Package Leaflet: Information for the user

Esomeprazole ratiopharm 20 mg Hard Capsules EFG

Esomeprazolratiopharmcontains 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 the stomach.

Adults

Esomeprazolratiopharmis used to treat the following diseases:

• “Gastroesophageal reflux disease” (GERD). Where the acid from the stomach rises up into the esophagus (the tube that connects the throat with the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or the upper part of the small 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 medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol ratiopharm may 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).

• Continuation treatment for the prevention of bleeding from peptic ulcer induced by intravenous route.

Adolescents 12 years and older

• Gastroesophageal reflux disease (GERD). Where the acid from the stomach rises up into the esophagus (the tube that connects the throat with the stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or the upper part of the small 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.

Do not take Esomeprazol 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 (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• 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 unsure, 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 similar medicine to Esomeprazol ratiopharm to reduce stomach acid.
• You are due to have a specific blood test (Cromogranin A).

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

• You lose a lot of weight without any reason and have trouble swallowing,
• You feel stomach pain or indigestion,
• You start vomiting food or blood,
• Your stools are black (stools with blood).

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

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

Rashes and skin symptoms

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

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may include mouth ulcers, throat, nose, genital and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after symptoms similar to flu, 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.

Children under 12 years

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

Other medicines and Esomeprazol ratiopharm

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine. This is because Esomeprazol ratiopharm may affect the way some medicines work and some medicines may affect Esomeprazol ratiopharm.

Do not take Esomeprazol ratiopharm if you are taking a medicine that contains nelfinavir (used to treat HIV).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV),
• 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 epilepsy),
• Fenitoin (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 – pain in the legs when walking caused by a lack of blood supply),
• Cisapride (used to treat indigestion and heartburn),
• Digoxin (used for heart problems),
• Metotrexate (chemotherapy used at high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may stop 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 together with Esomeprazol ratiopharm to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor if you are taking any other medicine.

Taking Esomeprazol ratiopharm with food and drink

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 are planning to become pregnant, consult your doctor or pharmacist before using any medicine. Your doctor will decide if you can take Esomeprazol ratiopharm during this time.

Esomeprazol ratiopharm is not known to pass into breast milk. Therefore, you should not take Esomeprazol ratiopharm if you are breastfeeding.

Driving and using machines

Esomeprazol ratiopharm is unlikely to affect your ability to drive vehicles or use any tools or machines.However, rare side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you notice any of these side effects.

Esomeprazol ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it 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 him before taking this medicine.

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

• If you are taking this medication for a long period of time, your doctor will want to monitor you (particularly if you are taking it for more than a year).
• If your doctor has told you to take this medication 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, your 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 capsule of esomeprazole 40 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once your throat has healed is one capsule of esomeprazole 20 mg once a day.
• If your throat has not been damaged, the recommended dose is one capsule of esomeprazole 20 mg per day. Once the situation is under control, your doctor may tell you to take your medication as and when you need it, up to a maximum of one capsule of esomeprazole 20 mg per day.
• If you have severe liver problems, your doctor will tell you a lower dose.

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

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

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

• The recommended dose is one capsule of esomeprazole 20 mg once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs

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

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

• The recommended dose is one capsule of 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and will decide for how long you will have to take the medication. The maximum dose is 80 mg twice a day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced by intravenous route

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

Adolescents 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 capsule of esomeprazole 40 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once your esophagus has healed is one capsule of esomeprazole 20 mg once a day.
• If your throat has not been damaged, the recommended dose is one capsule of esomeprazole 20 mg per day. Once the situation is under control, your doctor may tell you to take your medication as and when you need it, up to a maximum of one capsule of esomeprazole 20 mg per day.
• If you have severe liver problems, your doctor will tell you a lower dose.

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

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

How to take this medication

• 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 medication from being broken down by the acid in your stomach. It is essential 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 pour the pellets into half a glass of water (without gas). Do not use other liquids.
• Drink the mixture directly or within 30 minutes. Always rinse the glass well with half a glass of water and drink it. This medication contains whole pieces - do not chew or crush them.

• If you cannot swallow anything, the pellets can be mixed with a little water and put into a syringe. This can be administered directly into your stomach ("gastric tube"). It is essential to analyze the suitability of the syringe and tube to be used.

Children under 12 years

Esomeprazole ratiopharm is not recommended for children under 12 years.

Older 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Esomeprazol ratiopharmmay cause side effects, although not everyone will experience them.

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

• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

• Sudden difficulty breathing, swelling of the lips, tongue, and throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

These side effects are rare and may affect up to 1 in 1,000 people.

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Blisters may also appear on the lips, eyes, mouth, nose, and genitals. Skin rashes may become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It may be a “multiforme erythema”,“Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”.

These side effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

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

Frequent(may affect up to 1 in 10 patients)

• Headache,
• Effects on your stomach or intestines: diarrhea, stomach pain, constipation, flatulence,
• Sensation of dizziness (nausea) or discomfort (vomiting),
• Benign stomach polyps.

Infrequent(may affect up to 1 in 100 patients)

• Swelling of the feet and ankles,
• Sleep disturbances (insomnia),
• Dizziness, sensation of tingling, numbness,
• Sensation of vertigo,
• Dry mouth,
• Changes in blood tests that control liver function,
• Skin rash, hives, and itching.
• Fracture of the wrist, hip, or spine

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

• Blood disorders such as a reduced number of white blood cells or platelets. This causes weakness, bruises, or frequent infections,
• Low sodium levels in the blood. This may cause weakness, discomfort (vomiting), and muscle cramps,
• Sensation of agitation, confusion, or depression,
• Changes in taste,
• Eye problems such as blurred vision,
• Sudden sensation of difficulty breathing or lack of breath (bronchospasm),
• Inflammation of the inside of the mouth,
• An infection called “candidiasis” that may affect the intestines and is caused by a fungus,
• Liver problems, including jaundice that may cause yellowing of the skin, dark urine, and fatigue,
• Hair loss (alopecia),
• Skin rash after exposure to the sun,
• Pain in the joints (arthritis) or muscles (myalgia),
• Sensation of general discomfort and lack of energy,
• Increased sweating.

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

• Changes in blood counts, including agranulocytosis (lack of white blood cells),
• Aggression,
• To see, feel, or hear things that do not exist (hallucinations),
• Severe liver problems that lead to liver failure and brain inflammation,
• Sudden appearance of a severe rash or blisters or peeling of the skin. This may be associated with a 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,
• Increased breast size in men.

Esomeprazol ratiopharm may, in very rare cases, affect white blood cells, leading to immunodeficiency. If you have an infection with symptoms such as fever with a general condition that is very reduced or fever with symptoms of a local infection such as neck pain, throat pain, 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 to provide information about your medication.

Unknown frequency (cannot be estimated from available data)

• If you are taking Esomeprazol ratiopharm for more than three months, it is possible that magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, tetany, delirium, convulsions, dizziness, or increased heart rate. If you experience any of these problems, consult your doctor immediately. Low magnesium levels in the blood 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 (which may trigger diarrhea)
• Skin rash, possibly with joint pain

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication 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 packaging

Do not store at a temperature above30 °C.

Store in the original packaging to protect it from moisture.

HDPE bottle

Do not store at a temperature above30 °C.

Store the sealed container to protect it from moisture.

After opening the container:

Do not store at a temperature above25 °C.

Store the sealed container to protect it from moisture.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Esomeprazol ratiopharm 20 mg

• The active ingredient is esomeprazole magnesium. Each gastro-resistant hard 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, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion 30%, and polysorbate 80 in the pellets in the capsule core and gelatin; titanium dioxide (E-171) and iron oxide red (E-172) in the capsule body.

Appearance of the product and contents of the packaging

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

The capsules are available in packaging of7, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 90, 98, and 100 capsules in blister packaging and packaging of 98 capsules and desiccant capsule in HDPE bottles. Do not ingest the desiccant capsule that comes in the bottle.

Only some sizes of packaging may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor, Alcobendas

28108 Madrid-Spain

Responsible 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 with the following names:

PortugalEsomeprazol ratiopharm

SpainEsomeprazol ratiopharm

Last revision date of this leaflet:March 2023