Esomeprazole Cinfa 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

esomeprazole cinfa 40 mg gastro-resistant tablets EFG

sodium esomeprazole

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What esomeprazole cinfa is and what it is used for

Esomeprazole contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazole is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid moves up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcer previously treated with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid moves up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before starting to take esomeprazole cinfa

Do not take esomeprazole cinfa

• If you are allergic to esomeprazole or to 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 containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

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

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 medicine similar to esomeprazole used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if you experience 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 difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

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

Serious skin reactions including 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 immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Taking a proton pump inhibitor such as esomeprazole, particularly for more than one year, may slightly increase the risk of fracture 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 develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with esomeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Children under 12 years

The use of esomeprazole gastro-resistant tablets is not recommended in children under 12 years of age.

Taking esomeprazole cinfa with other medicines

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

This includes medicines obtained 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 containing nelfinavir (used to treat HIV infection).

Inform your doctor 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 (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for treatment of depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (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 less likely to clot, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy drug used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your esomeprazole treatment.
• Tacrolimus (organ transplant).
• 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 in addition to esomeprazole to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking esomeprazole cinfa with food and drinks

You may 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 medicine. Your doctor will decide whether you can take esomeprazole during this time.

It is unknown whether esomeprazole passes into breast milk. Therefore, esomeprazole should not be taken during breastfeeding.

Driving and using machines

Esomeprazole is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

Esomeprazole cinfa contains Sunset Yellow FCF (E-110)

This medicine may cause allergic reactions because it contains Sunset Yellow FCF (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".

3. How to take esomeprazole cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience 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 condition, age, and liver function.
• The recommended doses are indicated below.

Use in adults from 18 years of age

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

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg esomeprazole tablet daily for 4 weeks. Your doctor may instruct you to continue 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 pancreatic tumor (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg esomeprazole tablet twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment for prevention of rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole tablet once daily for 4 weeks.

Use in adolescents from 12 years of age

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

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg esomeprazole tablet daily for 4 weeks. Your doctor may instruct you to continue 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 the medicine

• You may take the tablets at any time of day.
• You may take the tablets with or without food.
• 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 medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Place the tablets in a glass of non-carbonated water. Do not use other liquids.

• Stir until the tablets disintegrate (the solution will not be clear). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.

• To ensure you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

• If you cannot swallow at all, the tablets may be dispersed in water and drawn 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 tablets are not recommended for children under 12 years of age.

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more esomeprazole cinfa 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions about 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 everyone will experience them.

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

• Sudden difficulty breathing, swelling of the lips, tongue and throat, or swelling of the whole body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Skin redness with blisters or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. This could be a case of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the 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 rarely observed.

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

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, skin itching.
• Fracture of 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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Disturbance in taste.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the esophagus.
• Liver problems including jaundice, which may cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (reduction in white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. 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 breasts in men.

Frequency not known (cannot be estimated from available data)

• If you are being treated with esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present 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 may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation in the intestine (may lead to diarrhea).
• Skin rash, possibly accompanied by joint pain.

In very rare cases, esomeprazole may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a serious deterioration in general condition, or fever with signs of a localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduction in white blood cell count (agranulocytosis) through a blood test. It is important that, in such cases, you inform your doctor about the medication you are taking.

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of esomeprazole cinfa

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

Do not use this medicine after the expiry date stated on the label, carton, or blister after EXP. The expiry date refers to the last day of the month indicated.

Blister packs

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Containers:

Do not store above 30°C.

Shelf life after first opening of the container: 100 days

Keep the container tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of esomeprazol cinfa

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

• The other components are:

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

• Coating: Opadry II Dark Blue 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake / FD&C Blue #2 (E-132), black iron oxide (E-172), and aluminum lake of FD&C Yellow #6 / Sunset Yellow S (E-110)).

Appearance of the product and contents of the pack

Esomeprazol cinfa 40 mg are blue, oval-shaped, gastro-resistant tablets.

It is available in packs of 14, 28, 56, and 100 tablets (clinical pack) in blister packs and bottles.

Only certain pack 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/ San Martí, 75-97

Martorelles, 08107 Barcelona

Spain

Date of the most recent revision of this leaflet: January 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/75074/P_75074.html

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

This information is intended for healthcare professionals only:

Administration via gastric tube

1. Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For certain tubes, dispersion in 50 ml of water may be required to prevent pellets from blocking the tube.
2. Immediately shake the syringe vigorously for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip pointing upward and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip downward. Immediately inject 5–10 ml into the tube.

After injection, invert the syringe and shake it (the syringe must be kept with the tip upward to prevent blockage of the tip).

1. Reposition the syringe with the tip downward and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.

Refill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any remaining residue from the syringe. For certain tubes, 50 ml of water may be required.