ESOMEPRAZOL PENSA 20 mg GASTRO-RESISTANT TABLETS

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

Do not take Esomeprazole 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 inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• 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 Esomeprazole Pensa that reduces stomach acid.

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

Warnings and precautions

Consult your doctor or pharmacist before taking esomeprazole if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Pensa that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

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 the use of esomeprazole. Stop taking esomeprazole and contact your doctor immediately if you notice any of the following symptoms: skin rash, itching, fever, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, blistering of the skin and bleeding in the eyes, mouth or genitals.

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

• You lose a lot of weight for no reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.

• Your stools are black (blood-stained).

If your doctor has prescribed esomeprazole for you only when you have symptoms, you should contact your doctor if your symptoms change or if you notice any of the above.

Taking a proton pump inhibitor like esomeprazole, especially over a period of more than one year, may slightly increase your risk of fracture of 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. This is to decide if you should stop taking esomeprazole. Also remember to mention any other symptoms that you may have such as joint pain or arthritis.

Children under 12 years

Esomeprazole Pensa gastro-resistant tablets are not recommended for children under 12 years of age.

Using Esomeprazole Pensa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This is because esomeprazole may affect the way some medicines work and some medicines may affect the way esomeprazole works.

Do not take esomeprazole if you are taking:

• a medicine containing nelfinavir(used to treat HIV infection).

Tell your doctor if you are taking:

• 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, as a muscle relaxant or to treat epilepsy).
• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking esomeprazole.
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazole.
• 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 need to temporarily stop your treatment with esomeprazole.
• tacrolimus (used to prevent organ rejection after transplant).
• rifampicin (used to treat tuberculosis).
• St John’s Wort (used to treat mild depression).

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

Using Esomeprazole Pensa with food and drink

You can take your tablets 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take esomeprazole during this time.

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

Driving and using machines

Esomeprazole is not likely to affect your ability to drive or use any tools or machines. However, sometimes side effects such as dizziness or blurred vision may occur. Do not drive or use any tools or machines if you are affected.

3. How to take Esomeprazole Pensa

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 (particularly 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.

Taking this medicine

• You can take your tablets at any time of the day.
• You can take your tablets with or without food.
• Swallow your tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets 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 tablets:

• Put the tablets in a glass of water. Do not use other liquids.
• Stir until the tablets break up (the mixture will not be clear). You can take the mixture immediately or within 30 minutes. Always stir well before taking.
• To make sure you get the full dose of the medicine, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (orally or through a nasogastric tube).

How much to take

Your doctor will tell you how many tablets to take and when to take them. This will depend on your condition, age and kidney function. The recommended doses are given below.

Adults aged 18 years and above

For gastro-oesophageal reflux disease

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Esomeprazole Pensa 40 mg gastro-resistant tablet per 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. Once the oesophagus has healed, your doctor may tell you to take a dose of one Esomeprazole Pensa 20 mg gastro-resistant tablet per day to stop the problem coming back.
• If your gullet (oesophagus) is not damaged, the recommended dose is one Esomeprazole Pensa 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For ulcers caused by Helicobacter pyloriinfection and to stop them coming back

• The recommended dose is one Esomeprazole Pensa 20 mg gastro-resistant tablet twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

For stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

• The recommended dose is one Esomeprazole Pensa 20 mg gastro-resistant tablet per day for 4-8 weeks.

To stop stomach ulcers if you are taking NSAIDs

• The recommended dose is one Esomeprazole Pensa 20 mg gastro-resistant tablet per day.

For too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome)

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

Adolescents from 12 years of age

For gastro-oesophageal reflux disease

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Esomeprazole Pensa 40 mg gastro-resistant tablet per 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. Once the oesophagus has healed, your doctor may tell you to take a dose of one Esomeprazole Pensa 20 mg gastro-resistant tablet per day to stop the problem coming back.
• If your gullet (oesophagus) is not damaged, the recommended dose is one Esomeprazole Pensa 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For ulcers caused by Helicobacter pyloriinfection and to stop them coming back

• The recommended dose is one Esomeprazole Pensa 20 mg gastro-resistant tablet twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

Children under 12 years of age

Esomeprazole is not recommended for children under 12 years of age.

Elderly

No dose adjustment is necessary for elderly patients.

If you take more Esomeprazole Pensa than you should

If you have taken more Esomeprazole Pensa than you should, contact your doctor or pharmacist immediately or go to the nearest hospital. Bring the medicine and this leaflet with you.

If you forget to take Esomeprazole 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, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose.

4. Possible Adverse Effects

Like all medicines, Esomeprazol Pensa can cause adverse effects, although not all people suffer from them.

If you observe any of the following serious adverse effects, stop taking esomeprazol and contact a doctor 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. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. This could be a "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and fatigue that 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 10 people)

• 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 people)

• 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, skin itching.
• Fracture of the hip, wrist, or spine (if esomeprazol 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 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 feeling of lack of air 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 that can cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• 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 people)

• 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 of the skin. 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 the breasts in men.

Frequency Not Known (frequency 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, involuntary 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 blood tests to monitor your magnesium levels.
• Inflammation of 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 severeworsening 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 Pensa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label, box, or blister after CAD. The expiration date is the last day of the month indicated.

Blisters:Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Bottles:Do not store at a temperature above 30°C. Validity time after the first opening of the bottle: 100 days. Keep the bottle perfectly closed to protect it from moisture.

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

6. Package Contents and Additional Information

Composition of Esomeprazol Pensa

The active ingredient is esomeprazol. There are two concentrations of Esomeprazol Pensa gastro-resistant tablets that contain 20 mg or 40 mg of esomeprazol (as sodium salt).

The other components are:

• Core:Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), 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 (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearyl fumarate.
• Coating:Opadry II Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum carmine indigo/blue FD&C #2 (E132), and yellow iron oxide (E172)).

Appearance of the Product and Package Contents

Esomeprazol Pensa 20 mg gastro-resistant tablets are oval, blue. They are presented in packages of 14, 28, 56, or 100 (clinical package) tablets in blisters and 14, 28, or 100 (clinical package) tablets in bottles. 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/