ESOMEPRAZOL AUROVITAS SPAIN 40 mg GASTRO-RESISTANT TABLETS

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

Esomeprazol Aurovitas Spain contains a medicine called esomeprazol, which belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazol Aurovitas Spain is used to treat the following conditions:

• 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.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazol intravenous.

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 to reduce stomach acid.

If any of these apply to you, do not take Esomeprazol Aurovitas Spain. If you are not sure, consult 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 to reduce stomach acid. If you get a skin rash, especially in areas of your skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with Esomeprazol Aurovitas Spain. Also remember to mention any other symptoms you might notice, such as joint pain.
• you have severe liver problems.
• you have severe kidney problems.
• a specific blood test (Chromogranin A) is planned.

Esomeprazol Aurovitas Spain may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while 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 (blood-stained).

If you have been prescribed Esomeprazol Aurovitas Spain only when your symptoms appear, 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 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).

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 esomeprazol. If you appear to develop any of these symptoms, stop taking esomeprazol and contact your doctor immediately.

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, including those obtained without a prescription. This is because Esomeprazol Aurovitas Spain may affect how these medicines work or these medicines may affect how Esomeprazol Aurovitas Spain works.

Do not take Esomeprazol Aurovitas Spain if you are taking:

• a medicine that contains nelfinavir(used for HIV infection).

Tell your doctor if you are taking:

• atazanavir (used for 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 in seizures).
• phenytoin (used to treat seizures). 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 pain in your legs when you walk which is caused by an insufficient blood supply).
• cisapride (used for indigestion and heartburn).
• digoxin (used for heart problems).
• methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Aurovitas Spain.
• 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 combination with Esomeprazol Aurovitas Spain to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor about any other medicines you are taking.

Esomeprazol Aurovitas Spainwith 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 during breast-feeding.

Driving and using machines

Esomeprazol Aurovitas Spain is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use machines if you are affected by these side effects.

Esomeprazol Aurovitas Spain contains orange yellow S (E110)

This medicine may cause allergic reactions because it contains orange yellow S (E110). This may cause asthma, especially in patients allergic to aspirin.

Esomeprazol Aurovitas Spain contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., it is 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 (especially if you take it for more than one year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms 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 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 drink this mixture immediately or within 30 minutes. Always stir well before drinking.
• 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 liver function.
• The recommended doses are described below.

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

Adults and children over 12 years:

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Esomeprazol Aurovitas Spain 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 healed yet.
• If you have serious liver problems, your doctor may give you a lower dose.

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

• Adults over 18 years: the recommended dose is Esomeprazol Aurovitas Spain 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you will take the medicine for. The maximum dose is 80 mg twice a day.

Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazol intravenous:

• The recommended dose is one Esomeprazol Aurovitas Spain 40 mg tablet per day for 4 weeks.

If you take more Esomeprazol Aurovitas Spain than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the national information center, phone: 91 562 04 20, indicating the medicine and the amount taken.

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 side effects

Like all medicines, Esomeprazol Aurovitas Spain can cause side effects, although not everybody gets them.

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

• Sudden onset of severe rash, blistering or peeling of the skin, severe itching, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose, genitals, hands or feet. This could be a condition called 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 (a condition called DRESS or drug rash with eosinophilia and systemic symptoms), which is a rare condition.

These effects are rare and occur in between 1 and 10 of every 10,000 patients.

Other side effects include:

Common (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling (prickling) sensations, numbness, somnolence.
• Vertigo (spinning sensation).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Rash, itching, urticaria.
• Fracture of the hip, wrist or spine (if Esomeprazol Aurovitas Spain is used in high doses and over a long period).

Rare (affects 1 to 10 users in 10,000)

• Disorders in blood count, such as a reduced number of white cells or platelets. This may cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
• Agitation, aggression, depression.
• Disturbances in taste.
• Eye problems such as blurred vision.
• Sudden onset of a severe rash or blistering or peeling of the skin and/or mucous membranes, possibly with fever, and/or changes in blood counts (including a decrease in the number of blood platelets) and swelling of lymph nodes (a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Swelling of the mouth, lips, tongue or throat which may cause difficulty breathing (angioedema).
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis.
• Inflammation of the gut leading to diarrhoea.

Very rare (affects less than 1 user in 10,000)

• Changes in blood count, including agranulocytosis (severe reduction in white blood cells).
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy in patients with pre-existing liver disease.
• Sudden onset of a severe rash or blistering or peeling of the skin and/or mucous membranes, possibly with fever, and/or changes in blood counts (including a decrease in the number of blood platelets) and swelling of lymph nodes (a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.
• Low levels of magnesium in the blood. This may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate.

Frequency not known

• If you are taking esomeprazol for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, fast or irregular heartbeats. If you experience any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in the levels of other nutrients in the blood, such as potassium and calcium. 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 fever, joint pains and swelling of lymph nodes.

In very rare cases, Esomeprazol Aurovitas Spain 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 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 Spanish Medicines Agency’s website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Aurovitas Spain

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the label, carton or blister after CAD. The expiry date is the last day of the month indicated.

Blister packs:

• Do not store above 30°C.
• Store in the original packaging to protect from moisture.

Bottles:

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

• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Esomeprazol Aurovitas Spain

• The active substance is esomeprazole. There are two concentrations of Esomeprazol Aurovitas Spain gastro-resistant tablets containing 20 mg or 40 mg of esomeprazole (as sodium salt).

• The other ingredients 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 Dark Blue 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine indigo/blue FD&C #2 (E132), iron oxide black (E172), and aluminum lake yellow FD&C #6/orange yellow S (E110).

Appearance of the product and package contents

• Esomeprazol Aurovitas Spain 40 mg gastro-resistant tablets are oval, blue tablets.

• Esomeprazol Aurovitas Spain 40 mg is available in packs of 14, 28, or 56 tablets in blister packs, and in 28 tablets in bottles.
• Clinical pack of 100 tablets in blister packs and bottles.
• Only certain pack 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 last revision of this leaflet: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/