Package Insert: Information for the User

Emanera 40 mg Hard Gastrorresistant Capsules EFG

esomeprazole

Read this package insert carefully before starting to take this medicine, because it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Emanera contains a medicine called esomeprazole magnesium dihydrate that belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazole is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment after prevention of bleeding from ulcers with intravenous esomeprazole.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

Do not take Emanera

• If you are allergic to esomeprazole or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).

If you find yourself in any of these situations, do not take Emanera. If you are unsure, consult your doctor or pharmacist before taking Emanera.

Warnings and precautions

Consult your doctor before starting to take Emanera:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have a vitamin B12 deficiency.
• If you have ever had a skin reaction after treatment with a similar medication to Emanera for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranin A).

Emanera may mask symptoms of other diseases.Therefore, if you observe any of the following events before taking or while taking Emanera, contact your doctor immediately:

• You lose a lot of weight without reason and have trouble swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (bloodstained).

If you have been prescribed Emanera only when you notice some symptoms, you should contact your doctor if the symptoms of your disease persist or change.

If you are taking proton pump inhibitors such as Emanera, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin eruptions and skin symptoms

If you experience a skin eruption, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Emanera. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin eruptions have occurred in patients taking esomeprazole (see also section 4). The eruption may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These skin eruptions usually appear after symptoms similar to the flu, such as fever, headache, and body aches. The eruption may cover large areas of the body with blisters and skin peeling. If you develop a rash or any of these skin symptoms during treatment (even after several weeks), stop taking this medication and contact your doctor immediately.

Children under 12 years

Esomeprazole is not recommended for children under 12 years.

Other medications and Emanera

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription. This is because Emanera may affect the way some medications work and some medications may influence the effect of Emanera.

Do not take Emanera capsules if you are taking a medication that contains nelfinavir (used for HIV treatment).

Inform your doctor or pharmacist if you are using any of the following medications:

• Atazanavir (used for HIV treatment).
• Clopidogrel (used for preventing blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used for anxiety, muscle relaxation, or epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Emanera.
• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Emanera.
• Cilostazol (used for intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Clarithromycin (used to treat bacterial infections).
• Digoxin (used to treat heart problems).
• Methotrexate (chemotherapy medication used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Emanera.
• Tacrolimus (organ transplant).
• Rifampicin (used for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum) (used for depression treatment).

If your doctor has prescribed antibiotics amoxicillin and clarithromycin, in addition to Emanera, to treat ulcers caused by Helicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Taking Emanera with food and drinks

You can take the capsules with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.Your doctor will decide if you can take Emanera during this period.

Emanera is unknown to pass into breast milk. Therefore, do not take Emanera during breastfeeding.

Driving and operating machinery

Emanera is unlikely to affect your ability to drive or use tools or machines.However, rare or very rare side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you notice any of these side effects.

Emanera contains saccharose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

• If you take this medication for a long period of time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has indicated that you should take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much Emanera to take

• Your doctor will indicate how many capsules you should take and when to take them. This will depend on your situation, age, and liver function.
• The recommended doses are indicated below.

Use in adults 18 years of age and older

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

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one capsule of esomeprazole 40 mg per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• The recommended dose is one capsule of esomeprazole 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take this medication. The maximum dose is 80 mg twice a day.

Continuation treatment after prevention of bleeding from ulcers with esomeprazole via intravenous administration.

• The usual dose is one capsule of esomeprazole 40 mg per day for 4 weeks.

Use in adolescents 12 years of age and older

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

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one capsule of esomeprazole 40 mg per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

How to take this medication

• You can take the capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated granules that prevent the medication from being destroyed by stomach acid. It is essential not to damage the pellets.

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 a glass of water without gas (without bubbles). Do not use other liquids.
• Then drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To ensure that you have taken all the medication, rinse the glass well with a glass of water and drink. The solid particles contain the medication – do not chew or crush the granules.

• If you cannot swallow at all, the granules can be mixed with a little water and administered directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age

Emanera capsules are not recommended for children under 12 years of age.

Older patients

No dose adjustment is necessary for older patients.

If you take more Emanera than you should

If you take more esomeprazole than your doctor has prescribed, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicology Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Emanera

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose (two doses at once) to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Emanera and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that may be symptoms of liver problems.

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

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

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

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes may become severe skin damage and potentially fatal consequences. It could be a “multiforme erythema”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”.

These side effects are very rare and may affect up to 1 in 10,000 patients.

Other side effects include:

Frequent: may affect up to1 in 10 patients

• Headache.
• Gastrointestinal effects: diarrhea, stomach pain, constipation, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach

Occasional: may affect up to1 in 100 patients

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, and numbness, somnolence.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if Emanera is used at high doses and for a long period)

Rare: may affect up to1 in 1,000 patients

• Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or increase the risk of infections.

• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden sensation of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A fungal infection known as “candidiasis” that may affect the esophagus.
• Liver problems, including jaundice that may cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare: may affect up to1 in 10,000 patients

• Changes in the number of blood cells, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden appearance of severe skin 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.
• Muscle weakness.
• Severe kidney problems.
• Increased breast size in men.

Frequency not known: the frequency cannot be estimated from the available data

• If you take esomeprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Emanera may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with severe worsening of the general condition or high fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) through a blood test. It is essential that, in this case, you inform your doctor about your medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister packaging consisting of an OPA/Al/PE + DES and an aluminum foil laminate

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Blister packaging consisting of an OPA/Al/PVC and an aluminum foil laminate

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

HDPE bottle

This medication does not require any special storage temperature.

Keep the container perfectly closed to protect it from moisture.

The medication must be used within six months after the first opening of the bottle.

Medications should not be thrown away through the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.By doing so, you will help protect the environment.

Composition of Emanera

• The active ingredient is esomeprazole. Each gastro-resistant capsule contains 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other components are sugar spheres (sucrose and cornstarch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol 6000, macrogol 3000, talc (E553b), heavy magnesium carbonate, poloxamer 80 (E433) and a copolymer of methacrylic acid - ethyl acrylate (1:1) dispersion at 30% in the capsule core, and gelatin, titanium dioxide (E171) and iron oxide red (E172) in the capsule cap. See section 2 “Emanera contains sucrose and sodium”

Appearance of the product and contents of the pack

The body and cap of the 40 mg gastro-resistant capsules are pink. The capsules contain white or almost white granules. Capsule size: No. 1

The capsules are available in blister packs in cartons of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 capsules and in HDPE bottles containing a desiccant capsule in cartons of 98 capsules. Do not ingest the desiccant capsule included in the bottle.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last update of this leaflet:June 2023

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals:

Administration via a gastric tube (gastric tubes with a minimum of 16 Charrière (≥ 16 CH) are recommended)

1. Open the capsule and pour the pellets into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air.

For some tubes, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.

1. Immediately agitate the syringe to distribute the granules uniformly throughout the suspension.
2. Hold the syringe with the tip pointing upwards and check that the tip has not become blocked.
3. Connect the syringe to the tube while maintaining the previous position.
4. Agitate the syringe and place it with the tip pointing downwards. Inject immediately 5–10 ml into the tube. Invert the syringe after injection and agitate (the syringe must be kept with the tip pointing upwards to prevent the tip from becoming blocked).
5. Place the syringe with the tip pointing downwards and inject immediately another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
6. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to draw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.