Esomeprazole Sandoz Care 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazol Sandoz Care 20 mg gastro-resistant hard capsules

Read the entire leaflet carefully before starting to take this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, consult your pharmacist.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 14 days.

Contents of the leaflet

1. What Esomeprazol Sandoz Care is and what it is used for

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

3. How to take Esomeprazol Sandoz Care

4. Possible side effects

5. Storage of Esomeprazol Sandoz Care

6. Contents of the pack and other information

1. What Esomeprazol Sandoz Care is and what it is used for

Esomeprazol Sandoz Care contains the active substance esomeprazole. It belongs to a group of medicines called "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

This medicine is used in adults for short-term treatment of reflux symptoms (for example, heartburn and acid regurgitation).

Reflux is the backward flow of acid from the stomach into the throat ("oesophagus"), which may cause inflammation and pain. This can lead to symptoms such as a painful sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Esomeprazol is not intended to provide immediate relief. You may need to take the capsules for 2-3 days consecutively before you start to feel better. You should consult a doctor if you do not improve or if your condition worsens after 14 days.

2. What you need to know before starting to take Esomeprazole Sandoz Care

Do not take Esomeprazol Sandoz Care:

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

Do not take this medicine if any of the above situations apply to you. 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 previously had a stomach ulcer or stomach surgery,
• you have been receiving continuous treatment for reflux or heartburn for 4 weeks or more,
• you have jaundice (yellowing of the skin or eyes) or serious liver problems,
• you have serious kidney problems,
• you are over 55 years old and have new or recently changed reflux symptoms, or need to take 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 for heartburn relief,
• you are scheduled for an endoscopy or a urea breath test,
• you are scheduled for a specific blood test (Chromogranin A).

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

• You lose a lot of weight without reason.
• You have difficulty 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-ground particles in your vomit.
• You have black stools (blood-stained faeces).
• You have severe or persistent diarrhoea; esomeprazole has been associated with a small increased risk of infectious diarrhoea.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with esomeprazole. Remember to mention any other symptoms you may experience, such as joint pain.

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

Severe skin reactions have been reported with esomeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). 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 any of the above situations apply to you (or you are unsure), consult your doctor immediately.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Esomeprazol Sandoz Care

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 containing 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 reduce stomach acid production, such as proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, or omeprazole) or H2 antagonists (e.g., ranitidine or famotidine).

You may take this medicine with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations of these) if needed.

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

• ketoconazole and itraconazole (for fungal infections),
• voriconazole (for fungal infections) and clarithromycin (for treating infections). Your doctor may adjust your dose of esomeprazole if you also have serious liver problems and are receiving long-term treatment,
• erlotinib (used in cancer treatment),
• methotrexate (for cancer and rheumatic disease treatment),
• digoxin (used to treat heart problems),
• atazanavir, saquinavir (used to treat HIV infection),
• citalopram, imipramine, clomipramine (for treatment of depression),
• diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy),
• phenytoin (for epilepsy),
• medicines used to make the blood less likely to clot, 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 flow),
• cisapride (used for indigestion and heartburn),
• rifampicin (to treat tuberculosis),
• tacrolimus (in organ transplantation),
• St John's wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breastfeeding

As a precautionary measure, you should preferably avoid taking esomeprazole during pregnancy. Esomeprazole should not be taken 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

Esomeprazole is unlikely to affect your ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may rarely occur (see section 4). If you are affected, you must 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 diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, it is essentially “sodium-free”.

3. How to take Esomeprazol Sandoz Care

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in 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 consecutive days before symptoms of reflux improve (e.g., heartburn and acid regurgitation).
• The duration of treatment is up to 14 days.
• Once 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 consecutive days, you must 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.

How to take this medicine

• You may take the capsule at any time of day, with or without food.
• 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 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, contact the Toxicology Information Service. Telephone 91 5620420, stating the name of 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 missed dose.

If you have any further questions about 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 everyone will experience them.

If you notice any of the following serious adverse 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),
• red, blistering or peeling skin. Severe blisters and bleeding from the lips, eyes, mouth, nose and genitals may also occur. These could be signs of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”, which are rarely observed,
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems, rarely observed,
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Speak 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 white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of your general condition, or fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor immediately so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that you provide information about your medication at this time.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• headache,
• stomach or intestinal problems: diarrhoea, 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 disturbances (insomnia), feeling drowsy,
• dizziness, tingling sensation and numbness,
• sensation of vertigo,
• dry mouth,
• increased liver enzymes in blood tests that assess liver function,
• skin rash, hives, skin itching.

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

• blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising or increase the likelihood of infections,
• low sodium levels in blood. This may cause weakness, vomiting and cramps,
• feeling restless, confusion or depression,
• altered taste,
• eye disorders such as blurred vision,
• sudden feeling of breathlessness or difficulty breathing (bronchospasm),
• inflammation inside the mouth,
• a fungal infection called “candidiasis” that may affect the oesophagus,
• hair loss (alopecia),
• dermatitis due to exposure to sunlight,
• joint pain (arthralgia) or muscle pain (myalgia),
• general feeling of malaise 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),
• aggressiveness,
• seeing, feeling or hearing things that are not real (hallucinations),
• serious liver disorders that may lead to liver failure or brain inflammation,
• muscle weakness,
• serious kidney disorders,
• breast enlargement in men.

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

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

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Sandoz Care

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

Do not use this medicine after the expiry date stated on the carton after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Esomeprazole Sandoz Care

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

Contents of the capsule:

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

Capsule coating:

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

Appearance of the medicine and contents of the pack

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

Esomeprazole Sandoz Care 20 mg gastro-resistant hard capsules are available in blisters made of OPA/Aluminium/PE + calcium oxide desiccant//Aluminium/PE.

Pack sizes: 7 and 14 gastro-resistant hard capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 latest revision of this leaflet: December 2024.

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

ADDITIONAL USEFUL INFORMATION

What are the symptoms of heartburn?

Typical reflux symptoms include a painful sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Why do these symptoms occur?

Heartburn may occur due to overeating, consuming high-fat foods, eating too quickly, or drinking excessive amounts of alcohol. You may notice that symptoms worsen when lying down. If you are overweight or smoke, your likelihood of experiencing heartburn increases.

What can I do to help relieve my symptoms?

• Eat healthier foods and try to avoid spicy and fatty foods, as well as large meals right before bedtime.
• Avoid carbonated drinks, coffee, chocolate, and alcohol.
• Eat slowly and in smaller portions.
• Try to lose weight.
• Stop smoking.

When should I seek advice or help?

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