Esomeprazole CINFA 40 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

esomeprazol cinfa 40 mg gastro-resistant hard capsules EFG

sodium esomeprazole

Read the entire 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

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

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

Esomeprazole cinfa 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

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer after initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older

Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back 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 or peeling 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.

Warnings and precautions

Talk to 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 acid.
• You are scheduled to have a specific blood test (Chromogranin A).

Esomeprazole may mask symptoms of other conditions. Therefore, if you experience any of the following events before 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 have 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 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 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 of age

Esomeprazole cinfa must not be used in children under 12 years of age.

Taking esomeprazole cinfa with other medicines

Tell 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).

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 (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 thin the blood 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 poor blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily stop 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 your capsules with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will decide whether you can take esomeprazole during this period.

It is not known whether esomeprazole passes into breast milk. Therefore, esomeprazole should not be taken during breast-feeding.

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 infrequently or rarely (see section 4). You should not drive or use machines if you experience any of these effects.

esomeprazole cinfa contains sucrose.

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

esomeprazole cinfa contains sodium.

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

3. How to take esomeprazole cinfa

Follow exactly the instructions for using this medicine 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 capsules 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 capsule once 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 tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of esomeprazole 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 to prevent rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole capsule 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 capsule 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 this medicine

• You may take the capsules at any time of day.
• You may 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 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 capsules:

• Open the capsule and empty the pellets into half a glass of water (non-carbonated). Do not use other liquids.
• Drink the mixture immediately or within 30 minutes. Always stir well just before drinking.
• To ensure you have taken the full dose, rinse the glass thoroughly with another half glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.
• If you are completely unable to swallow, the pellets 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 cinfa gastro-resistant capsules 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 number: 91 562 04 20, stating the medicine 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 make up for a missed dose.

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 lips, tongue and throat or entire body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Severe blistering and bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine and tiredness, 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 effects are rare and may affect up to 1 in 1,000 people. Other adverse effects include:

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Swelling of feet and ankles.

• Sleep disturbances (insomnia).

• Dizziness, tingling and numbness, drowsiness.

• Sensation of vertigo.

• Dry mouth.

• Abnormal blood test results indicating liver function abnormalities.

• Skin rash, hives, skin itching.

• Fractures 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 reduced 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.
• Taste disturbances.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" which may affect the oesophagus.
• Liver problems, including jaundice which may cause yellowish skin, dark urine and tiredness.
• 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 patients)

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells).
• Aggression.
• 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, blistering or skin peeling. These symptoms may be accompanied by high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis).
• Muscle weakness.
• Serious kidney disorders.
• Breast enlargement 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 diarrhoea).
• Skin rash, possibly with 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 local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) by means of a blood test. It is important that, in such cases, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 packaging after EXP. The expiry date is the last day of the month indicated.

Blister packs:

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Bottle:

Do not store above 30°C. Keep the container tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of esomeprazol cinfa

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

Contents of the capsule: sugar spheres (corn starch 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, iron oxide red (E-172), titanium dioxide (E-171), hypromellose, and black printing ink (containing shellac, potassium hydroxide, and black iron oxide E-172).

Appearance of the medicine and contents of the pack

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

Esomeprazol cinfa 40 mg is available in alu/alu blisters and in white opaque polyethylene bottles with a desiccant cap, containing 14, 28, and 56 capsules.

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

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

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) at 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 carton. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/82922/P_82922.html

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

This information is intended exclusively for healthcare professionals:

Administration via gastric tube

1. Open the capsule and empty the pellets into a suitable syringe. Fill the syringe with approximately 25 ml of water and approximately 5 ml of air.

For certain tubes, a dispersion in 50 ml of water may be required to prevent the pellets from blocking the tube.

2. Immediately shake the syringe to evenly distribute the granules throughout the suspension.
3. Hold the syringe with the tip pointing upwards 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 pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).

Reposition 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 flush any remaining residue from the syringe. For certain tubes, 50 ml of water may be required.