out by a blood test. It is important for you to give information about your medicine at this 
time.

Other side effects include:

Common (may affect up to 1 in 10 people)
 Headache.
 Effects on your stomach or gut: diarrhoea, stomach ache, constipation, wind (flatulence).
 Feeling sick (nausea) or being sick (vomiting).
 Benign growths (polyps) in the stomach.

Uncommon (may affect up to 1 in 100 people)
 Swelling of the feet and ankles.
 Disturbed sleep (insomnia), feeling sleepy.
 Dizziness, tingling feelings such as “pins and needles”.
 Spinning feeling (vertigo).
 Dry mouth.
 Increased liver enzymes shown in blood tests that check how the liver is working.
 Skin rash, lumpy rash (hives), and itchy skin.

Rare (may affect up to 1 in 1,000 people)
 Blood problems such as a reduced number of white blood cells or platelets. This can cause 

weakness, bruising, or make infections more likely.
 Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps
 Feeling agitated, confused, or depressed.
 Taste changes.



53

 Eyesight problems such as blurred vision.
 Suddenly feeling wheezy, or short of breath (bronchospasm).
 An inflammation on the inside of the mouth.
 An infection called “thrush” which can affect the gut and is caused by a fungus.
 Hair loss (alopecia).
 Skin rash on exposure to sunshine.
 Joint pain (arthralgia), or muscle pain (myalgia).
 Generally feeling unwell and lacking energy.
 Increased sweating.

Very rare (may affect up to 1 in 10,000 people)
 Low numbers of red blood cells, white blood cells, and platelets (a condition called 

pancytopenia).
 Aggression.
 Seeing, feeling, or hearing things that are not there (hallucinations).
 Severe liver problems leading to liver failure and inflammation of the brain.
 Muscle weakness.
 Severe kidney problems.
 Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)
 Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), 

cramps, tremor, and changes in heart rhythm (arrhythmias). If you have very low levels of 
magnesium, you may also have low levels of calcium and/or potassium in your blood.

 Inflammation of the gut (leading to diarrhoea).
 Rash, possibly with pain in the joints.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine.

5. How to store Nexium Control

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP. 
The expiry date refers to the last day of that month.

Do not store above 30°C.

Keep this medicine in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nexium Control contains 



54

 The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg 
esomeprazole (as magnesium trihydrate).

 The other ingredients are:
glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, magnesium stearate, 
methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, polysorbate 80, sugar 
spheres (sucrose and maize starch), talc, triethyl citrate, carmine (E120), indigo carmine (E132),
titanium dioxide (E171), yellow iron oxide (E172), erythrosine (E127), allura red AC (E129), 
povidone K-17, propylene glycol, shellac, sodium hydroxide, and gelatin (see section 2, “Nexium 
Control contains sucrose”.)

What Nexium Control looks like and contents of the pack
Nexium Control 20 mg gastro-resistant hard capsules are approximately 11 x 5 mm capsules with a 
clear body, and an amethyst cap imprinted with “NEXIUM 20 MG” in white. The capsule has a 
yellow centre band, and contains yellow and purple enteric coated pellets.

Nexium Control is available in high-density polyethylene (HDPE) bottles with an induction seal 
closure and child resistant closure. The bottle also contains a sealed container with silica gel desiccant.

Each pack contains either 1 or 2 bottles, each with 14 gastro-resistant hard capsules. 
Not all pack sizes may be marketed.

Marketing Authorisation Holder 

GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, 
Ireland 

Manufacturer
Pfizer Consumer Manufacturing Italy S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italy.

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien,Luxembourg/
Luxemburg
GlaxoSmithKline Consumer Healthcare s.a./n.v.
Tél/Tel: + 32 10858600

Latvija
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
lv-epasts@gsk.com

България
ГлаксоСмитКлайн Консюмър Хелткеър
Teл.: + 359 2 953 10 34

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00
info.lt@gsk.com

Česká republika
GlaxoSmithKline Consumer Healthcare Czech
Republic s.r.o. 
Tel.: + 420  222 001 111
cz.info@gsk.com

Magyarország
GlaxoSmithKline-Consumer Kft.
Tel.: + 36 1 225 5800

Danmark
GlaxoSmithKline Consumer Healthcare ApS
Tel.: + 45 80 25 16 27
scanda.consumer-relations@gsk.com

Nederland,
GlaxoSmithKline Consumer Healthcare BV
Tel: 800 4090005
Info.nlch@gsk.com



55

Deutschland
GlaxoSmithKline Consumer Healthcare GmbH
& Co.KG. 
Tel.: + 49 (0) 800 6645626

Österreich , 
GSK-Gebro Consumer Healthcare GmbH
Tel: +43 (0) 5354 563350

Eesti
GlaxoSmithKline Eesti OÜ
Tel: + 372 6676 900 
estonia@gsk.com

Norge
GlaxoSmithKline Consumer Healthcare
Tlf:  + 47 80 05 86 30
scanda.consumer-relations@gsk.com

Ελλάδα
GSK CH Ελλάς Μονοπρόσωπη Α.Ε.

Λεωφ. Κηφισίας 274, 152 32, Χαλάνδρι
Τηλ.: 210 6882100

Polska
GlaxoSmithKline Consumer Healthcare Sp.z.o.o.
Tel: + 48 (0)22 576 96 00 

España
GlaxoSmithKline Consumer Healthcare, S.A.
Tel: + 34 900 816 705

Portugal
GlaxoSmithKline Consumer Healthcare –
Produtos para a Saúde e Higiene, Lda. 
Tel: 800 784 695 
apoio.consumidor@gsk.com

France
GlaxoSmithKline Santé Grand Public
Tél. : + 33 (0)1 39 17 60 07

România
GlaxoSmithKline Consumer Healthcare S.R.L
Tel: + 40 21 302 8 208 

Hrvatsk
GlaxoSmithKline d.o.o.
Tel:+385 1 6051 999

Slovenija
GSK d.o.o., Ljubljana
Tel: + 386 (0)1 280 25 00

Ireland, Malta
GlaxoSmithKline Consumer Healthcare
(Ireland) Limited 
Tel.: 800 441 442 

Slovenská republika
GlaxoSmithKline Consumer Healthcare Slovakia 
s.r.o. 
Tel: + 421 248 261 111
cz.info@gsk.com

Ísland
Vistor hf. GlaxoSmithKline ehf.
Sími: + 354 535 700

Suomi/Finland
GlaxoSmithKline Oy
Consumer Healthcare
Puh/Tel: 080 077 40 80
scanda.consumer-relations @gsk.com

Italia
GlaxoSmithKline Consumer Healthcare S.r.l. 
Tel.: + 39 02 38062020

Sverige
GlaxoSmithKline Consumer Healthcare
Tel: 020-100579
scanda.consumer-relations @gsk.com

Κύπρος
C. A. Papaellinas Ltd,
Τ.Θ. 24018, 1700 Λευκωσία
Tηλ. +357 22 741 741

United Kingdom
GlaxoSmithKline Consumer Healthcare (UK) 
Trading Limited 
Tel.: 0800 783 8881 



56

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

FURTHER HELPFUL INFORMATION

What are the symptoms of heartburn? 
The normal symptoms of reflux are a painful sensation in the chest rising up to your throat (heartburn) 
and a sour taste in the mouth (acid regurgitation). 

Why do you get these symptoms?
Heartburn can be a result of eating too much, eating high fat food, eating too quickly and drinking lots 
of alcohol. You may also notice that when you lie down, that your heartburn gets worse. If you are 
overweight or smoke you increase the probability of suffering from heartburn.

What can I do to help relieve my symptoms?
 Eat healthier food and try to avoid spicy and fatty foods and large meals late before bedtime. 
 Avoid fizzy drinks, coffee, chocolate and alcohol.
 Eat slowly and eat smaller portions.
 Try to lose weight.
 Stop smoking.

When should I seek advice or help?
 You should seek urgent medical advice if you experience chest pain with light-headedness, 

sweating, dizziness or shoulder pain with shortness of breath.
 If you experience any of the symptoms detailed in Section 2 of this leaflet and it advises you 

to talk to your doctor or pharmacist.
 If you are suffering from any of the side effects detailed in Section 4 which require medical 

attention.


	1. NAME OF THE MEDICINAL PRODUCT
	2. QUALITATIVE AND QUANTITATIVE COMPOSITION
	3. PHARMACEUTICAL FORM
	4. CLINICAL PARTICULARS
	4.1 Therapeutic indications
	4.2 Posology and method of administration
	Special populations
	Patients with renal impairment
	Patients with hepatic impairment
	Elderly patients (≥65 years old)
	Paediatric population



	4.3 Contraindications
	4.4 Special warnings and precautions for use
	General
	Interference with laboratory tests


	4.5 Interaction with other medicinal products and other forms of interaction
	Effects of esomeprazole on the pharmacokinetics of other medicinal products
	Protease inhibitors
	Methotrexate
	Tacrolimus

	Medicinal products with pH dependent absorption
	Medicinal products metabolised by CYP2C19
	Warfarin

	Clopidogrel
	Phenytoin
	Cilostazol
	Cisapride

	Investigated medicinal products with no clinically relevant interaction
	Amoxicillin and quinidine
	Naproxen or rofecoxib
	Effects of other medicinal products on the pharmacokinetics of esomeprazole



	4.6 Fertility, pregnancy and lactation
	Pregnancy
	Breast-feeding
	Fertility

	4.7 Effects on ability to drive and use machines
	4.8 Undesirable effects
	Summary of the safety profile
	Tabulated list of adverse reactions

	4.9 Overdose

	5. PHARMACOLOGICAL PROPERTIES
	5.1  Pharmacodynamic properties
	5.2 Pharmacokinetic properties
	Absorption
	Elimination

	Special patient populations
	Poor metabolisers
	Gender
	Elderly patients (≥65 years old)




	5.3 Preclinical safety data

	6. PHARMACEUTICAL PARTICULARS
	6.1 List of excipients
	6.2 Incompatibilities
	6.3 Shelf life
	6.4 Special precautions for storage
	6.5 Nature and contents of container
	6.6 Special precautions for disposal

	7. MARKETING AUTHORISATION HOLDER
	8. MARKETING AUTHORISATION NUMBER(S)
	EU/1/13/860/001
	EU/1/13/860/002
	9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
	10. DATE OF REVISION OF THE TEXT
	1. NAME OF THE MEDICINAL PRODUCT
	2. QUALITATIVE AND QUANTITATIVE COMPOSITION
	3. PHARMACEUTICAL FORM
	4. CLINICAL PARTICULARS
	4.1 Therapeutic indications
	4.2 Posology and method of administration
	Special populations
	Patients with renal impairment
	Patients with hepatic impairment
	Elderly patients (≥65 years old)
	Paediatric population



	4.3 Contraindications
	4.4 Special warnings and precautions for use
	General
	Interference with laboratory tests


	4.5 Interaction with other medicinal products and other forms of interaction
	Effects of esomeprazole on the pharmacokinetics of other medicinal products
	Protease inhibitors
	Methotrexate
	Tacrolimus

	Medicinal products with pH dependent absorption
	Medicinal products metabolised by CYP2C19
	Warfarin

	Clopidogrel
	Phenytoin
	Cilostazol
	Cisapride

	Investigated medicinal products with no clinically relevant interaction
	Amoxicillin and quinidine
	Naproxen or rofecoxib
	Effects of other medicinal products on the pharmacokinetics of esomeprazole



	4.6 Fertility, pregnancy and lactation
	Pregnancy
	Breast-feeding
	Fertility

	4.7 Effects on ability to drive and use machines
	4.8 Undesirable effects
	Summary of the safety profile
	Tabulated list of adverse reactions

	4.9 Overdose

	5. PHARMACOLOGICAL PROPERTIES
	5.1  Pharmacodynamic properties
	5.2 Pharmacokinetic properties
	Absorption
	Elimination

	Special patient populations
	Poor metabolisers
	Gender
	Elderly patients (≥65 years old)




	5.3 Preclinical safety data

	6. PHARMACEUTICAL PARTICULARS
	6.1 List of excipients
	6.2 Incompatibilities
	6.3 Shelf life
	6.4 Special precautions for storage
	6.5 Nature and contents of container
	6.6 Special precautions for disposal

	7. MARKETING AUTHORISATION HOLDER
	8. MARKETING AUTHORISATION NUMBER(S)
	EU/1/13/860/005
	9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
	10. DATE OF REVISION OF THE TEXT
	ANNEX II
	A.  MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	LABELLING AND PACKAGE LEAFLET
	EU/1/13/860/001 7 gastro-resistant tablets
	EU/1/13/860/003 14 gastro-resistant hard capsules
	1. What Nexium Control is and what it is used for
	2. What you need to know before you take Nexium Control
	3. How to take Nexium Control
	4. Possible side effects
	5. How to store Nexium Control
	6. Contents of the pack and other information
	1. What Nexium Control is and what it is used for
	2. What you need to know before you take Nexium Control
	3. How to take Nexium Control
	4. Possible side effects
	5. How to store Nexium Control
	6. Contents of the pack and other information