ESOMEPRAZOL STADA 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

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, 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 and other information

1. What is Esomeprazol Stada and what is it used for
2. What you need to know before you take Esomeprazol Stada
3. How to take Esomeprazol Stada
4. Possible side effects

5 Storage of Esomeprazol Stada

1. Contents of the pack and further information

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

Esomeprazol Stada contains a medicine called esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that your stomach produces.

Esomeprazole is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers of the duodenum (the tube leading out of the stomach) caused by a 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.
• Stomach ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole can also be used to prevent stomach ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of bleeding from stomach ulcers caused by a certain type of medicine used to reduce the risk of blood clots (dual antiplatelet therapy) in patients who have had a certain type of stroke or heart attack.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.

Stomach ulcers or ulcers of the duodenum (the tube leading out of the stomach) caused by a 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 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 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. You should not take esomeprazole if you are sensitive to the medicines mentioned above.
• if your doctor has told you that you have a low level of magnesium in your blood;
• if you are due to have an endoscopy or a test to find out how much acid your stomach is producing;

Esomeprazol may hide the symptoms of other diseases. Therefore, if you get any of the following symptoms, or get worse while taking esomeprazol, you should 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" (i.e. when you have symptoms), you should contact your doctor if your symptoms persist or get worse.

If you are taking esomeprazole for a long time (more than 1 year), your doctor will regularly check that you need it. Your doctor may also check that your levels of magnesium in the blood are normal.

If you take esomeprazole for a long time (more than 1 year), there is an increased risk of bone fractures, particularly of the hip, wrist and spine. Your doctor will consider this when deciding whether you should take esomeprazole.

Children under 12 years

Esomeprazol is not recommended for children under 12 years.

Using other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

Food and drink

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

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.

Esomeprazole 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 may occur. Do not drive or use any tools or machines if you are affected.

Esomeprazol Stada contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, 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 that you need it;
• if you are taking this medicine "on demand" (i.e. when you have symptoms), you should contact your doctor if your symptoms persist or get worse.

Dose

• 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 gastro-oesophageal reflux disease

• 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 a further 4 weeks if your gullet has not healed yet;
• once your gullet has healed, the recommended dose is one 20 mg capsule once a day;
• if your gullet is not damaged, the recommended dose is one 20 mg capsule each day.

For stomach ulcers caused by Helicobacter pylori infection and to stop them coming back

• the recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics to treat the infection;

For stomach ulcers caused by NSAIDs

• 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 too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome)

• the recommended dose is one 40 mg capsule twice a day;

Prevention of bleeding from stomach ulcers caused by a certain type of medicine used to reduce the risk of blood clots (dual antiplatelet therapy) in patients who have had a certain type of stroke or heart attack

• the recommended dose is one 40 mg capsule once a day for 4 weeks;

Use in adolescents aged 12 and above

For gastro-oesophageal reflux disease

• 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 a further 4 weeks if your gullet has not healed yet;
• once your gullet has healed, the recommended dose is one 20 mg capsule once a day.

For stomach ulcers caused by Helicobacter pylori infection and to stop them coming back

• the recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics to treat the infection;

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 or their contents. 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 capsule and swallow the contents with half a glass of non-fizzy water;
• always stir the mixture just before drinking it. The mixture will not be clear;
• to make sure that you have taken all of the medicine, rinse the glass with half a glass of water and drink it. The solid contents of the capsule do not dissolve in water. Do not chew or crush the pellets.

Use in children under 12 years

Esomeprazol is not recommended for children under 12 years.

Patients with kidney problems

No dose adjustment is necessary in patients with kidney problems.

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 notice any of the following effects, contact your doctor or pharmacist:

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;
• do not take a double dose (two doses at the same time) to make up for a forgotten dose.

4. Possible Adverse Effects

Like all medicines, esomeprazol can cause adverse effects, although not all people suffer from them.

If you notice 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 can 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: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 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: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
• eye problems, such as blurred vision
• sudden feeling of shortness of breath or difficulty breathing (bronchospasm)
• inflammation inside the mouth
• a type of 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: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)
• 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 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:the frequency cannot be estimated from the 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 essential that, in this case, you inform about the medication you are taking at that time.

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: 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 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 at the SIGRE Point in 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 hydrogen carbonate

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

Some package sizes may only 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/.