Emanera 40 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Emanera 40 mg gastro-resistant hard capsules EFG

esomeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Emanera is and what it is used for

2. What you need to know 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 called esomeprazole magnesium dihydrate, which belongs to a group of medicines known as "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

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation of treatment after prevention of re-bleeding from ulcers with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before taking Emanera

Do not take Emanera

• If you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash or peeling of the skin, blistering, or mouth ulcers after taking Emanera or other related medicines.

Do not take Emanera if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking Emanera.

Warnings and precautions

Talk to 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 used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).

Emanera may mask symptoms of other conditions. Therefore, if you experience any of the following events before 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 (stained with blood).

If Emanera has been prescribed for you to take only when symptoms occur, you should contact your doctor if your symptoms persist or change.

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

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Emanera. Remember to mention any other symptoms you may notice, 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 in association with treatment with Emanera. Stop taking Emanera and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children under 12 years

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

Other medicines and Emanera

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 influence the effect of Emanera.

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

Inform 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, itraconazol, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for treatment of 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 when you start or stop taking Emanera.
• Medicines used to make the blood less likely to clot, such as warfarin. Your doctor may need to monitor when you start or stop taking Emanera.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Clarithromycin (used to treat bacterial infections).
• Digoxin (used to treat heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – 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 in addition to Emanera to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Emanera with food and drinks

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take Emanera during this period.

It is unknown whether Emanera passes into breast milk. Therefore, Emanera should not be taken during breastfeeding.

Driving and using machines

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

Emanera contains sucrose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Emanera

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience 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 indicated below.

Use in adults aged 18 years and older

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

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg esomeprazole capsule per day for 4 weeks. Your doctor may instruct you to continue 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 pancreatic tumor (Zollinger-Ellison syndrome):

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

Continuation treatment following prevention of ulcer rebleeding with intravenous esomeprazole:

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

Use in adolescents aged 12 years and older

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

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg esomeprazole capsule per day for 4 weeks. Your doctor may instruct you to continue 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 medicine

• You may take the capsules at any time of day.
• You may 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 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 granules into half a glass of still (non-carbonated) water. Do not use any other liquids.

• Immediately drink the mixture, or within 30 minutes. Always stir well just before drinking.

• To ensure you have taken the full dose, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

• If you are completely unable to swallow, the granules can be mixed with a small amount of water and drawn into a syringe. They can then be administered 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

Dose adjustment is not necessary in elderly patients.

If you take more Emanera than you should

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine 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 the same time) to make up for a missed dose.

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

4. Possible adverse effects

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

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

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems.

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

• Sudden difficulty breathing, swelling of the lips, tongue, throat, or entire body, 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. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to serious skin damage and potentially life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”.

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

• Widespread rash, high body temperature, and swollen 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:

Common: may affect up to1 in 10 patients**

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

Uncommon: may affect up to1 in 100 patients**

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling or numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, itching.
• 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 reduced numbers of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.

• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.

• Restlessness, confusion, or depression.

• Taste disturbances.

• Eye disorders such as blurred vision.

• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).

• Inflammation inside the mouth.

• A fungal infection known as “candidiasis” which may affect the oesophagus.

• Liver problems, including jaundice which may cause yellowish skin, dark urine, and tiredness.

• Hair loss (alopecia).

• Dermatitis due to exposure to sunlight.

• Joint pain (arthralgia) or muscle pain (myalgia).

• General feeling of malaise and lack of energy.

• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (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.
• Serious kidney disorders.
• Enlargement of the breasts in men.

Frequency not known: frequency cannot be estimated from available data

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

In very rare cases, Emanera may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general health, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about the medication you are taking.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

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 film and an Al film

Do not store above 30 °C.

Store in the original packaging to protect it from moisture.

HDPE bottle

This medicine does not require any special storage temperature.

Keep the container tightly closed to protect it from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emanera

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other components 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% 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 hard capsules are pink in colour. The capsules contain white or almost white granules. Capsule size: No. 1.

The capsules are available in blister packs contained in cartons of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 capsules, and in HDPE bottles containing one 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 more 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 European Economic Area member states under the following names:

Date of the last review of this leaflet: June 2025

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

This information is intended for healthcare professionals only:

Administration via 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; 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 pellets from blocking the tube.

1. Shake the syringe immediately to distribute the granules evenly throughout the suspension.
2. Hold the syringe with the tip facing upwards and check that the tip is not blocked.
3. Connect the syringe to the tube while maintaining the previous position.
4. Shake the syringe and position it with the tip facing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip facing upwards to prevent blockage of the tip).
5. Reposition the syringe with the tip facing downwards and immediately inject 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 flush any remaining sediment from the syringe. For some tubes, 50 ml of water may be required.