ESOMEPRAZOL KERN PHARMA 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Kern Pharma 40 mg Gastro-Resistant Tablets EFG

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.
• 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 signs of illness are the same as yours.
• If you get 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

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

1. What is Esomeprazol Kern Pharma and what is it used for

Esomeprazol Kern Pharma contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazole is used for the treatment of the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazole injection.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.

2. What you need to know before you take Esomeprazol Kern Pharma

Do not take Esomeprazol Kern 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 inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).

• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• if you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Kern Pharma that reduces stomach acid.

If any of the above apply to you, do not take Esomeprazol Kern Pharma. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before taking 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 medicine similar to Esomeprazol Kern Pharma that reduces stomach acid.
• a specific blood test (Chromogranin A) is planned.

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

• you lose a lot of weight for no reason and have problems swallowing.
• you get stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (blood-stained).

If your doctor has prescribed Esomeprazol Kern Pharma only when you have symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like esomeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine.

Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Rashes and skin lesions

If you get a rash or skin lesion, especially in areas of the skin exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop treatment with Esomeprazol Kern Pharma. Also remember to mention any other symptoms that you may have, such as arthralgia.

Severe skin lesions have been reported with esomeprazole (see also section 4). The lesions can include ulceration of the mouth, lips, eyes, genital and anal areas, and can be accompanied by fever, joint pain and general feeling of being unwell. These lesions can be preceded by a flu-like syndrome with fever, headache and body aches.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and erythema multiforme have been reported with esomeprazol (see section 4). Stop taking this medicine and contact your doctor immediately if you get 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 experience a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

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

Using Esomeprazol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can obtain without a prescription. This is because esomeprazole may affect the way some medicines work and some medicines may affect the way Esomeprazol Kern Pharma works.

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

Tell your doctor 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, 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 may need to monitor you when you start or stop taking Esomeprazol Kern Pharma.
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Kern Pharma.
• cilostazol (used to treat intermittent claudication – a condition where the leg muscles do not receive enough oxygen and you experience pain in your legs when walking).
• cisapride (used for indigestion and heartburn).
• digoxin (used for heart problems).
• methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with Esomeprazol Kern Pharma.
• tacrolimus (used to prevent organ rejection after 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 with Esomeprazol Kern Pharma to treat ulcers caused by Helicobacter pylori bacteria, it is very important that you tell your doctor about any other medicines you are taking.

Taking Esomeprazol Kern Pharma with food and drink

You can take the tablets at any time of the day, with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 Esomeprazol Kern Pharma during this time.

It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazol Kern Pharma during breast-feeding.

Driving and using machines

Esomeprazol Kern Pharma is not likely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol Kern Pharma contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per gastro-resistant tablet, i.e. essentially “sodium-free”.

Esomeprazol Kern Pharma contains sunset yellow FCF (E110)

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110). This may cause asthma, especially in patients allergic to aspirin.

3. How to take Esomeprazol Kern Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you take it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, you should contact your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, age and kidney function.
• The recommended doses are described below:

Use in adults aged 18 years and above

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• If you have severe liver problems, your doctor may give you a lower dose.

For excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg tablet twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take the medicine for. The maximum dose is two 40 mg tablets twice a day.

Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazole injection:

• The recommended dose is one 40 mg tablet once a day for 4 weeks.

Use in adolescents aged 12 years and above

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• If you have severe liver problems, your doctor may give you a lower dose.

Taking this medicine

• You can take the tablets at any time of the day.
• You can take the tablets with or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in the stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Put the tablets in a glass of water. Do not use other liquids.
• Stir until the tablets break up (the mixture will not be clear). You can then drink the mixture. You must always stir the mixture just before drinking it.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

• If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (oral syringe).

Use in children under 12 years of age

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

Elderly

No dose adjustment is necessary for the elderly.

If you take more Esomeprazol Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Telephone your national emergency number or the National Poison Centre (telephone number: 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Esomeprazol Kern Pharma

• 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 and continue as usual.
• 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Esomeprazol Kern Pharma can produce adverse effects, although not all people suffer from them.

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

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems. These effects are rare and can affect up to 1 in 1,000 people.

• A sudden difficulty breathing, swelling of the lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and can affect up to 1 in 1,000 people.
• The sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a "multiform erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".
• Widespread rash, high body temperature, and increased lymph node size (DRESS or drug hypersensitivity syndrome), which is very rare.

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

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

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

Infrequent (may affect up to 1 in 100 people)

• Swelling of the 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.
• 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 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.
• Taste alteration.
• Ocular 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.
• 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 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 (multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Increased breast size in men.

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

• If you are being treated with Esomeprazol Kern Pharma for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Inflammation of the intestine (can lead to diarrhea).

• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Kern Pharma can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of the general condition or fever with symptoms of a local infection such as 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 important that, in this case, you report 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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esomeprazol Kern Pharma

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

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

Blister packs:

• Do not store at a temperature above 30°C.
• Keep in the original packaging to protect it from moisture.

Bottles:

• Do not store at a temperature above 30°C.
• Validity period after the first opening of the bottle: 100 days.
• Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown away through the sewers or in 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. Content of the Package and Additional Information

Composition of Esomeprazol Kern Pharma

• The active principle is esomeprazol. Each tablet contains 40 mg of esomeprazol (as sodium salt).

• The other components are:

• Core:Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), glycerol monostearate, 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), triethyl citrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearyl fumarate.
• Coating:Opadry II Dark Blue 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum carmine indigo / blue FD&C #2 (E132), black iron oxide (E172), and aluminum lake yellow FD&C #6 / orange yellow S (E110).

Appearance of the Product and Content of the Package

Esomeprazol Kern Pharma 40 mg: oval blue tablets.

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

Only some package sizes may be marketed.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles - Barcelona

Spain

Date of the Last Revision of this Prospectus:February 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/