ESOMEPRAZOL STADA 20 mg GASTRO-RESISTANT TABLETS

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

Do not take Esomeprazol Stada:

• if you are allergic to 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 containing nelfinavir (used to treat HIV).
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid.

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

Warnings and precautions

Tell your doctor or pharmacist before taking Esomeprazol Stada if:

• you have severe liver problems.
• you have severe kidney problems.
• you have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazol (see section 4). Stop taking esomeprazol and contact your doctor immediately if you get any of the following symptoms: blistering of the skin, mouth, eyes and genitals, and patchy areas of skin which may be itchy or painful.
• a specific blood test (Chromogranin A) is planned.

Esomeprazol may hide the symptoms of other diseases. Therefore, if you notice any of the following happen before or while you are taking esomeprazol, consult 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 (a sign of bleeding in the stomach or intestines).

If your doctor has prescribed esomeprazol only when you have symptoms, you should contact your doctor if your symptoms persist or get worse.

If you are taking proton pump inhibitors like esomeprazol, especially over a period of more than one year, you may be at increased risk of fracture of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

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 esomeprazol. Remember to also mention any other symptoms that you may have, such as arthralgia (joint pain).

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazol (see section 4). The skin reaction may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and itchy eyes). These conditions may be accompanied by fever, headache and/or diarrhoea and can be life-threatening. If you experience any of these symptoms, stop taking esomeprazol and contact your doctor immediately.

Taking Esomeprazol Stada 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 may affect how these medicines work or they may affect how esomeprazol works.

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

Tell your doctor or pharmacist if you are taking any of the following medicines:

• atazanavir (used to treat HIV).
• clopidogrel (used to prevent blood clots).
• ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• erlotinib (used to treat cancer).
• citalopram, imipramine, 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 Esomeprazol Stada.
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Stada.
• 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 to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your Esomeprazol Stada treatment.
• tacrolimus (used to prevent organ rejection after 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 Stada 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 Stada 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 during this time.

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

Driving and using machines

Esomeprazol is not likely to affect your ability to drive or use any tools or machines.

However, sometimes side effects such as dizziness or blurred vision (see section 4) can occur. Do not drive or use any tools or machines if you are affected in this way.

Esomeprazol Stada contains sugar

Esomeprazol Stada 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 Stada contains sodium

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

3. How to take Esomeprazol Stada

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 regularly check your condition.
• If your doctor has told you to take this medicine as and when you need it, you should 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 described below.

Adults aged 18 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is 40 mg 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 your oesophagus has healed, the recommended dose is 20 mg once a day.
• If your gullet (oesophagus) is not damaged, the recommended dose is 20 mg 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 stop them coming back:

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

To prevent stomach ulcers or ulcers in the duodenum if you are taking NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of too much acid in the stomach caused by a tumour 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 should take the medicine for. The maximum dose is 80 mg twice a day.

Treatment of NSAID-associated gastric and duodenal ulcers, and prevention of NSAID-associated gastric and duodenal ulcers in patients at risk:

• The recommended dose is 20-40 mg once a day.

Adolescents from 12 years of age

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is 40 mg 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 your oesophagus has healed, the recommended dose is 20 mg once a day.
• If your gullet (oesophagus) is not damaged, the recommended dose is 20 mg 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 stop them coming back:

• The recommended dose is 20 mg 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 the tablets at any time of the day.
• You can take the tablets with or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets 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

• 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 this mixture straight away or within 30 minutes. Always stir well before drinking.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

Children under 12 years of age

Esomeprazol is not recommended for children under 12 years of age.

Older people

No dose adjustment is necessary for older people.

If you take more Esomeprazol Stada 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 the National Poison Information Service on 020 7188 0200.

If you forget to take Esomeprazol Stada

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 to make up for a forgotten dose.

If you have any further questions on the use of this product, 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.
• 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. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a "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.

• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other adverse effects include:

Frequent (may affect up to 1 in 10 patients)

• Headache.
• Effects on the stomach or intestine: stomach pain, constipation, diarrhea, gas (flatulence).
• Feeling of discomfort (nausea) or discomfort (vomiting).
  • Benign polyps in the stomach.

Infrequent (may affect up to 1 in 100 patients)

• Swelling of feet and ankles.
• Disruption of sleep (insomnia).
• Dizziness, feeling of tingling and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, skin itching.
• Hip, wrist, or spine fracture (if Esomeprazol Stada is used at high doses and for a long period).

Rare (may affect up to 1 in 1,000 patients)

• 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.
• Eye 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).
• Dermatitis due to sun exposure.
• Pain in the joints (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 patients)

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• 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.

• Increased breast size in men.

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

• If you are taking esomeprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see a doctor immediately. Low magnesium levels can also produce a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (can lead to diarrhea).
• 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 the 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 Stada

Keep this medicine out of sight and reach of children.

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

Do not store at a temperature above 30 °C.

Medicines should not be thrown away through drains or waste. Deposit the containers and medicines that you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Stada 20 mg

• The active ingredient is esomeprazol.

Each tablet contains 20 mg of esomeprazol (as amorphous esomeprazol magnesium).

• The other components are:

Core of the tablet: Hydroxypropylcellulose (E-463), Crospovidone (Type A).

Coating:Povidone (K30), Macrogol 400, Macrogol 4000, Macrogol 6000, Hypromellose phthalate (HP-55S), Hypromellose phthalate (HP-50), Diethyl phthalate, Hydroxypropylcellulose, Microcrystalline cellulose (PH 101), Microcrystalline cellulose (PH 112), Crospovidone (Type B), Sodium stearyl fumarate, Opadry 03B86651 Brown (HMPC 2910/Hypromellose 6cP, titanium dioxide (E171), Macrogol/PEG 400, red iron oxide (E172)), Sugar spheres (sucrose and cornstarch), Talc (E553b).

Appearance of the Product and Package Contents

Esomeprazol Stada 20 mg gastro-resistant EFG tablets are film-coated, oval, biconvex, and light brick red to brown in color, with the inscription "E5" in low relief on one side and smooth on the other side.

The medicine is presented in the following types of packages:

OPA-Al-PE-desiccant-HDPE/Alu blister pack with 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Cold-formed laminated Poliamide-Al-PVC/Al blister pack with 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca

Romania

Date of the Last Revision of this Prospectus:February 2025

Detailed and updated information on 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. Insert the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water is required to prevent the pellets from clogging the tube.
2. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip has not become clogged.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe 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 of the tip).
6. 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.
7. 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.