ESOMEPRAZOL SUN 40 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Esomeprazol SUN

Do not take Esomeprazol SUN

• If you are allergicto esomeprazol 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, omeprazol).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).

If any of these apply to you, do not take Esomeprazol SUN. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazol SUN.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazol SUN

• 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 SUN that reduces stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Esomeprazol SUN may hide the symptoms of other diseases. Therefore, if you notice any of the following, contact your doctor immediately:

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

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

If you are taking proton pump inhibitors like Esomeprazol SUN, especially over a period of more than one year, you may have a slightly increased risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop treatment with esomeprazol. Also remember to mention any other symptoms that you may have, such as joint pain.

Tell your doctor immediately if you notice any of the following serious side effects: severe skin rash, severe allergic reactions, or liver problems. These can be serious and sometimes life-threatening conditions.

Esomeprazol SUN should be stopped immediately if you experience any of these symptoms.

Treatment should not be restarted in patients with severe skin rash.

Children under 12 years of age

Esomeprazol SUN should not be used in children under 12 years of age.

Using Esomeprazol SUN 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 buy without a prescription.

This is because Esomeprazol SUN can affect the way some medicines work and some medicines may affect the way Esomeprazol SUN works.

Do not take Esomeprazol SUN if you are taking a medicine that contains 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 (for fungal infections)
  • Erlotinib (used to treat cancer).
  • Citalopram, imipramine, or 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 Esomeprazol SUN.
  • Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol SUN.
  • Cilostazol (used to treat 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 (a chemotherapy medicine used at high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol SUN.
• 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 with Esomeprazol SUN to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor if you are taking any other medicines.

Taking Esomeprazol SUN with food and drink

You can take the tablets 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 SUN during this time.

It is not known if Esomeprazol SUN passes into breast milk. Therefore, you should not take Esomeprazol SUN if you are breast-feeding.

Driving and using machines

Esomeprazol SUN is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you experience these side effects.

Esomeprazol SUN contains sucrose,

Esomeprazol SUN contains sucrose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Esomeprazol SUN contains sodium

Esomeprazol SUN contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Esomeprazol SUN

Take Esomeprazol SUN exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• 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 one year).
• If your doctor has told you to take this medicine only when you have symptoms, tell your doctor if your symptoms change.

How much to take

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

Use in adults aged 18 years and over

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

• If your doctor has found that your gullet (esophagus) 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 esophagus has not yet healed.
• Once your esophagus has healed, the recommended dose is one 20 mg tablet once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg tablet once a day. Once your condition has been controlled, your doctor may tell you to take your medicine only when you have symptoms, up to a maximum of one 20 mg tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pyloriinfection and to prevent them from coming back:

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

For the treatment of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

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

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

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

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

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

Long-term treatment to prevent bleeding from stomach ulcers after treatment with esomeprazol given by injection:

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

Use in adolescents aged 12 years and over

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

• If your doctor has found that your gullet (esophagus) 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 esophagus has not yet healed.
• The recommended dose once your esophagus has healed is one 20 mg tablet once a day.
• If your gullet is not damaged, the recommended dose is one 20 mg tablet once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

To treat ulcers caused by Helicobacter pyloriinfection and to prevent them from coming back:

• The recommended dose is one 20 mg tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics, for example, amoxicillin and clarithromycin.

Taking this medicine

• 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 stop the medicine from being broken down by the acid in the stomach. It is important 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. Do not use other liquids.
  • Stir until the tablets break up (the mixture will not be clear). You can drink the mixture straight away or within 30 minutes. Always stir well before drinking.
  • To make sure you get 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 them.
  • • If you cannot swallow at all:
  • The tablets can be dispersed in water and given through a syringe into the stomach (gastric tube).

Use in children under 12 years of age

Esomeprazol SUN gastro-resistant tablets should not be used in children under 12 years of age. Other forms of esomeprazol are more suitable for this age group.

Elderly

No dose adjustment is needed in the elderly.

If you take more Esomeprazol SUN than you should

If you take more esomeprazol than you should, talk to your doctor or pharmacist straight away.

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

If you forget to take Esomeprazol SUN

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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

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

• A sudden difficulty breathing, swelling of lips, tongue, and throat or body in general, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. This could be a "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems.

These effects are rare and may affect 1 in every 1,000 patients.

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

• 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 to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, rash with bumps (urticaria), and itching of the skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol SUN 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.
• 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 yellowish 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. (Erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis). Drug reaction with eosinophilia and systemic symptoms (DRESS).

• Muscle weakness.
• Severe kidney disorders.
• Increased breast size in men.

Frequency Not Known (cannot be estimated from the available data)

• If you are taking Esomeprazol SUN for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, or an increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol SUN can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of your 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 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 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 SUN

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date indicated on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Keep in the original packaging (blister pack) to protect it from moisture.

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

6. Package Contents and Additional Information

Composition of Esomeprazol SUN 40 mg

• The active principle is esomeprazol.

Each tablet contains 40 mg of esomeprazol (as amorphous esomeprazol magnesium).

• The other components are:

Core of the tablet: Sugar spheres (sucrose and cornstarch), hydroxypropylcellulose (E-463), crospovidone (Type B), povidone, macrogol 400, talc (E553b), hypromellose phthalate (HP-55S), hypromellose phthalate (HP-50), diethyl phthalate, macrogol 6000, crospovidone (Type A), microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 112), and sodium stearyl fumarate.

Coating:Opadry 03B86651 Brown (HPMC 2910/Hypromellose 6cP (E464), titanium dioxide (E171), macrogol/PEG 400, talc (E553b), and red iron oxide (E172)).

Appearance of Esomeprazol SUN 40 mg and Package Contents

Esomeprazol SUN 40 mg gastro-resistant EFG tablets are film-coated, oval, biconvex, and light brick red to brown in color, with the inscription "E6" in low relief on one face and smooth on the other face.

The medicine is presented in OPA-Alu-PE-desiccant-HDPE/Alu or OPA-Alu-PVC/Alu blister packs with 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel.:+34 93 342 78 90

Date of the Last Revision of this Prospectus: August 2023

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/