Esomeprazole Teva-Ratiopharm 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Esomeprazol Teva-ratiopharm 20 mg gastro-resistant tablets EFG

Esomeprazol Teva-ratiopharm 40 mg gastro-resistant tablets EFG

esomeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Esomeprazol Teva-ratiopharm contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazol Teva-ratiopharm is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by infection with a bacterium called "Helicobacter pylori". If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol Teva-ratiopharm may also be used to prevent the development of ulcers if you are taking NSAIDs.
• Excessive stomach acid production due to a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcers initiated with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by infection with a bacterium called "Helicobacter pylori". If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before starting to take Esomeprazol Teva-ratiopharm

Do not take Esomeprazol Teva-ratiopharm

• 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 other medicines in the group of proton pump inhibitors (for example, pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

If you are in any of these situations, do not take Esomeprazol Teva-ratiopharm. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Teva-ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol Teva-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 medicine similar to Esomeprazol Teva-ratiopharm used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking esomeprazole, contact your doctor immediately:

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

If esomeprazole has been prescribed for you only when you notice symptoms, you should contact your doctor if your symptoms persist or change.

Taking proton pump inhibitors such as esomeprazole, especially for periods longer 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).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas exposed to sunlight, see your doctor as soon as possible, as it may be necessary to discontinue treatment with esomeprazole. 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 ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after flu-like symptoms 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

Esomeprazole must not be used in children under 12 years of age. There are other pharmaceutical forms of this medicine more suitable for children.

Taking Esomeprazol Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription. This is because esomeprazole may affect how some medicines work, and some medicines may influence the effect of esomeprazole.

Do not take esomeprazole 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, itraconazol, or voriconazole (for fungal infections)
• Erlotinib (used to treat cancer)
• Citalopram, imipramine, clomipramine (for the treatment of 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 when you start or stop taking esomeprazole
• Medicines used to make the blood less likely to clot, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood flow)
• 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 discontinue your esomeprazole treatment
• Tacrolimus (organ transplant)
• 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 in addition to Esomeprazol Teva-ratiopharm to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol Teva-ratiopharm with food and drinks

You may take the tablets 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 this medicine.

Your doctor will decide whether you can take esomeprazole during this period.

It is unknown whether esomeprazole passes into breast milk. Therefore, esomeprazole should not be taken during breastfeeding.

Driving and using machines

It is unlikely that esomeprazole will affect your ability to drive or use tools or machines. However, adverse reactions such as dizziness and blurred vision are uncommon or occur rarely (see section 4). If you are affected, you should not drive or use machinery.

Esomeprazol Teva-ratiopharm contains sucrose

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

Esomeprazol Teva-ratiopharm contains sodium

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

3. How to take Esomeprazole Tevagen

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you notice symptoms, inform your doctor if the 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 indicated below.

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

Adults and adolescents aged 12 years and older

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one 40 mg esomeprazole tablet daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazole tablet once daily.
• If your esophagus has not been affected, the recommended dose is one 20 mg esomeprazole tablet daily. Once the condition is under control, your doctor will instruct you to take the medicine as needed, up to a maximum of one 20 mg esomeprazole tablet daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent recurrences:

• Adults and adolescents aged 12 years and older: the recommended dose is one 20 mg esomeprazole tablet twice daily for one week.
• Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

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

• Adults aged 18 years and older: the recommended dose is one 20 mg esomeprazole tablet once daily for 4 to 8 weeks.

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

• Adults aged 18 years and older: the recommended dose is one 20 mg esomeprazole tablet once daily.

For the treatment of excessive acidity caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• Adults aged 18 years and older: the recommended dose is one 40 mg esomeprazole tablet twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment to prevent rebleeding from peptic ulcer induced with intravenous esomeprazole:

• Adults aged 18 years and older: the recommended dose is one 40 mg esomeprazole tablet once daily for 4 weeks.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:

• Place the tablets in half a glass of still water. Do not use any other liquids.

• Shake until the tablets break up (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir well just before drinking.

• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

• If you cannot swallow at all, the tablets may be dispersed in water and administered via a syringe. This allows direct delivery into the stomach through a tube (gastric tube).

Children and adolescents under 12 years of age

Esomeprazol Teva-ratiopharm is not recommended for children under 12 years of age. Other pharmaceutical forms of this medicine are more suitable.

Elderly patients

No dose adjustment is required in elderly patients.

If you take more Esomeprazol Teva-ratiopharm than you should

If you take more esomeprazole than prescribed by your doctor, consult your 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 ingested.

If you forget to take Esomeprazol Teva-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, do not take 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 about 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 everyone experiences them.

If you notice any of the following serious adverse effects, stop taking Esomeprazol Teva-ratiopharm and contact a doctor immediately:

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden difficulty breathing, swelling of the lips, tongue, 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 redness of the skin with blisters or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), with potentially life-threatening consequences. This could be a case of “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Common (affects up to 1 in 10 people)

• Headache
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Uncommon (affects up to 1 in 100 people)

• Swelling of feet and ankles
• Sleep disturbance (insomnia)
• Dizziness, tingling sensation, and numbness, drowsiness
• Sensation of vertigo
• Dry mouth
• Abnormal blood test results indicating liver function
• Skin rash, hives, skin itching
• Fractures of the hip, wrist, and spine (if esomeprazole is used at high doses or for prolonged periods)

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

• Blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps
• Agitation, confusion, or depression
• Disturbance of taste
• Eye disorders such as blurred vision
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm)
• Inflammation inside the mouth
• A fungal infection known as “candidiasis” that may affect the intestine
• Liver problems including jaundice, which may cause yellowing of the skin, dark urine, and tiredness
• Hair loss (alopecia)
• Dermatitis due to exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• General feeling of malaise and lack of energy
• Increased sweating

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

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells)
• Aggressiveness
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Liver disorders that may lead to liver failure or brain inflammation
• Sudden appearance of severe skin rash, blisters, or skin peeling. These symptoms may 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
• Breast enlargement in men

Frequency not known (cannot be estimated from available data)

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

In very rare cases, Esomeprazol Teva-ratiopharm may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Tevagen

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP” or “CAD”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazole Teva-ratiopharm

• The active substance is esomeprazole magnesium dihydrate.

Each Esomeprazole Teva-ratiopharm 20 mg tablet contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate).

Each Esomeprazole Teva-ratiopharm 40 mg tablet contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).

• The other components are:

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

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

Appearance of the product and pack contents

Esomeprazole Teva-ratiopharm 20 mg are pinkish, film-coated, biconvex, elliptical tablets, 6.55 x 13.6 mm in size.

Esomeprazole Teva-ratiopharm 40 mg are pink, film-coated, biconvex, elliptical tablets, 8.2 x 17 mm in size.

The tablets are presented in:

Pack sizes:

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

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

Some pack sizes may not be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shose Str.

Dupnitsa 2600

Bulgaria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

This patient information leaflet was approved in: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. 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 intended only for healthcare professionals:

Administration via gastric tube

1. Place the tablets into an appropriate syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For certain tubes, a dispersion in 50 ml of water may be required to prevent pellet blockage.
2. Shake the syringe immediately to disperse the tablet.
3. Hold the syringe with the tip facing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip facing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip facing upwards to prevent blockage).
6. Re-position the syringe with the tip facing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.

Refill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any remaining residue from the syringe. For certain tubes, 50 ml of water may be required.