Nexium 20 mg gastro-resistant tablets

Main information

  • Trade name:
  • Nexium 20 mg gastro-resistant tablets
  • Dosage:
  • 20 milligram(s)
  • Pharmaceutical form:
  • Gastro-resistant tablet
  • Prescription type:
  • Product subject to prescription which may be renewed (B)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nexium 20 mg gastro-resistant tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Proton pump inhibitors; esomeprazole

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PPA1097/031/001
  • Authorization date:
  • 27-10-2017
  • Last update:
  • 12-12-2018

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

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your

doctor or pharmacist.

This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them,

even if their signs of illness are the same as

yours.

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.

What is in this leaflet:

1. What Nexium is and what it is used for

2. What you need to know before you take

Nexium

3. How to take Nexium

4. Possible side effects

5. How to store Nexium

6. Contents of the pack and other information

1. What Nexium is and what it is used for

Nexium contains a medicine called esomeprazole.

This belongs to a group of medicines called

‘proton pump inhibitors’. They work by reducing

the amount of acid that your stomach produces.

Nexium is used to treat the following conditions:

Adults

‘Gastroesophageal reflux disease’ (GERD).

This is where acid from the stomach escapes

into the gullet (the tube which connects your

throat to your stomach) causing pain,

inflammation and heartburn.

Ulcers in the stomach or upper part of the gut

(intestine) that are infected with bacteria called

‘Helicobacter pylori’. If you have this condition,

your doctor may also prescribe antibiotics to

treat the infection and allow the ulcer to heal.

Stomach ulcers caused by medicines called

NSAIDs (Non-Steroidal Anti-Inflammatory

Drugs). Nexium can also be used to stop

stomach ulcers from forming if you are taking

NSAIDs.

Too much acid in the stomach caused by a

growth in the pancreas

(Zollinger-Ellison syndrome).

Prolonged treatment after prevention of

rebleeding of ulcers with intravenous Nexium.

Adolescents aged 12 years and above

‘Gastroesophageal reflux disease’ (GERD).

This is where acid from the stomach escapes

into the gullet (the tube which connects your

throat to your stomach) causing pain,

inflammation and heartburn.

Ulcers in the stomach or upper part of the gut

(intestine) that are infected with bacteria called

‘Helicobacter pylori’. If you have this condition,

your doctor may also prescribe antibiotics to

treat the infection and allow the ulcer to heal.

2. What you need to know before you take

Nexium:

Do not take Nexium:

If you are allergic to esomeprazole or any of the

other ingredients of this medicine (listed in

section 6).

If you are allergic to other proton pump inhibitor

medicines (e.g. pantoprazole, lanzoprazole,

rabeprazole, omeprazole).

If you are taking a medicine containing nelfinavir

(used to treat HIV infection).

Do not take Nexium if any of the above apply to

you. If you are not sure, talk to your doctor or

pharmacist before taking Nexium.

6. Contents of the pack and other information

What Nexium contains:

The active substance is esomeprazole. Nexium

gastro-resistant tablets come in two strengths

containing 20 mg or 40 mg of esomeprazole

(as magnesium trihydrate).

The other ingredients are glycerol monostearate

40-55, hyprolose, hypromellose, iron oxide

reddish-brown, yellow (E172), magnesium

stearate, methacrylic acid ethyl acrylate copolymer

(1:1) dispersion 30 per cent, microcrystalline

cellulose, synthetic paraffin, macrogol, polysorbate

80, crospovidone, sodium stearyl fumarate, sugar

spheres (sucrose and maize starch), talc, titanium

dioxide (E171), triethyl citrate.

What Nexium looks like and contents of the

pack

Nexium 20 mg gastro-resistant tablets are light

pink with an on one side and 20 mg on the

other side.

Your tablets will come in a blister pack in cartons

containing 28 tablets.

Product procured from within the EU, repackaged

and distributed by the Parallel Product

Authorisation Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch,

Worcestershire, B98 0RE, UK.

Manufactured by:

AstraZeneca AB, S-151 85, Södertälje, Sweden or

Corden Pharma GmbH, Otto-Hahn-Strasse 68723,

Plankstadt, Germany or AstraZeneca UK Limited,

Silk Road Business Park, Macclesfield, Cheshire

SK10 2NA, United Kingdom.

PPA1097/031/001

Nexium is a registered trademark of AstraZeneca

group of companies.

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone LTT Pharma Limited,

Tel: +44 (0)1527 505414 for help.

The following information is intended for

healthcare professionals only:

Administration through gastric tube

1. Put the tablet into an appropriate syringe and

fill the syringe with approximately 25 ml water

and approximately 5 ml air. For some tubes,

dispersion in 50 ml water is needed to prevent

the pellets from clogging the tube.

2. Immediately shake the syringe for

approximately 2 minutes to disperse the tablet.

3. Hold the syringe with the tip up and check that

the tip has not clogged.

Attach the syringe to the tube whilst maintaining

the above position.

5. Shake the syringe and position it with the tip

pointing down. Immediately inject 5 – 10 ml into

the tube. Invert the syringe after injection and

shake (the syringe must be held with the tip

pointing up to avoid clogging of the tip)

6. Turn the syringe with the tip down and

immediately inject another 5 – 10 ml into the

tube. Repeat this procedure until the syringe

is empty.

7. Fill the syringe with 25 ml of water and 5 ml

of air and repeat step 5 if necessary to wash

down any sediment left in the syringe.

For some tubes, 50 ml water is needed.

Leaflet revision date: 12/10/17

Warnings and precautions

Talk to your doctor or pharmacist before taking

Nexium:

If you have severe liver problems.

If you have severe kidney problems.

If you have ever had a skin reaction after

treatment with a medicine similar to Nexium

that reduces stomach acid.

If you are due to have a specific blood test

(Chromogranin A).

Nexium may hide the symptoms of other diseases.

Therefore, if any of the following happen to

you before you start taking Nexium or while

you are taking it, talk to your doctor straight

away:

You lose a lot of weight for no reason and have

problems swallowing.

You get stomach pain or indigestion.

You begin to vomit food or blood.

You pass black stools (blood-stained faeces).

If you have been prescribed Nexium "on demand"

you should contact your doctor if your symptoms

continue or change in character.

Taking a proton pump inhibitor like Nexium,

especially over a period of more than one year,

may slightly increase your risk of fracture in the

hip, wrist or spine. Tell your doctor if you have

osteoporosis or if you are taking corticosteroids

(which can increase the risk of osteoporosis).

If 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. Remember to also mention any other

ill-effects like pain in your joints.

Children under the age of 12 years

Information on dosing for children aged 1 to 11

years is provided in Nexium sachet product

information (ask your doctor or pharmacist if you

require further information).

Other medicines and Nexium

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines. This includes medicines that you buy

without a prescription. This is because Nexium

can affect the way some medicines work and

some medicines can have an effect on Nexium.

Do not take Nexium Tablets if you are taking a

medicine containing nelfinavir (used to treat HIV

infection).

Tell your doctor or pharmacist if you are taking any

of the following medicines:

Atazanavir (used to treat HIV infection).

Clopidogrel (used to prevent blood clots).

Ketoconazole, itraconazole or voriconazole

(used to treat infections caused by a fungus).

Erlotinib (used to treat cancer).

Citalopram, imipramine or clomipramine (used to

treat depression).

Diazepam (used to treat anxiety, relax muscles

or in epilepsy).

Phenytoin (used in epilepsy). If you are taking

phenytoin, your doctor will need to monitor you

when you start or stop taking Nexium.

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.

Cilostazol (used to treat intermittent claudication

– a pain in your legs when you walk which is

caused by an insufficient blood supply).

Cisapride (used for indigestion and heartburn).

Digoxin (used for heart problems).

Methotrexate (a chemotherapy medicine used in

high doses to treat cancer) – if you are taking a

high dose of methotrexate, your doctor may

temporarily stop your Nexium treatment.

Tacrolimus (organ transplantation).

Rifampicin (used for treatment of tuberculosis).

Package leaflet: Information for the patient

Nexium 20 mg gastro-resistant tablets

(esomeprazole)

POM

®

Ref:1097/031/001/121017/F/1

Skin rash on exposure to sunshine.

Joint pains (arthralgia) or muscle pains

(myalgia).

Generally feeling unwell and lacking energy.

Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

Changes in blood count including

agranulocytosis (lack of white blood cells)

Aggression.

Seeing, feeling or hearing things that are not

there (hallucinations).

Severe liver problems leading to liver failure and

inflammation of the brain.

Sudden onset of a severe rash or blistering or

peeling skin. This may be associated with a high

fever and joint pains (Erythema multiforme,

Stevens-Johnson syndrome, toxic epidermal

necrolysis).

Muscle weakness.

Severe kidney problems.

Enlarged breasts in men.

Not known (frequency cannot be estimated from

the available data)

If you are on Nexium for more than three months

it is possible that the levels of magnesium in

your blood may fall. Low levels of magnesium

can be seen as fatigue, involuntary muscle

contractions, disorientation, convulsions,

dizziness or increased heart rate. If you get any

of these symptoms, please tell your doctor

promptly. Low levels of magnesium can also

lead to a reduction in potassium or calcium

levels in the blood.

Your doctor may decide to perform regular blood

tests to monitor your levels of magnesium.

Inflammation in the gut (leading to diarrhoea).

Rash, possibly with pain in the joints.

Nexium 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 medication at this time.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly (see details below).

By reporting side effects you can help provide

more information on the safety of this medicine.

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

5. How to store Nexium

Keep this medicine out of the sight and reach of

children.

Do not store above 30°C.

Store this medicine in the original package in

order to protect from moisture.

Do not use this medicine after the expiry date

which is stated on the carton and blister foil after

EXP. The expiry date refers to the last day of

that month.

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.

Use in children under the age of 12 years

Nexium gastro-resistant tablets are not

recommended for children less than 12 years old.

Information on dosing for children aged 1 to 11

years is provided in Nexium sachet product

information (ask your doctor or pharmacist if you

require further information).

Elderly

Dose adjustment is not required in the elderly.

If you take more Nexium than you should

If you take more Nexium than prescribed by your

doctor, talk to your doctor or pharmacist straight

away.

If you forget to take Nexium

If you forget to take a dose, take it as soon as

you remember it. However, if it is almost time for

your next dose, skip the missed dose.

Do not take a double dose (two doses at the

same time) 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 and contact a

doctor immediately:

Sudden wheezing, swelling of your lips, tongue

and throat or body, rash, fainting or difficulties in

swallowing (severe allergic reaction).

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’.

Yellow skin, dark urine and tiredness which can

be symptoms of liver problems.

These effects are rare, and may affect up to 1 in

1,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

Headache

Effects on your stomach or gut: diarrhoea,

stomach pain, constipation, wind (flatulence).

Feeling sick (nausea) or being sick (vomiting).

Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.

Disturbed sleep (insomnia).

Dizziness, tingling feelings such as “pins and

needles”, feeling sleepy.

Spinning feeling (vertigo).

Dry mouth.

Changes in blood tests that check how the liver

is working.

Skin rash, lumpy rash (hives) and itchy skin.

Fracture of the hip, wrist or spine (if Nexium is

used in high doses and over long duration).

Rare (may affect up to 1 in 1,000 people)

Blood problems such as a reduced number of

white 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 of the inside of the mouth.

An infection called “thrush” which can affect the

gut and is caused by a fungus.

Liver problems, including jaundice which can

cause yellow skin, dark urine, and tiredness.

Hair loss (alopecia).

St. John’s wort (Hypericum perforatum) (used to

treat depression).

If your doctor has prescribed the antibiotics

amoxicillin and clarithromycin as well as Nexium

to treat ulcers caused by Helicobacter pylori

infection, it is very important that you tell your

doctor about any other medicines you are taking.

Nexium with food and drink

You can take your tablets with food or on an

empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or

are planning to have a baby, ask your doctor or

pharmacist for advice before taking this medicine.

Your doctor will decide whether you can take

Nexium during this time. It is not known if Nexium

passes into breast milk. Therefore, you should not

take Nexium if you are breastfeeding.

Driving and using machines

Nexium is not likely to affect you being able to

drive or use any tools or machines. However, side

effects such as dizziness and blurred vision may

uncommonly or rarely occur (see section 4).

If affected, you should not drive or use machines.

Nexium contains sucrose

Nexium 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, talk to your doctor before taking this

medicine.

3. How to take Nexium

Always take this medicine exactly as your doctor

or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

If you are taking this medicine for a long time,

your doctor will want to monitor you (particularly

if you are taking it for more than a year).

If your doctor has told you to take this medicine

as and when you need it, tell your doctor if your

symptoms change.

How much to take

Your doctor will tell you how many tablets to take

and how long to take them for. This will depend

on your condition, how old you are and how well

your liver works.

The recommended doses are given below.

Use in adults aged 18 and above

To treat heartburn caused by

gastroesophageal reflux disease (GERD):

If your doctor has found that your food pipe

(gullet) has been slightly damaged, the

recommended dose is one Nexium 40 mg

gastro-resistant tablet once a day for 4 weeks.

Your doctor may tell you to take the same

dose for a further 4 weeks if your gullet has not

yet healed.

The recommended dose once the gullet has

healed is one Nexium 20 mg gastro-resistant

tablet once a day.

If your gullet has not been damaged, the

recommended dose is one Nexium 20 mg

gastro-resistant tablet each day. Once the

condition has been controlled, your doctor may

tell you to take your medicine as and when you

need it, up to a maximum of one Nexium 20 mg

gastro-resistant tablet each day.

If you have severe liver problems, your doctor

may give you a lower dose.

To treat ulcers caused by Helicobacter pylori

infection and to stop them coming back:

The recommended dose is one Nexium 20 mg

gastro-resistant tablet twice a day for one week.

Your doctor will also tell you to take antibiotics

for example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs

(Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one Nexium 20 mg

gastro-resistant tablet once a day for 4 to 8

weeks.

To prevent stomach ulcers if you are taking

NSAIDs (Non-Steroidal Anti-Inflammatory

Drugs):

The recommended dose is one Nexium 20 mg

gastro-resistant tablet once a day.

To treat too much acid in the stomach caused

by a growth in the pancreas

(Zollinger-Ellison syndrome):

The recommended dose is Nexium 40 mg twice

a day.

Your doctor will adjust the dose depending on

your needs and will also decide how long you

need to take the medicine for. The maximum

dose is 80 mg twice a day.

Prolonged treatment after prevention of

re-bleeding of ulcers with intravenous Nexium:

The recommended dose is one Nexium 40 mg

tablet once a day for 4 weeks.

Use in adolescents aged 12 or above

To treat heartburn caused by

gastroesophageal reflux disease (GERD):

If your doctor has found that your food pipe

(gullet) has been slightly damaged, the

recommended dose is one Nexium 40 mg

gastro-resistant tablet once a day for 4 weeks.

Your doctor may tell you to take the same dose

for a further 4 weeks if your gullet has not yet

healed.

The recommended dose once the gullet has

healed is one Nexium 20 mg

gastro-resistant tablet once a day.

If your gullet has not been damaged, the

recommended dose is one Nexium 20 mg

gastro-resistant tablet each day.

If you have severe liver problems, your doctor

may give you a lower dose.

To treat ulcers caused by Helicobacter pylori

infection and to stop them coming back:

The recommended dose is one Nexium 20 mg

gastro-resistant tablet twice a day for one week.

Your doctor will also tell you to take antibiotics

for example amoxicillin and clarithromycin.

Taking this medicine

You can take your tablets at any time of the day.

You can take your tablets with food or on an

empty stomach.

Swallow your tablets whole with a drink of water.

Do not chew or crush the tablets. This is

because the tablets contain coated pellets which

stop the medicine from being broken down by

the acid in your stomach.

It is important not to damage the pellets.

What to do if you have trouble swallowing the

tablets

If you have trouble swallowing the tablets:

- Put them into a glass of still (non-fizzy) water.

Do not use any other liquids.

- Stir until the tablets break 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 cannot swallow at all, the tablet can be

mixed with some water and put into a syringe.

It can then be given to you through a tube

directly into your stomach (‘gastric tube’).

Ref: 1097/031/001/121017/B/1