Esomeprazole Pensa 40 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazol Pensa 40 mg gastro-resistant hard capsules EFG

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 others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Esomeprazol Pensa is and what it is used for

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

Esomeprazol Pensa is used to treat the following conditions:

Adults:

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• Excessive stomach acidity caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

• Continuation treatment to prevent rebleeding from peptic ulcer after initial intravenous esomeprazole therapy.

Adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before taking Esomeprazol Pensa

Do not take Esomeprazol Pensa:

• 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 (such as 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 skin, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol Pensa

• 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 Pensa used to reduce stomach acid.

• if you are scheduled to have a specific blood test (Chromogranin A).

Severe 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 Esomeprazol Pensa and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Esomeprazol Pensa may mask symptoms of other diseases. Therefore, if you experience any of the following events before starting or while taking Esomeprazol Pensa, 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 Esomeprazol Pensa has been prescribed only for use when symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Esomeprazol Pensa, especially 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 Esomeprazol Pensa. Remember to mention any other symptoms you may notice, such as joint pain.

Use of Esomeprazol Pensa 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 Esomeprazol Pensa may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Pensa.

Do not take Esomeprazol Pensa if you are taking a medicine containing nelfinavir (used for the treatment of HIV infection).

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

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (used for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (used for the treatment of depression).
• Diazepam (used for 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 Esomeprazol Pensa.
• 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 Esomeprazol Pensa.
• Cilostazol (used for the treatment of 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 treatment with Esomeprazol Pensa.
• Tacrolimus (organ transplant).
• Rifampicin (used for the treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used for depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazol Pensa to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol Pensa with food and drinks

You may take the 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 become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can take Esomeprazol Pensa during this period.

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

Driving and using machines

Esomeprazol Pensa 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.

Esomeprazol Pensa contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Esomeprazol Pensa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 your 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 capsule of Esomeprazol Pensa 40 mg 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 one capsule of Esomeprazol Pensa 40 mg 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 capsule of Esomeprazol Pensa 40 mg 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 gastro-resistant capsule of Esomeprazol Pensa 40 mg per day 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 granules that protect 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 granules into half a glass of still (non-carbonated) water. Do not use other liquids.

• Stir the mixture and drink it immediately or within 30 minutes. Always stir just before drinking.

• To ensure you have taken all 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 the granules.

  • If you cannot swallow at all, the granules can be mixed with a small amount of water and drawn into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

Children under 12 years of age

Esomeprazol Pensa is not recommended for children under 12 years of age.

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Pensa than you should

If you take more Esomeprazol Pensa 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: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Esomeprazol Pensa

• 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 (two doses at the same time) 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 Esomeprazol Pensa and contact a doctor immediately:

• Sudden difficulty breathing, swelling of lips, tongue and throat or the whole body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Severe blisters 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 people)

• 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 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function problems.
• Skin rash, hives, skin itching.
• Fracture of hip, wrist or spine (if Esomeprazol Pensa 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 increase the likelihood 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 people)

• 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 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 (frequency cannot be estimated from available data)

• If you are being treated with Esomeprazol Pensa 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, consult 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 of the intestine (which may lead to diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Pensa 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 pain, sore throat, mouth sores 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 this case, you inform your doctor about the medication you are taking.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Esomeprazol Pensa

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.

Vial:

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 collection point at your pharmacy. If you are unsure, 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 Pensa

• The active substance is esomeprazole (as sodium salt). Each capsule contains 40 mg of esomeprazole (as sodium salt).
• The other components are:

Capsule contents: sugar spheres (corn starch and sucrose), methylcellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate 80, methacrylic acid – ethyl acrylate copolymer, sodium lauryl sulfate, and triethyl citrate.

Capsule shell: carrageenan, potassium chloride, iron oxide red, titanium dioxide (E171), hypromellose, and black printing ink (containing shellac, dehydrated alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water, and black iron oxide E-172).

Appearance of the product and contents of the pack

Esomeprazol Pensa 40 mg are opaque pink hard capsules, size 2 (approximately 18 mm), printed (cap ES/body 40), containing spherical granules.

Esomeprazol Pensa 40 mg is available in:

• Aluminum/Aluminum blisters of 14, 28, and 56 capsules.
• White opaque polyethylene (PE) bottles containing silica gel as desiccant, with tamper-evident polyethylene (PE) screw cap, containing 14 or 28 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer:

Towa Pharmaceutical Europe, S.L.
C/ de Sant Martí 75-97
08107 Martorelles (Barcelona)
Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

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 some 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 in the suspension.
3. Hold the syringe with the tip facing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the above position.
5. Shake the syringe and position it with the tip facing 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 facing upwards to prevent blockage of the tip).
6. Re-position the syringe with the tip facing 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 flush any remaining residue from the syringe. For some tubes, 50 ml of water may be required.