EMANERA 40 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Emanera 40 mg gastro-resistant hard capsules EFG

esomeprazole

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, as 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Emanera and what is it used for
2. What you need to know before you take Emanera
3. How to take Emanera
4. Possible side effects
5. Storing Emanera

1. Contents of the pack and further information

1. What is Emanera and what is it used for

Emanera contains the active substance esomeprazole magnesium dihydrate, which 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 for the treatment of the following conditions:

Adults

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

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This is when stomach acid rises up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before you take Emanera

Do not take Emanera

• 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 (e.g., pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a severe skin rash or blistering of the skin, or mouth ulcers after taking Emanera or other medicines similar to Emanera.

If you are in any of these situations, do not take Emanera. If you are not sure, 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 medicine similar to Emanera to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Emanera may mask the symptoms of other diseases. Therefore, if you notice 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 difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

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

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

Skin rashes and skin symptoms

If you get a skin rash, especially in areas of the skin exposed to the sun, 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 reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with Emanera. Stop taking Emanera and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children under 12 years of age

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

Other medicines and Emanera

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because Emanera may affect how some medicines work and some medicines may affect the way Emanera works.

Do not take the Emanera capsules if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine, clomipramine (for depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Emanera.
• Medicines that make the blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking Emanera.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood pumping).
• Cisapride (used for indigestion and heartburn).
• Clarithromycin (used to treat bacterial infections).
• Digoxin (used to treat heart problems).
• Methotrexate (chemotherapy medicine used at high doses in the treatment of cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Emanera.
• Tacrolimus (organ transplant).
• 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 along with Emanera to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

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 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 during this time.

It is not known if Emanera passes into breast milk. Therefore, you should not take Emanera during breastfeeding.

Driving and using machines

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

Emanera contains sucrose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Emanera

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has told you to take this medicine only when you notice symptoms, inform your doctor if the symptoms change.

How much Emanera to take

• Your doctor will tell you how many capsules to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are given below.

Use in adults from 18 years of age

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

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

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

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

Continuation treatment after prevention of bleeding ulcers with intravenous esomeprazole:

• The usual dose is one 40 mg esomeprazole capsule once a day for 4 weeks.

Use in adolescents from 12 years of age

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

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

Taking this medicine

• 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 pellets that prevent the medicine from being destroyed by stomach acid. It is important 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 pellets into half a glass of non-fizzy water. Do not use other liquids.
• Then drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To make sure you have taken all the medicine, rinse the glass with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush the pellets.

• If you cannot swallow at all, the pellets can be mixed with a little water and put into a syringe. Then they can be given directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age

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

Elderly patients

No dose adjustment is necessary in elderly 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, stating the medicine and the amount taken.

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 the same time) to make up for the missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

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

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

These 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. Also, significant blisters and bleeding of the lips, eyes, mouth, nose, and genitals may appear. Skin rashes can become serious skin damage and potentially fatal consequences. It could be a "multiform erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis".

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

• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 patients.

Other adverse effects include:

Frequent: may affect up to1 in 10 patients

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

Infrequent: may affect up to1 in 100 patients

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, skin itching.
• Hip, wrist, or spine fracture (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 can cause weakness, bruising, or increase the likelihood of infections.

• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden sensation of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems, including jaundice that can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Pain in the joints (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 cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that can lead to liver failure or brain inflammation.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms can 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 disorders.
• Enlargement of the breasts in men.

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

• If you take esomeprazol for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can 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 (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Emanera can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of the general condition or fever with symptoms of a local infection such as pain in the neck, throat, mouth, 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 about your medication.

Reporting of adverse effects

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

5. Storage of Emanera

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

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

Blister pack consisting of an OPA/Al/PE + DES layer and an Al layer

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Blister pack consisting of an OPA/Al/PVC layer and an Al layer

Do not store above 30 ºC.

Store in the original packaging to protect it from moisture.

HDPE bottle

This medicine does not require any special storage temperature.

Keep the container perfectly closed to protect it from moisture.

The medicine should be used within six months after the first opening of the bottle.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Emanera

• The active ingredient is esomeprazol. Each hard gastro-resistant capsule contains 40 mg of esomeprazol (as esomeprazol 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, polysorbate 80 (E433), and methacrylic acid copolymer - ethyl acrylate (1:1) dispersion at 30% in the core of the capsule, and gelatin, titanium dioxide (E171), and red iron oxide (E172) in the capsule cap. See section 2 "Emanera contains sucrose and sodium".

Appearance of the product and package contents

The body and cap of the 40 mg hard 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 boxes of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules, and in HDPE bottles containing a desiccant capsule in boxes of 98 capsules. Do not ingest the desiccant capsule included in the bottle.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

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

You can request more information about this medicine by contacting 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 medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last revision of this prospectus:June 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended only for healthcare professionals:

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

1. Open the capsule and empty 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 clogging the tube.

1. Shake the syringe immediately to distribute the granules evenly throughout the suspension.
2. Hold the syringe with the tip up and check that the tip is not clogged.
3. Connect the syringe to the tube while maintaining the previous position.
4. Shake the syringe and place it with the tip down. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to prevent clogging the tip).
5. Put the syringe back with the tip down 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 drag any sediment that remains in the syringe. For some tubes, 50 ml of water are necessary.