ESOMEPRAZOL SUN 40 mg GASTRO-RESISTANT HARD 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 is Esomeprazol Sun and what is it 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 is Esomeprazol Sun and what is it 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 which connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or duodenum (the tube leading out of the stomach) 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 tumor 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 which connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or duodenum (the tube leading out of the stomach) 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 inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine that contains 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, consult your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Consult your doctor or pharmacist before taking esomeprazole:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have a deficiency of vitamin B12 or a risk of deficiency of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazole to reduce stomach acid. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with esomeprazole. Stop taking esomeprazol and seek immediate medical attention if you get any of the symptoms described in section 4.
• If it is planned that you will have an analysis for a specific blood test (Chromogranin A).

Esomeprazole may mask the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking esomeprazole, 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 you have been prescribed esomeprazole 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 of 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 symptoms

If you get a rash, especially in areas of skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking esomeprazole. Remember to also mention any other symptoms you might notice, such as joint pain.

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with esomeprazole (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and itchy eyes). These severe skin reactions may start with flu-like symptoms such as fever, headache and body ache. The rash may cover a large area of the body and may include blisters and peeling skin.

If at any time during treatment (even after several weeks) you develop a rash or some of these skin symptoms, stop taking this medicine 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 can buy without a prescription. This is because esomeprazole may affect how these medicines work, and these medicines may also affect how esomeprazole works.

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

Tell your doctor if you are using 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, relax muscles or for epilepsy).
• Phenytoin (for 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 at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with esomeprazole.
• Tacrolimus (used after organ transplants).
• Rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed you antibiotics called amoxicillin and clarithromycin as well as esomeprazole 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 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 unlikely to affect your ability to drive or use machines. However, side effects such as dizziness or blurred vision may occur (see section 4). Do not drive or use machines if you are affected by these side effects.

Esomeprazol Sun contains sucrose

Esomeprazol Sun contains sugar spheres which contain 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

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant capsule, i.e. 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 as follows.

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 esophagus is slightly damaged, the recommended dose is one 40 mg esomeprazole capsule 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 esomeprazole capsule once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg esomeprazole capsule 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 esomeprazole capsule per day.
• If you have severe liver problems, your doctor may give you a lower dose.

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

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

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

• The recommended dose is one 20 mg esomeprazole capsule once a day for 4 to 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 esomeprazole capsule 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 of esomeprazole twice a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. 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 esomeprazole 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 esophagus is slightly damaged, the recommended dose is one 40 mg esomeprazole capsule 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 esomeprazole capsule once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg esomeprazole 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 infection and to prevent them coming back:

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

Taking this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the 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 the 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 non-fizzy water. Do not use other liquids.
  • Stir gently and drink the mixture straight away. Always stir just before drinking.
  • To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the pellets.
• If you cannot swallow at all, the contents of the capsules (the pellets) can be mixed with water and put into a syringe. They 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 to 11 years is presented in the esomeprazol product information for sachets (contact your doctor or pharmacist if you need additional information).

Elderly patients

No dose adjustment is necessary for elderly patients.

If you take more Esomeprazol Sun than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, 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 the 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, 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 skin redness with blisters or peeling, even after several weeks of treatment. Blisters can also appear on the lips, eyes, mouth, nose, and genitals. Skin rashes can become severe 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 (can 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 (can affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Fracture of the hip, wrist, or spine (if esomeprazol is used at high doses and for a long period).

Rare (can 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.
• Alteration of taste.
• Ocular disorders such as blurred vision.
• Sudden feeling 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).
• Photodermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (can 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).

Unknown frequency (frequency cannot be estimated from available data)

• If you are being treated with esomeprazol for more than three months, 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 in 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 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. Storage 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 down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This 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 Packaging 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 HDPE 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 pellet.
2. Hold the syringe with the tip upwards 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 downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip upwards to avoid clogging).
5. Put the syringe back with the tip downwards 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.