Esomeprazole Teva-Ratiopharm 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Esomeprazol Teva-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, 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Esomeprazol Teva-ratiopharm contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Adults

Esomeprazol Teva-ratiopharm is used to treat the following conditions:

• “Gastro-oesophageal reflux disease” (GORD). This is when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• Stomach or upper intestinal ulcers caused by infection with a bacterium 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 known as NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol Teva-ratiopharm may also be used to prevent stomach ulcers if you are taking NSAIDs.

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

• Continuation treatment to prevent rebleeding from peptic ulcer following intravenous therapy.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This is when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by infection with a bacterium 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 starting to take Esomeprazol Teva-ratiopharm

Do not take Esomeprazol Teva-ratiopharm

• if you are allergic to esomeprazole or to any of the other ingredients of this medicine (see section 6),
• if you are allergic to any other proton pump inhibitor medicine (for example pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking esomeprazole or other related medicines,
• if you are taking medicines containing nelfinavir (used to treat HIV).

Do not take Esomeprazol Teva-ratiopharm if any of the above apply to you. If you are not sure, speak with your doctor or pharmacist before taking Esomeprazol Teva-ratiopharm.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazol Teva-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 Teva-ratiopharm used to reduce stomach acid,
• you are scheduled to have a specific blood test (Chromogranin A).

Esomeprazol Teva-ratiopharm may mask symptoms of other conditions. Therefore, if any of the following occur before you start taking Esomeprazol Teva-ratiopharm or while you are taking it, contact your doctor immediately:

• you lose weight significantly without reason and have difficulty swallowing,
• you experience stomach pain or indigestion,
• you start vomiting food or blood,
• your stools are black (blood in stools).

If Esomeprazol Teva-ratiopharm has been prescribed for you, you should contact your doctor if your symptoms persist or change.

Taking proton pump inhibitors such as Esomeprazol Teva-ratiopharm, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Consult your doctor if you have osteoporosis or 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 Esomeprazol Teva-ratiopharm. Remember to mention any other symptoms you may notice, such as joint pain.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association 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.

Children under 12 years

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

Other medicines and Esomeprazol Teva-ratiopharm

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. This is because Esomeprazol Teva-ratiopharm may affect how some medicines work, and some medicines may affect Esomeprazol Teva-ratiopharm.

Do not take Esomeprazol Teva-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, to 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 Teva-ratiopharm,
• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping Esomeprazol Teva-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 (a chemotherapy medicine used at high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may stop treatment with Esomeprazol Teva-ratiopharm,
• Tacrolimus (used in organ transplantation),
• 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 together with Esomeprazol Teva-ratiopharm to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicine.

Taking Esomeprazol Teva-ratiopharm with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine. Your doctor will decide whether you can take Esomeprazol Teva-ratiopharm during this time.

It is not known whether Esomeprazol Teva-ratiopharm passes into breast milk. Therefore, you should not take Esomeprazol Teva-ratiopharm while breastfeeding.

Driving and using machines

It is unlikely that Esomeprazol Teva-ratiopharm will 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 operate machinery if you experience any of these effects.

Esomeprazol Teva-ratiopharm contains sodium

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

Esomeprazol Teva-ratiopharm contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Esomeprazol Teva-ratiopharm

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you are taking this medicine for a long period of time, your doctor will want to monitor you (particularly if you are taking it for more than one 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 you should take and for how long. This will always depend on your condition, your age, and how well your liver is functioning.
• 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 esomeprazole capsule once daily for 4 weeks. Your doctor may instruct you to 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 esomeprazole capsule once daily.
• If your throat has not been damaged, the recommended dose is one 20 mg esomeprazole capsule daily. Once the condition is under control, your doctor may tell you to take your medicine as and when needed, up to a maximum of one 20 mg esomeprazole capsule per day.
• If you have severe liver problems, your doctor will prescribe a lower dose.

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

• The recommended dose is one 20 mg esomeprazole capsule twice daily 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 esomeprazole capsule once daily 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 esomeprazole capsule once daily.

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

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

Continuation treatment to prevent re-bleeding from peptic ulcer after intravenous therapy:

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

Adolescents aged 12 years or older

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 esomeprazole capsule once daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazole capsule once daily.
• If your throat has not been damaged, the recommended dose is one 20 mg esomeprazole capsule daily. Once the condition is under control, your doctor may tell you to take your medicine as and when needed, up to a maximum of one 20 mg esomeprazole capsule per day.
• If you have severe liver problems, your doctor will prescribe a lower dose.

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

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

How to take this medicine

• You may take the capsules at any time of day.
• You may 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 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 empty the pellets into half a glass of water (non-carbonated). Do not use other liquids.

• Drink the mixture immediately or within 30 minutes. Always stir the mixture before taking it.

• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. This medicine contains whole particles—do not chew or crush them.

• If you cannot swallow anything, the pellets may be mixed with a small amount of water and administered via a syringe. This can be delivered through a tube directly into your stomach ("gastric tube"). It is important to assess the suitability of the syringe and tube to be used.

Children under 12 years of age

Esomeprazol Teva-ratiopharm is not recommended in children under 12 years of age.

Elderly patients

No dose adjustment is required for this group of patients.

If you take more Esomeprazol Teva-ratiopharm than you should

If you take more Esomeprazol Teva-ratiopharm than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Esomeprazol Teva-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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Esomeprazol Teva-ratiopharm can produce adverse effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Esomeprazol Teva-ratiopharm and contact your 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, throat, or entire body, skin 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 redness of the skin with blistering or peeling, even after several weeks of treatment. You may also develop severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals. 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”, 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 swollen 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 assessment of adverse effects:

Common (may affect up to 1 in 10 patients)

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

Uncommon (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 monitoring liver function,
• skin rash, raised rash (urticaria), and skin itching.
• fracture of wrist, hip, or spine

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

• blood disorders such as reduced number of white blood cells or platelets. This causes weakness, bruising, or more frequent infections,
• low sodium levels in blood. This may cause weakness, discomfort (vomiting), and cramps,
• feeling of restlessness, confusion, or depression,
• taste disturbances,
• vision problems such as blurred vision,
• sudden feeling of difficulty breathing or shortness of breath (bronchospasm),
• inflammation inside the mouth,
• a fungal infection called “candidiasis” that may affect the intestine,
• liver problems, including jaundice which may cause yellowing of the skin, dark urine, and fatigue,
• hair loss (alopecia),
• skin rash after exposure to sunlight,
• joint pain (arthralgia) or muscle pain (myalgia),
• general feeling of malaise 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 onset of a severe rash, blisters, or skin peeling. This may 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,
• breast enlargement in men.

Esomeprazol Teva-ratiopharm may very rarely affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a markedly reduced general condition, or fever with signs 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 a 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 Teva-ratiopharm for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, tetany, delirium, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low blood magnesium levels may 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 (possibly leading to 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 not listed in this leaflet. You may also report them directly through 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 Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Blister pack

Do not store above 30 °C.

Keep in the original packaging to protect from moisture.

HDPE bottle

Do not store above 30 °C.

Keep the container tightly closed to protect from moisture.

After opening the container:

Do not store above 25 °C.

Keep the container tightly closed to protect from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Teva-ratiopharm 20 mg

• The active substance is esomeprazole magnesium. Each gastro-resistant hard capsule contains 20 mg of esomeprazole (as magnesium dihydrate).
• The other components (excipients) are saccharose, maize starch, 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; gelatin; titanium dioxide (E-171) and iron oxide red (E-172) in the capsule shell.

Appearance of the product and contents of the container

The body and cap of Esomeprazol Teva-ratiopharm 20 mg gastro-resistant hard capsules EFG are slightly pink in colour. 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 in HDPE bottles containing 98 capsules with a desiccant capsule. Do not ingest the desiccant capsule included in the bottle.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor, 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 medicinal product is authorized in the European Economic Area member states under the following names:

Portugal Esomeprazol ratiopharm

Spain Esomeprazol Teva-ratiopharm

Date of the most recent revision of this leaflet: June 2025