Emanera

Package leaflet: Information for the patient

Emanera, 20 mg, enteric hard capsules
Emanera, 40 mg, enteric hard capsules
esomeprazolum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Emanera is and what it is 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 pack and other information

1. What Emanera is and what it is used for

Emanera contains the active substance - esomeprazole, which belongs to a group of medicines called
"proton pump inhibitors". These medicines work by reducing the amount of acid produced by the
stomach.
Emanera is indicated for use in:
Adults

• Gastro-oesophageal reflux disease (GERD). This condition involves the backflow of acidic stomach contents into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. Emanera is prescribed to:
  • heal the oesophagus if it has been damaged or if inflammation has developed,
  • prevent recurrence of such conditions,
  • relieve unpleasant symptoms commonly associated with these conditions.
• Peptic ulcer disease of the stomach and upper part of the intestine associated with Helicobacter pylori infection. In such cases, your doctor may prescribe Emanera in combination with antibiotics to:
  • heal duodenal ulcers caused by Helicobacter pylori infection,
  • prevent recurrence of peptic ulcer disease caused by this bacterium.
• Peptic ulcer disease of the stomach caused by non-steroidal anti-inflammatory drugs (NSAIDs). Emanera is prescribed to:
  • heal NSAID-induced gastric ulcers,
  • prevent the formation of ulcers during NSAID therapy.
• Long-term treatment following prevention of recurrent bleeding from ulcers with intravenous esomeprazole.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GERD). This condition involves the backflow of acidic stomach contents into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Peptic ulcer disease of the stomach and upper part of the intestine associated with Helicobacter pylori infection. In such cases, your doctor may prescribe Emanera in combination with antibiotics to heal ulcers associated with Helicobacter pylori infection.

2. Important information before using Emanera

When not to use Emanera:

• if the patient is allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced allergy to other medicines in the proton pump inhibitor group (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if the patient is taking nelfinavir (a medicine used to treat HIV infections),
• if the patient has ever experienced severe skin rash or skin peeling, blistering and/or oral mucosal ulcers after taking Emanera or other similar medicines.

Do not use Emanera if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before using Emanera.
Warnings and precautions
Before using Emanera, consult a doctor or pharmacist if:

• the patient has severe liver disease,
• the patient has severe kidney disease,
• the patient has vitamin B₁₂ deficiency,
• the patient has ever experienced a skin reaction when taking a medicine similar to Emanera that reduces stomach acid secretion,
• the patient is scheduled for a specific blood test (chromogranin A level).

Skin rash and skin-related symptoms
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Emanera may be necessary. Also report any other adverse reactions such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Emanera treatment. The patient should stop taking Emanera and seek immediate medical advice if any of the symptoms associated with these severe skin reactions described in section 4 occur.

Emanera may mask symptoms of other diseases. Therefore, inform the doctor immediately about the
following symptoms occurring before or during treatment with Emanera:

• significant, unintentional weight loss and difficulty swallowing,
• abdominal pain or indigestion,
• vomiting of food or blood,
• black stools (containing blood).

If Emanera is used on an as-needed basis, consult a doctor if symptoms do not resolve or change in nature.

Taking proton pump inhibitors such as Emanera, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. 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 use in children under 12 years of age.

Emanera and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This includes medicines purchased without a prescription. Emanera may interact with certain other medicines, and some medicines may affect the action of Emanera.

Do not take Emanera together with the following medicine:

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

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

• atazanavir (a medicine used to treat HIV infections),
• ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections),
• digoxin (a medicine used to treat heart disorders),
• erlotinib (a medicine used to treat cancer),
• citalopram, imipramine, or clomipramine (medicines used to treat depression),
• diazepam (a medicine used for anxiety, muscle relaxation, or in epilepsy treatment),
• phenytoin (a medicine used to treat epilepsy) – if taking phenytoin, the patient should be monitored by a doctor when starting and stopping Emanera treatment,
• anticoagulant medicines such as warfarin – the patient may be monitored by a doctor when starting and stopping Emanera treatment,
• cilostazol (a medicine used to treat intermittent claudication – leg pain during walking due to poor blood circulation),
• cisapride (a medicine used to treat indigestion and heartburn),
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is taking high-dose methotrexate, the doctor may temporarily recommend stopping 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 herbal remedy used to treat depression).

If amoxicillin and clarithromycin are taken together with Emanera for the treatment of ulcers caused by Helicobacter pylori infection, it is extremely important to inform the doctor about all other medicines being taken.

Emanera with food and drink
Emanera may be taken with food or on an empty stomach.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether Emanera should be used.

There are no data on the passage of Emanera into human breast milk; therefore, Emanera should not be taken during breastfeeding.

Driving and operating machinery
It is unlikely that Emanera affects the ability to drive or operate tools or machines. However, dizziness and blurred vision (see section 4) may occur uncommonly or rarely. If these occur, do not drive or operate machinery.

Emanera contains sucrose and sodium
If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Emanera

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

• If you are taking this medicine for a prolonged period (especially longer than one year), medical monitoring may be necessary.
• If your doctor has advised you to take the medicine on an as-needed basis, you should inform them of any changes in your symptoms.

Dosage

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

Adults aged 18 years and older
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• For patients with mild esophageal damage, the usual dose is 40 mg of Emanera once daily for 4 weeks. If healing has not occurred, your doctor may recommend continuing the same dose for another 4 weeks.
• The usual dose after healing of the esophagus is 20 mg of Emanera once daily.
• If the esophagus was not damaged, the usual dose of Emanera is 20 mg once daily. After symptoms have resolved, your doctor may recommend taking the medicine on an as-needed basis at a dose of up to 20 mg per day.
• In case of severe liver disease, your doctor may prescribe a lower dose.

Treatment of peptic ulcer caused by Helicobacter pylori infection and prevention of
disease recurrence:

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

Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of gastric ulcers during therapy with non-steroidal anti-inflammatory drugs (NSAIDs):

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

Continuation of treatment after intravenous esomeprazole therapy to prevent recurrent bleeding from ulcers:

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

Treatment of excess stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The usual dose is 40 mg of Emanera twice daily.
• Your doctor will adjust the dose according to your individual needs and will also decide on the duration of treatment. The maximum dose is 80 mg twice daily.

Adolescents aged 12 years and older
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

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

Treatment of peptic ulcer caused by Helicobacter pylori infection and prevention of
disease recurrence:

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

How to take Emanera

• Emanera can be taken at any time of day.
• Emanera can be taken with or without food.
• Capsules should be swallowed whole with water. Do not chew or crush the capsules, as they contain pellets coated with an acid-protective layer. It is very important not to damage the pellets.

If you have difficulty swallowing capsules

• If you have difficulty swallowing the capsule:
• Open the capsule and mix the pellets with half a glass of water (non-carbonated). Do not use any other liquid.
• The mixture should be drunk immediately after preparation or within 30 minutes. Always mix the solution immediately before drinking.
• To ensure the entire dose is taken, refill the glass with half a glass of water and drink it. The undissolved residue contains the medicine – do not chew or crush it.
• If you are unable to swallow on your own, open the capsule, mix the pellets with water, transfer to a syringe, and administer via a gastric tube.

Children and adolescents under 12 years of age
Emanera is not recommended for use in children under 12 years of age.
Elderly patients
There is no need to adjust the dose in elderly patients.
Taking more Emanera than prescribed
If you take more Emanera than prescribed by your doctor, seek immediate advice from your doctor or pharmacist.
Missed dose of Emanera

• If you miss a dose, take it as soon as possible. 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 missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking Emanera and contact your doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver disease. These adverse reactions are rare and affect less than 1 in 1,000 patients.
• Wheezing, swelling of the lips, tongue or throat, rash, fainting, or difficulty swallowing (severe allergic reaction). These adverse reactions are rare and affect less than 1 in 1,000 patients.
• Sudden onset of severe rash or redness of the skin with blisters or skin peeling. Blisters and bleeding from the lips, eyes, mouth, nose, or genital organs may also occur. Rashes may progress to serious, widespread skin damage (peeling of the outer layer of skin and superficial mucous membranes) with life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis". These adverse reactions are very rare and affect less than 1 in 10,000 patients.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These adverse reactions are very rare and affect less than 1 in 10,000 patients.

Other adverse reactions include:
Common adverse reactions (may occur in up to 1 in 10 patients):

• Headache.
• Effects on stomach or intestines: diarrhoea, abdominal pain, constipation, bloating (with passing of wind).
• Nausea or vomiting.
• Mild gastric polyps.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Vertigo (spinning sensation).
• Dryness of the mouth.
• Changes in blood test results indicating liver function abnormalities.
• Skin rash, nodular rash (urticaria), itching of the skin.
• Fractures of the hip, wrist, or spine (if Emanera is used in high doses and for a long period of time).

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Blood disorders such as reduced number of white blood cells (leukopenia) or platelets (thrombocytopenia). This may cause weakness, easy bruising, and increased susceptibility to infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Feeling of restlessness, disorientation, or depression.
• Taste disturbances.
• Vision disorders, such as blurred vision.
• Sudden shortness of breath or breathlessness (bronchospasm).
• Inflammation of the mouth.
• Fungal infection called candidiasis, which may affect the intestines.
• Liver diseases, including jaundice, causing yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint or muscle pain.
• Malaise and lack of energy.
• Excessive sweating.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Blood cell count disorders, such as deficiency of white blood cells (agranulocytosis).
• Aggression.
• Hallucinations (seeing, hearing, or sensing things that are not there).
• Severe liver disease leading to liver failure and encephalopathy.
• Sudden appearance of severe rash, blisters, or skin peeling. These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Decreased muscle strength.
• Severe kidney disease.
• Enlargement of breasts in men.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• If Emanera has been taken for longer than three months, there may be a risk of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms are observed, inform your doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Inflammation of the intestine (leading to diarrhoea).
• Rash associated with joint pain.

In very rare cases, Emanera may adversely affect white blood cells, leading to immunodeficiency. If infections occur with symptoms such as fever accompanied by very poor general condition, or fever with signs of localized infection such as neck, throat or mouth pain, or difficulty urinating, contact your doctor immediately for blood tests to rule out agranulocytosis (deficiency of white blood cells). It is very important to inform your doctor about taking this medicine.
Do not be alarmed by this list of adverse reactions. None of them may occur.

Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Emanera

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

6. Contents of the pack and other information

What Emanera contains

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

What Emanera looks like and contents of the pack
20 mg: light pink, enteric hard capsules. The capsule contains pellets of white to almost white colour.
40 mg: pink, enteric hard capsules. The capsule contains pellets of white to almost white colour.
Pack sizes: 7, 14, 28, 56, 60, 84 or 90 capsules in blister packs, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500

Information intended exclusively for medical professionals:

Administration via gastric tube (≥16 French gauge)

1. Open the capsule and transfer the pellets into a suitable syringe. Fill the syringe with approximately 25 mL of water and approximately 5 mL of air. In case of using certain types of tubes, mix the pellets with 50 mL of water to prevent tube blockage.
2. Immediately after adding water, shake the syringe to ensure uniform mixing of the pellets.
3. Turn the syringe with the administration end upwards and check whether it is blocked.
4. Connect the tube and syringe, holding the syringe with the administration end pointing upwards.
5. Shake the syringe and then turn it with the administration end downwards. Immediately administer 5 to 10 mL into the tube. After administration, turn the syringe with the administration end upwards and shake it (hold the syringe with the administration end upwards to prevent blockage).
6. Turn the syringe with the administration end downwards and immediately administer another 5 to 10 mL into the tube. Repeat these steps until the syringe is empty.
7. If necessary, refill the syringe with 25 mL of water and 5 mL of air and repeat the procedure described in point 5 to remove any residue remaining in the syringe. In case of using certain types of tubes, it may be necessary to add 50 mL of water.