ESOMEPRAZOL AUROVITAS SPAIN 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Esomeprazol Aurovitas Spain 20 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.

• 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 pack:

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

1. What is Esomeprazol Aurovitas Spain and what is it used for

Esomeprazol Aurovitas Spain contains a medicine called esomeprazol. It belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that your stomach produces.

Esomeprazol Aurovitas Spain is used to treat the following conditions:

Adults and adolescents aged 12 years and above

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers of the duodenum (the tube leading out of the stomach) caused by a bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazol Aurovitas Spain can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

2. What you need to know before you take Esomeprazol Aurovitas Spain

Do not take Esomeprazol Aurovitas Spain

• If you are allergic (hypersensitive) to esomeprazol or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitors.
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Aurovitas Spain that reduces stomach acid.

If any of the above apply to you, do not take Esomeprazol Aurovitas Spain. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazol Aurovitas Spain.

Warnings and precautions

Before taking this medicine, tell your doctor if:

• You have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Aurovitas Spain that reduces stomach acid. If you get a skin rash or swelling, stop taking Esomeprazol Aurovitas Spain and contact your doctor as soon as possible. Also, remember to mention any other symptoms that you may have, such as fever or joint pain.
• You have severe liver problems.
• You have severe kidney problems.
• You are due to have a specific blood test (Chromogranin A).

Esomeprazol Aurovitas Spain may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking Esomeprazol Aurovitas Spain, 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 (a sign of bleeding).

If your doctor has prescribed Esomeprazol Aurovitas Spain only when you have symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like Esomeprazol Aurovitas Spain, 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).

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 esomeprazol treatment. Stop taking esomeprazol and contact your doctor immediately if you notice any of the following symptoms: skin rash, blistering of the skin, and bleeding in the eyes, mouth and genital areas, swollen lymph nodes, high fever, high blood pressure, abnormal heartbeat, and swollen face, lips, tongue or throat which may cause difficulty in breathing.

Children

Esomeprazol Aurovitas Spain gastro-resistant tablets are not recommended for children under 12 years.

Other medicines and Esomeprazol Aurovitas Spain

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 Aurovitas Spain can affect how these medicines work and these medicines may also affect how Esomeprazol Aurovitas Spain works.

Do not take Esomeprazol Aurovitas Spain if you are taking:

• A medicine that contains 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 or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazol Aurovitas Spain.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Aurovitas Spain.
• 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 temporarily stop your Esomeprazol Aurovitas Spain treatment.
• Tacrolimus (used in 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 with Esomeprazol Aurovitas Spain to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Esomeprazol Aurovitas Spain with food and drink

You can take the tablets with or without food.

Pregnancy and breast-feeding

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 Esomeprazol Aurovitas Spain during this time.

It is not known if Esomeprazol Aurovitas Spain passes into breast milk. Therefore, you should not take Esomeprazol Aurovitas Spain if you are breast-feeding.

Driving and using machines

Esomeprazol Aurovitas Spain 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.

Esomeprazol Aurovitas Spain contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Esomeprazol Aurovitas Spain

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 (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 persist or change.

Taking this medicine

• You can take the tablets at any time of the day.
• You can take the tablets with or without food.
• Swallow the 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 the 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 drink this mixture straight away or within 30 minutes. Always stir well before drinking.
• 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 (a large syringe should be used).

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.

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

Adults and adolescents aged 12 years and above:

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is 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 healed yet.
• Once your oesophagus has healed, the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet once a day.
• If your gullet (oesophagus) is not damaged, the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet once a day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to stop them coming back:

• Adults and adolescents aged 12 years and above: the recommended dose is one Esomeprazol Aurovitas Spain 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 the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• Adults aged 18 years and above: the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet once a day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• Adults aged 18 years and above: the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet once a day.

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

• Adults aged 18 years and above: the recommended dose is Esomeprazol Aurovitas Spain 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 Esomeprazol Aurovitas Spain 80 mg twice a day.

If you take more Esomeprazol Aurovitas Spain than you should

If you have taken more Esomeprazol Aurovitas Spain than you should, contact your doctor or pharmacist immediately or go to the nearest hospital. Take the medicine pack with you.

If you forget to take Esomeprazol Aurovitas Spain

• 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 Adverse Effects

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

If you observe any of the following serious adverse effects, stop taking Esomeprazol Aurovitas Spain 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, occurring in between 1 and 10 out of every 10,000 people.

Other adverse effects include:

Frequent (Between 1 and 10 out of every 100 people)

• Headache.
• Effects on the stomach or intestine: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Infrequent (Between 1 and 10 out of every 1,000 people)

• Swelling of feet and ankles.
• Disruption of sleep (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol Aurovitas Spain is used at high doses and for a long period).

Rare (Between 1 and 10 out of every 10,000 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.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden sensation 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).
• Dermatitis due to sun exposure.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very Rare (In less than 1 out of every 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 pain in the joints. (Erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.
• Low magnesium levels in the blood. This can cause weakness, nausea (vomiting), cramps, tremors, and arrhythmias (alterations of heart rhythm).

Unknown Frequency

• If you are taking esomeprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see a doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (which can lead to diarrhea).
• Skin rash, possibly with pain in the joints.

In very rare cases, Esomeprazol Aurovitas Spain 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 pain in the 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 inform 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 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 Aurovitas Spain

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.

Blister packs:

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from moisture.

Bottles:

Do not store at a temperature above 30°C.

Validity period 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. Content of the Package and Additional Information

Composition of Esomeprazol Aurovitas Spain

• The active ingredient is esomeprazol. There are two concentrations of Esomeprazol Aurovitas Spain 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 lake carmine indigo/blue FD&C #2 (E132), and yellow iron oxide (E172)).

Appearance of the Product and Content of the Package

• Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablets are oval, blue tablets.
• Esomeprazol Aurovitas Spain 20 mg is presented in packages of 14, 28, and 56 tablets in blister packs, and in 28 tablets in bottles.
• Clinical package of 100 tablets in blister packs and bottles.
• Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The holder is:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

The manufacturer is:

Towa Pharmaceutical Europe S.L.

C/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

Date of the Last Revision of this Prospectus: February 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/