Package Leaflet: Information for the User

Esomeprazole Cinfa40mg gastro-resistant tabletsEFG

Esomeprazole sodium

Read this leaflet carefully before you start taking this medicine becauseit containsimportant 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of theleaflet

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

Esomeprazol contains a medicine called esomeprazol that 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 for the treatment of the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach rises up the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment for the prevention of bleeding from a peptic ulcer induced with esomeprazol intravenous.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach rises up the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

Do not take esomeprazolecinfa

• 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 medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash or skin peeling, blistering or ulcers in the mouth after taking esomeprazole or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take esomeprazole cinfa

• 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 medicine to esomeprazole to reduce stomach acid.
• If you are due to have a specific blood test (Cromogranin A).

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

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

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

Severe skin reactions that include Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. Stop taking esomeprazole and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Taking a proton pump inhibitor like esomeprazole, especially for more than a year, may slightly increase the risk of breaking a hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with esomeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Children under 12 years

Esomeprazole tablets are not recommended for children under 12 years.

Taking esomeprazole cinfa with other medicines

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 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 that contains nelfinavir (used for HIV treatment).

Inform your doctor if you are using any of the following medicines:

• Atazanavir (used for HIV treatment).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for depression).
• Diazepam (used for 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 esomeprazole.
• Medicines used to make the blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole.
• Cilostazol (used for intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Metotrexate (chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with esomeprazole.
• Tacrolimus (organ transplant).
• Rifampicin (used for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

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

Taking esomeprazole cinfa with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take esomeprazole during this period.

The safety of esomeprazole for use during pregnancy has not been established. Therefore, esomeprazole should not be taken during pregnancy.

The safety of esomeprazole for use during breastfeeding has not been established. Therefore, esomeprazole should not be taken during breastfeeding.

Driving and operating machines

Esomeprazole is unlikely to affect your ability to drive or use 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.

Esomeprazole cinfa contains yellow orange S (E-110)

This medicine may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Esomeprazole cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Incase of doubt, consult your doctor orpharmacist 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 ayear).
• If your doctor has told you to take this medication only when you notice some symptoms, inform your doctor if the symptomschange.

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 aged 18 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 indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of excessive stomach acid 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 per day for 4 weeks.

Use in adolescents aged 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 indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

How to take thismedication

• You can take the tablets at any time of theday.
• You can take the tablets with food or on anemptystomach.
• 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 thegranules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing thetablets:

• Place the tablets in a glass of water without gas. Do not use otherliquids.
• Stir until the tablets disintegrate (the solution will not be transparent). You can drink themiximmediately or within 30 minutes. Stir always just beforedrinking.
• To ensure that you have taken all the medication, rinse the glass well with half a glass of water anddrink. The solid particles contain the medication – do not chew or crush thegranules.

• If you cannot swallow at all, the tablets can be dispersed in water and introduced into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age

Esomeprazole tablets are not recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary for older adults.

If you take more esomeprazole cinfa than you should

If you take more esomeprazole than your doctor has indicated, 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 esomeprazole cinfa

•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 to compensate for the missed doses.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you notice any of the following severe side effects, stop taking esomeprazole and contact a doctor immediately:

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems.
• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These side effects are rare and may affect up to 1 in 1,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

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

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if esomeprazole 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 decrease in the number of white blood cells or platelets. This can cause weakness, bruises, or increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Restlessness, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A fungal infection known as "candidiasis" that can affect the esophagus.
• Liver problems including jaundice that can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthritis) or muscles (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (may 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).
• Aggression.
• 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 peeling of the skin. These symptoms may be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

Frequency unknown (cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazole may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with severe worsening of your general condition or 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 to inform your doctor about your medication in this case.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the 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 medication.

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

Do not use this medication after the expiration date that appears on the label, the box, or blister pack after CAD. The expiration date is the last day of the month indicated.

Blister packs

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Bottles:

Do not store at a temperature above 30°C.

Shelf life after the first opening of the bottle: 100 days

Keep the bottle perfectly closed to protect it from moisture.

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

Esomeprazole Cinfa Composition

• The active ingredient is esomeprazole. It contains 40 mg of esomeprazole (as esomeprazole sodium).

• The other components are:

• Core:Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), monoestearate of glycerol, polisorbate 80, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polisorbate 80, and copolymer of methacrylic acid-ethyl acrylate), triethylcitrate (E-1505), macrogol, microcrystalline cellulose (E-460i), crospovidone (type A), and sodium stearate fumarate.

• Covering:Opadry II Dark Blue 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine blue / FD&C #2 (E-132), iron oxide black (E-172), and aluminum lake yellow blue FD&C #6 / yellow orange S (E-110)

Product Appearance and Packaging Contents

Esomeprazole cinfa 40 mg are oval-shaped, gastro-resistant tablets of blue color.

They are presented in blister packs and bottles of 14, 28, 56, and 100 (clinical pack) tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Responsible Manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10 - Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

or

TOWA PHARMACEUTICAL EUROPE S.L.

C/ San Martí, 75-97

Martorelles, 08107 Barcelona

Spain

Last Review Date of this Leaflet:January 2025

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/75074/P_75074.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/75074/P_75074.html

This information is intended solely for healthcare professionals:

Administration through a gastric tube

1.Insert the tablet into 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.Immediately agitate the syringe for approximately 2 minutes to disperse the tablet.

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

4.Connect the syringe to 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 kept with the tip upwards to prevent the tip from becoming blocked).

6.Place the syringe with the tip downwards and immediately inject 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 draw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.