ESOMEPRAZOL STADA 40 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 esomeprazole or any 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 esomeprazol. If you are not sure, consult your doctor or pharmacist before taking esomeprazol.

Warnings and precautions

Consult 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 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. If you get any of the following symptoms, stop taking esomeprazol and contact your doctor immediately: severe skin rash, blistering of the skin, mouth, eyes and genitals, skin peeling, high fever, swelling, increase of eosinophils in the blood (see section 4).
• a specific blood test (Chromogranin A) is planned.

Esomeprazol may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking esomeprazol, 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 esomeprazol only when your symptoms appear, you should contact your doctor if your symptoms persist or change.

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).

Subacute cutaneous lupus erythematosus (SCLE)

SCLE is a condition where the skin becomes inflamed and you may get rashes, especially on the arms, chest and hands, which can develop into open sores. This condition is more likely to occur in women than in men and in people taking other medicines, such as hydrochlorothiazide. If you notice any of the following symptoms, contact your doctor immediately: inflamed skin, especially on the arms, chest and hands, rashes which can develop into open sores.

Rash and skin lesions

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 erythema multiforme have been reported (see section 4). These conditions can be life-threatening and you may need to be hospitalized. The rash may cover a large area of the body, and it may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These reactions may be accompanied by fever, headache and/or diarrhoea.

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

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 includes medicines that you can buy without a prescription.

This is because esomeprazol may affect how these medicines work, and these medicines may also affect how esomeprazol works.

Do not take esomeprazol 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 Esomeprazol Stada.
• medicines that are 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 leg does 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 temporarily stop your treatment with Esomeprazol Stada.
• tacrolimus (used to prevent organ rejection after transplant).
• rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat mild depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin with Esomeprazol Stada to treat ulcers caused by Helicobacter pylori bacteria, 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 unlikely to affect your ability to drive or use any tools or machines.

However, sometimes dizziness or blurred vision may 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 monitor you (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, you should contact 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 dose is given below.

Adults aged 18 years and above

For 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 yet healed.
• If you have severe liver problems, your doctor may give you a lower dose.

For stomach acid produced too much by a growth in the pancreas (Zollinger-Ellison syndrome):

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

Prevention of re-bleeding following gastric or duodenal ulcers treated with esomeprazole intravenously:

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

Adolescents from 12 years of age

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg gastro-resistant tablet 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 yet healed.
• The recommended dose once the oesophagus has healed is one 20 mg tablet once a day.
• If your oesophagus has not been damaged, the recommended dose is one 20 mg tablet once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

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 the 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 then drink the mixture. You must always stir the mixture just before drinking it.
• To make sure you get the full dose of the medicine, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
• If you cannot swallow at all, the tablets can be mixed with water and given through a syringe into the stomach via a tube.

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, contact your doctor or pharmacist immediately.

In case of overdose, contact the national Poison Centre on 91 562 04 20.

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 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, this medicine 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 may 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 may 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 (exfoliation 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 may 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).
• 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 skin peeling. 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 your blood magnesium levels 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 your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium or calcium levels. 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 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 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 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. Conservation of Esomeprazol Stada

Keep this medicine out of the 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 wastewater or household waste. 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 40 mg

• The active ingredient is esomeprazol.

Each tablet contains 40 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 40 mg gastro-resistant EFG tablets are film-coated, oval, biconvex, and light brick red to brown in color, with the inscription "E6" 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 is not 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 avoid clogging 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 remaining sediment from the syringe. For some tubes, 50 ml of water are required.