Esomeprazole Stada 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Esomeprazol Stada 20 mg gastro-resistant tablets EFG

Read this entire 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 could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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 esomeprazol, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazol is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid flows back up into the oesophagus (the tube from the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely 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). Esomeprazol may also be used to prevent the formation of ulcers or duodenal ulcers in patients taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcer after initial treatment with intravenous esomeprazol.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid flows back up into the oesophagus (the tube from the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely 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 any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitors (e.g. 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 any of these apply to you, 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 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 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 with esomeprazole treatment. Stop taking esomeprazole and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
• you are scheduled for a specific blood test (Chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if you experience any of the following events before starting or while taking esomeprazole, contact your doctor immediately:

• You lose a lot of weight without reason and have trouble 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 only when symptoms occur, you should contact your doctor if your symptoms persist or change.

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, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes 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 taking esomeprazole (see also section 4). The rash may include mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). These serious skin rashes usually appear after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

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.

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 includes medicines obtained without a prescription.

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 to treat HIV infection).

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 (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for treatment of 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 you when starting or stopping Esomeprazol Stada.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeprazol.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood flow).
• 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 discontinue your treatment with Esomeprazol.
• Tacrolimus (organ 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 in addition to Esomeprazol Stada 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 drinks

You may take the tablets with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 not known 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 use tools or machines.

However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or use machines if you experience any of these effects.

Esomeprazol Stada contains sucrose

Esomeprazol Stada contains sugar spheres containing sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Esomeprazol Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this 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 in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you have symptoms, inform your doctor if your symptoms change.

How much to take

• Your doctor will have told 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 given below.

Use in adults aged 18 years and older

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 40 mg once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one tablet of esomeprazole 20 mg once daily.
• If your esophagus is not affected, the recommended dose is one tablet of esomeprazole 20 mg once daily. Once your condition has been controlled, your doctor may instruct you to take the medicine only when you experience symptoms, up to a maximum of one tablet of esomeprazole 20 mg 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 tablet of esomeprazole 20 mg twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one tablet of esomeprazole 20 mg once daily for 4 to 8 weeks.

To prevent gastric ulcers or ulcers in the upper part of the intestine if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

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

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

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

Continuation treatment to prevent re-bleeding from peptic ulcer induced with intravenous esomeprazole:

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

Use in adolescents aged 12 years and older

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 gastro-resistant tablet of esomeprazole 40 mg daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once the esophagus has healed is one tablet of esomeprazole 20 mg once daily.
• If your esophagus is not affected, the recommended dose is one tablet of esomeprazole 20 mg once daily.
• 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 gastro-resistant tablet of esomeprazole 20 mg twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may 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 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

• If you have difficulty swallowing the tablets:
  • Place the tablets in a glass of still water. Do not use other liquids.
  • Stir until the tablets disintegrate (the solution will not be clear). You may drink the mixture immediately or within 30 minutes. Always stir well just before drinking.
  • To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.
• If you cannot swallow at all, the tablets may be dispersed in water and administered via a syringe. They can then be delivered directly into the stomach through a tube (gastric tube).

Children under 12 years of age

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

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Stada than you should

If you take more esomeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420.

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 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, this medicine can cause adverse effects, although not everyone will experience them.

If you notice 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, 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 reddening of the skin with blistering or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. 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 patients)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhoea, gas (flatulence).
• Feeling unwell (nausea) or sickness (vomiting).
  • Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 patients)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or numbness sensation, drowsiness.
• Dizziness or vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, skin itching.
• Fracture of hip, wrist, or spine (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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden shortness of breath 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 yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of unwellness and lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 patients)

• 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.

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

• If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (which may cause diarrhoea).
• Rash, possibly with joint pain.

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 deterioration in general condition, or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced white blood cell count (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://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 use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Stada 20 mg

• The active substance is esomeprazole.

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

• The other components are:

Tablet core: 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, iron oxide red (E172)), Sugar spheres (sucrose and corn starch), Talc (E553b).

Nature of the product and pack contents

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

The medicine is available in the following pack types:

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

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review of this leaflet: February 2025

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

This information is intended for healthcare professionals only:

Administration via gastric tube

1. Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For certain tubes, dispersion in 50 ml of water may be required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip facing 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 facing 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 facing upwards to prevent blockage).
6. Reposition the syringe with the tip facing 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 residue from the syringe. For certain tubes, 50 ml of water may be required.