Nexium Control

Main information

  • Trade name:
  • Nexium Control
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nexium Control
    European Union
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Proton pump inhibitors
  • Therapeutic area:
  • Gastroesophageal Reflux
  • Therapeutic indications:
  • Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.,
  • Product summary:
  • Revision: 12

Status

  • Source:
  • EMA - European Medicines Agency
  • Authorization status:
  • Authorised
  • Authorization number:
  • EMEA/H/C/002618
  • Authorization date:
  • 25-08-2013
  • EMEA code:
  • EMEA/H/C/002618
  • Last update:
  • 25-03-2019

Public Assessment Report

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

EMA/410916/2013

EMEA/H/C/002618

EPAR summary for the public

Nexium Control

esomeprazole

This is a summary of the European public assessment report (EPAR) for Nexium Control. It explains

how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of

use. It is not intended to provide practical advice on how to use Nexium Control.

For practical information about using Nexium Control, patients should read the package leaflet or

contact their doctor or pharmacist.

What is Nexium Control and what is it used for?

Nexium Control is a medicine that contains the active substance esomeprazole. It is used in adults for

the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and

acid regurgitation.

Nexium Control is similar to a ‘reference medicine’ already authorized in the European Union (EU)

containing the same active substance, called Nexium. The reference medicine is only available with a

prescription, but Nexium Control is intended for short term use without a prescription.

How is Nexium Control used?

Nexium Control can be obtained without a prescription. It is available as tablets (20 mg) which are

gastro-resistant (the contents pass through the stomach without being broken down until they reach

the intestine). The recommended dose is one tablet per day for up to 2 weeks until the symptoms are

relieved. If symptoms persist after 2 weeks, the patient should see a doctor. For further information,

see the package leaflet.

How does Nexium Control work?

The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor. It works by

blocking ‘proton pumps’, proteins found in specialised cells in the stomach lining, which pump acid into

Nexium Control

EMA/410916/2013

Page 2/3

the stomach. By blocking the pumps, esomeprazole reduces acid production, thereby relieving the

symptoms of acid reflux.

What benefits of Nexium Control have been shown in studies?

Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving

718 adult patients with reflux symptoms including heartburn. The patients were treated for 4 weeks.

The main measure of effectiveness in both studies was the percentage of patients whose heartburn

symptoms had completely cleared up at the end of the study.

In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had

no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124).

In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more

heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118). In both

studies, most patients whose symptoms completely cleared up had already achieved this in the first 2

weeks, while patients whose symptoms did not completely clear up in 2 weeks showed little further

improvement from continued treatment.

What are the risks associated with Nexium Control?

Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with

Nexium Control (which may affect up to 1 in 10 patients). For the full list of all side effects reported

with Nexium Control, see the package leaflet.

Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV

infection). For the full list of restrictions, see the package leaflet.

Why is Nexium Control approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control’s

benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP

concluded that the medicine’s effects were already well established, as esomeprazole-containing

medicines have been authorised in EU countries since 2000, and that its short-term benefits had been

demonstrated in studies where most patients’ symptoms cleared up in 2 weeks. The Committee

concluded that patients could safely treat themselves with the medicine for up to 2 weeks.

What measures are being taken to ensure the safe and effective use of

Nexium Control?

A risk management plan has been developed to ensure that Nexium Control is used as safely as

possible. Based on this plan, safety information has been included in the summary of product

characteristics and the package leaflet for Nexium Control, including the appropriate precautions to be

followed by healthcare professionals and patients.

Other information about Nexium Control

The European Commission granted a marketing authorisation valid throughout the European Union for

Nexium Control on 26 August 2013.

The full EPAR for Nexium Control can be found on the Agency’s website:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. For more information about

Nexium Control

EMA/410916/2013

Page 3/3

treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor

or pharmacist.

This summary was last updated in 08-2013.

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

B. PACKAGE LEAFLET

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

What Nexium Control is and what it is used for

What you need to know before you take Nexium Control

How to take Nexium Control

Possible side effects

How to store Nexium Control

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.

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 H

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)

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.

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).

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.

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 and 14 gastro-resistant tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,

D24 NT20.

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:

Česká republika

Pfizer PFE, spol. s.r.o.

Tel: + 420 283 004 111

Magyarország

Pfizer Gyógyszerkereskedelmi Kft.

Consumer Healthcare

Tel.: +36 1 488 37 00

Danmark, Norge, Ísland, Suomi/Finland,

Sverige

Pfizer ApS, Consumer Healthcare

(Danmark/Danmörk/Tanska)

Tlf: +45 4420 1100

Nederland, België/Belgique/Belgien,

Luxembourg/Luxemburg

Pfizer bv (Pays-Bas/Nederland/Niederlande)

Tel: +31 (0)10 4064 200

Deutschland

Pfizer Consumer Healthcare GmbH

Tel: +49 (0)30 550055-01

Österreich, Eesti, Hrvatska, Latvija,

Lietuva, Slovenija, България

Pfizer Corporation Austria GmbH

(Austria/Austrija/Avstrija/Австрия)

Consumer Healthcare

Tel.: +43 (0)1 521 15-0

Ελλάδα

Pfizer Ελλάς A.E.

Τηλ.: +30 210 67 85 800

Polska

Pfizer Trading Polska Sp. z.o.o.

Tel.: + 48 22 335 61 00

España

Pfizer, S.L.

Tel: + 34 91 490 99 00

Portugal

Pfizer Biofarmacêutica, Sociedade Unipessoal

Lda.

Tel: + 351 214 235 500

France

Pfizer Santé Familiale

Tél: + 33 (0) 1 58 07 39 81

România

Pfizer Romania S.R.L.

Tel: +40 21 207 28 00

Ireland, Malta

Pfizer Healthcare Ireland

Tel: +353 (0)1467 6627

Slovenská republika

Pfizer Luxembourg SARL, o.z.

Tel: +421 (0)2 3355 5500

Italia

Pfizer Italia S.r.l. – Divisione Consumer

Healthcare

Tel: (+ 39) 06 33 18 21

United Kingdom

Pfizer Consumer Healthcare Ltd (UK)

Tel: +44 (0) 333 555 2526

Κύπρος

Pfizer Ελλάς Α.Ε. (Cyprus Pharmaceutical

Organization Ltd.)

Τηλ: +357 22 863100

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.

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

What Nexium Control is and what it is used for

What you need to know before you take Nexium Control

How to take Nexium Control

Possible side effects

How to store Nexium Control

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.

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 H

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).

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.

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.

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

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 a pack size of 14 gastro-resistant hard capsules 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.

Marketing Authorisation Holder

Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,

D24 NT20.

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:

Česká republika

Pfizer PFE, spol. s.r.o.

Tel: + 420 283 004 111

Magyarország

Pfizer Gyógyszerkereskedelmi Kft.

Consumer Healthcare

Tel.: +36 1 488 37 00

Danmark, Norge, Ísland, Suomi/Finland,

Sverige

Pfizer ApS, Consumer Healthcare

(Danmark/Danmörk/Tanska)

Tlf: +45 4420 1100

Nederland, België/Belgique/Belgien,

Luxembourg/Luxemburg

Pfizer bv (Pays-Bas/Nederland/Niederlande)

Tel: +31 (0)10 4064 200

Deutschland

Pfizer Consumer Healthcare GmbH

Tel: +49 (0)30 550055-01

Österreich, Eesti, Hrvatska, Latvija,

Lietuva, Slovenija, България

Pfizer Corporation Austria GmbH

(Austria/Austrija/Avstrija/Австрия)

Consumer Healthcare

Tel.: +43 (0)1 521 15-0

Ελλάδα

Pfizer Ελλάς A.E.

Τηλ.: +30 210 67 85 800

Polska

Pfizer Trading Polska Sp. z.o.o.

Tel.: + 48 22 335 61 00

España

Pfizer, S.L.

Tel: + 34 91 490 99 00

Portugal

Pfizer Biofarmacêutica, Sociedade Unipessoal

Lda.

Tel: + 351 214 235 500

France

Pfizer Santé Familiale

Tél: + 33 (0) 1 58 07 39 81

România

Pfizer Romania S.R.L.

Tel: +40 21 207 28 00

Ireland, Malta

Pfizer Healthcare Ireland

Tel: +353 (0)1467 6627

Slovenská republika

Pfizer Luxembourg SARL, o.z.

Tel: +421 (0)2 3355 5500

Italia

Pfizer Italia S.r.l. – Divisione Consumer

Healthcare

Tel: (+ 39) 06 33 18 21

United Kingdom

Pfizer Consumer Healthcare Ltd (UK)

Tel: +44 (0) 333 555 2526

Κύπρος

Pfizer Ελλάς Α.Ε. (Cyprus Pharmaceutical

Organization Ltd.)

Τηλ: +357 22 863100

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.

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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.