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EESOMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): ESOMEPRAZOLE SODIUM

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Package leaflet: Information for the patient
Esomeprazole HWI Analytik 20 mg gastro-resistant capsules, hard
Esomeprazole HWI Analytik 40 mg gastro-resistant capsules, hard
Esomeprazole
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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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 HWI Analytik is and what it is used for
2. What you need to know before you take Esomeprazole HWI Analytik
3. How to take Esomeprazole HWI Analytik
4. Possible side effects
5. How to store Esomeprazole HWI Analytik
6. Contents of the pack and other information

1. What Esomeprazole HWI Analytik is and what it is used for
Esomeprazole HWI Analytik 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.
Esomeprazole HWI Analytik 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). Esomeprazole HWI Analytik 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.
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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 HWI Analytik
Do not take Esomeprazole HWI Analytik
- 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,
lansoprazole, rabeprazole, omeprazole).
- if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Do not take Esomeprazole HWI Analytik if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Esomeprazole HWI Analytik .
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole HWI Analytik :
- 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 Esomeprazole
HWI Analytik that reduces stomach acid.
- if you are due to have a specific blood test (Chromogranin A).
Esomeprazole HWI Analytik may hide the symptoms of other diseases. Therefore, if any of
the following happen to you before you start taking Esomeprazole HWI Analytik 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 Esomeprazole HWI Analytik “on demand” you should contact your
doctor if your symptoms continue or change in character.
Taking a proton pump inhibitor like Esomeprazole HWI Analytik , 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 Esomeprazole HWI Analytik .
Remember to also mention any other ill-effects like pain in your joints.

Other medicines and Esomeprazole HWI Analytik
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
Esomeprazole HWI Analytik can affect the way some medicines work and some medicines can
have an effect on Esomeprazole HWI Analytik .
Do not take Esomeprazole HWI Analytik 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 treat or prevent blood clots).
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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 Esomeprazole HWI Analytik .
Medicines that are used to thin your blood, such as warfarin. Your doctor may need to
monitor you when you start or stop taking Esomeprazole HWI Analytik .
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).
Tacrolimus (organ transplantation).
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 Esomeprazole
HWI Analytik treatment.
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
Esomeprazole HWI Analytik to treat ulcers caused by Helicobacter pylori infection, it is very
important that you tell your doctor about any other medicines you are taking.
Esomeprazole HWI Analytik with food and drink
You can take your capsules 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 Esomeprazole HWI Analytik during this time. It is not known if Esomeprazole HWI
Analytik passes into breast milk. Therefore, you should not take Esomeprazole HWI Analytik if
you are breastfeeding.
Driving and using machines
Esomeprazole HWI Analytik 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.
Esomeprazole HWI Analytik contains sucrose
Esomeprazole HWI Analytik 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 Esomeprazole HWI Analytik
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
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Your doctor will tell you how many capsules 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.

Adults aged 18 and above
To treat heartburn caused by gastro-oesophageal reflux disease (GERD):
- If your doctor has found that your food pipe (gullet) has been slightly damaged, the
recommended dose is one capsule of Esomeprazole HWI Analytik 40 mg 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 capsule of Esomeprazole HWI
Analytik 20 mg once a day.
- If your gullet has not been damaged, the recommended dose is one capsule Esomeprazole
HWI Analytik 20 mg 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 capsule of
Esomeprazole HWI Analytik 20 mg 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 capsule of Esomeprazole HWI Analytik 20 mg 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 capsule of Esomeprazole HWI Analytik 20 mg 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 capsule of Esomeprazole HWI Analytik 20 mg once a day.
To treat too much acid in the stomach caused by a growth in the pancreas (ZollingerEllison syndrome):
- The recommended dose is one capsule of Esomeprazole HWI Analytik 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 rebleeding of ulcers with intravenous
Esomeprazole:
The recommended dose is one capsule of Esomeprazole HWI Analytik 40 mg once a day for 4
weeks.
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 capsule of Esomeprazole HWI Analytik 40 mg 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 capsule of Esomeprazole HWI
Analytik 20 mg once a day.
- If your gullet has not been damaged, the recommended dose is one capsule of Esomeprazole
HWI Analytik 20 mg each day.
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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 capsule of Esomeprazole HWI Analytik 20 mg 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 capsules at any time of the day.
- You can take your capsules with food or on an empty stomach.
- Swallow your capsules whole with a glass of water. Do not chew or crush the capsules or
their contents. This is because the capsules contain coated granules which stop the medicine
from being broken down by the acid in your stomach. It is important not to damage the
granules.
What to do if you have trouble swallowing the capsules
- If you have trouble swallowing the capsules:
1) Open the capsule carefully above a glass of still (non-fizzy) water and empty the content of
the capsule (granules) into the glass. Do not use any other liquids.
2) Stir. Then drink the mixture straight away or within 30 minutes. Always stir the mixture just
before drinking it.
3) 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 content of the capsule 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’).
Children under the age of 12 years
Esomeprazole HWI Analytik is not recommended for children less than 12 years old.
Elderly
Dose adjustment is not required in the elderly.
If you take more Esomeprazole HWI Analytik than you should
If you take more Esomeprazole HWI Analytik than prescribed by your doctor, talk to your
doctor or pharmacist straight away.
If you forget to take Esomeprazole HWI Analytik
- 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 Esomeprazole HWI
Analytik 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).

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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 Esomeprazole HWI Analytik 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).
- 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.
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Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)
- If you are on Esomeprazole HWI Analytik 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, 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.
Esomeprazole HWI Analytik 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the internet at
www.mhra.gov.uk/yellowcard; or you can report via Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local
pharmacy. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Esomeprazole HWI Analytik
- 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 or bottle or
blister foil. The expiry date refers to the last day of that month.
- Blister: Do not store above 30 °C. Store in the original package in order to protect from
moisture.
- Bottle: Do not store above 30 °C. Keep the bottle tightly closed in order to protect from
moisture.
- Bottle: Shelf life after the first opening: 200 days.
- 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 HWI Analytik contains
- The active substance is esomeprazole.
Esomeprazole HWI Analytik capsules come in two strengths containing 20 mg or 40 mg of
esomeprazole (as sodium salt).
- The other ingredients are:
Capsule content:
Sugar spheres (containing maize starch and sucrose), methyl cellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate-80, sodium lauryl sulphate, methacrylic acid-ethyl
acrylate copolymer and triethyl citrate.
Capsule shell:

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Carrageenan, potassium chloride, red iron oxide (E-172), titanium tioxide (E-171),
hypromellose, printing ink (containing Shellac, potassium hydroxide and black iron oxide
(E172)).
What Esomeprazole HWI Analytik looks like and contents of the pack
- Esomeprazole HWI Analytik 20 mg hard capsules have opaque light pink cap and body,
size 4 (of 14 mm approximately), printed (cap ES/body 20) and containing spherical pellets.
- Esomeprazole HWI Analytik 40 mg hard capsules have opaque pink cap and body, size 2
(of 18 mm approximately), printed (cap ES/body 40) and containing spherical pellets.
Esomeprazole HWI Analytik is available in:
Aluminium/Aluminium blisters:
7, 14, 15, 28, 30, 56, 60, 90 (2x45), 98 (2x49) and 100 (2x50) capsules
White opaque polyethylene (PE) bottles, containing desiccant (silica gel) sachets, and a
polyethylene (PE) cap with a tamper evident ring closure:
7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100 and 500 capsules
Esomeprazole HWI Analytik is available in:
Aluminium/Aluminium blisters:
7, 14, 15, 28, 30, 56, 60, 90 (2x45), and 100 (2x50) capsules
White opaque polyethylene (PE) bottles, containing desiccant (silica gel) sachets, and a
polyethylene (PE) cap with a tamper evident ring closure:
7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100 and 500 capsules
Not all pack size may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DISTRIQUIMICA, S.A.
Av. Mare de Déu de Montserrat, 221 - Bajos
08041 Barcelona
Spain
Manufacturer
Laboratorios Dr. Esteve S. A.
Sant Marti, s/n, Polígono Industrial
08107 Martorelles (Barcelona)
Spain

This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany:
Belgium
The Netherlands
United Kingdom

Esoval 20 mg magensaftresistente Hartkapseln
Esoval 40 mg magensaftresistente Hartkapseln
Esomeprazole HWI Analytik 20 mg gélule gastro-résistante
Esomeprazole HWI Analytik 40 mg gélule gastro-résistante
Esoval 20 mg maagsapresistente capsules, harde
Esoval 40 mg maagsapresistente capsules, harde
Esomerpazole HWI Analytik 20 mg gastro-resistant capsules, hard
Esomerpazole HWI Analytik 40 mg gastro-resistant capsules, hard

This leaflet was last revised in 02/2017.
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The following information is intended for healthcare professionals only:
Administration through gastric tube
Administration through gastric tube
1. Add the contents of a capsule into approximately 25 ml or 50 ml of water. (For some tubes,
dispersion in 50 ml water is needed to prevent the granules from clogging the tube). Stir.
2. Draw the suspension into a syringe and add approximately 5 ml of air.
3. Immediately shake the syringe for approximately 2 minutes to disperse the granules.
4. Hold the syringe with the tip up and check that the tip has not clogged.
5. Attach the syringe to the tube whilst maintaining the above position.
6. 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).
7. 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.
8. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to wash
down any sediment left in the syringe. For some tubes, 50 ml water is needed.
Any unused product or waste material should be disposed of in accordance with local
requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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