ESOMEPRAZOL RATIOPHARM 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Prospect: Information for the user

Esomeprazol ratiopharm 40 mg hard gastro-resistant capsules EFG

Read the entire prospectus carefully before starting to take this medication, because

it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others,

even if they have the same symptoms, as it may harm them.

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

Contents of the prospectus:

1. What is Esomeprazol ratiopharm and what is it used for
2. What you need to know before taking Esomeprazol ratiopharm
3. How to take Esomeprazol ratiopharm
4. Possible adverse effects
5. Storage of Esomeprazol ratiopharm
6. Package contents and additional information

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

Esomeprazol ratiopharm contains a medicine called esomeprazol. This belongs to a group of medicines called “proton pump inhibitors”. They work by reducing the amount of acid produced by your stomach.

Esomeprazol ratiopharm is used to treat the following diseases:

Adults

• “Gastroesophageal reflux disease” (GERD). Where stomach acid rises

towards the esophagus (the tube that connects the throat to the stomach) causing pain,

inflammation and heartburn.

• Ulcers in the stomach or in the upper part of the intestine that are infected with the

bacteria called "Helicobacter pylori". If you have this disease, your doctor may

also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Stomach ulcer caused by medications called NSAIDs (non-steroidal anti-inflammatory drugs).

Esomeprazol ratiopharm can also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.

• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

• Treatment for the prevention of rebleeding from peptic ulcer induced by intravenous route.

Adolescents 12 years and older

• Gastroesophageal reflux disease (GERD). Where stomach acid rises towards the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn

Ulcers in the stomach or in the upper part of the intestine that are infected with the bacteria called "Helicobacter pylori". If you have this disease, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol ratiopharm

Do not take Esomeprazol ratiopharm

• if you are allergic to esomeprazol, or to any of the other components of this medication (see section 6).
• if you are allergic to any other proton pump inhibitor medicine (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you have ever developed a severe skin rash, blistering, or peeling after taking esomeprazol or other similar medicines,
• if you are taking medicines that contain 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.
• If you have severe kidney problems.
  • If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol ratiopharm to reduce stomach acid.
  • If you are scheduled to have a specific blood test (Chromogranin A).

Esomeprazol ratiopharm may mask the symptoms of other diseases. Therefore, if

any of the following happen to you before starting to take Esomeprazol ratiopharm or while you are taking it, contact your doctor immediately:

• you lose a lot of weight without reason and have trouble swallowing,
• you feel stomach pain or indigestion,
• you start vomiting food or blood,
• your stools are black (blood-stained stools).

If you have been prescribed Esomeprazol ratiopharm, you should contact your doctor if the symptoms of your disease persist or change.

Taking proton pump inhibitors like Esomeprazol ratiopharm, especially for more than a year, may slightly increase the risk of fracture of the hip, wrist, or spine. Consult your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rashes and symptoms

If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol ratiopharm. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with esomeprazol. Stop taking esomeprazol and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children under 12 years

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

Other medicines and Esomeprazol ratiopharm

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because Esomeprazol ratiopharm may affect how some medicines work and some medicines may have an effect on Esomeprazol ratiopharm.

Do not take Esomeprazol ratiopharm if you are taking a medicine that contains 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 starting or stopping Esomeprazol ratiopharm,

• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping Esomeprazol ratiopharm,

• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood supply),
• Cisapride (used for indigestion and heartburn),

• Digoxin (used for heart problems),
• Methotrexate (chemotherapy medicine used at high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may interrupt treatment with Esomeprazol ratiopharm,
• 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 with Esomeprazol ratiopharm to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform your doctor if you are taking any other medicine.

Taking Esomeprazol ratiopharm with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

Your doctor will decide if 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 breastfeeding.

Driving and using machines

It is unlikely that Esomeprazol ratiopharm will affect your ability to drive or use tools or machines. However, dizziness or blurred vision may occur with uncommon or rare frequency (see section 4). Do not drive or use machines if you notice any of these 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 your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Esomeprazol ratiopharm

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• 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 needed, inform your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many capsules to take and for how long. It will always depend on your disease, age, and how your liver works.

• The recommended dose is indicated below:

Adults

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus (throat) is slightly damaged, the recommended dose is one 40 mg esomeprazol gastro-resistant capsule once a day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once the throat has healed is one 20 mg esomeprazol capsule once a day.
• If your throat has not been damaged, the recommended dose is one 20 mg esomeprazol capsule per day. Once the situation is under control, your doctor may tell you to take your medicine as needed, up to a maximum of one 20 mg esomeprazol capsule per day.
• If you have severe liver problems, your doctor will indicate a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence

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

To treat stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs)

• The recommended dose is one 20 mg esomeprazol 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 esomeprazol capsule once a day.

To treat excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome)

• The recommended dose is one 40 mg esomeprazol capsule twice a day.

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

Treatment for the prevention of rebleeding from peptic ulcer induced by intravenous route

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

Adolescents 12 years and older

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is slightly damaged, the recommended dose is one 40 mg esomeprazol hard gastro-resistant capsule once a day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not healed.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazol capsule once a day.
• If your esophagus has not been damaged, the recommended dose is one 20 mg esomeprazol capsule per day. Once the situation is under control, your doctor may tell you to take your medicine as needed, up to a maximum of one 20 mg esomeprazol capsule per day.
• If you have severe liver problems, your doctor will indicate a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence

• The recommended dose is one 20 mg esomeprazol 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 food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets that prevent 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 half a glass of water (still water). Do not use other liquids.
• Drink the mixture directly or within 30 minutes. Always stir the mixture before taking it.
• To make sure you drink all the medicine, rinse the glass very well with half a glass of water and drink it. This medicine contains whole pieces - do not chew or crush them.

• If you cannot swallow, the pellets can be mixed with a little water and placed in a syringe. This can be administered through a tube directly into your stomach (“gastric tube”). It is essential to check the suitability of the syringe and tube to be used.

Children under 12 years

Esomeprazol ratiopharm 20 mg gastro-resistant capsules are not recommended for children under 12 years.

Elderly patients

No dose adjustment is required in this type of patient.

If you take more Esomeprazol ratiopharm than you should

If you take more Esomeprazol ratiopharm than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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 the missed dose.

If you have any other doubts about 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.

• A sudden difficulty breathing, swelling of the 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 (peeling 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 enlargement of lymph nodes (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 type of infection called "candidiasis" that can affect the intestine and is caused by a fungus,
• 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,
• enlargement of the breasts in men.

Esomeprazol ratiopharm may very rarely affect the 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 pain in the neck, throat, or mouth, 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 the available data)

• If you are taking Esomeprazol ratiopharm for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can manifest as fatigue, tetanus, delirium, convulsions, dizziness, increased heart rate. If you suffer from 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 EffectsIf 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. Storage of Esomeprazol ratiopharm

Keep this medicine out of the 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 closed to protect it from moisture.

After opening the container:

Do not store at a temperature above 25 °C.

Store the container hermetically closed to protect it from moisture.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that 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 that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol ratiopharm 40 mg

• The active ingredient is esomeprazole magnesium. Each hard gastro-resistant capsule contains 40 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 (E171), and red iron oxide (E172) in the capsule body.

Appearance of the Product and Package Contents

The body and cap of the Esomeprazol ratiopharm 40 mg hard gastro-resistant capsules EFG are 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-Strassee 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