ESOMEPRAZOL 40 mg Gastro-Resistant Tablets

Contents of the leaflet

1. Introduction
2. What is Esomeprazole Pensa and what is it used for
3. What you need to know before you take Esomeprazole Pensa
4. How to take Esomeprazole Pensa
5. Possible side effects
6. Storage of Esomeprazol Pensa
7. Package Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Esomeprazole Pensa 40 mg Gastro-Resistant Tablets 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.

Contents of the Package Leaflet

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

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

Esomeprazole Pensa contains a medicine called esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that the stomach produces.

Esomeprazole 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 which connects the throat to the stomach) causing pain and inflammation.
• Stomach acid produced too much by a growth in the pancreas (Zollinger-Ellison syndrome).
• Prevention of relapse of peptic ulcer bleeding in patients treated with esomeprazole intravenously.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain and inflammation.

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 these apply to you, do not take esomeprazole. If you are not sure, talk to your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Talk to 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 to reduce 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 in association with the use of esomeprazole. If you get any of the following symptoms you should contact your doctor immediately:

• Severe skin rash.
• Blistering of the skin.
• Sores in the mouth.
• Flaking skin.

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

• Unintentional weight loss.
• Difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.

If you have been prescribed esomeprazole only when your symptoms appear, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like esomeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in 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 tell your doctor as soon as possible, as you may need to stop your treatment with esomeprazole. Also remember to mention any other symptoms that you may have such as joint pain.

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. This includes medicines that you buy without a prescription. This is because esomeprazole can affect the way some medicines work and some medicines can increase the chance of you getting side effects.

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, relax muscles or for 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 esomeprazole treatment.
• Tacrolimus (used to prevent organ rejection after 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 combination with esomeprazole for treatment of ulcers caused by Helicobacter pylori, 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 at any time of the day either with food or without food.

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 in this way.

Esomeprazole Pensa contains sunset yellow FCF (E 110)

This medicine contains sunset yellow FCF (E 110), which may cause allergic reactions.

3. How to take Esomeprazole Pensa

Always take this medicine exactly as your doctor 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 (especially if you are taking 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 persist or worsen.
• You can take your tablets at any time of the day either with food or without food.

Swallow your tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets are coated to protect the medicine from the acid in your stomach. It is important not to damage the coating.

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 into little pellets (the mixture will not be clear). You can then drink the mixture. You must always stir the mixture just before you drink it.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid particles 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 or 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

• 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 gullet has not healed.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of too much acid in the stomach caused by a growth 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 also will decide how long you will take the medicine. The maximum dose is Esomeprazole Pensa 80 mg twice a day.

Prevention of relapse of peptic ulcer bleeding in patients treated with esomeprazole intravenously:

• The recommended dose is one Esomeprazole Pensa 40 mg tablet per day for 4 weeks.

Adolescents from 12 years of age

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

• 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 gullet has not healed.
• If you have severe liver problems, your doctor may give you a lower dose.

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, talk to your doctor or pharmacist straight away. In the event of an overdose, you should contact your doctor or pharmacist, or go to the nearest hospital or emergency department immediately. Take the medicine pack 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 (two doses at the same time) to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Esomeprazole Pensa can cause side effects, although not everybody gets them.

Stop taking Esomeprazole Pensa and contact a doctor immediately if you notice any of the following serious side effects:

• Sudden onset of severe rash, blistering or peeling of the skin and/or mucous membranes and/or eye inflammation.
• Severe skin blistering, peeling and bleeding (Bullous Pemphigoid).
• Yellow skin, dark urine and tiredness which can be signs of liver problems.

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.
• Effects on the stomach or intestines: stomach pain, constipation, diarrhoea, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet, ankles, or hands.
• Disturbed sleep.
• Dizziness, tingling or numbness (prickling sensations), feeling sleepy.
• Spinning sensation (vertigo).
• Dry mouth.
• Abnormal liver function tests (seen in blood tests).
• Rash, itching, or hives (urticaria).
• Fracture of the hip, wrist or spine (if esomeprazole is used in high doses and over long periods of time).

Rare (may affect up to 1 in 1,000 people)

• Disorders in blood count, such as agranulocytosis (lack of white blood cells), thrombocytopenia (lack of platelets) or anaemia (lack of red blood cells), which may cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood.
• Agitation, confusion, depression.
• Disturbances in taste.
• Eye problems, such as blurred vision or double vision.
• Sudden onset of a severe rash or blistering or peeling of the skin and/or mucous membranes, possibly with fever (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS)).
• Yellowing of the skin or eyes (jaundice), reduced platelet count, which may cause an increased risk of bleeding or bruising.
• Increased sweating.
• Generally feeling unwell, lack of energy or fever.

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

• Changes in blood count, including agranulocytosis (severe lack of white blood cells), which may cause weakness, bruising or make infections more likely.
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).
• Severe liver problems, including liver failure or inflammation of the liver.
• Sudden onset of a severe rash or blistering or peeling of the skin and/or mucous membranes, possibly with fever, and possibly involving the eyes, ears, mouth, throat, or genital areas (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS)).
• Muscle weakness.
• Kidney problems.
• Enlargement of the breasts in men.

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

• If you are taking esomeprazole for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause tiredness, muscle weakness, convulsions, dizziness or an irregular heartbeat. If you get any of these symptoms, you should tell your doctor promptly. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Inflammation of the gut (leading to diarrhoea).
• Rash, possibly with a fever.

In very rare cases, esomeprazole may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth, or difficulty in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your doctor about your medicine.

Reporting of side effects

If you get 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 national reporting system listed in the Spanish Medicines Agency website. 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 label, box, or blister after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. 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. 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 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine indigo/blue FD&C #2 (E132), black iron oxide (E172), and aluminum lake yellow FD&C #6/orange yellow S (E110)).

Appearance of the Product and Package Contents

Esomeprazol Pensa 40 mg gastro-resistant tablets are oval and blue in color. They are available in packages of 14, 28, 56, or 100 (clinical package) tablets in blister packs and 14, 28, or 100 (clinical package) tablets in bottles. Not all 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/