Package Leaflet: Information for the User

Esomeprazole cinfa 20 mg gastro-resistant tablets EFG

Esomeprazole sodium

Read this leaflet carefully before you start to take 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 for the treatment of the following disorders:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach 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 disorder, 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 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).

Adolescents aged 12 years and above

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach 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.Helicobacter pylori.If you have this disorder, 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 medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazol, lansoprazol, rabeprazol, omeprazol).
• If you are taking a medication 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 medications.

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 medication to esomeprazol to reduce stomach acid.
• If you are scheduled 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 experience stomach pain or indigestion.
• You begin to vomit food or blood.
• Your stools appear black (blood-stained).

If you have been 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 a period of more than one year, may slightly increase the risk of fractures of the 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 experience 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 tablets are not recommended for children under 12 years.

Taking esomeprazol cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This includes medications purchased without a prescription. This is because esomeprazol may affect the way some medications work and some medications may influence the effect of esomeprazol.

Do not take esomeprazol if you are taking

• a medication that containsnelfinavir(used for HIV treatment).

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

• Atazanavir (used for HIV treatment).
• Clopidogrel (used for preventing blood clots).
• Ketoconazol, itraconazol, or voriconazol (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramina, clomipramina (for depression treatment).
• Diazepam (used for anxiety, muscle relaxation, or epilepsy).
• Fenitoína (for epilepsy). If you are taking fenitoína, your doctor will need to monitor when you start or stop taking esomeprazol.
• Medications used to make blood thinner, such as warfarina. Your doctor may need to monitor 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 medication 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 for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum) (used for depression treatment).

If your doctor has prescribed antibiotics amoxicilina and claritromicina in addition to esomeprazol to treat ulcers caused by Helicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Taking esomeprazol 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, 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 during this period.

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

Driving and operating machinery

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 effects.

Esomeprazol cinfa contains sodium.This medication 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. 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 told you how many tablets to 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 esomeprazole 40 mg tablet 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.

Once your esophagus has healed, the recommended dose is one esomeprazole 20 mg tablet per day.

• If your esophagus is not affected, the recommended dose is one esomeprazole 20 mg tablet per day. Once your condition has been controlled, your doctor may tell you to take your medication only when you notice some symptoms, up to a maximum of one esomeprazole 20 mg tablet 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 esomeprazole 20 mg tablet twice a day for one week.
• Your doctor will also prescribe antibiotics known as, for example, amoxicillin and clarithromycin.

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

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

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

• The recommended dose is one esomeprazole 20 mg tablet per 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 how long you should take this medication. The maximum dose is 80 mg twice a day.

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 esomeprazole 40 mg tablet 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.
• Once your esophagus has healed, the recommended dose is one esomeprazole 20 mg tablet per day.
• If your esophagus is not affected, the recommended dose is one esomeprazole 20 mg tablet 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 esomeprazole 20 mg tablet twice a day for one week.
• Your doctor will also prescribe antibiotics known as, for example, amoxicillin and clarithromycin.

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

• If you have difficulty swallowing the tablets:
• Put the tablets in a glass of water without gas. Do not use other liquids.
• Stir until the tablets disperse (the solution will not be transparent). You can drink the mixture immediately 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.
• 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 coated granules are not recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary in older adults.

If you take more esomeprazole than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take esomeprazole

• 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 make up 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 can cause side effects, although not everyone will experience them.

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

• Sudden difficulty breathing, swelling of the lips, tongue, and throat, or body, 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 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.
• Insomnia (sleep disturbance).
• Dizziness, tingling, numbness, somnolence.
• Dizziness.
• 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 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 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 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 white blood cells).
• Aggression.
• To see, feel, or hear 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 not known(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 the 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 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 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 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 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of esomeprazole cinfa

• The active ingredient is esomeprazole. It contains 20 mg of esomeprazole (as esomeprazole sodium).

• Core: Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), monoestearate of glycerol, polysorbate 80, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid-ethyl acrylate), triethylcitrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearate fumarate.
• Covering: Opadry II Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine / indigo blue FD&C #2 (E132), and iron oxide yellow (E172)).

Appearance of the product and contents of the package

Esomeprazole cinfa 20 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - España

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - España

or

TOWA PHARMACEUTICAL EUROPE S.L.

C/ San Martí, 75-97

Martorelles, 08107 Barcelona

España

Last review date of this leaflet: January 2025

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/

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/75071/P_75071.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75071/P_75071.html

This information is intended only for healthcare professionals:

Administration through 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 pointing 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 pointing downwards. Immediately inject 5-10 ml into the tube.

Invert the syringe after injection and agitate (the syringe must be kept with the tip pointing upwards to prevent the tip from becoming blocked).

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