ESOMEPRAZOLO 20 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Esomeprazolo Sandoz GmbH 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules
   1. What Esomeprazolo Sandoz GmbH is and what it is used for
   2. What you need to know before you take Esomeprazolo Sandoz GmbH
   3. How to take Esomeprazolo Sandoz GmbH
   4. Possible side effects
   5. How to store Esomeprazolo Sandoz GmbH
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Esomeprazolo Sandoz GmbH is and what it is used for
• 2. What you need to know before you take Esomeprazolo Sandoz GmbH
• 3. How to take Esomeprazolo Sandoz GmbH
• 4. Possible side effects
• 5. How to store Esomeprazolo Sandoz GmbH
• 6. 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 called “proton pump inhibitors”. These medicines work by reducing
the amount of acid produced by your stomach.
Esomeprazolo Sandoz GmbH is used for the treatment of the following conditions:
Adults

• Gastroesophageal reflux disease (GERD). In this disease, acid rises from the stomach into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and burning.
• Stomach or upper digestive tract (intestine) ulcers that are infected with bacteria called " Helicobacter pylori". If you have this condition, your doctor may also prescribe you 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 prevent stomach ulcers from forming if you are taking NSAIDs.
• Excess acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). Prolonged treatment of bleeding ulcers after prevention with intravenous esomeprazole. Adolescents over the age of 12 years
• Gastroesophageal reflux disease (GERD). In this disease, acid rises from the stomach into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and burning.
• Stomach or upper digestive tract (intestine) ulcers that are infected with bacteria called " Helicobacter pylori". If you have this condition, your doctor may also prescribe you antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Esomeprazolo Sandoz GmbH

Do not take Esomeprazolo 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 medicines that reduce stomach acid production (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Esomeprazolo Sandoz GmbH if any of these apply to you. If you are unsure,
ask your doctor or pharmacist before taking Esomeprazolo Sandoz GmbH.

Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazolo 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 Esomeprazolo Sandoz GmbH that reduces stomach acid.
• if you are going to have a specific blood test (Chromogranin A)

Esomeprazolo Sandoz GmbH can mask the symptoms of other diseases. Therefore, if any of the following occur before taking Esomeprazolo Sandoz GmbH or while you are
taking it, tell your doctor immediately:

• if you lose a lot of weight without a reason and have difficulty swallowing
• if you have stomach pain or indigestion
• if you start vomiting food or blood
• if your stools are black (blood in the stools).

If you have been prescribed Esomeprazolo Sandoz GmbH ‘as needed’ you should contact your doctor if the
symptoms persist or change in nature.
If you have been prescribed a proton pump inhibitor like Esomeprazolo Sandoz GmbH,
especially 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 can increase the risk of osteoporosis) consult your doctor.

Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as you may need to stop treatment with Esomeprazolo
Sandoz GmbH. Also remember to report any other undesirable effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also
section 4). The rash may include ulcers of the mouth, throat, nose, genitals
and conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, muscle pain. The rash may cover large areas
of the body with blisters and peeling skin.
If at any time during treatment (even after several weeks) a rash or any of these skin symptoms develop, stop taking this medicine and
contact your doctor immediately.

Other medicines and Esomeprazolo Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines you buy without a prescription. This is because
Esomeprazolo Sandoz GmbH can affect the way other medicines work and other
medicines can have effects on Esomeprazolo Sandoz GmbH.
Do not take Esomeprazolo Sandoz GmbH 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:

• Atanazavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used in the treatment of 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 you start or stop treatment with Esomeprazolo Sandoz GmbH.
• Medicines used to make the blood thinner, such as warfarin. Your doctor may need to monitor you when you start or stop treatment with Esomeprazolo Sandoz GmbH.
• Cilostazol (used to treat intermittent claudication - a pain in the legs when walking that is caused by insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Tacrolimus (organ transplant).
• Methotrexate (a chemotherapy medicine used at high doses) - if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazolo Sandoz GmbH.
• Rifampicin (used to treat tuberculosis)
• St John's Wort (Hypericum perforatum)(used to treat depression)

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Esomeprazolo
Sandoz GmbH to treat ulcers caused by infection with Helicobacter pylori, it is very important
that you tell your doctor if you are taking any other medicines.

Esomeprazolo Sandoz GmbH with food and drink
You can take the capsules with food or on an empty stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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 if you can take
Esomeprazolo Sandoz GmbH during this period. It is not known whether Esomeprazolo Sandoz GmbH
passes into breast milk. Therefore, you should not take Esomeprazolo Sandoz GmbH if you are breastfeeding with
breast milk.

Driving and operating machinery
It is unlikely that this medicine will affect your ability to drive or operate tools or
machinery. However, undesirable effects such as dizziness and blurred vision may occur uncommonly
or rarely (see section 4). If these occur, do not drive or use machines.

Esomeprazolo Sandoz GmbH contains sucrose
Esomeprazolo Sandoz GmbH contains sugar spheres that contain sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking
this medicine.

Esomeprazolo 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 Esomeprazolo Sandoz GmbH

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

• If you are taking this medicine for a long time, your doctor will monitor you (in

particular if you are taking it for more than one year).

• If your doctor has told you to take this medicine when needed, as required, inform your doctor if the symptoms of the disease change.

How much Esomeprazolo 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 provided below.

Adults over 18 years of age
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed that your esophagus has been slightly damaged, the recommended dose is one Esomeprazolo Sandoz GmbH 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the esophagus has not yet healed.
• The recommended dose to take once your esophagus has healed is one Esomeprazolo Sandoz GmbH 20 mg capsule once a day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazolo Sandoz GmbH 20 mg capsule per day. Once the condition is under control, your doctor will inform you that you can take the medicine when needed, up to a maximum of one Esomeprazolo Sandoz GmbH 20 mg capsule per day.
• If you have serious liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused byHelicobacter pyloriinfection and prevention of their
recurrence or:

• The recommended dose is one Esomeprazolo Sandoz GmbH 20 mg capsule twice a day 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 Esomeprazolo Sandoz GmbH 20 mg capsule once a day 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 Esomeprazolo Sandoz GmbH 20 mg capsule once a day.

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

• The recommended dose is one Esomeprazolo Sandoz GmbH 40 mg capsule twice a day.
• 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 a day.

Prolonged treatment of re-bleeding ulcers, after prevention with esomeprazole intravenously.

• The recommended dose is one Esomeprazolo Sandoz GmbH 40 mg capsule once a day for 4 weeks.

Adolescents over 12 years of age
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed that your esophagus has been slightly damaged, the recommended dose is one Esomeprazolo Sandoz GmbH 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the esophagus has not yet healed.
• The recommended dose to take once your esophagus has healed is one Esomeprazolo Sandoz GmbH 20 mg capsule once a day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazolo Sandoz GmbH 20 mg capsule per day.
• If you have serious liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused byHelicobacter pyloriinfection and to prevent them
from returning:

• The recommended dose is one Esomeprazolo Sandoz GmbH 20 mg capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

How to take this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Take the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain granules with a coating that prevents your medicine from being inactivated by stomach acids. 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 and empty the granules into a glass of plain water (non-carbonated). Do not use other liquids.
• 2) Mix. Drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking.
• 3) To make sure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. 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 inserted into a syringe. In this way, it can be administered to you directly into the stomach ('gastric tube').

Use in children under 12 years of age
Esomeprazolo Sandoz GmbH is not recommended in children under 12 years of age.

Elderly
No dose adjustment is required in the elderly.

If you take more Esomeprazolo Sandoz GmbH than you should
If you take more Esomeprazolo Sandoz GmbH than prescribed by your doctor, talk
immediately to your doctor or pharmacist.

If you forget to take Esomeprazolo Sandoz GmbH

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed 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 shortness of breath, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Yellowing of the skin, dark urine and fatigue, which can be symptoms of liver problems.

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

• The sudden onset of a severe skin rash or reddening of the skin with blisters or peeling can occur even after several weeks of treatment. Severe blisters and bleeding may also occur on the lips, eyes, mouth, nose and genitals. The rashes may develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis" or "drug reaction with eosinophilia and systemic symptoms". These 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.
• Effects on stomach or intestines: diarrhea, stomach pain, constipation, flatulence (gas).
• Feeling unwell (nausea) or sick (vomiting).
• Benign polyps in the stomach.

Not common (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling sensations like “pins and needles”, drowsiness.
• Feeling of spinning (vertigo).
• Dry mouth.
• Changes in the values of blood tests used to check 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 period).

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

• Blood problems, such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling agitated, confused or depressed.
• Altered taste.
• Vision problems such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the esophagus and is caused by a fungus.
• Liver problems, including jaundice which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash following exposure to the sun.
• 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 (deficiency of white blood cells).
• Aggressiveness.
• 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 skin rash or blisters or peeling of the skin. 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, it is possible that your blood magnesium levels may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. Your doctor may decide to check your blood magnesium levels periodically.
• Inflammation of the intestine (causing diarrhea).
• Skin rash with possible joint pain.

Esomeprazolo Sandoz GmbH can very rarely affect white blood cells causing an
immunodeficiency. 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 sore throat, sore throat or mouth, or
difficulty urinating, you should consult a doctor as soon as possible so that a
deficiency 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 the medicines you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Esomeprazolo Sandoz GmbH

• 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 blister, bottle or the carton after “Exp.”. The expiry date refers to the last day of that month.
• Blister:Do not store at a temperature above 30 °C. Store in the original package to protect the medicine from moisture.
• Bottle:Do not store at a temperature above 30 °C. Store in the original package 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 in 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 ingredient is esomeprazole. Esomeprazolo Sandoz GmbH is available in two dosages containing 20 mg or 40 mg of esomeprazole (as sodium salt).
• The other ingredients are:

Capsule content
Sugar spheres (containing sucrose and corn starch), methyl cellulose, talc, titanium
dioxide (E171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, acrylic acid
methacrylic-ethyl acrylate copolymer, triethyl citrate.
Capsule shell:
Carrageenan, potassium chloride, red iron oxide (E172), titanium dioxide (E171), hypromellose,
printing ink (containing shellac, potassium hydroxide and black iron oxide (E172)).

Description of the appearance of Esomeprazolo Sandoz GmbH and package contents

• Esomeprazolo Sandoz GmbH 20 mg hard capsules have an opaque light pink 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 an opaque pink 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
Aluminum/aluminum blisters:
7, 14, 15, 28, 30, 56, 60, 90 (2x45), 98 (2x49) and 100 (2x50) capsules
Opaque white polyethylene bottle, containing a desiccant (silica gel) in sachets and a
polyethylene (PE) cap with a tamper-evident seal:
7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100 and 500 capsules
Esomeprazolo Sandoz GmbH 40 mg is available in
Aluminum/aluminum blisters:
7, 14, 15, 28, 30, 56, 60, 90 (2x45) and 100 (2x50) capsules
Opaque white polyethylene bottle, containing a desiccant (silica gel) in sachets and a
polyethylene (PE) cap with a tamper-evident seal:
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
Representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milano
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 authorised in the Member States of the European Economic Area under the
following denominations:
Croatia Naxesy 20 mg hard gastro-resistant capsules
Naxesy 40 mg hard gastro-resistant capsules
Estonia Esomeprazole Sandoz
France ESOMEPRAZOLE SANDOZ, 20 mg, gastro-resistant capsule
ESOMEPRAZOLE SANDOZ, 40 mg, gastro-resistant capsule
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, hard maagsapresistente capsules
Esomeprazol Sandoz 40 mg, hard 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 only for doctors or healthcare professionals
Administration via gastric tube

• 1. Add the contents of the capsule to approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml of water is necessary to prevent the granules from blocking the tube). Mix
• 2. Aspirate the suspension into a syringe and add approximately 5 ml of air.
• 3. Immediately shake the syringe for about 2 minutes to disperse the granules in the suspension.
• 4. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
• 5. Connect the syringe to the tube, maintaining the above position.
• 6. Shake the syringe and position it with the tip downwards. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip upwards to prevent blockage of the tip).
• 7. Turn the syringe with the tip downwards and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is emptied.
• 8. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to remove any sediment remaining in the syringe. For some tubes, 50 ml of water is required. Any unused medicine and waste materials derived from such medicine should be disposed of in accordance with local regulations