Esomeprazole Krka

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole Krka 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Esomeprazole
Equivalent medicine
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. What Esomeprazole Krka is and what it is used for

Esomeprazole Krka contains a medicine called esomeprazole magnesium dihydrate, which belongs
to a group of medicines called "proton pump inhibitors". These medicines work
by reducing the amount of acid produced by your stomach.
Esomeprazole Krka is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). In this condition, acid flows from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach or upper digestive tract (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). Esomeprazole Krka can also be used to prevent stomach ulcers from developing if you are taking NSAIDs.
• Excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of re-bleeding from ulcers with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). In this condition, acid flows from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach or upper digestive tract (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.

2. What you need to know before taking Esomeprazole Krka

Do not take Esomeprazole Krka

• if you are allergic to esomeprazole or to any of the excipients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV). Do not take Esomeprazole Krka if any of these situations apply to you. If you are in any doubt, speak with your doctor or pharmacist before taking Esomeprazole Krka.

Warnings and precautions
Check with your doctor or pharmacist before taking Esomeprazole Krka:

• if you have severe liver problems,
• if you have severe kidney problems,
• if you have vitamin B12 deficiency,
• if you have had an allergic reaction after treatment with a medicine similar to Esomeprazole Krka that reduces stomach acidity.

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Esomeprazole Krka may need to be stopped. Remember to also report any other side effects, such as joint pain.
Esomeprazole Krka may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking Esomeprazole Krka, 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 Krka has been prescribed “on request”, you should contact your doctor if symptoms persist or change in nature.

If you take a proton pump inhibitor such as Esomeprazole Krka, especially for more 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 Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Esomeprazole Krka may affect how other medicines work, and other medicines may affect Esomeprazole Krka.
Do not take Esomeprazole Krka capsules if you are taking a medicine containing nelfinavir (used to treat HIV).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat 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, 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 Krka.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with Esomeprazole Krka.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
• Cisapride (used for indigestion and heartburn).
• Methotrexate (a chemotherapy drug used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with Esomeprazole Krka.
• Clopidogrel (used to prevent blood clots (thrombi)).
• Tacrolimus (used in organ transplantation).
• 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 Krka to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.
Esomeprazole Krka with food and drink
You may take the capsules with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant, think you might 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 Krka during this time.
It is not known whether Esomeprazole Krka passes into breast milk. Therefore, you must not take Esomeprazole Krka if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazole Krka will affect your ability to drive or use tools or machinery. However, side effects such as dizziness and blurred vision are uncommon or rare (see section 4). If you are affected, do not drive or use machinery.
Esomeprazole Krka contains sucrose
Esomeprazole Krka contains sugar spheres that contain sucrose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Esomeprazole Krka

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 (particularly if you have been taking it for more than one year).
• If your doctor has told you to take this medicine as and when needed, inform your doctor if your symptoms change.

How much 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 your liver function.
• The recommended doses are given below.

Adults aged 18 years and older
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has diagnosed that your food pipe (oesophagus) has been mildly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Krka 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 once your oesophagus has healed is one gastro-resistant capsule of Esomeprazole Krka 20 mg once daily.
• If your oesophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Krka 20 mg daily. Once your condition is under control, your doctor may instruct you to take the medicine as and when needed, up to a maximum dose of one gastro-resistant capsule of Esomeprazole Krka 20 mg daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent them from returning:

• The recommended dose is one gastro-resistant capsule of Esomeprazole Krka 20 mg twice daily for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

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

• The recommended dose is one gastro-resistant capsule of Esomeprazole Krka 20 mg once daily for 4–8 weeks.

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

• The recommended dose is one gastro-resistant capsule of Esomeprazole Krka 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 gastro-resistant capsule of Esomeprazole Krka 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 following prevention of re-bleeding of ulcers with intravenous esomeprazole:

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

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

• If your doctor has diagnosed that your food pipe (oesophagus) has been mildly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Krka 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 once your oesophagus has healed is one gastro-resistant capsule of Esomeprazole Krka 20 mg once daily.
• If your oesophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Krka 20 mg daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent them from returning:

• The recommended dose is one gastro-resistant capsule of Esomeprazole Krka 20 mg twice daily for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

How to take this medicine

• You may take your capsules at any time of day.
• You may 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. This is because the capsules contain 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:
• Open the capsule and empty the granules into half a glass of still (non-carbonated) water. Do not use any other liquids.
• Drink the mixture immediately or within 30 minutes. Always stir the mixture 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 unable to swallow anything, the granules can be mixed with a small amount of water and administered via a syringe. They can then be delivered through a tube directly into the stomach (‘gastric tube’).

Children under 12 years of age
Esomeprazole Krka is not recommended for children under 12 years of age.
Elderly Dose adjustment is not required in the elderly.
If you take more Esomeprazole Krka than you should
If you take more Esomeprazole Krka than prescribed by your doctor, speak to your doctor or pharmacist immediately.
If you forget to take Esomeprazole Krka

• 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 (two doses at the same time) to make up for a forgotten dose.

If you have 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 treatment with Esomeprazole Krka and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering and peeling. There may be severe blistering and bleeding on the lips, eyes, mouth, nose and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine and tiredness, which may be symptoms of liver problems.

These side effects are rare and may 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 effects: diarrhoea, stomach pain, constipation, flatulence (wind)
• Feeling unwell (nausea) or being unwell (vomiting)

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

• Swelling of the feet and ankles
• Sleep disorders (insomnia)
• Dizziness, tingling sensations such as “pins and needles”, drowsiness
• Vertigo
• Dry mouth
• Changes in blood test results used to monitor liver function
• Skin rash, urticaria and itchy skin
• Fracture of the hip, wrist, or spine (if Esomeprazole Krka is used at high doses and for a long duration).

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

• Blood disorders, such as reduced 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 feeling of breathlessness or shortness of breath (bronchospasm)
• Inflammation inside the mouth
• A fungal infection called “thrush” that may affect the oesophagus.
• Liver problems, including jaundice which may cause yellowing of the skin, dark urine and tiredness.
• Hair loss (alopecia)
• Skin rash 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 (pancytopenia), including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling or hearing things that do not exist (hallucinations)
• Severe liver problems leading to liver failure and brain inflammation
• Sudden onset of severe rash, blistering or peeling of the skin. 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 Krka for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, 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 should decide whether to monitor your blood magnesium levels periodically.
• Inflammation in the intestine (resulting in diarrhoea).
• Skin rash, possible joint pain. Esomeprazole Krka may, in very rare cases, affect white blood cells causing immunodeficiency. If you develop 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 consult your doctor as soon as possible so that a deficiency in 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 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 Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of the month.

Blister pack made of OPA/Al/PE + DES film/aluminium foil
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from moisture.

Blister pack made of OPA/Al/PVC and aluminium foil
Store below 30°C.
Store in the original packaging to protect from moisture.

HDPE bottle
This medicine does not require any special storage conditions.
Keep the bottle tightly closed to protect the medicine from moisture.
After first opening the bottle, the medicine should be used within 6 months.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Esomeprazole Krka contains

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The excipients are sugar spheres (sucrose and maize starch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol 6000, macrogol 3000, talc (E553b), heavy magnesium carbonate, polysorbate 80 (E433), and methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent in the capsule granules; and gelatin (E441), titanium dioxide (E171) and red iron oxide (E172) in the capsule coating. See section 2 "Esomeprazole Krka contains sucrose".

Description of the appearance of Esomeprazole Krka and package contents
The body and cap of the 20 mg gastro-resistant hard capsules are light pink in colour. The capsules contain white to off-white granules. Capsule size: No. 3.
The body and cap of the 40 mg gastro-resistant hard capsules are pink in colour. The capsules contain white to off-white granules. Capsule size: No. 1.
The capsules are available in boxes of 7, 10, 14, 15, 28, 30, 50, 50 x 1, 56, 60, 90, 98 and 100 capsules in blisters, and in boxes of 98 capsules with one desiccant capsule in an HDPE container. Do not swallow the desiccant capsule provided in the container.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano (IT)

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto (site Locna), Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:

The following information is intended for healthcare professionals only:

Administration via gastric tube:

1. Open the capsule and empty the granules into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water is required to prevent the granules from blocking the tube.
2. Immediately shake the syringe to evenly distribute the granules throughout the suspension.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Attach the syringe to the tube while maintaining the above position.
5. Shake the syringe and position 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).
6. 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.
7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to wash out any remaining sediment from the syringe. For some tubes, 50 ml of water may be required.