Esomeprazole Sandoz GmbH: detailed information

Patient Information Leaflet

Esomeprazolo Sandoz GmbH 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Equivalent medicinal product
Please read this leaflet carefully before taking 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 you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Esomeprazolo Sandoz GmbH is and what it is used for
What you need to know before taking Esomeprazolo Sandoz GmbH
How to take Esomeprazolo Sandoz GmbH
Possible side effects
How to store Esomeprazolo Sandoz GmbH
Contents of the pack and other information

1. What Esomeprazolo Sandoz GmbH is and what it is used for

Esomeprazolo Sandoz GmbH contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by your stomach.
Esomeprazolo Sandoz GmbH is used to treat the following conditions:
Adults

Gastroesophageal reflux disease (GERD). In this condition, acid moves from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper digestive tract (intestine) 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 non-steroidal anti-inflammatory drugs (NSAIDs). This medicine can also be used to help prevent stomach ulcers if you are taking NSAIDs.
Excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome). Long-term treatment to prevent recurrent bleeding from ulcers after initial prevention with intravenous esomeprazole. Adolescents over 12 years of age
Gastroesophageal reflux disease (GERD). In this condition, acid moves from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper digestive tract (intestine) 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.

2. What you need to know before taking Esomeprazole Sandoz GmbH

Do not take Esomeprazole Sandoz GmbH

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 Sandoz GmbH if any of these situations apply to you. If you have any doubts,
consult your doctor or pharmacist before taking Esomeprazole Sandoz GmbH.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole Sandoz GmbH:

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 Sandoz GmbH that reduces stomach acidity.
if you are due to have a specific blood test (chromogranin A)

Esomeprazole Sandoz GmbH may mask the symptoms of other diseases. Therefore, if any of the
following occur before or while you are taking Esomeprazole Sandoz GmbH, speak to your doctor
immediately:

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 Esomeprazole Sandoz GmbH has been prescribed “as needed”, contact your doctor if symptoms
persist or change in nature.
If you have been prescribed a proton pump inhibitor such as Esomeprazole Sandoz GmbH,
particularly for a period longer than one year, there may be a slight increase in the risk of fracture 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.
Skin rash and skin-related symptoms
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 discontinue treatment with Esomeprazole
Sandoz GmbH. Also remember to report any other adverse effects such as joint pain.
Severe skin reactions have occurred in patients taking esomeprazole (see also section 4). The skin rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin reactions often occur after flu-like symptoms such as fever, headache, and muscle pain. The skin rash may cover large areas of the body with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin-related symptoms, stop taking this medicine and contact your doctor immediately.
Other medicines and Esomeprazole Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is because Esomeprazole Sandoz GmbH may affect how other medicines work, and other medicines may affect Esomeprazole Sandoz GmbH.
Do not take Esomeprazole Sandoz GmbH 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 in cancer treatment).
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 treatment with Esomeprazole Sandoz GmbH.
Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with Esomeprazole Sandoz GmbH.
Cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Tacrolimus (used in organ transplantation).
Methotrexate (a chemotherapeutic agent used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazole Sandoz GmbH.
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 together with Esomeprazole
Sandoz GmbH to treat ulcers caused by Helicobacter pylori infection, it is very important
that you inform your doctor if you are taking other medicines.
Esomeprazole Sandoz GmbH with food and drinks
You may take the capsules with food or on an empty stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take
Esomeprazole Sandoz GmbH during this period. It is not known whether Esomeprazole Sandoz GmbH
passes into breast milk. Therefore, you must not take Esomeprazole Sandoz GmbH if you are breastfeeding.
Driving and using machines
It is unlikely that this medicine 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 they occur, you must not drive or use machinery.
Esomeprazole Sandoz GmbH contains sucrose
Esomeprazole Sandoz GmbH contains sugar spheres that contain sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking
this medicine.
Esomeprazole Sandoz GmbH contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Esomeprazole Sandoz GmbH

Take this medicine exactly as directed 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 monitor you (in
particular if you have been taking it for more than one year).
If your doctor has told you to take this medicine as needed, inform your doctor if your symptoms change.

How much Esomeprazole Sandoz GmbH to take

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

Adults over 18 years of age
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

If your doctor has diagnosed that your oesophagus has been mildly damaged, the recommended dose is one capsule of Esomeprazole Sandoz GmbH 40 mg once daily for 4 weeks. Your doctor may tell you to continue taking the same dose for another 4 weeks if your oesophagus has not yet healed.
The recommended dose to take once your oesophagus has healed is one capsule of Esomeprazole Sandoz GmbH 20 mg once daily.
If your oesophagus has not been damaged, the recommended dose is one capsule of Esomeprazole Sandoz GmbH 20 mg daily. Once your condition is under control, your doctor will inform you that you may take the medicine as needed, up to a maximum of one capsule of Esomeprazole Sandoz GmbH 20 mg per day.
If you have severe liver problems, your doctor may prescribe you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

The recommended dose is one capsule of Esomeprazole Sandoz GmbH 20 mg twice daily for one week.
Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

For the treatment of ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one capsule of Esomeprazole Sandoz GmbH 20 mg once daily for 4 to 8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one capsule of Esomeprazole Sandoz GmbH 20 mg once daily.

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

The recommended dose is one capsule of Esomeprazole Sandoz GmbH 40 mg twice daily.
Your doctor will adjust your dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Long-term treatment of re-bleeding of ulcers, after prevention with intravenous esomeprazole.

The recommended dose is one capsule of Esomeprazole Sandoz GmbH 40 mg once daily for 4 weeks.

Adolescents over 12 years of age
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

If your doctor has diagnosed that your oesophagus has been mildly damaged, the recommended dose is one capsule of Esomeprazole Sandoz GmbH 40 mg once daily for 4 weeks. Your doctor may tell you to continue taking the same dose for another 4 weeks if your oesophagus has not healed.
The recommended dose to take once your oesophagus has healed is one capsule of Esomeprazole Sandoz GmbH 20 mg once daily.
If your oesophagus is not damaged, the recommended dose is one capsule of Esomeprazole Sandoz GmbH 20 mg daily.
If you have severe liver problems, your doctor may prescribe you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

The recommended dose is one capsule of Esomeprazole Sandoz GmbH 20 mg twice daily for one week.
Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

How to take this medicine

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

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules: 1) Open the capsule and empty the granules into a glass of plain water (not sparkling). Do not use other liquids. 2) Stir. Drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking. 3) To ensure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. The solid particles contain the medicine – do not chew or crush them.
If you are unable to swallow, the contents of the capsule can be mixed with a little water and administered via a syringe. In this way, it can be given through a tube directly into the stomach (‘gastric tube’).

Use in children under 12 years of age
Esomeprazole Sandoz GmbH is not recommended for children under 12 years of age.
Elderly
No dose adjustment is required in the elderly.
If you take more Esomeprazole Sandoz GmbH than you should
If you take more Esomeprazole Sandoz GmbH than prescribed by your doctor, speak
immediately with your doctor or pharmacist.
If you forget to take Esomeprazole Sandoz GmbH

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 any further questions about 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 this medicine and contact your doctor immediately:

Sudden breathlessness, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

Sudden onset of a severe skin rash or reddening of the skin with blistering or peeling may occur even after several weeks of treatment. Severe blisters and bleeding may also occur in the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms" (DRESS). These side effects are very rare and may affect up to 1 in 10,000 people.

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

Headache.
Stomach or bowel problems: diarrhoea, stomach ache, constipation, bloating (flatulence).
Feeling unwell (nausea) or sickness (vomiting).
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling sensations such as “pins and needles”, drowsiness.
Feeling of spinning (vertigo).
Dry mouth.
Changes in blood test values used to monitor liver function.
Skin rash, hives, and itching.
Fracture of the hip, wrist, or spine (if this medicine is taken at high doses and for a long time).

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

Blood problems, such as a reduction in the number of white blood cells or platelets. This may cause weakness, bruising, or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
Feeling agitated, confused, or depressed.
Altered taste.
Vision problems such as blurred vision.
Sudden breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “candidiasis” that may affect the oesophagus and is caused by a fungus.
Liver problems, including jaundice which may cause yellowing of the skin, dark urine, and fatigue.
Hair loss (alopecia).
Skin redness after exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
Feeling generally unwell and lacking energy.
Increased sweating.

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

Changes in the number of blood cells 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 brain inflammation.
Sudden onset of a severe skin rash or blisters or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take Esomeprazolo Sandoz GmbH for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience 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 may decide to monitor your blood magnesium levels periodically.
Inflammation of the intestine (causing diarrhoea).
Skin rash possibly accompanied by joint pain.

Esomeprazolo Sandoz GmbH may, in very rare cases, affect white blood cells causing
immunodeficiency. If you have an infection with symptoms such as fever with a severely
worsened general condition or fever with signs of a local infection such as neck, throat or mouth pain, or
difficulty urinating, you must contact your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that you provide your
doctor with any information about medicines you are taking.
Reporting of side effects
If you experience any side effects, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, or carton after "Exp.". The expiry date refers to the last day of that month.
Blister: Do not store above 30 °C. Store in the original packaging to protect the medicine from moisture.
Bottle: Do not store above 30 °C. Store in the original packaging and keep the bottle tightly closed to protect the medicine from moisture.
Bottle: Period of validity after first opening: 200 days
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 Sandoz GmbH contains

The active substance is esomeprazole. Esomeprazolo Sandoz GmbH is available in two strengths containing 20 mg or 40 mg of esomeprazole (as sodium salt).
The other components are:

Capsule contents
Sugar spheres (containing sucrose and maize starch), methylcellulose, talc, titanium
dioxide (E171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid copolymer – ethyl acrylate, triethyl citrate.
Capsule coating:
Carrageenan, potassium chloride, iron oxide red (E172), titanium dioxide (E171), hypromellose,
printing ink (containing shellac, potassium hydroxide and iron oxide black (E172)).

Description of the appearance of Esomeprazolo Sandoz GmbH and package contents

Esomeprazolo Sandoz GmbH 20 mg hard capsules have a light pink opaque body and cap, size 4 (approximately 14 mm), with "ES" printed on the cap and "20" on the body, and contain spherical granules.
Esomeprazolo Sandoz GmbH 40 mg hard capsules have a pink opaque body and cap, size 2 (approximately 18 mm), with "ES" printed on the cap and "40" on the body, and contain spherical granules.

Esomeprazolo Sandoz GmbH 20 mg is available in
Aluminium/aluminium blisters:
7, 14, 15, 28, 30, 56, 60, 90 (2x45), 98 (2x49) and 100 (2x50) capsules
White opaque polyethylene bottle containing desiccant (silica gel) in sachets and a polyethylene (PE) cap with tamper-evident ring closure:
7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100 and 500 capsules

Esomeprazolo Sandoz GmbH 40 mg is available in
Aluminium/aluminium blisters:
7, 14, 15, 28, 30, 56, 60, 90 (2x45) and 100 (2x50) capsules
White opaque polyethylene bottle containing desiccant (silica gel) in sachets and a polyethylene (PE) cap with tamper-evident ring closure:
7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100 and 500 capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Sandoz GmbH,
Biochemiestrasse 10
6250 Kundl,
Austria
Local representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Towa Pharmaceutical Europe S.L.
C/ De Sant Marti', 75-97
08107 Martorelles (Barcelona)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Croatia Naxesy 20 mg tvrde želučanootporne kapsule
Naxesy 40 mg tvrde želučanootporne kapsule
Estonia Esomeprazole Sandoz
France ESOMEPRAZOLE SANDOZ, 20 mg, gélule gastro-résistante
ESOMEPRAZOLE SANDOZ, 40 mg, gélule gastro-résistante
Germany ESOMEP 20 mg / 40 mg magensaftresistente Hartkapseln
Italy Esomeprazolo Sandoz GmbH
Latvia Esomeprazole Sandoz 20 mg zarnās šķīstošās cietās kapsulas
Esomeprazole Sandoz 40 mg zarnās šķīstošās cietās kapsulas
Netherlands Esomeprazol Sandoz 20 mg, harde maagsapresistente capsules
Esomeprazol Sandoz 40 mg, harde maagsapresistente capsules
Portugal Esomeprazol Sandoz
Slovenia Esomeprazol Sandoz 20 mg gastrorezistentne trde kapsule
Esomeprazol Sandoz 40 mg gastrorezistentne trde kapsule

The following information is intended exclusively for physicians or healthcare professionals

Administration via gastric tube

Add the contents of the capsule to approximately 25 ml or 50 ml of water. (For certain tubes, dispersion in 50 ml of water is required to prevent granules from blocking the tube.) Mix.
Draw the suspension into a syringe and add approximately 5 ml of air.
Immediately shake the syringe vigorously for about 2 minutes to disperse the granules in the suspension.
Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
Connect the syringe to the tube while maintaining the above position.
Shake the syringe and reposition it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be held with the tip pointing upwards to prevent blockage of the tip).
Turn the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with 25 ml of water and 5 ml of air, and repeat step 6 if necessary to remove any remaining residue from the syringe. For certain tubes, 50 ml of water may be required. Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.