Esomeprazole Sun 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazol SUN 40 mg gastro-resistant tablets EFG

esomeprazole

Read the entire leaflet carefully before you start taking this medicine, because 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Esomeprazol SUN contains a medicine called esomeprazole. It belongs to a group of medicines known as 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 flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or upper part of the intestine (duodenum) that are infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Gastric ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole may also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcer after intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or upper part of the intestine (duodenum) infected 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 SUN

Do not take Esomeprazol SUN

• If you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the proton pump inhibitor group (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Esomeprazol SUN if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol SUN.

Warnings and precautions

Consult your doctor or pharmacist before starting 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 used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A).

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

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

If Esomeprazol SUN has been prescribed only to be taken when symptoms occur, you should contact your doctor if your symptoms persist or change.

If you are taking proton pump inhibitors such as Esomeprazol SUN, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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 discontinue treatment with esomeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Inform your doctor immediately if you notice any signs or symptoms suggestive of serious cutaneous adverse reactions (SCAR), such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS).

Esomeprazol SUN must be discontinued immediately upon signs or symptoms of serious skin reactions.

Treatment must not be restarted in patients who have experienced EM/SJS/TEN/DRESS.

Children under 12 years of age

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

Taking Esomeprazol SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you can buy without a prescription.

This is because Esomeprazol SUN may affect how some medicines work, and some medicines may influence the effect of Esomeprazol SUN.

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

Inform 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 in cancer treatment).
  • Citalopram, imipramine, clomipramine (for the treatment of 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 when you start or stop taking Esomeprazol SUN.
  • Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol SUN.
  • Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood flow).
  • Cisapride (used for indigestion and heartburn).

• Digoxin (used for heart problems).

• Methotrexate (a chemotherapeutic agent used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your Esomeprazol SUN treatment.

• 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 in addition to Esomeprazol SUN to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol SUN with food and drinks

You may take the tablets with or without food.

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 whether you may take Esomeprazol SUN during this period.

It is not known whether Esomeprazol SUN passes into breast milk. Therefore, Esomeprazol SUN should not be taken during breastfeeding.

Driving and using machines

Esomeprazol SUN is unlikely to affect your ability to drive or use machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

Esomeprazol SUN contains sucrose

Esomeprazol SUN contains sucrose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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

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

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told 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 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 40 mg esomeprazole gastro-resistant tablet once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one 20 mg esomeprazole gastro-resistant tablet once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg esomeprazole gastro-resistant tablet once daily. Once your condition is under control, your doctor may instruct you to take the medicine only when you experience symptoms, up to a maximum of one 20 mg esomeprazole 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 20 mg esomeprazole gastro-resistant tablet twice daily for one week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

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

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

To prevent gastric ulcers in patients taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole gastro-resistant tablet once daily.

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

• The recommended dose is 40 mg esomeprazole twice daily.
• Your doctor will adjust the dose according to your needs and determine how long you should take this medicine. The maximum dose is 80 mg twice daily.

Long-term treatment of rebleeding from peptic ulcers after intravenous esomeprazole prevention:

The recommended dose is one 40 mg esomeprazole tablet once daily 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 40 mg esomeprazole tablet daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazole tablet once daily.
• If your throat has not been affected, the recommended dose is one 20 mg esomeprazole tablet daily.
• 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 20 mg esomeprazole tablet 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 tablets at any time of day.
• You may 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 medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:
  • Place the tablets in a glass of still (non-carbonated) water. Do not use any other liquid.
  • Stir until the tablets disintegrate (the solution will not be transparent). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.
  • To ensure you have taken all the medication, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medication – do not chew or crush the granules.
    • If you cannot swallow at all:
  • The tablets may be dispersed in water and drawn into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age

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

Elderly patients

No dose adjustment is required for elderly patients.

If you take more Esomeprazol SUN than you should

If you take more esomeprazole than prescribed by your doctor, consult 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: 91 562 04 20 (indicating the medicine 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 a missed 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, Esomeprazole can cause adverse effects, although not everyone experiences them.

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

• Sudden difficulty breathing, swelling of lips, tongue, throat or body in general, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be a case of “Stevens-Johnson Syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the 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 patients.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: diarrhea, stomach pain, constipation, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating 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 decreased number of white blood cells or platelets. This may cause weakness, bruising or increase the likelihood of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
• Restlessness, confusion or depression.
• Disturbance in taste.
• Eye disorders such as blurred vision.
• Sudden feeling of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the esophagus.
• Liver problems, including jaundice which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Dermatitis due to 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 cell counts, including agranulocytosis (decreased number of white blood cells).
• Aggressiveness.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters or skin peeling. 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 problems.
• Breast enlargement in men.

Frequency not known (cannot be estimated from available data)

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

In very rare cases, Esomeprazol SUN may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in 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 to rule out a reduced white blood cell count (agranulocytosis) via a blood test. It is important that, in this case, you inform your doctor 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 not listed in this leaflet. You may 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 SUN

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

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

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

6. Contents of the pack and other information

Composition of Esomeprazol SUN 40 mg

• The active substance is esomeprazole.

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

• The other components are:

Tablet core: Sugar spheres (sucrose and corn starch), 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 iron oxide red (E172)).

Appearance of Esomeprazol SUN 40 mg and pack contents

Esomeprazol SUN 40 mg gastro-resistant tablets EFG are film-coated, oval, biconvex tablets, light brick-red to brown in colour, with the imprint “E6” in relief on one side and smooth on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132JH Hoofddorp

The 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 most recent review of this leaflet: August 2023

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