20 mg, 40 mg enteric capsule, hard 
esomeprazole

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Esomeprazole Krka is and what it is used for 
2. What you need to know before you use Esomeprazole Krka 
3. How to use Esomeprazole Krka 
4. Possible side effects 
5. How to store Esomeprazole Krka 
6. Contents of the pack and other information 

What Esomeprazole Krka is and what it is used for

Esomeprazole Krka contains a drug called esomeprazole magnesium dihydrate. It belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid produced in the stomach.

Esomeprazole Krka is used to treat the following conditions:

Adults

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation, and heartburn.
  • Ulcers in the stomach or upper intestine are infected by a bacterium called ” Helicobacter pylori “. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
  • A gastric ulcer is caused by so-called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole Krka can also be used to prevent stomach ulcers when taking NSAIDs.
  • Too much acid in the stomach is caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
  • Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole.

Young people from 12 years

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation, and heartburn
  • Ulcers in the stomach or upper intestine are infected by a bacterium called ” Helicobacter pylori”. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.

Esomeprazole contained in Esomeprazole Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional and always follow their instructions.

What you need to know before using Esomeprazole Krka

Do not use Esomeprazole Krka

  • 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 inhibitors (eg pantoprazole, lansoprazole, rabeprazole, omeprazole)
  • if you are taking a medicine containing nelfinavir (used to treat HIV – infection )

Do not take Esomeprazole Krka if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole Krka.

Warnings and cautions

Talk to your doctor or pharmacist before taking Esomeprazole Krka if:

  • you have severe liver problems
  • you have severe kidney problems
  • you are deficient in vitamin B12
  • you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Krka that reduces stomach acid.
  • you should undergo a specific blood test (chromogranin A).

If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Esomeprazole Krka. Also remember to mention any other side effects, such as joint pain.

Esomeprazole Krka can mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Esomeprazole Krka or while you are taking it, contact your doctor immediately :

  • you lose a lot of weight for no reason and have trouble swallowing
  • you get stomach pains or indigestion
  • you start vomiting food or blood
  • you get black stools (blood-mixed stools)

If you have been prescribed Esomeprazole Krka take “as needed”, contact your doctor if your symptoms persist or change in nature.

Using proton pump inhibitors such as Esomeprazole Krka, and especially if you use Esomeprazole Krka for more than a year, may slightly increase the risk of hip, wrist, or vertebral fracture. Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.

Other medicines and Esomeprazole Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Esomeprazole Krka can affect the way other medicines work and other medicines can affect the effect of Esomeprazole Krka.

Do not take Esomeprazole Krka if you are also taking a medicine that contains nelfinavir (for the treatment of HIV ).

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • atazanavir (for the treatment of HIV – infection )
  • digoxin (used to treat heart problems)
  • 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, for muscle relaxation, or epilepsy )
  • phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor will need to monitor you when you start or stop using Esomeprazole Krka.
  • drugs used for blood thinning, such as warfarin. Your doctor may need to monitor your condition when you start or stop taking Esomeprazole Krka.
  • cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs)
  • cisapride (used for digestive problems or heartburn)
  • methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you are taking high doses of methotrexate your doctor may temporarily stop your treatment with Esomeprazole Krka
  • clopidogrel (used to prevent blood clots)
  • tacrolimus (organ transplant)
  • rifampicin (used to treat tuberculosis )
  • St. John’s wort ( Hypericum perforatum ) (used to treat depression)

If your doctor has prescribed antibiotics amoxicillin and clarithromycin, coupled with Esomeprazole Krka to treat ulcers caused by Helicobacter pylori – infection, you must tell your doctor if you are also taking other medicines.

Esomeprazole Krka with food, drink, and alcohol

You can take your capsules with a meal or on an empty stomach.

Pregnancy, breastfeeding, 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 if you can take Esomeprazole Krka during that time.

It is not known if Esomeprazole Krka passes into breast milk. Therefore, you should not take Esomeprazole Krka if you are breast-feeding.

Driving and using machines

Esomeprazole Krka is unlikely to affect your ability to drive or handle tools or machines. However, side effects such as dizziness and visual disturbances may occur in less common cases (see section 4). If you are affected, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Esomeprazole Krka contains excipients

Esomeprazole Krka enteric capsules contain sugar spheres, which contain sucrose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Esomeprazole Krka

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • If you have been using Esomeprazole Krka capsules for a long time, your doctor will need to monitor your treatment (especially if you are taking the medicine for more than a year).
  • If you have been told by your doctor that you must take this medicine, tell your doctor if your symptoms change.

How much to take

  • Your doctor will tell you how many capsules to take and how long to take them. The treatment time depends on your condition, how old you are, and how well your liver is working.
  • The recommended doses are given below.

Adults from 18 years

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD )

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is an Esomeprazole Krka 40 mg enteric capsule once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed.
  • The recommended dose one after the esophagus is healed is an Esomeprazole Krka 20 mg enteric capsule once daily.
  • If your esophagus is not damaged, the recommended dose is an Esomeprazole Krka 20 mg enteric capsule once daily. When your condition is under control, your doctor may recommend that you take the medicine up to a maximum of one Esomeprazole Krka 20 mg enteric capsule once a day if necessary.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose.

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:

  • The recommended dose is an Esomeprazole Krka 20 mg enteric capsule twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin

For the treatment of stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

  • The recommended dose is an Esomeprazole Krka 20 mg enteric capsule once daily for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs:

  • The recommended dose is an Esomeprazole Krka 20 mg enteric capsule once daily.

For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger

Ellison syndrome):

  • The recommended dose is Esomeprazole Krka 40 mg 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.

Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole:  

  • The recommended dose is an Esomeprazole Krka 40 mg enteric capsule once daily for 4 weeks.

Young people from 12 years

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is an Esomeprazole Krka 40 mg enteric capsule once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed.
  • The recommended dose one after the esophagus is healed is an Esomeprazole Krka 20 mg enteric capsule once daily.
  • If your esophagus is not damaged, the recommended dose is an Esomeprazole Krka 20 mg enteric capsule once daily.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:

  • The recommended dose is an Esomeprazole Krka 20 mg enteric capsule twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin.

Taking the medicine

  • You can take the capsules at any time of the day.
  • You can take the capsules with a meal or on an empty stomach.
  • The capsules should be swallowed whole with water. Do not chew or crush the capsules. This is because the capsules contain coated granules that prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What you can do if you have difficulty swallowing the capsules

  • If you have problems swallowing the capsules:
    • Open the capsule and empty the granules into half a glass (not carbonated) water. Do not use other liquids.
    • Drink mixture immediately or within 30 minutes. Always stir the mixture just before drinking it.
    • To make sure you have ingested all the medicine, rinse the glass thoroughly with another half glass of water and drink it up. The solid particles contain the medicine – do not chew or crush them.
  • If you can not swallow at all, the granules can be mixed with a little water and placed in a syringe. Mixture one can then be given directly into the stomach via a gastric tube.

Children under 12 years

Esomeprazole Krka is not recommended for children under 12 years of age.

Older

Dose adjustment is not necessary for elderly patients.

If you use more Esomeprazole Krka then you should  

If you take more Esomeprazole Krka than your doctor tells you to, contact your doctor or pharmacist immediately.

If you have ingested too much medicine or if e.g. if a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice

If you forget to use Esomeprazole Krka

  • If you forget to take a dose , take it as soon as you notice. If it is almost time to take the 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 product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Esomeprazole Krka and contact your doctor immediately, if you notice any of the following serious side effects:

  • Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction ).
  • Redness of the skin with blistering or flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose and genitals may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis .
  • Yellow skin, dark urine and fatigue, which can be symptoms of liver problems.

These side effects are rare and may affect less than 1 in 1,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people):

  • headache
  • effects on the stomach or intestines: diarrhea, abdominal pain, constipation, flatulence
  • nausea or vomiting
  • benign polyps in the stomach

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

  • swelling of the feet and ankles
  • sleep disorders (insomnia)
  • dizziness, tingling, drowsiness
  • dizziness
  • dry mouth
  • changes in the blood picture that show the function of the liver.
  • skin rash, hives and itching
  • hip, wrist or vertebral fractures (if Esomeprazole Krka is used in high doses and for a long time)

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

  • altered blood count such as decreased white blood cell or platelet count . This may cause weakness, bruising or increase susceptibility to infection.
  • low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
  • feeling of upset, confusion or depression
  • taste changes
  • vision problems, e.g. dimsyn
  • sudden wheezing or shortness of breath ( bronchospasm )
  • inflammation of the oral cavity
  • a fungal infection called cod that can affect the gut
  • liver problems including jaundice, which can cause yellow skin, dark urine and fatigue
  • hair loss ( alopecia )
  • skin rash after exposure to the sun
  • joint pain ( arthralgia ) or muscle pain ( myalgia )
  • general malaise and weakness
  • increased sweating

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

  • changes in the blood picture (pancytopenia) including agranulocytosis (lack of white blood cells )
  • aggressiveness
  • hallucinations (see, feel or hear non-existent things)
  • severe liver problems leading to liver failure and encephalitis
  • sudden onset of severe rash, blistering or flaky skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis ).
  • muscle weakness
  • severe kidney problems
  • enlargement of the mammary glands in men

Has been reported (occurs in an unknown number of users):

  • if you use Esomeprazole Krka for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
  • inflammation of the intestine (causes diarrhea)
  • skin rash, possibly with joint pain

Esomeprazole Krka can in very rare cases affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever and severe general malaise or fever with symptoms of local infection such as pain in the throat, throat or mouth or difficulty urinating, you must contact a doctor as soon as possible so that any lack of white blood cells ( agranulocytosis ) can excluded by a blood test. It is important that you then inform

your doctor about your medication.

5. How to store Esomeprazole Krka

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. The expiration date is the last day of the specified month.

Blister pack consisting of OPA / Alu / PE + DES film / Alu foil

No special temperature instructions.

Store in the original package. Moisture sensitive.

Blister pack consisting of OPA / Alu / PVC / Al foil

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

HDPE Jar

No special temperature instructions.

Close the jar tightly. Moisture sensitive.

The drug should be used within 6 months of first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is esomeprazole. Each enteric capsule contains 20 mg or 40 mg of esomeprazole (in the form of esomeprazole magnesium dihydrate)
  • The other ingredients are sugar spheres (sucrose and maize starch), povidone, sodium lauryl sulphate, poly (vinyl alcohol), titanium dioxide (E171), macrogol 6000, macrogol 3000, talc (E553b), heavy magnesium subcarbonate, polysorbate 80 (Elacrylate) 1), dispersion 30% in the granules in the capsule and gelatin (E441), titanium dioxide (E171) red iron oxide (E172) in the capsule shell.

Pack sizes

The capsules are available in pack sizes of 7, 10, 14, 15, 28, 30, 50, 50×1, 56, 60, 90, 98 and 100 capsules in blister packs and 98 capsules with desiccant capsule in HDPE jar.

The desiccant capsule contained in the jar must not be eaten.

Not all pack sizes may be marketed.

What the medicine looks like and contents of the pack

20 mg: the top and bottom of the capsule are pale pink. The capsules contain white to almost white granules. Capsule size: no. 3.

40 mg: the top and bottom of the capsule are pink. The capsules contain white to almost white granules. Capsule size: no. 1.

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Str.5, 27472 Cuxhaven, Germany

Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia

Muhammad Nadeem

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