ESOMEPRAZOL SANDOZ CARE 20 mg HARD GASTRO-RESISTANT CAPSULES

2. What you need to know before taking Esomeprazol Sandoz Care

Do not take Esomeprazol Sandoz Care:

• If you are allergic to esomeprazole or any of the other components of this medicine (listed in section 6).
• If you are allergic to other medicines that contain other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, or omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash or skin peeling, blistering, or ulcers in the mouth after taking esomeprazole or other related medicines.

Do not take this medicine if you experience any of the above situations. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting to take esomeprazole if:

• you have had stomach ulcers or stomach surgery in the past,
• you have been receiving continuous treatment for reflux or acidity for 4 weeks or more,
• you have jaundice (yellowing of the skin or eyes) or severe liver problems,
• you have severe kidney problems,
• you are over 55 years old and have new or recently changed reflux symptoms or need to take an over-the-counter treatment for indigestion or heartburn every day,
• you have ever had a skin reaction after treatment with a medicine similar to esomeprazole to reduce heartburn,
• you are going to have an endoscopy or a breath test with urea,
• a specific blood test (Chromogranin A) is scheduled for you

Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be a sign of a more serious illness.

• You lose a lot of weight without reason.
• You have problems or pain when swallowing.
• You have stomach pain or signs of indigestion such as nausea, fullness, bloating, especially after eating.
• You start vomiting food or blood, which may appear as dark coffee grounds in your vomit.
• You have black stools (blood-stained feces).
• You have severe or persistent diarrhea; esomeprazole has been associated with a small increased risk of infectious diarrhea.
• If you suffer a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with esomeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Seek urgent medical attention if you experience chest pain with dizziness, sweating, dizziness, or shoulder pain with difficulty breathing. This could be a sign of a serious heart condition.

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), in relation to treatment with esomeprazole. Stop taking esomeprazole and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you are in any of the above situations (or are unsure), consult your doctor immediately.

Children and adolescents

This medicine should not be used by children and adolescents under 18 years of age.

Other medicines and Esomeprazol Sandoz Care

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine. This is because esomeprazole can affect how some medicines work and some medicines can influence the effect of esomeprazole.

Do not take this medicine if you are also taking a medicine that contains nelfinavir (used to treat HIV infection).

You must specifically inform your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).

Do not take this medicine with other medicines that limit the amount of acid produced in your stomach, such as proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, or omeprazole) or an H2 antagonist (e.g., ranitidine or famotidine).

You can take this medicine with antacids (e.g., magaldrate, algic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations of these) if necessary.

Tell your doctor if you are taking any of the following medicines:

• ketoconazole and itraconazole (for fungal infections),
• voriconazole (for fungal infections) and clarithromycin (to treat infections). Your doctor may adjust your dose of esomeprazole if you also have severe liver problems and receive treatment for a prolonged period,
• erlotinib (used to treat cancer),
• methotrexate (for cancer and rheumatic disease),
• digoxin (used to treat heart problems),
• atazanavir, saquinavir (used to treat HIV infection),
• citalopram, imipramine, clomipramine (for depression),
• diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy),
• phenytoin (for epilepsy),
• medicines used to make blood more fluid, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole,
• cilostazol (used to treat intermittent claudication – leg pain and difficulty walking caused by insufficient blood pumping),
• cisapride (used for indigestion and heartburn),
• rifampicin (to treat tuberculosis),
• tacrolimus (in case of organ transplantation),
• St. John's Wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breastfeeding

As a precaution, you should preferably avoid taking esomeprazole during pregnancy. You should not take esomeprazole during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Esomeprazol has a low probability of affecting your ability to drive or use machines. However, rare side effects such as dizziness and visual disturbances (see section 4) may occur. If you are affected, do not drive or use machines.

Esomeprazol Sandoz Care contains sucrose and sodium

This medicine contains sugar spheres that contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule; this is, essentially "sodium-free".

3. How to take Esomeprazol Sandoz Care

Follow the administration instructions of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

• The recommended dose is one capsule per day.
• Do not take more than the recommended dose of one capsule per day (20 mg), even if you do not feel immediate improvement.
• You may need to take the capsules for 2 or 3 days in a row before your reflux symptoms improve (e.g., heartburn and acid regurgitation).
• The treatment duration is up to 14 days.
• When your reflux symptoms have completely disappeared, you should stop taking this medicine.
• If your reflux symptoms worsen or do not improve after taking this medicine for 14 days in a row, you should consult a doctor.

If you have persistent or long-lasting symptoms that recur frequently even after treatment with this medicine, you should consult your doctor.

Taking this medicine

• You can take the capsule at any time of day with food or on an empty stomach.
• Swallow the capsule whole with half a glass of water. Do not chew, crush, or open the capsule.

This is because the capsule contains coated granules that prevent the stomach acid from breaking down the medicine. It is important not to damage the granules.

If you take more Esomeprazol Sandoz Care than you should

If you take more esomeprazole than recommended, consult your doctor or pharmacist immediately. You may experience symptoms such as diarrhea, stomach pain, constipation, nausea, or vomiting and weakness.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 5620420, indicating the medicine and the amount ingested. If you forget to take Esomeprazol Sandoz Care

If you forget to take a dose, take it as soon as you remember, on the same day. Do not take a double dose to make up for the forgotten dose.

If you forget to take Esomeprazol Sandoz Care

If you forget to take a dose, take it as soon as you remember, on the same day. Do not take a double dose to make up for the forgotten dose.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• sudden wheezing, swelling of the lips, tongue, and throat, skin rash, fainting, or difficulty swallowing (severe allergic reaction, uncommon),
• redness of the skin with blisters or peeling. Blisters or bleeding of the lips, eyes, mouth, nose, and genitals may also appear. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis", which are rare.
• yellow skin, dark urine, and fatigue, which can be symptoms of liver problems, rarely observed,
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome), which is very rare.

Talk to your doctor as soon as possible if you experience any of the following signs of infection:

This medicine may, in very rare cases, affect the white blood cells, causing immunodeficiency. If you have an infection with symptoms such as fever with a seriousworsening of your condition or fever with symptoms of a local infection such as pain in the neck, throat, or mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) with a blood test. It is important that you provide information about your medicine at that time.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache,
• effects on your stomach or intestine: diarrhea, stomach pain, constipation, gas (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 and ankles,
• sleep disturbance (insomnia), feeling drowsy,
• dizziness, sensation of tingling and numbness,
• vertigo sensation,
• dry mouth,
• increased liver enzymes in blood tests that determine liver function,
• skin rash, hives, itching.

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

• blood disorders such as decreased 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,
• feeling of agitation, confusion, or depression,
• taste disturbance,
• eye disorders such as blurred vision,
• sudden shortness of breath or difficulty breathing (bronchospasm),
• inflammation inside the mouth,
• a fungal infection called "candidiasis" that can affect the esophagus,
• hair loss (alopecia),
• dermatitis due to sun exposure,
• joint pain (arthralgia) or muscle pain (myalgia),
• general feeling of discomfort and lack of energy,
• increased sweating.

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

• low number of red blood cells, white blood cells, and platelets in the blood (a condition called pancytopenia),
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• severe liver disorders that can lead to liver failure or brain inflammation,
• muscle weakness,
• severe kidney disorders,
• enlargement of the breasts in men.

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

• low magnesium levels in the blood. This can cause weakness, vomiting, cramps, tremors, and changes in heart rhythm (arrhythmias). If you have very low magnesium levels, you may also have low potassium and/or calcium levels in the blood,
• inflammation in the intestine (which can lead to diarrhea),
• skin rash, possibly with joint pain.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Esomeprazol Sandoz Care

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

Do not use this medicine after the expiration date that appears on the box after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep it in the original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Esomeprazol Sandoz Care

• The active ingredient is esomeprazole. Each hard gastro-resistant capsule contains 20 mg of esomeprazole (as sodium salt).
• The other components are:

Capsule content:

Sugar spheres (contains corn starch and sucrose), methylcellulose, talc, titanium dioxide (E-171), glycerol monostearate 40-55, polysorbate-80, sodium lauryl sulfate, copolymer of methacrylic acid and ethyl acrylate, and triethyl citrate.

Capsule shell:

1. Carrageenan, potassium chloride, red iron oxide (E-172), titanium dioxide (E-171), hypromellose, printing ink (contains shellac, potassium hydroxide, and black iron oxide (E-172)).

Product Appearance and Container Content

The hard gastro-resistant capsules of esomeprazole are light pink opaque in color on the cap and body and printed in black, both on the cap and body (ES on the cap/20 on the body). The length of the capsules is approximately 14 mm.

Esomeprazol Sandoz Care 20 mg hard gastro-resistant capsules are available in OPA/Aluminum/PE + calcium oxide desiccant//Aluminum/PE blisters.

The pack sizes are 7 and 14 hard gastro-resistant capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

TOWA PHARMACEUTICAL EUROPE S.L.

C/ de Sant Martí, 75-97, Martorelles,

08107 Barcelona

Spain

or

Lek Pharmaceuticals d.d.

Verovskova ulica 57,

1526, Ljubljana,

Slovenia

Date of the Last Revision of this Leaflet:December 2024.

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

OTHER USEFUL INFORMATION

What are the symptoms of heartburn?

The normal symptoms of reflux are a painful sensation in the chest that rises to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Why do these symptoms occur?

Heartburn can occur from eating too much, eating food with high fat content, eating too quickly, and drinking too much alcohol. You may notice that when you lie down, the heartburn worsens. If you are overweight or smoke, the likelihood of suffering from heartburn increases.

What can I do to help relieve my symptoms?

• Eat healthier foods and try to avoid spicy and fatty foods and large meals just before bedtime.
• Avoid carbonated drinks, coffee, chocolate, and alcohol.
• Eat slowly and in small portions.
• Try to lose weight.
• Quit smoking.

When should I seek advice or help?

• Seek urgent medical attention if you experience chest pain accompanied by dizziness, sweating, fainting, or shoulder pain with difficulty breathing.
• If you experience any of the symptoms detailed in section 2 of this leaflet and for which it is advised to speak with your doctor or pharmacist.
• If you suffer from any of the adverse effects detailed in section 4 that require medical attention.