Emanera

Leaflet accompanying the packaging: patient information

Emanera, 20 mg, gastro-resistant hard capsules

Emanera, 40 mg, gastro-resistant hard capsules

Esomeprazole

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Emanera and what is it used for
• 2. Important information before taking Emanera
• 3. How to take Emanera
• 4. Possible side effects
• 5. How to store Emanera
• 6. Contents of the packaging and other information

1. What is Emanera and what is it used for

Emanera contains the active substance ezomeprazole, which belongs to a group of medicines called "proton pump inhibitors". The action of these medicines is to reduce the amount of acid produced by the stomach.
Emanera is indicated for use in:
Adults

• Gastroesophageal reflux disease (GERD). This disease involves the reflux of acidic stomach contents into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. Emanera is prescribed to:
  
• heal the esophagus if it has been damaged or if it has become inflamed,
• prevent relapses of such conditions,
• eliminate unpleasant symptoms that often occur with such conditions.
• Stomach and duodenal ulcers with Helicobacter pylori infection. In the case of these conditions, the doctor may prescribe Emanera in combination with antibiotics to:
  
• heal duodenal ulcers associated with Helicobacter pylori infection,
• prevent relapses of peptic ulcer disease caused by this bacterium.
• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Emanera is prescribed to:
  
• heal stomach ulcers caused by NSAIDs,
• prevent the formation of ulcers during NSAID therapy.
• Prolonged treatment after preventing rebleeding from ulcers using intravenous ezomeprazole.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

Adolescents aged 12 and over

• Gastroesophageal reflux disease (GERD). This disease involves the reflux of acidic stomach contents into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach and duodenal ulcers with Helicobacter pylori infection. In the case of these conditions, the doctor may prescribe Emanera in combination with antibiotics to heal ulcers associated with Helicobacter pylori infection.

2. Important information before taking Emanera

When not to take Emanera:

Do not take Emanera if any of the above situations apply to you.
In case of doubts, consult a doctor or pharmacist before taking Emanera.

Warnings and precautions

Before taking Emanera, consult a doctor or pharmacist if:

• you have severe liver disease,
• you have severe kidney disease,
• you have a vitamin B12 deficiency,
• you have ever had a skin reaction after taking a medicine similar to Emanera that reduces stomach acid.
• a specific blood test (chromogranin A level) is planned.

Rash and skin symptoms

If a skin rash appears, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Emanera. Also, tell your doctor about any other side effects, such as joint pain.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with Emanera. The patient should stop taking Emanera and consult a doctor immediately if they notice any of the symptoms associated with these severe skin reactions described in section 4.
Emanera may mask the symptoms of other diseases. Therefore, you should immediately inform your doctor about the following symptoms that occur before or during treatment with Emanera:

Emanera:

• significant, unintended weight loss and difficulty swallowing,
• abdominal pain or indigestion,
• vomiting food or blood,
• black stools (with blood). If you are taking Emanera on demand, you should consult a doctor if the symptoms do not disappear or change.

When taking proton pump inhibitors like Emanera, especially for a period longer than one year, the risk of bone fractures in the hip, wrist, or spine may increase slightly. You should inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Children and adolescents under 12 years of age

Emanera is not recommended for children under 12 years of age.

Emanera and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. This includes medicines bought without a prescription.
Emanera may interact with some other medicines, and some other medicines may affect the action of Emanera.
Do not take Emanera at the same time as the following medicine:

• nelfinavir (a medicine used to treat HIV infections).

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

• atazanavir (a medicine used to treat HIV infections),
• ketokonazole, itraconazole, or voriconazole (medicines used to treat fungal infections),
• digoxin (a medicine used to treat heart rhythm disorders),
• erlotinib (a medicine used to treat cancer),
• citalopram, imipramine, or clomipramine (medicines used to treat depression),
• diazepam (a medicine used to treat anxiety, as a muscle relaxant, or to treat epilepsy),
• phenytoin (a medicine used to treat epilepsy) - if you are taking phenytoin, you should be monitored by your doctor when starting or stopping treatment with Emanera,
• blood-thinning medicines such as warfarin - you may be monitored by your doctor when starting or stopping treatment with Emanera,
• cilostazol (a medicine used to treat intermittent claudication - pain in the legs when walking due to poor blood circulation),
• cisapride (a medicine used to treat indigestion and heartburn),
• methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may advise you to temporarily stop taking Emanera,
• clopidogrel (an antiplatelet medicine),
• tacrolimus (a medicine used after organ transplantation),
• rifampicin (a medicine used to treat tuberculosis),
• St. John's Wort (Hypericum perforatum) (a medicine used to treat depression).

If you are taking amoxicillin and clarithromycin and Emanera to treat ulcers caused by Helicobacter pylori infection, it is very important to tell your doctor about all other medicines you are taking.

Emanera with food and drink

Emanera can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 whether you can take Emanera.
There is no information on the passage of Emanera into breast milk, so you should not take Emanera while breastfeeding.

Driving and using machines

It is unlikely that Emanera will affect your ability to drive or use machines. However, dizziness and blurred vision (see section 4) may occur rarely. If they do, do not drive or use machines.

Emanera contains sugar and sodium

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Emanera

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

• In case of long-term use (especially for more than a year), medical supervision may be necessary.
• If your doctor has advised you to take the medicine on demand, you should inform them about any changes in your symptoms.

Dosage

• Your doctor will decide on the dose and duration of treatment. The dose depends on your condition, age, and liver function.
• The recommended doses are given below.

Adults aged 18 and over

Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• In patients with mild esophageal damage, the recommended dose is 40 mg of Emanera once daily for 4 weeks. If the esophagus has not healed, the doctor may prescribe the same dose for another 4 weeks.
• The recommended dose after healing the esophagus is 20 mg of Emanera once daily.
• If the esophagus was not damaged, the recommended dose of Emanera is 20 mg once daily. After symptoms have been controlled, the doctor may prescribe the medicine on demand in a dose of up to 20 mg once daily.
• In case of severe liver disease, the doctor may prescribe a lower dose of Emanera.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of relapses:

• The recommended dose is 20 mg of Emanera twice daily for one week.
• The doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Treatment of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg of Emanera once daily for 4 to 8 weeks.

Prevention of stomach ulcers during NSAID therapy:

• The recommended dose is 20 mg of Emanera once daily.

Prolonged treatment after preventing rebleeding from ulcers using intravenous ezomeprazole:

• The recommended dose is 40 mg of Emanera once daily for 4 weeks.

Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of Emanera twice daily.
• The doctor will adjust the dose according to the patient's needs and decide on the duration of treatment. The maximum dose of Emanera is 80 mg twice daily.

Adolescents aged 12 and over

Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• In patients with mild esophageal damage, the recommended dose is 40 mg of Emanera once daily for 4 weeks. If the esophagus has not healed, the doctor may prescribe the same dose for another 4 weeks.
• The recommended dose after healing the esophagus is 20 mg of Emanera once daily.
• If the esophagus was not damaged, the recommended dose of Emanera is 20 mg once daily.
• In case of severe liver disease, the doctor may prescribe a lower dose of Emanera.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of relapses:

• The recommended dose is 20 mg of Emanera twice daily for one week.
• The doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Taking Emanera

• Emanera can be taken at any time of the day.
• Emanera can be taken with or without food.
• The capsules should be swallowed whole with water. The capsules should not be chewed or crushed, as they contain pellets coated with a protective layer that prevents them from coming into contact with stomach acid. It is very important not to damage the pellets.

In case of difficulty swallowing the capsules

• If the patient has difficulty swallowing the capsule:
• Open the capsule and mix the pellets with half a glass of water (still water). Do not use any other liquids.
• Drink the mixture immediately or within 30 minutes. Always stir the mixture before drinking.
• To ensure that all the medicine is taken, refill the glass with water to half and drink. The undissolved solid residue contains the medicine - do not chew or crush it.
• If the patient is unable to swallow, open the capsule, mix the pellets with water, and transfer them to a syringe, then administer through a gastric tube.

Children and adolescents under 12 years of age

Emanera is not recommended for children under 12 years of age.

Elderly patients

No dose adjustment is necessary for elderly patients.

Taking a higher dose of Emanera than recommended

If you have taken a higher dose of Emanera than prescribed by your doctor, consult your doctor or pharmacist immediately.

Missing a dose of Emanera

• If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Emanera and consult your doctor immediately:

• Yellow skin, dark urine, and fatigue, which may be signs of liver disease. These side effects are rare and affect less than 1 in 1,000 patients.
• Wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). These side effects are rare and affect less than 1 in 1,000 patients.
• Sudden onset of severe rash or redness of the skin with blisters or peeling, possibly with high fever and joint pain. These side effects are very rare and affect less than 1 in 10,000 patients.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or hypersensitivity syndrome). These side effects are very rare and affect less than 1 in 10,000 patients.

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

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, bloating (with gas).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon side effects (may affect up to 1 in 100 patients):

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, drowsiness.
• Dizziness of inner ear origin (feeling of spinning).
• Dry mouth.
• Changes in blood test results showing liver function.
• Skin rash, urticaria, itching.
• Bone fractures in the hip, wrist, or spine (if Emanera is taken in high doses and for a long period).

Rare side effects (may affect up to 1 in 1,000 patients):

• Blood disorders, such as a decrease in white blood cells (leukopenia) or platelets (thrombocytopenia). This may cause weakness, easy bruising, and increased risk of infection.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Vision disturbances, such as blurred vision.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Oral thrush (fungal infection).
• Fungal infections that can affect the intestines.
• Liver disease, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash that can occur after exposure to sunlight.
• Joint pain or muscle pain.
• General feeling of being unwell and lack of energy.
• Excessive sweating.

Very rare side effects (may affect less than 1 in 10,000 patients):

• Blood disorders, such as a lack of white blood cells (agranulocytosis).
• Aggression.
• Hallucinations (seeing, hearing, or feeling things that are not there).
• Severe liver disease leading to liver failure and encephalopathy.
• Sudden onset of severe rash or blisters or peeling of the skin. These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disease.
• Enlarged breasts in men.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• If you have taken Emanera for more than three months, there is a possibility of a decrease in magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, and rapid heartbeat. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Intestinal inflammation (leading to diarrhea).
• Rash that can occur with joint pain.

In very rare cases, Emanera may have a negative effect on white blood cells, leading to a lack of immunity. If you experience infections with symptoms such as fever with a very bad general condition, or fever with signs of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, you should immediately consult a doctor for blood tests to rule out agranulocytosis (lack of white blood cells). It is very important to inform your doctor that you are taking Emanera.
Do not be concerned by this list of side effects. You may not experience any of them.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Emanera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
Blisters of OPA/Aluminum/PE + desiccant/Aluminum:
Store in the original packaging to protect from moisture.
Blisters of OPA/Aluminum/PVC/Aluminum:
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Emanera contains

• The active substance of Emanera is ezomeprazole. Each gastro-resistant hard capsule contains 20 mg or 40 mg of ezomeprazole, in the form of a magnesium dihydrate salt.
• The other ingredients are sucrose, cornstarch, povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, macrogol 6000, talc, heavy magnesium carbonate, methacrylic acid - ethyl acrylate copolymer (1:1), 30% dispersion, and polysorbate 80 in the pellet core, and gelatin, titanium dioxide (E 171), and red iron oxide (E 172) in the capsule shell. See section 2 "Emanera contains sugar and sodium".

What Emanera looks like and contents of the pack

20 mg: light pink gastro-resistant hard capsules. The capsule contains white to almost white pellets.
40 mg: pink gastro-resistant hard capsules. The capsule contains white to almost white pellets.
Packaging: 7, 14, 28, 56, 60, 84, or 90 capsules in blisters, in a cardboard box.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:06.06.2025
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Information intended for healthcare professionals only:
Administration through a gastric tube (≥16 French gauge)

• 1. Open the capsule and insert the pellets into a suitable syringe. Fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some types of tubes, mix the pellets with 50 ml of water to avoid clogging the tube.
• 2. Immediately after adding water, shake the syringe to mix the pellets evenly.
• 3. Turn the syringe upside down with the tip pointing upwards and check if it is not clogged.
• 4. Connect the tube and syringe, holding the syringe with the tip pointing upwards.
• 5. Shake the syringe and turn it upside down with the tip pointing downwards. Administer 5 to 10 ml to the tube immediately. After administration, turn the syringe upside down with the tip pointing upwards and shake (hold the syringe with the tip pointing upwards to avoid clogging).
• 6. Turn the syringe upside down with the tip pointing downwards and administer another 5 to 10 ml to the tube immediately. Repeat these steps until the syringe is empty.
• 7. If necessary, fill the syringe with 25 ml of water and 5 ml of air and repeat the procedure described in step 5 to remove any residue that may have remained in the syringe. For some types of tubes, it may be necessary to add 50 ml of water.