ESOMEPRAZOL ARISTO 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Aristo 40 mg Gastro-Resistant Hard Capsules 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. See section 4.

Contents of the pack and other information

1. What is Esomeprazol Aristo and what is it used for
2. What you need to know before you take Esomeprazol Aristo
3. How to take Esomeprazol Aristo
4. Possible side effects
5. Storage of Esomeprazol Aristo

1. Contents of the pack and further information

1. What is Esomeprazol Aristo and what is it used for

Esomeprazol Aristo contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazole 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 carries food from the mouth to the stomach) causing pain and inflammation.
• Ulcers in the stomach or duodenum (part of the gut) that are infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers in the stomach or duodenum caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole can also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Treatment of NSAID-associated gastric and duodenal ulcers, and prevention of NSAID-associated gastric and duodenal ulcers in patients at risk.

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 carries food from the mouth to the stomach) causing pain and inflammation.
• Ulcers in the stomach or duodenum (part of the gut) that are infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Esomeprazol Aristo

Do not take Esomeprazol Aristo

• 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 that reduces stomach acid.

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

Warnings and precautions

Tell your doctor or pharmacist before taking esomeprazole:

• if you have severe liver problems,
• if you have severe kidney problems,
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazole that reduces stomach acid. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazole (see section 4). If you get any of the following symptoms, tell your doctor immediately: severe skin rash, blistering of the skin, mouth, eyes and genitals, skin peeling, high fever, swelling, increase of eosinophils in the blood (a type of white blood cell);
• if you are due to have a specific blood test (Chromogranin A),

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

• you lose a lot of weight for no reason and have problems swallowing,
• you get stomach pain or indigestion,
• you start vomiting food or blood,
• your stools are black (a sign of bleeding in the stomach or gut).

If you have been prescribed esomeprazole “on demand” (i.e. when you have symptoms), you should contact your doctor if your symptoms persist or worsen.

If you take esomeprazol for more than 3 months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can make you feel tired, confused, dizzy, have muscle twitches, cramps, and an irregular heartbeat. If you get 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, including potassium and calcium. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

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).

Skin rash and blisters

If you get a rash, or if you notice blisters on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible. Remember to also mention any other symptoms that you may be experiencing, such as joint pain or fever. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazole (see section 4). The rash may be a sign of a more serious condition and your doctor will need to decide whether you should continue to take esomeprazole.

If you get any of the following symptoms, stop taking esomeprazole and contact your doctor immediately:

A severe skin rash which may include blistering and peeling of the skin, particularly around the mouth, eyes, and genitals. This may be accompanied by fever, and changes in blood counts (eosinophilia) and in kidney function.

Children under 12 years

Esomeprazol is not recommended for children under 12 years.

Other medicines and Esomeprazol Aristo

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 esomeprazole can affect the way some medicines work and some medicines can increase the chance of you getting side effects.

Do not take esomeprazole capsules if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist 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 (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 help you sleep),
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor may 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),
• Metotrexate (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 mild depression),

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

Using Esomeprazol Aristo with food and drink

You can take the capsules 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 esomeprazole during this time.

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

Esomeprazol Aristo contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Esomeprazol Aristo

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 (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, tell your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many capsules to take and when to take them. This will depend on your condition, age and liver function.
• The recommended doses are described below.

Use in adults aged 18 and above

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your oesophagus has not yet healed.
• Once the oesophagus has healed, the recommended dose is one 20 mg capsule once a day.
• If your gullet (oesophagus) is not damaged, the recommended dose is one 20 mg capsule each day.

For the treatment of ulcers in the stomach or duodenum caused by Helicobacter pylori infection:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take at the same time as esomeprazole.

For the treatment of stomach ulcers caused by NSAIDs:

• The recommended dose is one 20 mg capsule once a day for 4-8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs:

• The recommended dose is one 20 mg capsule once a day.

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

• The recommended dose is one 40 mg capsule twice a day.

Use in adolescents aged 12 and above

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your oesophagus has not yet healed.
• Once the oesophagus has healed, the recommended dose is one 20 mg capsule once a day.

For the treatment of ulcers in the stomach or duodenum caused by Helicobacter pylori infection:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take at the same time as esomeprazole.

Taking this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain coated granules which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and swallow the contents with half a glass of non-fizzy water.
• Always stir the mixture just before you drink it. The mixture will not be clear.

Use in children under 12 years

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

Elderly

No dose adjustment is necessary for patients over 65 years.

If you take more Esomeprazol Aristo than you should

If you have taken more esomeprazole than you should, talk to your doctor or pharmacist straight away.

In case of overdose, contact your doctor or pharmacist or go to the nearest hospital casualty department straight away. Take the medicine pack with you.

If you forget to take Esomeprazol Aristo

• 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine 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:

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems. These effects are rare and can affect up to 1 in 1,000 people.

• A sudden difficulty breathing, swelling of lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and can affect up to 1 in 1,000 people.

• Sudden appearance of a severe skin rash or skin redness with blisters or peeling, even after several weeks of treatment. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms". These effects are very rare and can affect up to 1 in 10,000 people.
• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

Other adverse effects include:

Frequent:can affect up to 1 in 10 people

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

Infrequent:can affect up to 1 in 100 people

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Vertigo sensation.
• 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 is used at high doses and for a long period).

Rare:can 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 sensation of shortness of breath 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, which can cause yellow 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:can 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, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Increased breast size in men.

Frequency Not Known:frequency cannot be estimated from available data

• Inflammation of the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.
• Low magnesium levels in the blood (hypomagnesemia) (see section 2 "Warnings and Precautions").

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 the medication you are taking at that time.

Reporting 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 through the national notification system: Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Esomeprazol Aristo

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

• Do not store at a temperature above 25°C.

• Store in the original packaging (blister) or keep the container (bottle) perfectly closed to protect it from moisture.

• Do not use this medicine after the expiration date that appears on the packaging and on the blister or bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or waste. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Aristo Gastro-Resistant Capsules

• The active ingredient is esomeprazol.

There are two different doses of Esomeprazol Aristo gastro-resistant capsules that contain 20 mg or 40 mg of esomeprazol (as magnesium dihydrate salt).

• The other components are:

Contents of the capsules

Granules:carrageenan, microcrystalline cellulose, mannitol, sodium hydroxide, sodium carbonate

Insulating coating:polyethylene glycol-polyvinyl alcohol copolymer, sodium hydroxide, talc, titanium dioxide (E171), colloidal hydrated silica.

Gastro-resistant coating:methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, titanium dioxide (E171).

Capsule

Cap:gelatin, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172)

Body:gelatin, titanium dioxide (E171)

Appearance of the Product and Package Contents

Esomeprazol Aristo 40 mg Hard Gastro-Resistant Capsules

Capsule with white opaque body and orange opaque cap, containing white or almost white gastro-resistant granules.

The capsules are presented in high-density polyethylene bottles with a desiccant capsule and a polypropylene cap, and aluminum/aluminum blisters. Do not ingest the desiccant capsule that comes in the bottle.

Package sizes:

14, 28, and 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid, Spain

Manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Germany: Esogasec 40 mg magensaftresistente Hartkapseln

Poland: Esogasec

Spain: Esomeprazol Aristo 40 mg hard gastro-resistant capsules EFG

France: ESOMEPRAZOLE EVOLUGEN PHARMA 40 mg, gélule gastro-résistante

Portugal: Esomeprazol Aristo 40 mg gastro-resistant capsules

Date of the Last Revision of this Prospectus: April 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.