Esomeprazole Pensa 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Esomeprazol Pensa 40 mg gastro-resistant tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet Contents

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 for the treatment of the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows up into the esophagus (the tube that goes from the throat to the stomach), causing pain, inflammation, and heartburn.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer following intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows up into the esophagus (the tube that goes from 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 proton pump inhibitor group (for example, pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash, peeling skin, blisters, or mouth ulcers after taking esomeprazole or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting esomeprazole if:

• You have severe liver problems.
• You have severe kidney problems.
• You have previously had a skin reaction after treatment with a medicine similar to Esomeprazol Pensa used to reduce stomach acid.
• You are scheduled to have a specific blood test (chromogranin A).

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

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 symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as esomeprazole, particularly for more than one year, may slightly increase the risk of hip, wrist, or spine fracture. 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 treatment with esomeprazole may need to be discontinued. Remember to mention any other symptoms you may notice, such as joint pain.

Children under 12 years

Use of Esomeprazol Pensa gastro-resistant tablets is not recommended in children under 12 years of age.

Using Esomeprazol Pensa with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines, including those 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 to treat cancer).
• 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 (used after organ transplantation).
• 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 Esomeprazol Pensa 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 are planning to become pregnant, consult your doctor 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 operate tools or machinery. However, adverse effects such as dizziness or blurred vision may occur infrequently or rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

Esomeprazol Pensa contains sunset yellow FCF (E-110)

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Esomeprazol Pensa

Follow exactly the instructions given by your doctor 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 the symptoms change. You may take the tablets at any time of day.
• You may take the tablets with food or on an empty stomach.

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. If you have difficulty swallowing the tablets:

• Place the tablets in a glass of still (non-carbonated) water. Do not use any 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 administered via a syringe. They can then be delivered directly into the stomach through a tube (gastric tube).

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 given below.

Use in adults aged 18 years and older

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one Esomeprazol Pensa 40 mg gastro-resistant 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 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 re-bleeding from peptic ulcer after intravenous esomeprazole:

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

Use in adolescents aged 12 years and older

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 Esomeprazol Pensa 40 mg gastro-resistant 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.

Use in children under 12 years of age

Esomeprazole 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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating 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 the missed dose.

4. Possible adverse effects

Like all medicines, Esomeprazole Pensa can cause adverse effects, although not everyone experiences 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 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 liver function blood tests.
• Skin rash, hives, itching.
• Fracture of hip, wrist or spine (if esomeprazole is used at high doses and for a long period of time).

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.
• 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 yellowing of the skin, dark urine and tiredness.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• 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).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Liver disorders which 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 problems.
• Breast enlargement in men.

Frequency not known (frequency 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 carry out periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (may result in diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazole may affect white blood cells, causing immune deficiency. If you have an infection with symptoms such as fever accompanied by a severe 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 reduction in white blood cell count (agranulocytosis) via a blood test. It is important that, in this case, you inform your doctor about 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 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 Esomeprazole Pensa

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 pack following 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.

Vials: Do not store above 30°C. Shelf life after first opening the vial: 100 days. Keep the vial tightly closed to protect from moisture.

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

6. Contents of the pack and other information

Composition of Esomeprazol Pensa

The active substance is esomeprazole. There are two strengths of Esomeprazol Pensa gastro-resistant tablets containing 20 mg or 40 mg of esomeprazole (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 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 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake / FD&C Blue #2 (E132), black iron oxide (E172) and FD&C Yellow #6 / Sunset Yellow FCF aluminum lake (E110)).

Appearance of the product and contents of the pack

Esomeprazol Pensa 40 mg gastro-resistant tablets are oval-shaped and blue in colour. They are available in packs of 14, 28, 56 or 100 (clinical pack) tablets in blisters, and 14, 28 or 100 (clinical pack) tablets in bottles. Not all 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 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 Medical Devices (AEMPS) http://www.aemps.gob.es/