Patient Information Leaflet

Esomeprazol ratiopharm 40 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you

about your medicine

- Keep this leaflet, as you may need to read it again.

- If you are unsure about anything, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you start taking Esomeprazol ratiopharm

3. How to take Esomeprazol ratiopharm

4. Possible side effects

5. Storage of Esomeprazol ratiopharm

6. Contents of the pack and additional information

Esomeprazol ratiopharm contains a medicine called esomeprazole. 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 with the stomach) causing pain, inflammation, and heartburn.

towards the esophagus (the tube that connects the throat with the stomach) causing pain, inflammation, and heartburn.

inflammation and heartburn of the stomach.

- 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 medicines called NSAIDs (nonsteroidal 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).

- Continued treatment of the prevention of bleeding from peptic ulcers 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 with 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.

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 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 similar medicine to Esomeprazol ratiopharm to reduce stomach acid.
• If you are due to have a specific blood test (Cromogranina 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 for no reason and have trouble swallowing,

•you have 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 use 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).

Skin eruptions and skin symptoms

If you get a skin eruption, especially in sun-exposed areas, 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 eruptions have occurred in patients taking esomeprazole (see also section 4). The eruption may include mouth ulcers, throat, nose, genital ulcers and conjunctivitis (red and swollen eyes). These severe skin eruptions usually occur after symptoms similar to flu, such as fever, headache and body aches. The eruption 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 need 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 containsnelfinavir(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),

- Phenobarbital (used in epilepsy). If you are taking phenobarbital, 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 that is caused by a lack of blood supply),
• Cisapride (used to treat 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 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 with Esomeprazol ratiopharm to treat ulcers caused byHelicobacter pyloriinfection, it is very important to 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 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.

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

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 may occur (see section 4). 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 (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 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 40 mg esomeprazole gastro-resistant capsule 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 20 mg esomeprazole capsule once a day.

• If your throat has not been damaged, the recommended dose is one 20 mg esomeprazole capsule 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 20 mg esomeprazole capsule 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 20 mg esomeprazole capsule 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 20 mg esomeprazole capsule per day for 4 to 8 weeks.

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

• The recommended dose is one 20 mg esomeprazole capsule per day.

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

• The recommended dose is two 40 mg esomeprazole capsules per 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 40 mg esomeprazole capsule per 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 is slightly damaged, the recommended dose is one 40 mg esomeprazole gastro-resistant capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not healed.
• The recommended dose once your esophagus has healed is one 20 mg esomeprazole capsule per day.
• If your esophagus has not been damaged, the recommended dose is one 20 mg esomeprazole capsule 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 20 mg esomeprazole capsule 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 20 mg esomeprazole capsule 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 remove the mixture before taking it.
• To be sure you drank all the medication, clear the glass very 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 20 mg gastro-resistant capsules are not recommended for children under 12 years.

Older adults

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 doubts about the use of this medication, ask your doctor or pharmacist.

Esomeprazol ratiopharmlike all medications, may cause side effects, although not everyone will experience them.

If you notice any of the following serious 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)(may affect up to 1 in 10 patients)

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

Infrequent (may affect up to 1 in 100 patients)(may affect up to 1 in 100 patients)

• Swelling of the feet and ankles,
• Sleep disturbances (insomnia),
• Dizziness, tingling, numbness,
• Feeling 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)(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, bruising, or frequent infections,
• Low sodium levels in the blood. This may cause weakness, nausea, and cramps,
• Feeling agitated, confused, or depressed,
• Changes in taste,
• Eye problems such as blurred vision,
• Sudden feeling of difficulty breathing or lack of breath (bronchospasm),
• Inflammation of the inside of the mouth,
• An infection called “candidiasis” that can 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),
• General feeling of discomfort and lack of energy,
• Increased sweating.

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

• Changes in blood counts, including agranulocytosis (lack of white blood cells),
• Aggression,
• Seeing, feeling, or hearing things that do not exist (hallucinations),
• Severe liver problems that lead to liver failure and brain inflammation,
• Sudden appearance of a severe skin rash or blisters or peeling of the skin. 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,
• Enlargement of the breasts 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 essential 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 may 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 effectsIf 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 Pharmacovigilance 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 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 sealed container to protect it from moisture.

After opening the container:

Do not store at a temperature above 25 °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. By doing so, you will help protect the environment.

Composition of Esomeprazol ratiopharm 40 mg

• The active ingredient is esomeprazole magnesium. Each gastro-resistant hard 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, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion 30%, and polysorbate 80 in the pellets in the capsule core, and gelatin, titanium dioxide (E171), and iron oxide red (E172) in the capsule body.

Appearance of the product and content of the container

The body and cap of the Esomeprazol ratiopharm 40 mg gastro-resistant hard capsules EFG are pink. The capsules contain white or almost white pellets.

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

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, 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:

Portugal Esomeprazol ratiopharm

Spain Esomeprazol ratiopharm

Last review date of this leaflet : March 2023