ESOMEPRAZOL RATIOPHARM 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Esomeprazol ratiopharm 20 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.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Esomeprazol ratiopharm contains the active substance esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Adults

Esomeprazol ratiopharm is used for the treatment of the following conditions:

• “Gastroesophageal reflux disease” (GORD). Where the acid in your stomach rises up into the oesophagus (the tube that connects your throat to your stomach) causing pain, inflammation, and heartburn.
• Ulcers in the stomach or in the upper part of the intestine that are infected with 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 NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol ratiopharm may 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).

• Treatment of continuation of prevention of rebleeding from peptic ulcers induced by intravenous route.

Adolescents from 12 years and older

• Gastroesophageal reflux disease (GORD). Where the acid in your stomach rises up into the oesophagus (the tube that connects your throat to your stomach) causing pain, inflammation, and heartburn.
• Ulcers in the stomach or in the upper part of the intestine that are infected with 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 ratiopharm

Do not take Esomeprazol ratiopharm

• if you are allergic to esomeprazole or any of the other ingredients of this medicine (see section 6),
• if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you have ever had a severe skin reaction after taking esomeprazole or other medicines similar to Esomeprazol ratiopharm that reduce stomach acid,
• if you are taking a medicine containing nelfinavir (used to treat HIV).

Do not take Esomeprazol ratiopharm if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazol ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol ratiopharm 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 Esomeprazol ratiopharm that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

Esomeprazol ratiopharm may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazol ratiopharm or while you are taking it, talk to 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 ratiopharm, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like Esomeprazol ratiopharm, especially over a period of more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Check with 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, tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazol ratiopharm. Also remember to mention any other symptoms you might notice, such as joint pain.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. Stop taking esomeprazole and seek immediate medical attention if you get any of the symptoms described in section 4.

Children under 12 years

Esomeprazol ratiopharm gastro-resistant hard capsules are not recommended for children under 12 years.

Other medicines and Esomeprazol ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Esomeprazol ratiopharm may affect how these medicines work or these medicines may affect how Esomeprazol ratiopharm works.

Do not take Esomeprazol ratiopharm 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 ratiopharm,
• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when you start or stop taking Esomeprazol ratiopharm,
• Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply),
• Cisapride (used for indigestion and heartburn),
• Digoxin (used for heart problems),
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your Esomeprazol ratiopharm treatment,
• Tacrolimus (used after organ transplants),
• 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 Esomeprazol ratiopharm to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you tell your doctor about any other medicines you are taking.

Taking Esomeprazol ratiopharm with food and drink

You can take your capsules with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant, 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 ratiopharm during this time.

It is not known if Esomeprazol ratiopharm passes into breast milk. Therefore, you should not take Esomeprazol ratiopharm if you are breast-feeding.

Driving and using machines

Esomeprazol ratiopharm is unlikely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision may rarely occur. Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is essentially ‘sodium-free’.

Esomeprazol ratiopharm contains sucrose

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Esomeprazol ratiopharm

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 your condition.
• 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 for how long. This will depend on your condition, age and how well your liver works.
• The recommended dose is as follows:

Adults

For the treatment of heartburn caused by gastroesophageal reflux disease (GORD):

• If your doctor has found that your oesophagus (gullet) 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 another 4 weeks if your gullet has not healed.
• The recommended dose once the gullet has healed is one 20 mg capsule once a day.
• If your gullet has not been damaged, the recommended dose is one 20 mg capsule each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20 mg capsule per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent them coming back:

• The recommended dose is one 20 mg capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

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 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• 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 40 mg twice a day.
• Your doctor will adjust the dose depending on your needs and will decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Treatment of continuation of prevention of rebleeding from peptic ulcers induced by intravenous route:

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

Adolescents from 12 years and older

For the treatment of heartburn caused by gastroesophageal reflux disease (GORD):

• If your doctor has found that your oesophagus (gullet) 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 another 4 weeks if your gullet has not healed.
• The recommended dose once the oesophagus has healed is one 20 mg capsule once a day.
• If your gullet has not been damaged, the recommended dose is one 20 mg capsule each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20 mg capsule per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent them coming back:

• The recommended dose is one 20 mg capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

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. 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 trouble swallowing the capsules

• If you have trouble swallowing the capsules:

• Open the capsules and empty the pellets into a glass of water (not fizzy water). Do not use other liquids.
• Drink the mixture straight away or within 30 minutes. Always stir the mixture before drinking it.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The pellets must not be chewed or crushed.

• If you cannot swallow at all, the pellets can be mixed with some water and put into a syringe. This can then be given to you through a nasogastric tube. It is important to check the suitability of the syringe and tube to be used.

Children under 12 years

Esomeprazol ratiopharm is not recommended for children under 12 years.

Elderly patients

No dose adjustment is necessary in this group of patients.

If you take more Esomeprazol ratiopharm than you should

If you take more Esomeprazol ratiopharm than you should, talk to your doctor or pharmacist straight away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the National Poison Information Service on 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Esomeprazol ratiopharm

• 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.

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 ratiopharm can cause adverse effects, although not all people suffer from them.

If you notice any of the following serious side effects, stop taking Esomeprazol ratiopharm and consult your doctor immediately:

• Yellowish skin, dark-colored 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, 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 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. It could be a "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis".

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:

The following frequency categories are used in the evaluation of adverse effects:

Frequent(may affect up to 1 in 10 patients)

• headache,
• effects on your stomach or intestine: diarrhea, stomach pain, constipation, flatulence,
• feeling of dizziness (nausea) or discomfort (vomiting),
• benign polyps in the stomach.

Infrequent(may affect up to 1 in 100 patients)

• swelling of feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling sensation, numbness,
• feeling of vertigo,
• dry mouth,
• changes in blood tests that control how your liver works,
• skin rash, bulging rash (urticaria), and itching of the skin.
• wrist, hip, or spine fracture

Rare(may affect up to 1 in 1,000 patients)

• blood problems such as a reduced number of white blood cells or platelets. This causes weakness, bruising, or infections occur more often,
• low sodium levels in the blood. This can cause weakness, discomfort (vomiting), and cramps,
• feeling of agitation, confusion, or depression,
• taste disturbances,
• vision problems such as blurred vision,
• sudden feeling of difficulty breathing or shortness of breath (bronchospasm),
• inflammation of the inside of the mouth,
• a fungal infection called "candidiasis" that can affect the intestine,
• liver problems, including jaundice that can cause yellowish skin, dark urine, and fatigue,
• hair loss (alopecia),
• skin rash after sun exposure,
• joint pain (arthralgia) or muscle pain (myalgia),
• feeling of general discomfort and lack of energy,
• increased sweating.

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

• changes in blood count including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• severe liver problems leading to liver failure and brain inflammation,
• sudden appearance of a severe rash or blisters or peeling of the skin. This can be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms),
• muscle weakness,
• severe kidney problems,
• increase in breast size in men.

Esomeprazol ratiopharm may very rarely affect white blood cells, leading to immunodeficiency. If you have an infection with symptoms such as fever with a greatly reduced general condition or fever with symptoms of a local infection such as neck, throat, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible so that the lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you provide information about your medication.

Frequency not known (cannot be estimated from available data)

• If you are taking Esomeprazol ratiopharm for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, tetanus, delirium, convulsions, dizziness, increased heart rate. If you experience any of these problems, consult your doctor immediately. Low magnesium levels in the blood can trigger low potassium or calcium levels in the blood. Your doctor may decide to perform blood tests to monitor magnesium levels.
• Inflammation of the intestine (which can trigger diarrhea)
• Skin rash, possibly with joint pain

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.

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5. Storage of Esomeprazol ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Blister pack

Do not store at a temperature above 30 °C.

Store in the original packaging to protect it from moisture.

HDPE bottle

Do not store at a temperature above 30 °C.

Store the container hermetically sealed to protect it from moisture.

After opening the container:

Do not store at a temperature above 25 °C.

Store the container hermetically sealed to protect it from moisture.

After the first opening, the medicine should be used within 6 months.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging 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 packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol ratiopharm 20 mg

• The active ingredient is esomeprazole magnesium. Each hard gastro-resistant capsule contains 20 mg of esomeprazole (as magnesium dihydrate).
• The other components (excipients) are sucrose, cornstarch, povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E-171), macrogol 3000, macrogol 6000, talc, heavy magnesium carbonate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, and polysorbate 80 in the pellets in the capsule core and gelatin; titanium dioxide (E-171) iron oxide red (E-172) in the capsule body.

Appearance of the Product and Package Contents

The body and cap of the Esomeprazol ratiopharm 20 mg hard gastro-resistant capsules EFG are slightly pink in color. The capsules contain white or almost white pellets.

The capsules are available in packs of 7, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 90, 98, and 100 capsules in blister packs and packs of 98 capsules and a desiccant capsule in HDPE bottles. Do not ingest the desiccant capsule that comes in the bottle.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1ª planta, Alcobendas

28108 Madrid-Spain

Manufacturer

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia

or

Merckle GmbH Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal Esomeprazol ratiopharm

Spain Esomeprazol ratiopharm

Date of the last revision of this prospectus:June 2025