ESOMEPRAZOL TEVAGEN 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Tevagen 20 mg Gastro-Resistant Tablets EFG

Esomeprazol Tevagen 40 mg Gastro-Resistant Tablets EFG

esomeprazol

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

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

Esomeprazol Tevagen contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that the stomach produces.

Esomeprazol Tevagen is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers caused by 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 called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Tevagen can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of bleeding from stomach ulcers caused by Helicobacter pyloriin patients who have been treated with esomeprazole injection.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers caused by 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 taking Esomeprazol Tevagen

Do not take Esomeprazol Tevagen

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

If any of the above apply to you, do not take Esomeprazol Tevagen. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Tevagen.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol Tevagen:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Tevagen to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Esomeprazol may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while taking esomeprazol, contact your doctor immediately:

• You lose a lot of weight without reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If you have been prescribed esomeprazol only when you notice symptoms, you should contact your doctor if your symptoms persist or change.

Taking proton pump inhibitors like esomeprazol, especially over a period of more than one year, may slightly increase the risk of hip, wrist, and spine fractures. Consult your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Rashes and skin lesions

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with esomeprazol. Also, remember to mention any other symptoms that you may notice, such as joint pain.

Severe skin lesions have been reported in patients taking esomeprazol (see also section 4). The rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and itchy eyes). These severe skin lesions usually start after symptoms similar to flu, such as fever, headache, and body pain. The rash may cover large areas of the body with blisters and peeling skin.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin lesions, stop taking this medicine and contact your doctor immediately.

Children under 12 years

Esomeprazol should not be used in children under 12 years of age. There are other formulations of this medicine that are more suitable for these patients.

Taking Esomeprazol Tevagen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because esomeprazol may affect how these medicines work, and these medicines may also affect how esomeprazol works.

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

• Atazanavir or saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole, or voriconazole (for fungal infections)
• Ertonilib (used to treat cancer)
• Citalopram, imipramine, clomipramine (for depression)
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy)
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking esomeprazol
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazol
• Cilostazol (used to treat intermittent claudication - pain in the legs when walking, caused by poor blood circulation)
• Cisapride (used for indigestion and heartburn)
• Digoxin (used to treat heart problems)
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with esomeprazol
• Tacrolimus (organ transplantation)
• Rifampicin (used to treat tuberculosis)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin with Esomeprazol Tevagen to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

Taking Esomeprazol Tevagen with food and drink

You can take the tablets with or without food.

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 during this time.

It is not known if esomeprazol passes into breast milk. Therefore, you should not take esomeprazol during breast-feeding.

Driving and using machines

Esomeprazol is unlikely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness and blurred vision are uncommon or rare (see section 4). If you are affected, you should not drive or use machines.

Esomeprazol Tevagen contains sucrose

This medicine contains sugar spheres that contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Esomeprazol Tevagen contains sodium

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

3. How to take Esomeprazol Tevagen

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

• If you take this medicine for a long time, your doctor will need to keep a regular check on you (especially if you take it for more than one year).
• If your doctor has told you to take this medicine only when you notice symptoms, tell your doctor if your symptoms change.

How much to take

• Your doctor will have told you how many tablets to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are given below.

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

Adults and adolescents from 12 years of age

• If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one 40 mg tablet of esomeprazole once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is one 20 mg tablet of esomeprazole once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg tablet of esomeprazole once a day. Once the condition has been controlled, your doctor will tell you how to take your medicine as and when you need it, up to a maximum of one 20 mg tablet of esomeprazole once a day.
• If you have serious liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to prevent them coming back:

• Adults and adolescents from 12 years of age: the recommended dose is one 20 mg tablet of esomeprazole twice a day for one week.
• Your doctor will also prescribe antibiotics for you to take at the same time.

For the treatment of stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• Adults from 18 years of age: the recommended dose is one 20 mg tablet of esomeprazole once a day for 4-8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs)

• Adults from 18 years of age: the recommended dose is one 20 mg tablet of esomeprazole once a day.

For the treatment of too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• Adults from 18 years of age: the recommended dose is one 40 mg tablet of esomeprazole twice a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Prevention of bleeding from stomach ulcers caused by Helicobacter pyloriin patients who have been treated with esomeprazole injection:

• Adults from 18 years of age: the recommended dose is one 40 mg tablet of esomeprazole once a day for 4 weeks.

Taking this medicine

• You can take the tablets at any time of the day.
• You can take the tablets with or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules which stop the medicine being broken down by the acid in the stomach. It is important not to damage these granules.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:

• Put the tablet in half a glass of non-fizzy water. Do not use other liquids.
• Stir until the tablet breaks up (the mixture will not be clear). Drink the mixture straight away or within 30 minutes. Always stir just before drinking.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine - do not chew or crush them.

• If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (a syringe without a needle) directly into the stomach through a tube.

Children and adolescents under 12 years

Esomeprazol Tevagen is not recommended for children under 12 years of age. There are other formulations of this medicine that are more suitable for these patients.

Patients with kidney problems

No dose adjustment is necessary in patients with kidney problems.

If you take more Esomeprazol Tevagen than you should

If you take more esomeprazol than you should, talk to a doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, indicating the medicine and the amount taken.

If you forget to take Esomeprazol Tevagen

• 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 product, 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 observe any of the following serious adverse effects, stop taking Esomeprazol Tevagen and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden difficulty breathing, swelling of lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• Sudden appearance of a severe skin 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 (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms". These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Frequent (affect up to 1 in 10 people)

• Headache
• Effects on the stomach or intestine: stomach pain, constipation, diarrhea, gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Infrequent (affect up to 1 in 100 people)

• Swelling of feet and ankles
• Sleep disturbance (insomnia)
• Dizziness, tingling, and numbness, drowsiness
• Vertigo sensation
• Dry mouth
• Alteration of blood tests that determine liver function
• Skin rash, hives, skin itching
• Hip, wrist, and spine fractures (if esomeprazole is used at high doses or for prolonged periods)

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

• Blood disorders such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the likelihood of infections
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps
• Agitation, confusion, or depression
• Taste alteration
• Eye disorders such as blurred vision
• Sudden sensation of shortness of breath or difficulty breathing (bronchospasm)
• Inflammation inside the mouth
• An infection known as "candidiasis" that can affect the intestine and is caused by a fungus
• Liver problems including jaundice that can cause yellow skin, dark urine, and fatigue
• Hair loss (alopecia)
• Sunlight-induced dermatitis
• Joint pain (arthralgia) or muscle pain (myalgia)
• General feeling of discomfort and lack of energy
• Increased sweating

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

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells)
• Aggressiveness
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Liver disorders that can lead to liver failure or brain inflammation
• Sudden appearance of severe skin rash, blisters, or skin peeling. These symptoms can be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms)
• Muscle weakness
• Severe kidney disorders
• Increased breast size in men

Frequency not known (cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low blood magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, contact your doctor as soon as possible. Low magnesium levels can also trigger a reduction in blood potassium or calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation in the intestine (resulting in diarrhea).
• Skin rash, possibly with joint pain

In very rare cases, Esomeprazol Tevagen can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of your general condition or fever with symptoms of a local infection such as neck, throat, mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform about your medication.

Reporting Adverse Effects

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

5. Storage of Esomeprazol Tevagen

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date that appears on the packaging after "EXP" or "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines 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 you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Tevagen

• The active ingredient is esomeprazole magnesium dihydrate.

Each 20 mg Esomeprazol Tevagen tablet contains 20 mg of esomeprazole (corresponding to 21.75 mg of esomeprazole magnesium dihydrate).

Each 40 mg Esomeprazol Tevagen tablet contains 40 mg of esomeprazole (corresponding to 43.5 mg of esomeprazole magnesium dihydrate).

• The other components are:

Tablet content: Methacrylic acid-acrylic acid copolymer (1:1), talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol, mono-stearate 40-55, polysorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearyl fumarate.

Tablet coating: Hypromellose, titanium dioxide (E171), macrogol/PEG 400, red iron oxide (E172), yellow iron oxide (E172).

Product Appearance and Package Contents

Esomeprazol Tevagen 20 mg are film-coated tablets, biconvex, elliptical in shape, light pink in color, 6.55 x 13.6 mm.

Esomeprazol Tevagen 40 mg are film-coated tablets, biconvex, elliptical in shape, pink in color, 8.2 x 17 mm.

The tablets are available in:

Package sizes:

Bottle: 28, 30, 60, 100, or 250 tablets.

Blister: 7, 10, 14, 28, 30, 56, 60, 90, or 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shose Str.

Dupnitsa 2600

Bulgaria

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

This prospectus was approved in:June 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84119/P_84119.html

QR code + URL

The following information is only for healthcare professionals:

Administration through a gastric tube

1. Put the tablets in 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 required to avoid clogging the tube.
2. Shake the syringe immediately to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip is not clogged.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip down. Inject immediately 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. Put the syringe back with the tip down and inject immediately another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.

Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any remaining sediment from the syringe. For some tubes, 50 ml of water are required.