ESOMEPRAZOL PENSA 40 mg HARD GASTRORESISTENT CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Esomeprazol Pensa 40 mg Gastro-Resistant Hard Capsules EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Esomeprazol Pensa contains a medicine called esomeprazole, which belongs to a group of medicines called “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:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube that carries food from the mouth to the stomach), causing pain, inflammation, and heartburn.

• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of rebleeding from peptic ulcer with esomeprazol intravenous.

Adolescents from 12 years of age:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube that carries food from the mouth to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before you take Esomeprazol Pensa

Do not take Esomeprazol Pensa:

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a severe skin reaction or blistering of the skin, mouth, eyes, or genitals after taking esomeprazole or other medicines similar to Esomeprazol Pensa.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with 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 to reduce stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. Stop taking Esomeprazol Pensa and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

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

Taking a proton pump inhibitor like Esomeprazol Pensa, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform 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, as you may need to stop treatment with Esomeprazol Pensa. Remember to mention any other symptoms that you notice, such as joint pain.

Using Esomeprazol Pensa 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 Pensa can affect how some medicines work and some medicines may affect how Esomeprazol Pensa works.

Do not take Esomeprazol Pensa if you are taking a medicine that contains nelfinavir(used to treat HIV infection).

Tell your doctor if you are using any of the following medicines:

• Atazanavir (used to treat 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 to treat 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 you when you start or stop taking Esomeprazol Pensa.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Pensa.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood circulation).
• 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 to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used for depression).

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

Taking Esomeprazol Pensa with food and drink

You can take the capsules with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazol Pensa during this time.

It is not known if Esomeprazol Pensa passes into breast milk. Therefore, you should not take Esomeprazol Pensa during breastfeeding.

Driving and using machines

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

Esomeprazol Pensa containssucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Esomeprazol Pensa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• If you take this medicine for a long time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has told you to take this medicine only when you notice 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 listed below.

Use in adults aged 18 years and over

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one Esomeprazol Pensa 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 yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one Esomeprazol Pensa 40 mg capsule twice a day.
• 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 a day.

Continuation of prevention of rebleeding from peptic ulcer with esomeprazol intravenous:

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

Use in adolescents aged 12 years and over

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazol Pensa 40 mg 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 yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

Taking this medicine

• You can take the capsules at any time of the day.
• You can 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 pellets that prevent the medicine from being destroyed by the acid in the 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 empty the pellets into half a glass of water. Do not use other liquids.
• Stir the mixture and drink it immediately or within 30 minutes. Always stir just before drinking.
• To make sure you have taken all the medicine, rinse the glass with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush the pellets.
• If you cannot swallow at all, the pellets can be mixed with a little water and injected 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

No dose adjustment is necessary in elderly patients.

If you take more Esomeprazol Pensa than you should

If you take more Esomeprazol Pensa than you should, 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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 missed doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Sudden difficulty breathing, swelling of the lips, tongue, throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Also, blisters in the mouth and eyes, and genital areas. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellow skin, dark urine, and tiredness, which can be symptoms of liver problems.
• Widespread rash, high temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome), which is very rare.

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

Other side effects include:

Common(may affect up to 1 in 10 people)

• Headache.
• Stomach or intestine 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.
• Disturbed sleep (insomnia).
• Dizziness, tingling, numbness, or drowsiness.
• Vertigo.
• Dry mouth.
• Changes in blood tests that show how the liver is working.
• Skin rash, urticaria, itching.
• Fracture of the 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 a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Altered sense of taste.
• Eye disorders such as blurred vision.
• Sudden onset of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation in the mouth.
• An infection known as “candidiasis” that can affect the oesophagus and is caused by a fungus.
• Liver problems including jaundice, which can cause yellowing of the skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash caused by sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of being unwell and lack of energy.
• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).
• Liver problems that can lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or peeling of the skin. These symptoms can be accompanied by high fever and pain in the joints. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

Frequency not known(frequency cannot be estimated from the available data)

• If you are treated with Esomeprazol Pensa for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, go to 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 periodic tests to monitor your magnesium levels.
• Inflammation of the intestine (which can lead to diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Pensa may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of your general condition or fever with symptoms of a local infection such as sore throat, 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) with a blood test. It is important that you inform your doctor about your medication.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 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 pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Pensa

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

Capsule content: sugar spheres (cornstarch 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, red iron oxide, 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 Package Contents

Esomeprazol Pensa 40 mg are hard, opaque pink capsules, size 2 (approximately 18 mm), printed (head ES/body 40) and 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 a desiccant, with a tamper-evident polyethylene (PE) screw cap, containing 14 or 28 capsules.

Only some package 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 Last Revision of this Prospectus:January 2025

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

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, dispersion in 50 ml of water is required to prevent the pellets from clogging the tube.
2. Shake the syringe immediately to distribute the granules evenly in the suspension.
3. Hold the syringe with the tip upwards and check that the tip is not clogged.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip upwards to avoid clogging the tip).
6. Put the syringe back with the tip downwards and inject immediately 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 out any sediment remaining in the syringe. For some tubes, 50 ml of water are required.