Esomeprazole Teva 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esomeprazol Teva 20 mg gastro-resistant hard capsules EFG

Esomeprazol Teva 40 mg gastro-resistant hard capsules EFG

esomeprazole

Package leaflet contents:

1. What Esomeprazol Teva is and what it is used for
2. What you need to know before taking Esomeprazol Teva
3. How to take Esomeprazol Teva
4. Possible side effects
5. How to store Esomeprazol Teva
6. Contents of the pack and other information

1. What Esomeprazol Teva is and what it is used for

Esomeprazol Teva contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazol Teva is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by infection with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medications known as NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol Teva may also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer after initial intravenous therapy.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD), in which stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol Teva

Do not take Esomeprazol Teva

• if you are allergic to esomeprazol or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to any other proton pump inhibitor (for example pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you have ever developed a severe skin rash, peeling skin, blistering, or mouth ulcers after taking esomeprazol or other related medicines,
• if you are taking medicines containing nelfinavir (used to treat HIV).

Do not take Esomeprazol Teva if any of the above apply to you. If you are unsure, speak to your doctor or pharmacist before taking Esomeprazol Teva.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazol Teva if:

• You have severe liver problems.

• You have severe kidney problems.

• You have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Teva used to reduce stomach acidity.

• You are scheduled to have a specific blood test (Chromogranin A).

Esomeprazol Teva may mask symptoms of other conditions. Therefore, if any of the following occur before you start taking Esomeprazol Teva or while you are taking it, contact your doctor immediately:

• you lose weight significantly without reason and have difficulty swallowing,
• you experience stomach pain or indigestion,
• you start vomiting food or blood,
• your stools are black (blood in stools).

If Esomeprazol Teva has been prescribed to relieve symptoms, you should contact your doctor if your symptoms persist or change.

Taking proton pump inhibitors such as Esomeprazol Teva, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Consult your doctor if you have osteoporosis or 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 Esomeprazol Teva. 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 esomeprazol treatment. Stop taking esomeprazol and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children under 12 years of age

Esomeprazol Teva should not be used in children under 12 years of age, as there is no available data.

Other medicines and Esomeprazol Teva

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 Esomeprazol Teva can affect how some medicines work, and some medicines can affect Esomeprazol Teva.

Do not take Esomeprazol Teva if you are taking a medicine containing nelfinavir (used to treat HIV).

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Esomeprazol Teva.
• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping Esomeprazol Teva.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood supply).
• Cisapride (used for indigestion and heartburn),
• Digoxin (used to treat heart problems)
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may stop treatment with Esomeprazol Teva.
• 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 together with Esomeprazol Teva to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Taking Esomeprazol Teva with food and drink

You may take your capsules with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Your doctor will decide whether you can take Esomeprazol Teva during this time.

It is not known whether Esomeprazol Teva passes into breast milk. Therefore, you should not take Esomeprazol Teva while breast-feeding.

Driving and using machines

It is unlikely that Esomeprazol Teva will affect your ability to drive or operate tools or machinery.

However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or use machines if you experience any of these effects.

Esomeprazol Teva contains sodium

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

Esomeprazol Teva contains sucrose

This medicine contains sucrose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Esomeprazol Teva

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

• If you are taking this medicine for a long period of time, your doctor will want to monitor you (particularly if you are taking it for more than one year).
• If your doctor has told you to take this medicine as needed, inform your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many capsules to take and for how long. This will always depend on your condition, your age, and how well your liver is functioning.

• The recommended dose is indicated below:

Use in adults aged 18 years and older

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus (throat) is slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazol Teva 40 mg once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once the throat has healed is one gastro-resistant capsule of Esomeprazol Teva 20 mg once daily.
• If your esophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazol Teva 20 mg once daily. Once your condition is under control, your doctor may tell you to take the medicine as needed, up to a maximum of one gastro-resistant capsule of Esomeprazol Teva 20 mg per day.
• If you have severe liver problems, your doctor will prescribe a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one gastro-resistant capsule of Esomeprazol Teva 20 mg twice daily for one week.
• Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

To treat gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one gastro-resistant capsule of Esomeprazol Teva 20 mg once daily for 4 to 8 weeks.

To prevent gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one gastro-resistant capsule of Esomeprazol Teva 20 mg once daily.

To treat excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one gastro-resistant capsule of Esomeprazol Teva 40 mg twice daily.
• Your doctor will adjust the dose according to your needs and decide for how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment to prevent rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one gastro-resistant capsule of Esomeprazol Teva 40 mg once daily for 4 weeks.

Use in adolescents aged 12 years and older

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus (throat) is slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazol Teva 40 mg once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once the esophagus has healed is one gastro-resistant capsule of Esomeprazol Teva 20 mg once daily.
• If your esophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazol Teva 20 mg once daily.
• If you have severe liver problems, your doctor will prescribe a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one gastro-resistant capsule of Esomeprazol Teva 20 mg twice daily for one week.
• Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

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 pellets that prevent the medicine from being broken down 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 water (still water). Do not use other liquids.
  • Drink the mixture immediately or within 30 minutes. Always stir the mixture before drinking.
  • To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. This medicine contains whole particles—do not chew or crush them.
• If you cannot swallow anything, the pellets may be mixed with some water and administered via a syringe. This can be delivered through a tube directly into the stomach ("gastric tube").

Children under 12 years of age

Esomeprazol Teva must not be used in children under 12 years of age, as there are no available data.

Elderly patients

No dose adjustment is required for elderly patients.

If you take more Esomeprazol Teva than you should

If you take more Esomeprazol Teva than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol Teva

• If you forget to take a dose, take it as soon as you remember. 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 forgotten 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 experiences them.

If you notice any of the following serious side effects, stop taking Esomeprazole Teva and contact your doctor immediately:

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems. These effects are rare, occurring in fewer than 1 in 1,000 patients.

• Sudden wheezing, swelling of the lips, tongue, throat, or body, skin rash, dizziness, or difficulty swallowing (severe allergic reaction). These effects are rare, occurring in fewer than 1 in 1,000 patients.

• Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to 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 people.

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• headache,

• stomach or intestinal problems: diarrhea, stomach pain, constipation, flatulence, nausea, or discomfort (vomiting),

• benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• swelling of feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling sensation, numbness,
• sensation of dizziness (vertigo),
• dry mouth,
• changes in blood tests monitoring liver function,
• skin rash, raised rash (urticaria), and itching,
• fracture of wrist, hip, or spine (if Esomeprazole Teva is used at high doses and for a prolonged period).

Rare (may affect up to 1 in 1,000 people)

• blood disorders such as reduced number of white blood cells or platelets. This causes weakness, bruising, or increased frequency of infections,
• low levels of sodium in the blood. This may cause weakness, discomfort (vomiting), and cramps,
• feeling restless, confusion, or depression,
• taste disturbances,
• vision problems such as blurred vision,
• sudden sensation of difficulty breathing or shortness of breath (bronchospasm),
• inflammation inside the mouth,
• a fungal infection called “candidiasis” that may affect the intestine,
• liver problems, including jaundice which may cause yellowing of the skin, dark urine, and tiredness,
• hair loss (alopecia),
• skin rash after 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 to 1 in 10,000 people)

• changes in blood count including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling, or hearing things that are not real (hallucinations),
• serious liver problems leading to liver failure and brain inflammation,
• sudden onset of a severe rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms),
• muscle weakness,
• serious kidney problems,
• breast enlargement in men.

Frequency not known (cannot be estimated from available data)

• If you are taking Esomeprazole Teva for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, tetany, delirium, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low blood magnesium levels may trigger low potassium or calcium levels in the blood. Your doctor may decide to perform blood tests to monitor magnesium levels.
• Inflammation of the intestine (possibly leading to diarrhea)
• Skin rash, possibly with joint pain

Esomeprazole Teva may very rarely affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a markedly deteriorated general condition, 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 so that lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important to provide information about your medication.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Teva

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister (OPA/Al/PE + DES film/Al foil)

This medicine does not require any special storage conditions.

Store in the original packaging to protect it from moisture.

or

Blister (OPA/Al/PVC + Al foil)

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

HDPE bottle

This medicine does not require any special storage conditions.

Keep the container tightly closed to protect it from moisture.

After first opening, the medicine should be used within 6 months.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their empty containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Teva

The active substance is esomeprazole.

Each gastro-resistant hard capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).

The other components (excipients) are sugar spheres (sucrose and corn starch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E-171), macrogol 3000, macrogol 6000, talc (E-553b), heavy magnesium carbonate, polysorbate 80 (E-433), and methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% in the pellets within the capsule; and gelatin (E-441), titanium dioxide (E-171), and red iron oxide (E-172) in the capsule shell. See section 2 “Esomeprazol Teva contains sucrose”.

Appearance of the product and contents of the pack

The body and cap of Esomeprazol Teva 20 mg gastro-resistant hard capsules EFG are slightly pink in colour. The capsules contain white or almost white pellets. Capsule size: No. 3.

The body and cap of Esomeprazol Teva 40 mg gastro-resistant hard capsules EFG are pink in colour. The capsules contain white or almost white pellets. Capsule size: No. 1.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
Alcobendas, 28108 Madrid
Spain

Manufacturer

KRKA, D.D., NOVO MESTO
Smarjeska cesta 6
Novo mesto-8501 - Slovenia

OR

Merckle GmbH
Ludwig-Merckle-Strasse 3
D-89143 Blaubeuren
Germany

This medicinal product is authorized in the European Economic Area member states under the following names

Germany: Esomeprazol AbZ 20 mg magensaftresistente Hartkapseln
Esomeprazol AbZ 20 mg magensaftresistente Hartkapseln

Slovenia: Esora 20 mg trde gastrorezistentne kapsule
Esora 20 mg trde gastrorezistentne kapsule

Spain: Esomeprazol Teva 20 mg cápsulas duras gastrorresistentes EFG
Esomeprazol Teva 20 mg cápsulas duras gastrorresistentes EFG

Date of the most recent review of this leaflet: July 2025

The following information is intended exclusively for healthcare professionals:

Administration via gastric tube

1. Open the capsule and empty the granules into a suitable syringe, then fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water may be required to prevent granules from blocking the tube.
2. Immediately shake the syringe to evenly distribute the granules in the suspension.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Insert the syringe into the tube while maintaining the upright position.
5. Shake the syringe and position it with the tip pointing 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 pointing upwards to prevent blockage of the tip).
6. Rotate the syringe so the tip points downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
7. Refill 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.

Detailed and up-to-date 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/