ESOMEPRAZOL TEVA 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Esomeprazol Teva 20 mg gastro-resistant hard capsules EFG

Esomeprazol Teva 40 mg gastro-resistant hard capsules EFG

esomeprazol

Contents of the pack and other information

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

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

Esomeprazol Teva contains a medicine called esomeprazol. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

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

Adults

• Gastro-oesophageal reflux disease (GORD). Where the acid in your stomach rises into your oesophagus (the tube that connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in your stomach or the upper part of your 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.
• Ulcers in your stomach caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Teva may also be used to prevent ulcers caused by NSAIDs.
• Too much acid in your stomach caused by a tumour in your pancreas (Zollinger-Ellison syndrome).
• Treatment of a condition where your stomach produces too much acid, including Zollinger-Ellison syndrome.

Adolescents from 12 years of age and older

• Gastro-oesophageal reflux disease (GORD). Where the acid in your stomach rises into your oesophagus (the tube that connects your throat to your stomach) causing pain and inflammation.
• Ulcers in your stomach or the upper part of your intestine (duodenum) 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 Teva

Do not take Esomeprazol Teva

• if you are allergic to esomeprazol or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazol),
• if you are taking a medicine containing nelfinavir (used to treat HIV).

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

Warnings and precautions

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

Esomeprazol Teva may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazol Teva or while you are taking it, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If your doctor has prescribed Esomeprazol Teva for you, and you get any of these symptoms, you should contact your doctor immediately.

Taking a proton pump inhibitor like Esomeprazol Teva, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell 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 Teva. Also remember to mention any other side-effects like pain in your joints.

Children under 12 years

Esomeprazol Teva should not be used in children under the age of 12, as there is no experience of its use in this group.

Severe skin reactions, including Stevens-Johnson syndrome, have been reported with esomeprazol (see also section 4). The symptoms include redness, blistering and peeling of the skin, as well as fever, chills and a general feeling of being unwell. These reactions may start with a rash or a skin lesion and may progress to widespread peeling of the skin, which may also involve the eyes, mouth, and other areas of the body. If you experience any of these symptoms, stop taking Esomeprazol Teva and contact your doctor immediately.

Other medicines and Esomeprazol Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Esomeprazol Teva can affect the way some medicines work and some medicines can have an effect on Esomeprazol Teva.

Do not take Esomeprazol Teva if you are taking a medicine containing nelfinavir (used to treat HIV).

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 infections caused by

fungi).

• 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 Teva.

• Medicines used to thin your blood, such as warfarin. Your doctor may need to

monitor you when you start or stop taking Esomeprazol Teva.

• Cilostazol (used to treat intermittent claudication – a condition where your legs do not get enough blood when you walk, which can cause pain).
• 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 Teva 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 Teva 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 Teva with food and drink

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

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 Teva during this time.

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

Driving and using machines

Esomeprazol Teva is unlikely to affect your ability to drive or use any tools or machines.

However, sometimes side effects like dizziness or blurred vision (see section 4) can occur. Do not drive or use any tools or machines if you are affected in this way.

Esomeprazol Teva contains sodium

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

Esomeprazol Teva contains sucrose

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

3. How to take Esomeprazol Teva

Always take this medicine exactly as your doctor 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, especially if you are taking it for more than a year.
• 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:

Use in adults aged 18 years and older

To treat heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your oesophagus (gullet) is slightly damaged, the recommended dose is one 40 mg gastro-resistant capsule of Esomeprazol Teva 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 gastro-resistant capsule of Esomeprazol Teva once a day.
• If your gullet has not been damaged, the recommended dose is one 20 mg gastro-resistant capsule of Esomeprazol Teva once a 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 gastro-resistant capsule of Esomeprazol Teva per day.
• If you have severe liver problems, your doctor will give you a lower dose.

To treat ulcers caused by infection with Helicobacter pylori and to stop them coming back:

• The recommended dose is one 20 mg gastro-resistant capsule of Esomeprazol Teva twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant capsule of Esomeprazol Teva once a day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant capsule of Esomeprazol Teva once a day.

To treat too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg gastro-resistant capsule of Esomeprazol Teva twice a day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Treatment of a condition where your stomach produces too much acid, including Zollinger-Ellison syndrome.

Continuation of treatment to prevent bleeding from a stomach ulcer after an intravenous injection of esomeprazol:

• The recommended dose is one 40 mg gastro-resistant capsule of Esomeprazol Teva once a day for 4 weeks.

Use in adolescents aged 12 years and older

To treat heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your oesophagus (gullet) is slightly damaged, the recommended dose is one 40 mg gastro-resistant capsule of Esomeprazol Teva 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 gastro-resistant capsule of Esomeprazol Teva once a day.
• If your gullet has not been damaged, the recommended dose is one 20 mg gastro-resistant capsule of Esomeprazol Teva once a day.
• If you have severe liver problems, your doctor will give you a lower dose.

To treat ulcers caused by infection with Helicobacter pylori and to stop them coming back:

• The recommended dose is one 20 mg gastro-resistant capsule of Esomeprazol Teva twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

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. Do not use other liquids.
  • Drink the mixture straight away or within 30 minutes. Always stir the mixture before drinking it.
  • To make sure that you get all of the medicine, rinse the glass with half a glass of water and drink it. The medicine should 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 tube directly into your stomach (“gastric tube”).

Children under 12 years

Esomeprazol Teva should not be used in children under the age of 12, as there is no experience of its use in this group.

Elderly

No dose adjustment is necessary in patients over 65 years.

If you take more Esomeprazol Teva than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the national information centre, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Esomeprazol Teva

• 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, this medicine can cause adverse effects, although not all people suffer from them.

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

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems. These effects are rare, occurring in less than 1 in 1,000 patients.
• Sudden wheezing, inflammation of the lips, tongue, and throat or body, rash, feeling of dizziness or difficulty swallowing (severe allergic reaction). These effects are rare, occurring in less than 1 in 1,000 patients.
• 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. This could be a "multiform erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

• 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 people)

• swelling of feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling, numbness,
• feeling of (vertigo),
• dry mouth,
• changes in blood tests that control how your liver works,
• rash, bumpy rash (urticaria), and itching of the skin,
• fracture of the wrist, hip, or spine (if Esomeprazol Teva is used at high doses and for a long period)

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

• blood problems such as a reduced number of white blood cells or platelets. This can cause weakness, bruising, or frequent infections,
• 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 yellowing of the skin, dark urine, and fatigue,
• hair loss (alopecia),
• 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 people)

• 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 (multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms),
• muscle weakness,
• severe kidney problems,
• increase in breast size in men.

Frequency Not Known (cannot be estimated from the available data)

• If you are taking Esomeprazol Teva 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, and 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 cause diarrhea)
• Rash, possibly with joint pain

Esomeprazol Teva may, in very rare cases, 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 essential that you provide information about your medication.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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. Conservation of Esomeprazol Teva

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 CAD. The expiration date is the last day of the month indicated.

Blister pack (OPA/Al/PE + film DES/Al foil)

This medicine does not require any special storage temperature.

Keep in the original packaging to protect it from moisture

Or

Blister pack (OPA/Al/PVC + Al foil)

Do not store above 30°C

Keep in the original packaging to protect it from moisture

HDPE bottle

This medicine does not require any special storage temperature.

Keep the container perfectly closed 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 drains 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 Teva

The active ingredient is esomeprazole.

Each hard gastro-resistant capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).

The other components (excipients) are sugar spheres (sucrose and cornstarch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E-171), macrogol 3000, macrogol 6000, talc (E-553b), heavy magnesium carbonate, polysorbate 80 (E-433), and methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% in the pellets in the capsule, and gelatin (E-441), titanium dioxide (E-171), red iron oxide (E-172) in the body of the capsule. See section 2 "Esomeprazol Teva contains sucrose".

Appearance of the Product and Package Contents

The body and cap of the Esomeprazol Teva 20 mg hard gastro-resistant capsules EFG are slightly pink in color. The capsules contain white or almost white pellets. Capsule size: No. 3.

The body and cap of the Esomeprazol Teva 40 mg hard gastro-resistant capsules EFG are pink in color. The capsules contain white or almost white pellets. Capsule size: No. 1.

The capsules are available in packs of 7, 10, 14, 15, 28, 30, 50, 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Smarjeska cesta 6

Novo mesto-8501- Slovenia

Or

Merckle GmbH

Ludwig-Merckle-Strassee 3

D-89143 Blaubeuren

Germany

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

Germany: Esomeprazol AbZ 20 mg magensaftresistente Hartkapseln

Esomeprazol AbZ 40 mg magensaftresistente Hartkapseln

Slovenia: Esora 20 mg trde gastrorezistentne kapsule

Esora 40 mg trde gastrorezistentne kapsule

Spain: Esomeprazol Teva 20 mg cápsulas duras gastrorresistentes EFG

Esomeprazol Teva 40 mg cápsulas duras gastrorresistentes EFG

Date of the Last Revision of this Prospectus: April 2023

The following information is intended exclusively for healthcare professionals:

Administration through the gastric tube

1. Open the capsule and empty the granules into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water is needed to avoid clogging the tube.
2. Immediately shake the syringe to distribute the granules evenly in the suspension.
3. Keep the syringe with the tip up and check that the tip is not clogged.
4. Insert the syringe into the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip down. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to avoid clogging the tip)
6. Turn the syringe with the tip down and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
7. Fill the syringe with 25 ml of water and 5 ml of air passage and repeat step 5 if necessary to wash any sediment that remains in the syringe. For some tubes, 50 ml of water is needed.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/