Esomeprazole Sun Pharmaceutical Industries (Europe) BV: detailed information

Package leaflet: Information for the patient

Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Esomeprazole Sun Pharmaceutical Industries (Europe) BV is and what it is used for
What you need to know before taking Esomeprazole Sun Pharmaceutical Industries (Europe) BV
How to take Esomeprazole Sun Pharmaceutical Industries (Europe) BV
Possible side effects
How to store Esomeprazole Sun Pharmaceutical Industries (Europe) BV
Contents of the pack and other information

1. What Esomeprazolo Sun Pharmaceutical Industries (Europe) BV is and what it is used for

Esomeprazolo Sun Pharmaceutical Industries (Europe) BV contains a medicine called
esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These
work by reducing the amount of acid produced by the stomach.
Esomeprazolo Sun Pharmaceutical Industries (Europe) BV is used to treat the following
conditions:
Adults

"Gastro-oesophageal reflux disease" (GORD). This is a condition in which acid produced by the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers 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). Esomeprazolo Sun Pharmaceutical Industries (Europe) BV can also be used to prevent the formation of stomach or upper intestinal ulcers if you are taking NSAIDs.
Excess acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment following prevention of re-bleeding from ulcers with intravenous esomeprazole.

Adolescents over 12 years of age:

"Gastro-oesophageal reflux disease" (GORD). This is a condition in which acid produced by the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers infected with the bacterium 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 should know before taking Esomeprazole Sun Pharmaceutical Industries (Europe) BV

Do not take Esomeprazole Sun Pharmaceutical Industries (Europe) BV:

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 inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Esomeprazole Sun Pharmaceutical Industries (Europe) BV if you are in any of the
above conditions.
If you have any doubts, consult your doctor or pharmacist before taking Esomeprazole Sun Pharmaceutical
Industries (Europe) BV.

Warnings and precautions
Talk to your doctor before taking Esomeprazole Sun Pharmaceutical Industries (Europe) BV:

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 Sun Pharmaceutical Industries (Europe) BV that reduces stomach acid.
If you are about to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your
doctor as soon as possible, as it may be necessary to stop treatment with
Esomeprazole Sun Pharmaceutical Industries (Europe) BV. Remember to also report any other
side effects such as joint pain.
Esomeprazole Sun Pharmaceutical Industries (Europe) BV may mask symptoms of other
diseases. Therefore, inform your doctor immediately if, before starting or while taking
Esomeprazole Sun Pharmaceutical Industries (Europe) BV,
you experience any of the following conditions:

If you lose weight significantly without reason and have difficulty swallowing.
If you have stomach pain or indigestion.
If you start vomiting food or blood.
If your stools are dark-coloured (blood in stools).

If you have been prescribed Esomeprazole Sun Pharmaceutical Industries (Europe) BV to take as
needed, contact your doctor if symptoms persist or if the nature of the symptoms changes.
If you take a proton pump inhibitor such as Esomeprazole Sun Pharmaceutical Industries
(Europe) BV, especially for longer than one year, there may be a slight increase in the risk of
fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Other medicines and Esomeprazole Sun Pharmaceutical Industries (Europe) BV
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Esomeprazole Sun Pharmaceutical Industries (Europe) BV may alter the effect of some medicines and some medicines may affect Esomeprazole Sun Pharmaceutical Industries (Europe) BV.
Do not take Esomeprazole Sun Pharmaceutical Industries (Europe) BV if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform 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 fungal infections).
Erlotinib (used to treat cancer).
Citalopram, imipramine or clomipramine (used to treat depression).
Diazepam (used to treat anxiety, to relax muscles or in epilepsy).
Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Esomeprazole Sun Pharmaceutical Industries (Europe) BV.
Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeprazole Sun Pharmaceutical Industries (Europe) BV.
Cilostazol (used to treat intermittent claudication, leg pain occurring when walking due to insufficient blood flow).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a chemotherapy medicine used at high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with Esomeprazole Sun Pharmaceutical Industries (Europe) BV.
Tacrolimus (used for organ transplants).
Rifampicin (used to treat tuberculosis).
St John's wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazole Sun
Pharmaceutical Industries (Europe) BV to treat ulcers caused by Helicobacter pylori infection,
it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazole Sun Pharmaceutical Industries (Europe) BV with food and drink
You may take the tablets with food or on an empty stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole Sun Pharmaceutical Industries (Europe) BV during this period.
It is not known whether Esomeprazole Sun Pharmaceutical Industries (Europe) BV passes into breast milk. Therefore, do not take Esomeprazole Sun Pharmaceutical Industries (Europe) BV if you are breastfeeding.

Driving and using machines
It is unlikely that Esomeprazole Sun Pharmaceutical Industries (Europe) BV will affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If this happens to you, do not drive or operate machinery.

Esomeprazole Sun Pharmaceutical Industries (Europe) BV contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Esomeprazole Sun Pharmaceutical Industries (Europe) BV

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

If you have been taking this medicine for a long time, your doctor will want to monitor you (especially if you have been taking it for more than one year).
If your doctor has told you to take this medicine as needed, inform them if your symptoms change.

How much Esomeprazole Sun Pharmaceutical Industries (Europe) BV to take

Your doctor will tell you how many tablets to take and for how long. This will depend on your condition, your age, and your liver function.
The usual doses are given below.

Adults aged over 18 years
For treating heartburn caused by gastro-oesophageal reflux disease (GORD)

If your doctor has diagnosed that your digestive tube (oesophagus) has been slightly damaged, the recommended dose is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 40 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose once the oesophagus has healed is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg once daily.
If the oesophagus has not been damaged, the recommended dose is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg daily. Once your condition is under control, your doctor may prescribe you to take the medicine as needed, up to a maximum of one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg daily.
If you have severe liver problems, your doctor may give you a lower dose.

For treating ulcers caused by a Helicobacter pylori infection and to prevent them from recurring

The recommended dose is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg twice daily for one week.
Your doctor may also prescribe antibiotics, for example amoxicillin and clarithromycin.

For treating stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

The recommended dose is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg once daily for 4–8 weeks.

To prevent stomach or upper intestinal ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

The recommended dose is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg once daily.

For treating excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome)

The recommended dose is 40 mg of Esomeprazole Sun Pharmaceutical Industries (Europe) BV twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Long-term treatment after prevention of re-bleeding from ulcers with intravenous esomeprazole
The recommended dose is one tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 40 mg once daily for 4 weeks.

Adolescents aged 12 years and older
For treating heartburn caused by gastro-oesophageal reflux disease (GORD):

If your doctor has found that your digestive tube (oesophagus) has been slightly damaged, the recommended dose is one gastro-resistant tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 40 mg once daily for 4 weeks.
- The recommended dose once the oesophagus has healed is one gastro-resistant tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg once daily.
If the oesophagus has not yet healed, the recommended dose is one gastro-resistant tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV once daily.
If you have severe liver problems, your doctor may give you a lower dose.

For treating ulcers caused by a Helicobacter pylori infection and to prevent them from recurring:

The recommended dose is one gastro-resistant tablet of Esomeprazole Sun Pharmaceutical Industries (Europe) BV 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

Method and route of administration

You may take the tablets at any time of day.
You may take the tablets with food or on an empty stomach.
Swallow the tablets whole with water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being inactivated by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

If you have difficulty swallowing the tablets:
Place the tablets in a glass of plain water (not sparkling). Do not use any other liquid.
Stir until the tablets break up (the mixture will appear cloudy). Drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.
To ensure you have taken all the medicine, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine: do not chew or crush them.
If you are completely unable to swallow, the tablets may be mixed with some water and administered via a syringe. They may be given through a tube directly into the stomach ('gastric tube').

Children under 12 years of age
Esomeprazole Sun Pharmaceutical Industries (Europe) BV gastro-resistant tablets are not recommended in children under 12 years of age.

Elderly patients
Dose adjustment is not required in elderly patients.

If you take more Esomeprazole Sun Pharmaceutical Industries (Europe) BV than you should
If you take more Esomeprazole Sun Pharmaceutical Industries (Europe) BV than prescribed by your doctor, speak immediately with your doctor or pharmacist.

If you forget to take Esomeprazole Sun Pharmaceutical Industries (Europe) BV

If you forget to take a dose, take it as soon as you remember. 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 further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop taking
Esomeprazole Sun Pharmaceutical Industries (Europe) BV and contact a doctor immediately:

Sudden breathlessness, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
Reddening of the skin with blistering or peeling. Large blisters and severe bleeding of the lips, eyes, mouth, nose and genitals may also occur. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems. These effects are rare and affect fewer than 1 in 1,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people):

Headache.
Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence (gas).
Nausea or vomiting.
Benign stomach polyps.

Uncommon (may affect up to 1 in 100 people):

Swelling of feet and ankles.
Sleep disturbances (insomnia).
Dizziness, tingling sensations like "pins and needles", drowsiness.
Feeling of dizziness.
Dry mouth.
Changes in blood test results related to liver function.
Rash, hives and itching.
Fracture of the hip, wrist or spine (if Esomeprazole Sun Pharmaceutical Industries (Europe) BV is used at high doses and for a long period of time).

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

Blood problems such as reduced number of white blood cells or platelets. This may cause weakness, bruising or increased risk of infections.
Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
Restlessness, confusion or depression.
Changes in taste.
Vision problems such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
A fungal infection called "thrush" which may affect the intestine.
Liver problems, including jaundice which may cause yellowing of the skin, dark urine and fatigue.
Hair loss (alopecia).
Rash occurring after exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of being unwell and lack of energy.
Increased sweating.

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

Changes in blood cell counts including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of a severe rash, blisters or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take Esomeprazole Sun Pharmaceutical Industries (Europe) BV for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
Inflammation of the intestine (which may lead to diarrhoea).
Erythema, possible joint pain.

In very rare cases, Esomeprazole Sun Pharmaceutical Industries (Europe) BV may affect white
blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever with
a severely compromised general condition, or fever with signs of a local infection such as
pain in the neck, throat or mouth, or difficulty urinating, consult your doctor as soon as possible so
that a deficiency in white blood cells (agranulocytosis) can be ruled out by blood tests. At this stage,
it is important that you provide information about your treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole Sun Pharmaceutical Industries (Europe) BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep the blister in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo Sun Pharmaceutical Industries (Europe) BV contains
The active substance is esomeprazole.
20 mg: each tablet contains 20 mg of esomeprazole (as amorphous esomeprazole magnesium).
40 mg: each tablet contains 40 mg of esomeprazole (as amorphous esomeprazole magnesium).
The other components are:
Tablet core: hydroxypropyl cellulose (E463), crospovidone (Type A).
Coating: povidone K30, polyethylene glycol-400, polyethylene glycol-4000, polyethylene glycol 6000, hypromellose phthalate (HP-55S), hypromellose phthalate (HP-50), diethyl phthalate, hydroxypropyl cellulose, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 112), crospovidone (Type B), sodium stearyl fumarate, Opadry brown 03B86651 (HMPC 2910/Hypromellose 6cP, titanium dioxide (E171), polyethylene glycol/PEG 400, iron oxide red (E 172)) , sugar spheres (sucrose and maize starch), talc (E553b).

Description of the appearance of Esomeprazolo Sun Pharmaceutical Industries (Europe) BV and
pack contents
Esomeprazolo Sun Pharmaceutical Industries (Europe) BV 20 mg gastro-resistant tablets:
film-coated, oval, biconvex tablets, light brick-red to brown in colour, marked with "E5" on one side and smooth on the other side.
Esomeprazolo Sun Pharmaceutical Industries (Europe) BV 40 mg gastro-resistant tablets:
film-coated, oval, biconvex tablets, light brick-red to brown in colour, marked with "E6" on one side and smooth on the other side.
The tablets are available in the following pack sizes 20 mg and 40 mg:

OPA/AI/PE-desiccant-HDPE/Al blisters containing 7, 14, 15, 28, 30, 56, 60, 90 and 100 tablets.
Cold-form laminated blisters in OPA-Al-PVC/Al containing 7, 14, 15, 28, 30, 56, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries (Europe) B.V.
Polaris Avenue 87
2132 JH
B.V. 1441408, the Netherlands

Responsible manufacturers for batch release
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp, the Netherlands
Terapia SA
124 Fabricii Str.
400 632 Cluj-Napoca, Romania

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Belgium: Esomeprazole Apotex 20 mg/40 mg, Maagsapresistente Tabletten
France: ESOMEPRAZOLE SUN 20mg/40mg, Comprimé Gastro-Résistant
Germany: ESOMEPRAZOL BASICS 20mg/40mg, Magensaftresistente Tabletten
Italy: Esomeprazolo Sun Pharmaceutical Industries (Europe) BV 20mg/40mg, compresse gastroresistenti
Netherlands: ESOMEPRAZOL 20mg/40mg Ranbaxy, Maagsapresistente Tabletten
Portugal: EZOCLIP 20mg/40 mg, Comprimido Gastrorresistente
Sweden: Esomeprazole Ranbaxy 20mg/40mg, Enterotablett
United Kingdom: ESOMEPRAZOLE 20mg/40mg, Gastro-resistant Tablets

This patient information leaflet was last approved in: