ESOMEPRAZOL SUN 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

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

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

Esomeprazol Sun contains the active substance esomeprazole, which 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 is where acid from the stomach escapes into the gullet (the tube that carries food from the mouth to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or the first part of the intestine (duodenum) that are infected with 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 in the stomach caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole can also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
• Prevention of rebleeding from gastric or duodenal ulcers induced by esomeprazole intravenously.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube that carries food from the mouth to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or the first part of the intestine (duodenum) that are infected with 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.

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

Do not take Esomeprazol Sun

• 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 esomeprazole that reduces stomach acid.

If any of the above apply to you, do not take esomeprazole. If you are not sure, talk to your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Tell your doctor or pharmacist before taking esomeprazole:

• 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 esomeprazole that reduces stomach acid.
• if you have a deficiency of vitamin B12 or have a risk of deficiency of vitamin B12.
• if you are due to have a specific blood test (Chromogranin A).

Esomeprazole 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 get stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (blood-stained).

If you have been prescribed esomeprazole on demand, you should contact your doctor if your symptoms 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).

Skin rash and skin reactions

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

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 esomeprazole (see section 4). If you get any of the following symptoms, stop taking esomeprazole and contact your doctor immediately:

Other medicines and Esomeprazol Sun

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because esomeprazole can affect the way some medicines work and some medicines can increase the chance of you getting side effects.

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

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

Taking Esomeprazol Sun with food and drink

You can take your capsules with food or on an empty stomach.

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 esomeprazole during this time.

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

Driving and using machines

Esomeprazole 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 occur (see section 4). Do not drive or use any tools or machines if you are affected.

Esomeprazol Sun contains sugar

Esomeprazol Sun contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Esomeprazol Sun contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant capsule, that is to say essentially ‘sodium-free’.

3. How to take Esomeprazol Sun

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 one year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

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

Use in adults aged 18 years and above

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

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule 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 healed yet.
• Once the oesophagus has healed, the recommended dose is one 20 mg capsule once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg capsule each day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori and to prevent them coming back:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

For the prevention of stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

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

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

Prevention of rebleeding from gastric or duodenal ulcers induced by esomeprazole intravenously:

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

Use in adolescents aged 12 years and above

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

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule 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 healed yet.
• Once the oesophagus has healed, the recommended dose is one 20 mg capsule once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg capsule once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori and to prevent them coming back:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

Taking this medicine

• You can take your capsules at any time of the day.
• You can take your capsules with food or on an empty stomach.
• Swallow your capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules:
• • Open the capsules and put the pellets into a glass of still water. Do not use other liquids.
  • Stir the pellets into the water and drink the mixture straight away. Always stir well before drinking.
  • To make sure you get all of 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 contents of the capsules (the pellets) can be mixed with water and put into a syringe. The mixture can then be given through a nasogastric tube.

Use in children under 12 years of age

Esomeprazol Sun gastro-resistant capsules are not recommended for children under 12 years of age.

Information on the dosing for children aged 1-11 years is available in the esomeprazole granules for oral suspension package leaflet (ask your doctor or pharmacist if you need more information).

Elderly

No dose adjustment is necessary for the elderly.

If you take more Esomeprazol Sun than you should

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

In case of overdose, contact the national Poison Centre on 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, 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, this medicine can cause adverse effects, although not all people suffer from them.

If you observe any of the following serious adverse effects, stop taking esomeprazol 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.
• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.
• Sudden difficulty breathing, swelling of 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.

• 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.

Severe skin rashes can become serious and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a case of "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

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: 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, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching of the skin.
• Fracture of the hip, wrist, or spine (if esomeprazol 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 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).
• Sunlight-induced dermatitis.
• 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).

Muscle weakness.

Severe kidney disorders.

Enlargement of the breasts in men.

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

• If you are being treated with esomeprazol 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 experience 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 can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening 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 essential that you inform your doctor about your medication in this case.

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 is not listed 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 the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Store below 30 °C.
• Keep in the original packaging to protect it from moisture.
• Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in 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

• The active ingredient is esomeprazol. Each gastro-resistant capsule contains 20 or 40 mg of esomeprazol (as amorphous magnesium).
• Other components are:

Capsule content: sugar spheres, hydroxypropylcellulose (E 463), hypromellose (E 464), magnesium stearate (E 470b), talc (E 553 B), methacrylic acid - ethyl acrylate copolymer (1:1) - 30% dispersion, sodium lauryl sulfate (E 487), triethyl citrate (E 1505), glycerol monostearate 40-55, polysorbate 80 (E 433)

Capsule shell: red iron oxide (E 172), titanium dioxide (E 171), gelatin (E 441), sodium lauryl sulfate (E 487)

Printing ink: shellac (E 904), strong ammonia solution (E 527), black iron oxide (E 172), potassium hydroxide (E 525)

Product Appearance and Package Contents

Esomeprazol Sun 20 mg hard gastro-resistant capsules, hard gelatin capsules approximately 15 mm in length with an opaque pink cap and an opaque light pink body, cap printed with "E7" in black ink, containing white to brownish pellets.

Esomeprazol Sun 40 mg hard gastro-resistant capsules, hard gelatin capsules approximately 16 mm in length with an opaque brick-red cap and an opaque brick-red body, cap printed with "E8" in black ink, containing white to brownish pellets.

Package sizes:

Blister packs

14, 15, 28, 30, 56, 60, 90, 100 gastro-resistant capsules, in OPA/Al/PVC/Al and OPA/Al/PE/desiccant/Al/PE blisters.

HDPE bottles

28, 30, 56, 60, 90, 100 gastro-resistant capsules packaged in high-density polyethylene bottles with a screw cap and induction seal containing silica gel.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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.

Fabricii 124 Street,

400632, Cluj-Napoca

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: +34 93 3427890

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: ESOMEPRAZOL BASICS 20 mg magensaftresistente Hartkapseln

ESOMEPRAZOL BASICS 40 mg magensaftresistente Hartkapseln

Italy: Raciper

Romania: Esomeprazol Terapia 20 mg capsule gastrorezistente

Esomeprazol Terapia 40 mg capsule gastrorezistente

Sweden: Esomeprazol SUN 20 mg magsaftresistanta kapslar

Esomeprazol SUN 40 mg magsaftresistanta kapslar

United Kingdom (NI): Esomeprazole 20 mg gastro-resistant capsules, hard

Esomeprazole 40 mg gastro-resistant capsules, hard

Netherlands: Esomeprazol SUN 20 mg maagsapresistente capsules

Esomeprazol SUN 40 mg maagsapresistente capsules

Date of the last revision of this prospectus:February 2025

Other sources of information

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/.

This information is intended only for healthcare professionals:

Administration through a gastric tube

1. Open the capsule and introduce the pellets into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air.

For some tubes, a dispersion in 50 ml of water is required to prevent the pellets from clogging the tube.

1. Shake the syringe immediately to disperse the tablet.
2. Hold the syringe with the tip up and check that the tip is not clogged.
3. Connect the syringe to the tube while maintaining the previous position.
4. Shake the syringe with circular movements and place it with the tip down. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to prevent clogging).
5. Put the syringe back with the tip down and inject immediately another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
6. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any sediment remaining in the syringe. For some tubes, 50 ml of water are necessary.