Patient Information Leaflet

Esomeprazol SUN 40 mg gastro-resistant tablets EFG

esomeprazol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Esomeprazol SUN

4.Possible side effects

5.Storage of Esomeprazol SUN

6. Contents of the pack and additional information

Esomeprazol SUN contains a medicine called esomeprazol. It belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid produced by the stomach.

Esomeprazol 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. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol may also be used to prevent the formation of ulcers in the stomach if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent bleeding from peptic ulcers with esomeprazol administered 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 in the upper part of the small intestine (duodenum) that are infected with a bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Esomeprazol SUN

• If you areallergicto esomeprazol, or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazol, lansoprazol, rabeprazol, omeprazol).
• If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).

If you find yourself in any of these situations, do not takeEsomeprazol SUN. If you are unsure, consult your doctor or pharmacist before takingEsomeprazol SUN.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 similar medication to Esomeprazol Sun to reduce stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina A)

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

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

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

If you are taking proton pump inhibitors such as Esomeprazol SUN, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, or spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you experience 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. Remember to mention any other symptoms you may notice, such as joint pain.

Inform your doctor immediately when you observe any signs or symptoms indicative of severe cutaneous reactions (SCAR) such as erythema multiforme (EM), Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS).

Esomeprazol SUN should be discontinued immediately in the presence of signs and symptoms of severe cutaneous reactions.

The treatment should not be administered again in patients with EM/SSJ/NET/DRESS.

Children under 12 years

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

Use of Esomeprazol SUN with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications that can be purchased without a prescription.

This is because Esomeprazol SUN may affect the way some medications work and some medications may influence the effect of Esomeprazol SUN.

Do not take Esomeprazol SUN if you are taking a medication that containsnelfinavir(used for the treatment of HIV infection).

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

• Atazanavir(used for the treatment of HIV infection).
• Clopidogrel (used for the prevention of blood clots)
• • Ketoconazol, itraconazol, or voriconazol(for fungal infections)
  • Erlotinib (used in cancer treatment).
  • Citalopram,imipramina,clomipramina, (for depression treatment).
  • Diazepam (used for anxiety treatment, as a muscle relaxant or for epilepsy).
  • Fenitoína (for epilepsy). If you are taking fenitoína, your doctor will need to control when you start or stop taking Esomeprazol SUN.
  • Medications used to make blood thinner, such as warfarina. Your doctor may need to control when you start or stop taking Esomeprazol SUN.
  • Cilostazol(used for intermittent claudication – leg pain when walking caused by poor blood circulation).
  • Cisaprida (used for indigestion and stomach burning).

• Digoxina (used for heart problems).
• Metotrexato (chemotherapy medication used at high doses in cancer treatment) – if you are taking high doses of metotrexato, your doctor may temporarily interrupt your treatment with Esomeprazol SUN.
• Tacrolimus (organ transplant):
• Rifampicina (used for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum)(used to treat depression).

If your doctor has prescribed the antibiotics amoxicilina and claritromicina in addition to Esomeprazol SUN to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Taking Esomeprazol SUN with food and drinks

You can take the tablets with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take Esomeprazol SUN during this period.

The passage of Esomeprazol SUN into breast milk is unknown. Therefore, Esomeprazol SUN should not be taken during breastfeeding..

Driving and operating machinery

Esomeprazol SUN 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 SUN contains saccharose,

Esomeprazol SUN contains saccharose, a type of sugar.If your doctor has indicated that you have aintolerance to certain sugars, consult with them before taking this medication.

Esomeprazol SUN contains sodium.

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

Follow exactly the administration instructions for esomeprazole indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• 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 one esomeprazole 40 mg gastro-resistant 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 esomeprazole 20 mg gastro-resistant tablet once a day.
• If your esophagus is not affected, the recommended dose is one esomeprazole 20 mg gastro-resistant tablet once a day. Once your condition has been controlled, your doctor may tell you to take your medicine only when you notice some symptoms, up to a maximum of one esomeprazole 20 mg gastro-resistant 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 gastro-resistant tablet twice a day for one week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

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

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

To prevent gastric ulcers if you are taking NSAIDs:

• The recommended dose is one esomeprazole 20 mg gastro-resistant 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 esomeprazole 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and will also decide for how long you should take this medication. The maximum dose is 80 mg twice a day.

Prolonged treatment of bleeding peptic ulcers after prevention induced by esomeprazole via intravenous administration:

The recommended dose is one esomeprazole 40 mg tablet once a day 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 slightly affected, the recommended dose is one esomeprazole 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 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 amoxicillin and clarithromycin.

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. They can then be administered directly into the stomach through a tube (gastrostomy tube).

Use in children under 12 years of age

Esomeprazole gastro-resistant tablets should not be used in children under 12 years of age. There are other pharmaceutical forms of esomeprazole more suitable for this age group.

Older adults

No dose adjustment is required for older adults.

If you take more Esomeprazol SUN than you should

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

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

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 the missed doses.

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

Like all medications, Esomeprazol may cause side effects, although not everyone will experience them.

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

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

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

Other side effects include:

Frequent (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep alteration).
• Dizziness, tingling sensation, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, and itching.
• Fracture of the hip, wrist, or spine (if Esomeprazol SUN is used at high doses 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 may cause weakness, bruising, or an increased risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling 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.
• Pain in the joints (arthritis) or muscles (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 the number of 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 (DRESS))

• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

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

In rare cases, Esomeprazol SUN may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever and worsening of the general condition or 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 the number of 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 the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 indicated on the blister and carton packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Esomeprazol SUN 40 mg

- The active principle is esomeprazol.

Cada comprimido contiene 40 mg de esomeprazol (como esomeprazol magnésico amorfo).

- The other components are:

Core of the tablet: Sugar spheres (sacarosa 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 stearate fumarate.

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

Appearance of Esomeprazol SUN 40 mg and content of the container

Esomeprazol SUN 40 mg enteric-coated tablets EFGare film-coated tablets, oval, biconvex, and brick red to brown in color, with the inscription “E6” in 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 pack with 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the Marketing Authorization

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp

Netherlands

Responsible for manufacturing

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

Last review date of this leaflet: August 2023

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