Package Leaflet: Information for the User

Esomeprazol Teva 20 mg Hard Gastrorresistant Capsules EFG

Esomeprazol Teva 40 mg Hard Gastrorresistant Capsules EFG

Esomeprazole

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

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

3. How to take Esomeprazol Teva

4. Possible side effects

5. Storage of Esomeprazol Teva

6. Contents of the pack and additional information

Esomeprazol Teva contains a medicine called esomeprazole that belongs to a group of medicines called “proton pump inhibitors”. They work by reducing the amount of acid produced by the stomach.

Esomeprazol Teva is used to treat the following diseases:

Adults

• Gastroesophageal reflux disease (GERD). Where stomach acid 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 ulcers caused by medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Esomeprazol Teva 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 ulcers induced by intravenous administration.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). Where stomach acid 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 (duodenum) that are infected by a 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 Teva

• if you are allergic to esomeprazole, or to any of the other ingredients of this medicine (listed in 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 Teva if any of the above applies to you. If you are unsure, talk to your doctor or pharmacist before taking Esomeprazol Teva.

Warnings and precautions

Consult your doctor or pharmacistbefore 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 similar medicine to Esomeprazol Teva to reduce stomach acid.
• You are due to have a specific blood test (Cromogranin A).

Esomeprazol Teva may mask the symptoms of other diseases.Therefore, if any of the following happens before you start taking Esomeprazol Teva 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 Teva and notice any symptoms, you should contact your doctor if the symptoms of your disease persist or change.

The taking of proton pump inhibitors like Esomeprazol Teva, especially for a period of more than one 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 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 Teva. 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 peeling of the skin.

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 Teva should not be used in children under 12 years, as there is no data available.

Other medicines and Esomeprazol Teva

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines bought without a prescription. This is because Esomeprazol Teva may affect the way some medicines work and some medicines may affect Esomeprazol Teva.

Do not take Esomeprazol Teva 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).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Esomeprazol Teva.
• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping Esomeprazol Teva.
• 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 to treat heart problems)
• Methotrexate (chemotherapy used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may stop treatment with Esomeprazol Teva.
• Tacrolimus (organ transplant)
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat depression)

If your doctor has prescribed antibiotics amoxicillin and clarithromycin with Esomeprazol Teva to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor about any other medicine you are taking.

Taking Esomeprazol Teva 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 before using this medicine.

Your doctor will decide if 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 breastfeeding.

Driving and using machines

Esomeprazol Teva 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 Teva contains sodium

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

Esomeprazol Teva contains sucrose

This medicine contains sucrose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 have been 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, age, and how your liver works.

• The recommended dose is indicated below:

Use in adults 18 years and 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 Esomeprazol Teva 40 mg 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 Esomeprazol Teva 20 mg gastro-resistant capsule once a day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazol Teva 20 mg gastro-resistant capsule once a 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 Esomeprazol Teva 20 mg gastro-resistant 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 Esomeprazol Teva 20 mg gastro-resistant capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics such as amoxicillin and clarithromycin.

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

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

To prevent stomach ulcers if you are taking NSAIDs:

• The recommended dose is one Esomeprazol Teva 20 mg gastro-resistant capsule 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 Esomeprazol Teva 40 mg gastro-resistant capsule twice a day.
• Your doctor will adjust the dose according to your needs and will decide for how long you should take this medication. The maximum dose is 80 mg twice a day.

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

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

Use in adolescents 12 years and 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 Esomeprazol Teva 40 mg 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 esophagus has healed is one Esomeprazol Teva 20 mg gastro-resistant capsule once a day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazol Teva 20 mg gastro-resistant capsule once a 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 Esomeprazol Teva 20 mg gastro-resistant capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics such as 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 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 (gastrostomy).

Children under 12 years

Esomeprazol Teva should not be used in children under 12 years, as there is no available data.

Older adults

No dose adjustment is required in older adults.

If you take more Esomeprazol Teva than you should

If you take more Esomeprazol Teva 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 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 the missed dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 may 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, skin rash, sensation 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 skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes can turn into severe and generalized skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a “multiforme erythema”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Headache,

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

Occasional (may affect up to 1 in 100 people)

• 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 how your liver functions,
• Skin rash, hives, and itching on 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 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 people)

• 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 inflammation of the brain,
• 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),
• Weakness of the muscles,
• Severe kidney problems,
• Enlargement of the breasts in men.

Frequency unknown (cannot be estimated from available data)

• If you are taking Esomeprazol Teva 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

Esomeprazol Teva 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.

Reporting of side effects

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

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

Blister (OPA/Al/PE + DES/laminate Al)

This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture

or

Blister (OPA/Al/PVC + Al laminate)

Do not store at a temperature above 30°C

Store in the original packaging to protect it from moisture

HDPE Bottle

This medication does not require special storage conditions.

Store the container perfectly closed 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 trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Esomeprazol Teva

The active ingredient is esomeprazol.

Each gastro-resistant hard capsule contains 20 mg or 40 mg of esomeprazol (as esomeprazol 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, polisorbate 80 (E-433) and copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion 30% in the pellets in the capsule, and gelatin (E-441) titanium dioxide (E-171) iron oxide red (E-172) in the capsule body. See section 2 “Esomeprazol Teva contains sucrose”.

Appearance of the product and contents of the package

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

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

The capsules are available in blister packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules, and in HDPE bottles of 98 capsules and a desiccant capsule. Do not ingest the desiccant capsule that comes in the bottle.

Only some package sizes 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

Smarjeska cesta 6

Novo mesto-8501- Slovenia

Ó

Merckle GmbH

Ludwig-Merckle-Strassee 3

D-89143 Blaubeuren

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names

Germany:Esomeprazol AbZ 20 mg gastro-resistant hard capsules

Esomeprazol AbZ 20 mg gastro-resistant hard capsules

Slovenia:Esora 20 mg hard gastro-resistant capsules

Esora 20 mg hard gastro-resistant capsules

Spain:Esomeprazol Teva 20 mg gastro-resistant hard capsules EFG

Esomeprazol Teva 20 mg gastro-resistant hard capsules EFG

Last review date of this leaflet: 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 agitate the syringe to distribute the granules uniformly in the suspension.

3.Hold the syringe with the tip upwards and check that the tip has not become clogged.

4.Insert the syringe into the tube while maintaining the previous position.

5.Agitate the syringe and place it with the tip downwards. Immediately inject 5 - 10 ml into the tube. Invert the syringe after injection and agitate (the syringe must be held with the tip upwards to avoid clogging the tip)

6.Turn the syringe with the tip downwards and inject immediately 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.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/