Package Insert: Information for the Patient

EsomeprazoleKern Pharma20 mg gastro-resistant tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Esomeprazol Kern Pharma contains a medicine called esomeprazole 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.

• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria called Helicobacter pylori.

• Ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazole can also be used to prevent ulcers from forming if you are taking NSAIDs.

• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously.

Adolescents 12 years of age and older

• 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.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria called Helicobacter pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take EsomeprazolKern Pharma

• 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 in the treatment of HIV infection).
• if you have ever developed a severe skin rash or skin peeling, blistering or ulcers in the mouth after taking esomeprazole or other related medicines.

If you are in any of these situations, do not take Esomeprazol Kern Pharma. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol Kern Pharma:

• if you have severe liver problems.
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a similar medicine to Esomeprazol Kern Pharma to reduce stomach acid.
• if you are due to have a specific blood test (Cromogranin A).

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

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

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

Taking a proton pump inhibitor like esomeprazole, especially for more than a year, may slightly increase the risk of breaking a 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 sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol Kern Pharma.Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin rashes have been reported in patients taking esomeprazole (see also section 4). The rash may include mouth ulcers, throat, nose, genital and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after similar symptoms to flu, such as fever, headache and body aches. The rash may cover large areas of the body with blisters and skin peeling.

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), in relation to treatment with esomeprazole. Stop taking this medicine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

Esomeprazol Kern Pharma tablets are not recommended for children under 12 years.

Use of Esomeprazol Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines bought without a prescription. This is because esomeprazole may affect the way some medicines work and some medicines may influence the effect of Esomeprazol Kern Pharma.

Do not take Esomeprazol Kern Pharma if you are taking a medicine that contains nelfinavir (used for the treatment of HIV infection).

Inform your doctor if you are using any of the following medicines:

• Atazanavir (used for the treatment of 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 the treatment of depression).
• Diazepam (used for the treatment of 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 Esomeprazol Kern Pharma.
• Medicines used to make the blood thinner such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Kern Pharma.
• Cilostazol (used for the treatment of intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy used at high doses in the treatment of cancer) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol Kern Pharma.
• Tacrolimus (organ transplant).
• Rifampicin (used for the treatment of tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

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

Taking Esomeprazol Kern Pharma with food and drinks

You can take the tablets 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 if you can take Esomeprazol Kern Pharma during this period.

The safety of esomeprazole during pregnancy and lactation has not been established. Therefore, do not take this medicine during breastfeeding.

Driving and operating machines

Esomeprazol Kern Pharma 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.

Esomeprazol Kern Pharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per gastro-resistant tablet; that is, 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 told you to take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have indicated how many tablets 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 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 slightly affected, the recommended dose is 40 mg, one esomeprazole 40 mg tablet (or two esomeprazole 20 mg tablets) once a 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. Once your esophagus has healed, the recommended dose is one esomeprazole 20 mg tablet once a day.
• If your esophagus is not affected, the recommended dose is one esomeprazole 20 mg tablet once a day. Once your condition has been controlled, your doctor may indicate that you take your medication only when you notice some symptoms, up to a maximum of one esomeprazole 20 mg tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one esomeprazole 20 mg tablet twice a day for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one esomeprazole 20 mg tablet once a day for 4 to 8 weeks.

For the prevention of gastric ulcers if you are taking NSAIDs:

• The recommended dose is one esomeprazole 20 mg tablet once a day.

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

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

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 slightly affected, the recommended dose is one esomeprazole 40 mg tablet 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.
• Once your esophagus has healed, the recommended dose is one esomeprazole 20 mg tablet once a day.
• If your esophagus is not affected, the recommended dose is one esomeprazole 20 mg tablet once a day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one esomeprazole 20 mg tablet twice a day for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

How to take this medication

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

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Put the tablets in a glass of water without gas. Do not use other liquids.
• Stir until the tablets disintegrate (the solution will not be transparent). You can drink the mixture immediately or within 30 minutes. Stir always just before drinking.
• To ensure that you have taken all the medication, rinse the glass well with half 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 tablets can be dispersed in water and introduced into a syringe. Then, they can be administered directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age:

This medication is not recommended for children under 12 years of age.

Older patients

No dose adjustment is necessary for older patients.

If you take more Esomeprazol Kern Pharma than you should

If you take more Esomeprazol Kern Pharma than your doctor has indicated, consult your doctor or pharmacist immediately.

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

If you forget to take Esomeprazol Kern Pharma

• If you forget to take a dose, take it as soon as you remember. However, if there is little time left 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 medications, Esomeprazol Kern Pharma may cause side effects, although not everyone will experience them.

If you notice any of the following severe side effects, stop taking Esomeprazol Kern Pharma and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue, 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, and throat, or 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, even after several weeks of treatment. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes may become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It may be a "multiforme erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".
• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

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

Other side effects include:

Frequent (may affect up to 1 in 10 people)

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

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, 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 Esomeprazol Kern Pharma is used at high doses and for a long period).

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

• Blood disorders such as a decrease in 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.
• Restlessness, 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 to 1 in 10,000 people)

• Changes in the number of blood cells, including agranulocytosis (decrease in white blood cells).
• Aggression.
• Seeing, feeling, or hearing 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 peeling of the skin. 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 disorders.
• Enlargement of the breasts in men.

Frequency not known(the frequency cannot be estimated from the available data)

• If you are taking Esomeprazol Kern Pharma for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Kern Pharma 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 white blood cells (agranulocytosis) through a blood test. It is essential to inform your doctor about your medication in this case.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

• Do not use this medication after the expiration date that appears on the label, the box or blister after CAD. The expiration date is the last day of the month indicated.

Blister Packs

• Do not store at a temperature above30°C.
• Store in the original packaging to protect it from moisture.

Bottles

• Do not store at a temperature above30°C.
• Validity period after the first opening of the bottle: 100 days
• Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit 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. In this way, you will help protect the environment.

Composition of Esomeprazole Kern Pharma 20 mg

- The active ingredient is esomeprazole. Each tablet contains 20 mg of esomeprazole (as sodium salt).

• Other components are:

• Core: microcrystalline cellulose (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), monoestearate of glycerol, polysorbate 80, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid-ethyl acrylate), triethylcitrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearate fumarate.
• Coating: Opadry II Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine / indigo blue FD&C #2 (E132) and yellow iron oxide (E172)).

Appearance of the product and content of the container

Esomeprazole Kern Pharma 20 mg: oval-shaped tablets of blue color.

It is presented in blister packs of 14, 28, and 100 tablets, and in bottles of 100 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles - Barcelona

Spain

Last review date of this leaflet: February 2025

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