ESOMEPRAZOL STADA 20 mg HARD GASTRO-RESISTANT CAPSULES

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

Do not take Esomeprazol Stada

• 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;
• you have severe kidney problems;
• you have ever had a skin reaction after treatment with a medicine similar to esomeprazole that reduces stomach acid. Serious skin reactions such as 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 symptoms listed above, stop taking esomeprazole and contact your doctor immediately;
• a specific blood test (Chromogranin A) is planned.

Esomeprazole may hide the symptoms of other diseases. Therefore, if you get any of the following symptoms, or if they get worse, you should see a doctor as soon as possible:

• 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” (i.e. only when you have symptoms), you should see your doctor if your symptoms persist or come back.

If you are taking esomeprazol for more than 3 months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can make you feel tired, confused, dizzy, have muscle cramps, weakness, and an irregular heartbeat. If you get any of these symptoms, you should tell your doctor as soon as possible. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

If you are taking a proton pump inhibitor like esomeprazole, especially over a period of more than one year, you may have a slightly increased risk of fractures 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 reactions

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

Severe skin reactions such as 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). The rash may cover a large area of the body and may include ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These serious skin reactions may also be associated with other symptoms such as high temperature (fever), swollen lymph nodes, joint or muscle pain, and swollen face or body. If you get any of these symptoms, stop taking esomeprazole and contact your doctor immediately.

Children under 12 years

Esomeprazol is not recommended for children under 12 years.

Using Esomeprazol Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because esomeprazole can affect the way some medicines work and some medicines may affect the way esomeprazole works.

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 may need to monitor you when you start or stop taking esomeprazole;
• medicines that are used to thin the blood, such as warfarin.

Your doctor may need to monitor you when you start or stop taking esomeprazole if you are taking other medicines, such as:

• cilostazol (used to treat intermittent claudication – a condition where poor blood flow to the legs causes pain and difficulty walking);

• 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 esomeprazole treatment;
• ticagrelor (used to prevent blood clots);
• 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 your esomeprazole for treatment of ulcers caused by Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Using Esomeprazol Stada with food and drink

You can take the capsules with or without food.

Pregnancy and breast-feeding

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 uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol Stada contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per capsule, i.e. 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 monitor you;
• 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 and above

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

• once the oesophagus has healed, the recommended dose is one 20 mg capsule once a day;

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 called amoxicillin and clarithromycin 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.

To prevent stomach ulcers if you are taking NSAIDs:

• The recommended dose is one 20 mg capsule 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 one 40 mg capsule 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 two 40 mg capsules twice a day.

Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazole intravenous:

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

Use in adolescents aged 12 and above

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

• once the oesophagus has healed, the recommended dose is one 20 mg capsule once a day;

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 called amoxicillin and clarithromycin for you to take at the same time.

Taking this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain coated granules which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• open the capsule and mix the contents with half a glass of non-fizzy water;
• stir the mixture and drink it immediately or within 30 minutes. Stir the mixture well before drinking. The mixture will not be clear;
• to make sure that you have taken all the medicine, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine - do not chew or crush them.

Use in children under 12 years of age

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

Elderly

No dose adjustment is necessary for the elderly.

If you take more Esomeprazol Stada than you should

If you have taken more esomeprazole than you should, talk to your doctor or pharmacist straight away. If you can, take your medicine and the packaging with you to the hospital. If you are not sure what to do, contact your doctor or pharmacist for advice.

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 (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, esomeprazol 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.
• The sudden appearance of a severe skin rash or redness with blisters or peeling may occur even after several weeks of treatment. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals. Skin rashes can become severe and widespread skin damage (exfoliative dermatitis and superficial mucosal membranes) with potentially fatal consequences. This could be '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 people

• headache

• effects on the stomach or intestine: diarrhea, stomach pain, constipation, gas (flatulence)
• nausea or vomiting
• benign polyps in the stomach

Infrequent: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, hives, itching of the skin
• hip, wrist, or spine fracture (if esomeprazol is used in high doses or for a prolonged 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
• eye problems, such as blurred vision
• sudden sensation 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
• 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 may 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
• increase in breast size in men

Unknown:frequency cannot be estimated from available data

• Inflammation of the intestine (can cause diarrhea).
• Skin rash, possibly with joint pain.
• Low magnesium levels in the blood (hypomagnesemia) (see section 2 "Warnings and Precautions").

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 important that, in this case, you inform your doctor about the medication you are taking.

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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Esomeprazol Stada

• Keep this medicine out of the sight and reach of children.
• Do not store at a temperature above 25 °C.
• Keep this medicine in its original packaging (blister) or keep the container perfectly closed to protect it from moisture
• Do not use this medicine after the expiration date that appears on the packaging and on the blister or bottle, after CAD. The expiration date is the last day of the month indicated.
• Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Stada

• The active ingredient is esomeprazol. There are two different doses of Esomeprazol Stada hard gastro-resistant capsules that contain 20 mg or 40 mg of esomeprazol (as magnesium dihydrate salt).

• The other components are:

Contents of the capsules:

Granules:Kappa-Carrageenan Ph. Eur., microcrystalline cellulose, mannitol, sodium hydroxide, sodium carbonate

Insulating coating:polyethylene glycol-polyvinyl alcohol copolymer, sodium hydroxide, talc, titanium dioxide (E171), hydrated colloidal silica

Gastro-resistant coating:methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30%, triethyl citrate, talc, titanium dioxide (E171)

Capsule:

Esomeprazol Stada 20 mg hard gastro-resistant capsules

Cap:gelatin, titanium dioxide (E171), yellow iron oxide (E172)

Body:gelatin, titanium dioxide (E171)

Esomeprazol Stada 40 mg hard gastro-resistant capsules

Cap:gelatin, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172)

Body:gelatin, titanium dioxide (E171)

Appearance of the Product and Package Contents

Esomeprazol Stada 20 mg hard gastro-resistant capsules

Hard gastro-resistant capsule (capsule size 3), with a white opaque body and a yellow opaque cap, containing white or almost white gastro-resistant granules.

The hard capsules may have a characteristic odor that does not affect the quality of the product.

Esomeprazol Stada 40 mg hard gastro-resistant capsules

Hard gastro-resistant capsule (capsule size 1), with a white opaque body and an orange opaque cap, containing white or almost white gastro-resistant granules.

The hard capsules may have a characteristic odor that does not affect the quality of the product.

The capsules are presented in HDPE plastic bottles with a desiccant capsule and a PP cap or in poliamide-aluminum-PVC/aluminum blisters. Do not ingest the desiccant capsule.

Package sizes:

Blister packs

Esomeprazol Stada 20 mg hard gastro-resistant capsules

7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

Esomeprazol Stada 40 mg hard gastro-resistant capsules

14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

HDPE plastic bottles

14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

c/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Date of the Last Revision of this Prospectus:May 2025

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/.