Patient Information Leaflet

Esomeprazole Cinfa 20 mg Hard Capsules (Gastro-resistant, EFG)

Esomeprazole Sodium

Read this 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. Do not give it to others even if they have similar symptoms, as it may harm them.

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

1.What is Esomeprazole Cinfa and what it is used for

2.What you need to knowbefore starting to takeEsomeprazole 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 cinfa 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 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 burning.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria called Helicobacter pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol may 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 for the prevention of bleeding from peptic ulcers induced with esomeprazol intravenous.

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 burning.

Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria called Helicobacter pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take esomeprazol cinfa

-if you are allergic to esomeprazol 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. pantoprazol, lansoprazol, rabeprazol, omeprazol).
• 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 esomeprazol or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take esomeprazol 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 esomeprazol to reduce stomach acid.
• if you are due to have a specific blood test (Cromogranina A).

Esomeprazol may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking esomeprazol, 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 (bloodstained).

If your doctor has prescribed esomeprazol 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 relation to esomeprazol treatment. Stop taking esomeprazol 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 esomeprazol, 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 esomeprazol treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Children under 12 years

Esomeprazol cinfa should not be used in children under 12 years of age.

Taking esomeprazol 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 esomeprazolmay affect how some medicines work and some medicines may influence the effect of esomeprazol.

Do not take esomeprazol if you are taking a medicine that containsnelfinavir(used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used in the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazol, itraconazol or voriconazol (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramina, clomipramina (for depression treatment).
• Diazepam (used for anxiety, as a muscle relaxant or for epilepsy).
• Fenitoína (for epilepsy). If you are taking fenitoína, your doctor will need to control when you start or stop taking esomeprazol.
• Medicines used to make the blood thinner such as warfarina. Your doctor may need to control when you start or stop taking esomeprazol.
• Cilostazol (used for intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• Cisaprida (used for indigestion and heartburn).
• Digoxina (used for heart problems).
• Metotrexato (chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of metotrexato, your doctor may temporarily interrupt your esomeprazol treatment.
• Tacrolimus (organ transplant).
• Rifampicina (used to treat tuberculosis).
• St. John's Wort(Hypericum perforatum)(used to treat depression).

If your doctor has prescribed the antibiotics amoxicilina and claritromicina in addition toesomeprazolto treat ulcers caused byHelicobacter pylori,it is very importantthat you inform your doctor if you are taking any other medicine.

Taking esomeprazol cinfa with food and drinks

You can take your capsules with food or on an empty stomach.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 esomeprazol during this period.

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

Driving and using machines

Esomeprazol is unlikely to affect your ability to drive or use tools or machines. However, rare or very 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 cinfa contains saccharose.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Esomeprazol cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 medicationonly when you notice some symptoms, inform yourdoctor if the symptoms change.

How much to take

• Your doctor will have indicated how many capsules 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 capsule of esomeprazole 40 mg once a 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.
• Once your esophagus has healed, the recommended dose is one capsule of esomeprazole 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of esomeprazole 20 mg once a day. Once your condition has been controlled, your doctor may indicate that you take your medicine only when you notice some symptoms, up to a maximum of one capsule 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 their recurrence:

• The recommended dose is one capsule of esomeprazole 20 mg twice a day for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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

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

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

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

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

• The recommended dose is 40 mg of esomeprazole 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 intravenous:

• The recommended dose is one capsule of esomeprazole 40 mg once a 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 capsule of esomeprazole 40 mg once a 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.
• Once your esophagus has healed, the recommended dose is one capsule of esomeprazole 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of esomeprazole 20 mg once a 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 their recurrence:

• The recommended dose is one capsule of esomeprazole 20 mg twice a day for one week.

Your doctor will also prescribe antibiotics such as, for example, 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 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

If you have difficulty swallowing the capsules:

• Open the capsules and empty the pellets into half a glass of water (without gas). Do not use other liquids.
• Drink the mixture directly or within 30 minutes. Stir always just before drinking.
• To ensure that you have taken all the medication, rinse the glass well with half a glass of water and drink. The solid particles contain the medication - do not chew or crush the granules.

Ifyou cannot swallow at all, the pellets 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 gastro-resistant capsules are not recommended forchildren under12 years of age.

Patients with advanced age

No dose adjustment is necessary in patients of advanced age.

If you take moreesomeprazole 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 there is little time left 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 medicines, this medicine may cause side effects, although not everyone will experience them.

Ifyou observe 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 enlarged lymph nodes (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 patients)

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

Rare (may affect up to 1 in 100 patients)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• 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, or spine (if esomeprazole is used at high doses and for a long period).

Rare (may affect up to 1 in 1,000 patients)

• Blood disorders such as a decrease in white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, 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 known infection called "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems, including jaundice that can cause yellow skin, dark urine, and fatigue.
• Loss of hair (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 patients)

• Changes in the number of blood cells, including agranulocytosis (decrease in 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).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

• If you are being treated with 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 reduction 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 lead to 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 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 white blood cells (agranulocytosis) through a blood test. It is essential to report 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 on 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:

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Bottle:

Do not store at a temperature above 30°C. Keep the container perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications that you do not need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose ofthe containers and medications that you do notneed.By doing so, you will help protect the environment.

Esomeprazole Cinfa Composition

• The active ingredient is esomeprazole (as sodium salt)
• The other components are:

Contents of the capsule: esferas of sugar (cornstarch and sucrose), methylcellulose, talc, titanium dioxide (E-171), monoestearate of glycerol, polisorbate 80, sodium lauryl sulfate, copolymer of methacrylic acid – ethyl acrylate and triethylcitrate.

Capsule coating: carrageenan, potassium chloride, red iron oxide (E-172), titanium dioxide (E-171), hypromellose, and black printing ink (containing shellac, potassium hydroxide, and black iron oxide E-172).

Appearance of the product and contents of the package

Esomeprazole Cinfa 20 mg are hard, opaque, light pink capsules, size 4 (approximately 14 mm), printed with black ink (ES on the cap / 20 on the body), and contain spherical granules.

Esomeprazole Cinfa 20 mg is available in alu/alu blister packs of14, 28, and 56 capsulesand in white opaque polyethylene terephthalate (PET) bottles with a desiccant capsule and a14, 28, and 56capsule closure.

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/ Sant Martí, 75-97 – 08107 –Martorelles (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/82921/P_82921.html

QR code to:https://cima.aemps.es/cima/dochtml/p/82921/P_82921.html

This information is intended solely for healthcare professionals:

Administration via gastric tube

1. Open the capsule and pour the pellets into a suitable syringe and fill the syringe withapproximately 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 fromobstructing the tube.

1. Immediately agitate the syringe to distribute the granules uniformly throughout thesuspension.
2. Hold the syringe with the tip pointing upwards and check that the tip has not becomeobstructed.
3. Connect the syringe to the tube while maintaining the previous position.
4. Agitate the syringe and place it with the tip pointing downwards. Inject immediately 5–10 ml into the tube. Invert the syringe after injection and agitate (the syringe must be kept with the tip pointingupwards to prevent the tip from becoming obstructed).

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.

1. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary todraw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.