Esomeprazole Stada 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Esomeprazol Stada 20 mg gastro-resistant hard capsules EFG

Esomeprazol Stada 40 mg gastro-resistant hard capsules EFG

Read all of this 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, ask 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 you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effect is not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Esomeprazol Stada contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid your stomach produces.

Esomeprazole is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by infection with a bacterium called "Helicobacter pylori". If you have this condition, your doctor will 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 development of stomach ulcers if you are taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer induced by intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

Stomach or upper intestinal ulcers caused by infection with a bacterium called "Helicobacter pylori". If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol Stada

Do not take Esomeprazol Stada

• 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 group of proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole);
• if you are taking a medicine containing nelfinavir (used to treat HIV infection);
• if you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

If you are in any of the above situations, do not take esomeprazole. If you are unsure, consult your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Talk to 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 used to reduce stomach acid. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with esomeprazole. Stop taking esomeprazole and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4;
• if you are scheduled to have a specific blood test (chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if you experience any of the following before starting or while taking esomeprazole, 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 you have been prescribed esomeprazole "on-demand" (only when you notice symptoms), you should contact your doctor if your symptoms persist or change.

If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as esomeprazole, 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 are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash and skin symptoms

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

Serious skin rashes have occurred in patients treated with esomeprazole (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These serious skin rashes often follow flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blistering and skin peeling.

If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

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

Taking Esomeprazol Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because esomeprazole may affect how some medicines work, and some medicines may influence the effect of esomeprazole.

Do not take esomeprazole if you are taking a medicine containing nelfinavir (used in the treatment of HIV).

Inform 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 in cancer treatment).
• Citalopram, imipramine, or clomipramine (used to treat 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 esomeprazole.
• Medicines used to thin the blood, such as warfarin.

Your doctor may need to monitor when you start or stop taking esomeprazole.

• Cilostazol (used to treat intermittent claudication – a condition where poor blood supply to leg muscles causes pain and difficulty walking).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily stop your esomeprazole treatment.
• Tacrolimus (used in 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 in addition to esomeprazole 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 Stada with food and drink

You may take the capsules with food or on an empty stomach.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take esomeprazole during this time.

It is unknown whether esomeprazole passes into breast milk. Therefore, esomeprazole should not be taken during breastfeeding.

Driving and using machines

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

Esomeprazol Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; hence, it is essentially "sodium-free".

3. How to take Esomeprazol Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (particularly 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 your symptoms change.

How much to take

• Your doctor will have told 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 detailed below:

Use in adults from 18 years of age

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 capsule once daily for 4 weeks. Your doctor may instruct you to continue taking 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 capsule once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg esomeprazole capsule per day. Once your condition is under control, your doctor may instruct you to take the medicine only when necessary, up to a maximum of one 20 mg esomeprazole capsule 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 capsule 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 capsule once daily for 4 to 8 weeks.

For the prevention of gastric ulcers in patients taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole capsule once daily.

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

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

Continuation treatment for prevention of rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole capsule once daily for 4 weeks.

Use in adolescents from 12 years of age

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 capsule once daily for 4 weeks. Your doctor may instruct you to continue taking 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 capsule once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg esomeprazole capsule 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 capsule twice daily for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

How to take this medicine

• You may take the capsules at any time of day.
• You may 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 or their contents. This is because the capsules 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 the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and disperse the contents in half a glass of still (non-carbonated) water. Do not use any other liquids.
• Shake the mixture and drink it immediately or within the next 5 minutes. Always shake the mixture just before drinking it. The mixture will not be clear.
• To ensure you have taken all the medicine, rinse the glass with water (filling it halfway), and drink it. The solid particles contain the medicine; do not chew or crush the granules.
• If you are unable to swallow at all, the granules can 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 is not recommended for children under 12 years of age.

Elderly patients

No dose adjustment is necessary for elderly patients.

If you take more Esomeprazol Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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, 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 may cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop taking esomeprazole and contact a doctor immediately:

• 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 people.
• sudden difficulty breathing, swelling of the lips, tongue, or throat, or swelling of the face or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• sudden onset of a severe skin rash or redness with blistering or peeling, which 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 may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be 'erythema multiforme', 'Stevens-Johnson syndrome', 'toxic epidermal necrolysis', or 'drug reaction with eosinophilia and systemic symptoms (DRESS)'. These effects are very rare and may affect up to 1 in 10,000 people.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other adverse effects include:

Common: may affect up to 1 in 10 people

• headache
• stomach or intestinal effects: diarrhoea, 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 disturbances (insomnia)
• dizziness, tingling or numbness, drowsiness
• sensation of vertigo
• dry mouth
• abnormal blood test results indicating liver function
• skin rash, hives, skin itching
• fracture of the hip, wrist, or spine (if esomeprazole is used at high doses or for a prolonged period of time)

Rare: may affect up to 1 in 1,000 people

• blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections
• low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps
• agitation, confusion, or depression
• altered taste
• eye problems, 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 oesophagus
• liver problems including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
• hair loss (alopecia)
• sun-induced dermatitis
• 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 (reduction in white blood cells)
• aggression
• 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, blistering, 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).

• muscle weakness
• severe kidney disorders
• breast enlargement in men

Not known: frequency cannot be estimated from available data

• Inflammation of the intestine (may cause diarrhoea).
• Skin rash, possibly with joint pain.
• Low magnesium levels in the blood (hypomagnesaemia) (see section 2 "Warnings and precautions").

In very rare cases, esomeprazole may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a local infection such as neck pain, sore throat, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in such cases, you inform your doctor about any medication you are currently taking.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Stada

• Keep this medicine out of the sight and reach of children.
• Do not store above 25 °C.
• Store this medicine in its original packaging (blister pack) or keep the container tightly closed to protect it from moisture.
• Do not use this medicine after the expiry date stated on the packaging, blister, or bottle, after EXP. The expiry date refers to the last day of the month indicated.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Esomeprazol Stada

• The active substance is esomeprazole. There are two different strengths of Esomeprazol Stada gastro-resistant hard capsules containing 20 mg or 40 mg of esomeprazole (as magnesium salt dihydrate).

• The other components are:

Capsule contents:

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

Isolating 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) 30% dispersion, triethyl citrate, talc, titanium dioxide (E171)

Capsule:

Esomeprazol Stada 20 mg gastro-resistant hard capsules

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

Body: gelatin, titanium dioxide (E171)

Esomeprazol Stada 40 mg gastro-resistant hard capsules

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

Body: gelatin, titanium dioxide (E171)

Presentation of the product and pack contents

Esomeprazol Stada 20 mg gastro-resistant hard capsules

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

The hard capsules may have a characteristic odour which does not affect the quality of the product.

Esomeprazol Stada 40 mg gastro-resistant hard capsules

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

The hard capsules may have a characteristic odour which does not affect the quality of the product.

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

Pack sizes:

Blister packs

Esomeprazol Stada 20 mg gastro-resistant hard capsules

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

Esomeprazol Stada 40 mg gastro-resistant hard 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.

Only certain pack 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 most recent revision of this leaflet: May 2025

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

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This information is intended for healthcare professionals only:

Administration via gastric tube

Pellets should be administered using a gastric tube with a diameter of at least FR15 and with a side outlet. After dispersion in non-carbonated water, the pellets must be injected immediately. Administration via gastric tube must not take longer than 5 minutes in total.

1. Open the capsule and empty the granules into a suitable syringe, then 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 avoid pellet blockage.

2. Immediately shake the syringe for about 2 minutes to disperse the granules.

3. Hold the syringe with the tip upwards and check that the tip is not blocked.

4. Connect the syringe to the tube while maintaining the previous position.

5. Shake the syringe and position it with the tip downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip upwards to prevent blockage).

6. Reposition the syringe with the tip downwards and immediately inject 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 remaining sediment from the syringe. For some tubes, 50 ml of water may be required.