Package Insert: Patient Information

Esomeprazol ratiopharm 20 mg gastro-resistant tablets EFG

Esomeprazol ratiopharm 40 mg gastro-resistant tablets EFG

Read the package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Esomeprazol ratiopharm contains a medicine called esomeprazol. This belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazol is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and heartburn.
• Stomach ulcers or upper small intestine ulcers infected by a bacteria 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 certain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol ratiopharm can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent bleeding from peptic ulcers induced with intravenous esomeprazol.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and heartburn.
• Stomach ulcers or upper small intestine ulcers infected by a bacteria called “Helicobacter pylori”. If you have this condition, your doctor will 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 any of the other ingredients of this medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).

If you are in any of these situations, do not take Esomeprazol ratiopharm. If you are unsure, consult 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 medication to Esomeprazol ratiopharm to reduce stomach acid.
• If you are scheduled to have a specific blood test (Cromogranin A).

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

• You lose a lot of weight without reason and have trouble swallowing.
• You experience stomach pain or indigestion.
• You begin to vomit food or blood.
• Your stools appear black (blood-stained).

If you have been prescribed Esomeprazol ratiopharm only when you notice some symptoms, you should contact your doctor if the symptoms of your disease persist or change.

The use of proton pump inhibitors such as Esomeprazol ratiopharm, especially for periods of time exceeding one year, may slightly increase the risk of suffering a hip, wrist, or spinal column fracture. 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 experience a rash, especially in sun-exposed areas, go to your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol ratiopharm. 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 the flu, 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 medication and contact your doctor immediately.

Children under 12 years old

Esomeprazol ratiopharm should not be used in children under 12 years old. There are other pharmaceutical forms of this medication that are more suitable.

Taking Esomeprazol ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, even those purchased without a prescription. This is because Esomeprazol ratiopharm may affect the way some medications work and some medications may influence the effect of Esomeprazol ratiopharm.

Do not take Esomeprazol ratiopharm if you are taking a medication that containsnelfinavir(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)
• Digoxin (used to treat heart problems)
• Citalopram, imipramine, clomipramine (for depression treatment)
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy)
• Fenitoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol ratiopharm
• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol ratiopharm
• Cilostazol (used to treat intermittent claudication – leg pain caused by poor blood circulation)
• Cisaprida (used to treat indigestion and heartburn)
• Digoxin (used to treat heart problems)
• Metotrexato (a chemotherapy medication used at high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol ratiopharm
• Tacrolimús (organ transplant)
• Rifampicina (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 ratiopharm to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Taking Esomeprazol ratiopharm with food and drinks

You can take the tablets with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Your doctor will decide if you can take Esomeprazol ratiopharm during this period.

The passage of Esomeprazol ratiopharm into breast milk is unknown. Therefore, do not take Esomeprazol ratiopharm during breastfeeding.

Driving and operating machinery

Esomeprazol ratiopharm is unlikely to affect your ability to drive or use tools or machines. However, rare side effects such as dizziness and blurred vision may occur (see section 4). If it affects you, you should not drive or operate machinery.

Esomeprazol ratiopharm contains saccharose

This medication contains sugar spheres that contain saccharose, a type of sugar. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Esomeprazol ratiopharm contains sodium

This medication contains less than 1 mmol (23 mg of sodium) per dose; it is essentially "sodium-free".

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

• If you take this medication for a long period of time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has told you to take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

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

Use in adults and adolescents 12 years and older

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

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one tablet of esomeprazole 40 mg per day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once your esophagus has healed is one tablet of esomeprazole 20 mg once a day.
• If your esophagus has not been affected, the recommended dose is one tablet of esomeprazole 20 mg per day. Once the disorder has been controlled, your doctor will tell you to take the medication as needed, up to a maximum of one tablet of esomeprazole 20 mg per day.
• 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:

• The recommended dose is one tablet of esomeprazole 20 mg twice a day for one week.
• Your doctor will tell you to take the antibiotics, for example amoxicillin and clarithromycin, in addition.

Use in adults 18 years and older

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

• The recommended dose is one tablet of esomeprazole 20 mg once a day for 4 to 8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs:

• The recommended dose is one tablet of esomeprazole 20 mg once a day.

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

• The recommended dose is one tablet of esomeprazole 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also 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 intravenously:

• The recommended dose is one tablet of esomeprazole 40 mg once a day for 4 weeks.

How to take this medication

• You can take the tablets at any time of the day.
• You can 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 medication from being destroyed by the stomach acid. It is essential not to damage the granules.

What to do if you have difficulty swallowing the tablets

• If you cannot swallow at all, the tablets can be dispersed in water and introduced into a syringe. This way, you can administer it directly to the stomach through a tube (gastrostomy tube).

Use in children under 12 years

Esomeprazole ratiopharm is not recommended for children under 12 years. There are other pharmaceutical forms of this medication that are more suitable.

Older patients

No dose adjustment is required in older patients.

If you take more Esomeprazol ratiopharm than you should

If you take more esomeprazole than your doctor has prescribed, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420, 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, do not take the missed dose.
• Do not take a double dose (two doses at once) to compensate 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 can cause side effects, although not everyone will experience them.

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

• Yellow skin, dark urine, and fatigue that 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, 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 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 may become severe and widespread 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". These effects are very rare and may affect up to 1 in 10,000 people.

Other side 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 stomach polyps

Infrequent (affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Insomnia (sleep disturbance)
• Dizziness, tingling, numbness, somnolence
• Sensation of vertigo
• Dry mouth
• Alteration of blood tests that determine liver function
• Skin rash, urticaria, itching skin
• Fracture of the hip, wrist, and spine (if Esomeprazol ratiopharm 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 may cause weakness, bruising, or increase the risk of infections
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps
• Agitation, confusion, or depression
• Alteration of taste
• Eye disorders such as blurred vision
• Sudden sensation of lack of air or difficulty breathing (bronchospasm)
• Inflammation in the interior of the mouth
• A known infection called "candidiasis" that may affect the intestine and is caused by a fungus
• Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue
• Hair loss (alopecia)
• Dermatitis caused by exposure to sunlight
• 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 blood cells, including agranulocytosis (decrease in the number of white blood cells)
• Aggression
• To see, feel, or hear 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 peeling of the skin. 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
• 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 magnesium levels in the blood may decrease. Low magnesium levels in the blood may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor as soon as possible. Low magnesium levels may also trigger a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Inflammation in the intestine (producing diarrhea)
• Skin rash, possibly with joint pain

In very rare cases, Esomeprazol ratiopharm may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with severe worsening of the general condition or high fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, 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 essential that, in this case, you inform your doctor about your medication.

Reporting of side effects

If 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 UseWebsite:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not store at a temperature above 30°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Esomeprazol ratiopharm Composition

• The active ingredient is esomeprazole magnesium dihydrate.

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

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

• The other components are:

Tablet content:copolymer of methacrylic acid and ethyl acrylate (1:1), talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol, monoestearate 40-55, polisorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearate fumarate.

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

Product appearance and packaging content

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

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

The tablets are presented in:

Packaging sizes:

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

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Balkanpharma Dupnitsa AD.

3 Samakovsko Shose Str.

Dupnitsa 2600

Bulgaria

This leaflet was approved in:May 2023.

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

The following information is only for healthcare professionals:

Administration through a gastric tube

1. Place 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, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.
2. Shake the syringe immediately to disperse the tablet.
3. Hold the syringe with the tip pointing upwards and check that the tip has not become blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip pointing downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe should be kept with the tip pointing upwards to prevent the tip from becoming blocked).
6. Place the syringe with the tip pointing 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 and repeat step 5 if necessary to draw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.