ESOMEPRAZOL CINFA 40 mg HARD GASTRO-RESISTANT CAPSULES

2. What you need to know before you take esomeprazol cinfa

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 proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazol).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid.

If any of the above apply to you, do not take esomeprazol. If you are not sure, talk to your doctor or pharmacist before taking esomeprazol.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 medicine similar to esomeprazol that reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

Esomeprazol may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking esomeprazol, contact your doctor immediately:

• you lose a lot of weight for no reason and have problems swallowing.
• you get stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (blood-stained).

If you have been prescribed esomeprazol only when you have symptoms, you should contact your doctor if your symptoms persist or change.

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazol. Stop taking esomeprazol and contact your doctor immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.

Taking a proton pump inhibitor like esomeprazol, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible to rule out the diagnosis of subacute cutaneous lupus erythematosus (SCLE). This condition is a rare immune system disorder which may be associated with the use of esomeprazol.

Children under 12 years of age

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

Taking esomeprazol cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription.

This is because esomeprazol can affect how some other medicines work and some other medicines can increase the chance of you getting side effects.

Do not take esomeprazol if you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

• atazanavir (used to treat HIV infection).
• clopidogrel (used to prevent blood clots).
• ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• erlotinib (used to treat cancer).
• citalopram, imipramine, clomipramine (used to treat depression).
• diazepam (used to treat anxiety, relax muscles or in epilepsy).
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor needs to monitor you when you start or stop taking esomeprazol.
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazol.
• cilostazol (used to treat intermittent claudication – a condition where the legs do not get enough blood).
• cisapride (used for indigestion and heartburn).
• digoxin (used for heart problems).
• methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your esomeprazol treatment.
• tacrolimus (used in organ transplantation).
• rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin with esomeprazol to treat ulcers caused by Helicobacter pylori bacteria, it is very important that you tell your doctor about any other medicines you are taking.

Taking esomeprazol cinfa with food and drink

You can take your capsules with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will decide whether you can take esomeprazol during this time.

It is not known if esomeprazol passes into breast milk. Therefore, you should not take esomeprazol during breast-feeding.

Driving and using machines

Esomeprazol is unlikely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you experience such side effects.

esomeprazol cinfa contains sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

esomeprazol cinfa contains sodium.

This medicine contains less than 23 mg sodium (1 mmol) per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take esomeprazol cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you take it for more than a year).

• If your doctor has told you to take this medicine as and when you need it, you should contact your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition, age and liver function.

• The recommended doses are as follows:

Use in adults aged 18 years and above

Treatment of gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not healed yet.
• If you have serious liver disease, your doctor may give you a lower dose.

Treatment of stomach acid produced in excess due to a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you will need to take the medicine for. The maximum dose is 80 mg twice a day.

Prevention of relapse of bleeding peptic ulcers in patients treated with esomeprazol intravenously:

• The recommended dose is one 40 mg capsule once a day for 4 weeks.

Use in adolescents aged 12 years and above

Treatment of gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not healed yet.
• If you have serious liver disease, your doctor may give you a lower dose.

Taking this medicine

• You can take your capsules at any time of the day.
• You can take your capsules with or without food.
• Swallow your capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing

If you have difficulty swallowing the capsules:

• open the capsule and swallow the pellets with half a glass of water. Do not use other liquids.
• always stir the pellets just before drinking the mixture.
• drink the mixture within 30 minutes.
• to make sure you take all of the medicine, rinse the glass with half a glass of water and drink it.
• the solid particles contain the medicine - do not chew or crush them.
• if you cannot swallow at all, the pellets can be dispersed in water and given through a syringe (into the stomach via a tube).

Use in children under 12 years of age

Esomeprazol cinfa gastro-resistant hard capsules are not recommended for children under 12 years of age.

Patients with kidney problems

No dose adjustment is necessary in patients with kidney problems.

Patients with liver problems

If you have liver problems, your doctor may give you a lower dose.

Elderly patients

No dose adjustment is necessary for elderly patients.

If you take more esomeprazol cinfa than you should

If you take more esomeprazol than you have been told to take, contact your doctor or pharmacist immediately.

In case of overdose, contact your doctor or pharmacist or go to the emergency department of the nearest hospital. Take the medicine pack with you.

If you forget to take esomeprazol cinfa

• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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 all people suffer from them.

Ifyou notice anyof the following serious adverse effects, stop taking esomeprazol andcontact adoctor immediately:

• A sudden difficulty breathing, swelling of 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. Blisters can also appear in the eyes, mouth, nose, and genitals. This could be a "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and fatigue, which can be symptoms of liver problems.
• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These effects are rare and may affect up to 1 in 1,000 people. Other adverse effects include:

Frequent (may affect up to 1 in 10patients)

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

Infrequent(may affect up to 1 in 100 patients)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function,
• Skin rash, hives, itching.

• Hip, wrist, or spine fracture (if esomeprazol 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 the number of white blood cells or platelets. This can cause weakness, bruising, or increase the likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alteration.
• Eye disorders such as blurred vision.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Joint pain (arthralgia) or muscle pain (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 cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggressiveness.
• 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. These symptoms can be accompanied by high fever and joint pain (Erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of breasts in men.

Frequency Not Known (cannot be estimated from the available data)

• If you are being treated with esomeprazol for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have 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 periodic tests to monitor your magnesium levels.
• Inflammation in the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazol can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of the general condition or fever with symptoms of a local infection such as neck, throat, mouth, 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 important that, in this case, you report your medication.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esomeprazol Cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine 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.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Cinfa

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

Contents of the capsule: sugar spheres (cornstarch and sucrose), methylcellulose, talc, titanium dioxide (E-171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid - ethyl acrylate copolymer, and triethyl citrate.

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 Package Contents

Esomeprazol Cinfa 40 mg are hard, opaque, and pink capsules, size 2 (approximately 18 mm), printed with black ink (ES on the cap / 40 on the body), and containing spherical granules.

Esomeprazol Cinfa 40 mg is available in aluminum/aluminum blisters of 14, 28, and 56 capsules, and white opaque polyethylene bottles with a desiccant capsule and a cap of 14, 28, and 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

TOWA PHARMACEUTICAL EUROPE S.L.

C/ Sant Martí, 75-97 – 08107 – Martorelles (Barcelona)

Spain

Date of the Last Revision of this Prospectus:January 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82922/P_82922.html

QR code to: https://cima.aemps.es/cima/dochtml/p/82922/P_82922.html

This information is intended only for healthcare professionals:

Administration through a gastric tube

1. Open the capsule and empty the pellets 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 clogging the tube.

1. Shake the syringe immediately to distribute the granules evenly throughout the suspension.
2. Hold the syringe with the tip up and check that the tip is not clogged.
3. Connect the syringe to the tube while maintaining the previous position.
4. Shake the syringe and place it with the tip down. Inject immediately 5–10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to avoid clogging the tip).

Put the syringe back with the tip down and inject immediately 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 drag any sediment that remains in the syringe. For some tubes, 50 ml of water are necessary.