Package leaflet: Information for the user

Esomeprazole 20 mg gastro-resistant tablets

Esomeprazole 40 mg gastro-resistant tablets

Esomeprazole

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

1. What Esomeprazole is and what it is used for

Esomeprazole gastro-resistant tablets 20mg & 40mg 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.

This medicine 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). This
medicine 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 esomeprazole.

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.

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 2. What you need to know before you take Esomeprazole

Do not take Esomeprazole:

• If you are allergic to esomeprazole or to 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,
lansoprazole, rabeprazole, 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 or pharmacist before taking Esomeprazole:
• 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 this medicine that
reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

Rash and skin symptoms

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 this medicine. Remember to also mention any other ill-
effects like pain in your joints.

Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash can
involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious
skin rashes often come after flu-like symptoms such as fever, headache, body ache. The rash may cover
large parts of the body with blistering and peeling of the skin. If at any time during the treatment (even
after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and
contact your doctor immediately.

This medicine may hide the symptoms of other diseases. Therefore, if any of the following happen to
you before you start taking this medicine 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 this medicine “on demand” you should contact your doctor if your
symptoms continue or change in character.

Taking a proton pump inhibitor like this medicine, 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).

Esomeprazole may also reduce the absorption of vitamin B12, especially on long-term therapy. Talk to
your doctor or pharmacist if you are taking vitamin B12.

Other medicines and Esomeprazole

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 this medicine can affect the
way some medicines work and some medicines can have an effect on this medicine.
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 Do not take this medicine 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 this medicine.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor
you when you start or stop taking this medicine.
• 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 this medicine treatment.
• Tacrolimus (organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as this medicine to
treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about
any other medicines you are taking.

This medicine may affect the way that your body absorbs vitamin B12, particularly if you need to
take it for a long time. Please contact your doctor if you notice any of the following symptoms,
which could indicate low levels of Vitamin B12:

• Extreme tiredness or lack of energy

• Pins and needles
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Problems with memory, confusion, depression

Esomeprazole with food and drink

You can take your tablets with food or on an empty stomach.

Pregnancy and 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.
Your doctor will decide whether you can take this medicine during this time.
It is not known if this medicine passes into breast milk. Therefore, you should not take this medicine if
you are breast-feeding.

Driving and using machines

This medicine 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.

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Esomeprazole contains sucrose and lactose monohydrate and sodium
This medicine contains sucrose and lactose monohydrate, which is 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
medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.

3. How to take Esomeprazole

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

• This medicine are not recommended for children less than 12 years old.
• 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.

Taking Esomeprazole
• 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’).

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 dose is:

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 Esomeprazole 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 recommendeddose once the gullet has healed is one tablet of Esomeprazole gastro-resistant
tablets 20 mg once a day.
• If your gullet has not been damaged, the recommended dose is one Esomeprazole 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 Esomeprazole 20 mg gastro-
resistant tablet each day.
• If you have severe liver problems, your doctor may give you a lower dose.
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To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• - The recommended dose is one Esomeprazole 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 Esomeprazole 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 Esomeprazole 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 Esomeprazole 40 mg gastro-resistant tablet 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 esomeprazole:

• The recommended dose is one Esomeprazole 40 mg gastro-resistant 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 Esomeprazole 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 Esomeprazole 20 mg gastro-resistant
tablet once a day.
• If your gullet has not been damaged, the recommended dose is one Esomeprazole 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 Esomeprazole 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.

Elderly
Dose adjustment is not required in the elderly.

If you take more Esomeprazole than you should

If you take more this medicine than prescribed by your doctor, talk to your doctor or pharmacist
straight away.

If you forget to take Esomeprazole

• 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 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.

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If you notice any of the following serious side effects, stop taking this medicine and contact a
doctor immediately:

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

• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties
in swallowing (severe allergic reaction).
• Blood problems such as a reduced number of white cells or platelets. This can cause weakness,
bruising or make infections more likely.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

Very rare (may affect up to 1 in 10000 people)

• Sudden onset of a severe rash or reddening of the skin with blisters or peeling may occur even after
several weeks of treatment. There may also be severe blisters and bleeding in the lips, eyes, mouth,
nose and genitals. The skin rashes may develop into serious widespread skin damage (peeling of the
epidermis and superficial mucous membranes) with life threatening consequences. This could be
‘erythema multiforme’, ‘Stevens-Johnson syndrome’, ‘toxic epidermal necrolysis’ or ‘drug reaction
with eosinophilia and systemic symptoms’.
• Severe liver problems leading to liver failure and inflammation of the brain.
• Changes in blood count including agranulocytosis (lack of white blood cells).

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 medication at this time.

These effects are rare (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 this medicine is used in high doses and over long duration).

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

• 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.
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• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• 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)

• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• 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, drug
reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)

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

If you are on this medicine 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.

Reporting Side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole

Keep this medicine out of the sight and reach of children
This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label and carton 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.

6. Contents of the pack and other information

What Esomeprazole contains

• The active substance is esomeprazole magnesium dihydrate.
Esomeprazole 20 mg gastro-resistant tablets
Each gastro-resistant tablet contain 20 mg esomeprazole (as magnesium dihydrate).
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 Esomeprazole 40 mg gastro-resistant tablets
Each gastro-resistant tablet contain 40 mg esomeprazole (as magnesium dihydrate).

• The other ingredients are:

• Pellets: Hypromellose, sucrose, maize starch, liquid glucose, talc, Methacrylic acid –
ethylacrylate copolymer (1:1) dispersion 30 % , sodium laurilsulfate, polysorbate 80,
triethyl citrate, macrogol, microcrystalline cellulose , crospovidone, hypromellose ,
stearyl alcohol, silica colloidal anhydrous
• Tablet Core: Crospovidone, lactose monohydrate and cellulose
microcrystalline, Silica colloidal anhydrous, magnesium stearate,
• Tablet
coating: For 20
mg tablets
- Hypromellose , titanium dioxide (E171), macrogol and iron oxide red (E172)

For 40 mg tablets
- Hypromellose , titanium dioxide (E171), macrogol, iron oxide red (E172),
erythrosine aluminium lake (E127) & iron oxide black (E172)

What Esomeprazole looks like and contents of the pack

• Esomeprazole 20 mg gastro-resistant tablets: Pink coloured, capsule shaped, biconvex, film
coated tablets debossed ‘20’ on one side and plain on other side.
Length: 16.30 ±0.2mm, Breadth: 8.30 ±0.2mm.
• Esomeprazole 40 mg gastro-resistant tablets: Pink coloured, capsule shaped, biconvex film
coated tablets debossed ‘40’ on one side and plain on other side.
Length: 19.30 ±0.2mm, Breadth: 8.30 ±0.2mm.

• Your tablets will come in packs of:

Blister package of Plain aluminium Blister foil along with 3 ply Aluminium Laminated Film 20 mg,
40mg:
Blister packs of 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 90, 98, 100, 140

tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Cipla (EU) Limited

Dixcart House, Addlestone Road,
Bourne Business Park,
Addlestone, Surrey,
KT15 2LE,
United Kingdom

Manufacturer

Cipla (EU) Limited

Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United
Kingdom
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This leaflet was last revised in 02/2023.