Package Insert: Information for the Patient

Omeprazol Sandoz Care 20 mg Hard Gastroresistant Capsules

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

6. Contents of the pack and additional information

Omeprazol Sandoz Care hard-gastrorresistant capsules contain omeprazole as the active ingredient. It belongs to a group of medicines called "proton pump inhibitors". These medicines act by reducing the amount of acid produced by the stomach.

Omeprazole is indicated in adults for the short-term treatment of symptoms of reflux (for example, heartburn, acid regurgitation).

Reflux is the backflow of acid from the stomach into the esophagus, which can become inflamed and painful. This can cause symptoms such as a burning sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2-3 consecutive days to achieve an improvement in symptoms.

You should consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Omeprazol Sandoz Care

• if you are allergic to omeprazole or any of the other ingredients in this medicine (listed in section 6)
• if you are allergic to medicines that contain other proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• if you are taking any medicine that contains nelfinavir (for HIV infection)

Do not take this medicine if you are in any of the above situations. If you are unsure, talk to your doctor or pharmacist before taking Omeprazol Sandoz Care.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole.

Do not take omeprazole for more than 14 days without consulting your doctor. If you do not experience relief, or if you feel that your symptoms are worsening, consult your doctor.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular psoriasis (AGPP), have been reported in association with omeprazole treatment. Stop taking omeprazole and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

Omeprazole may mask the symptoms of other diseases. Therefore, consult your doctor immediately if you experience any of the following symptoms before starting to take omeprazole or during treatment:

• you lose weight significantly without apparent reason and have difficulty swallowing.
• you have stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (hematochezia).
• you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcer or gastrointestinal surgery.
• you are receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• you constantly experience indigestion or heartburn for 4 weeks or more. You have jaundice or a severe liver disease.
• you are over 55 years old and your symptoms have recently changed or are new.
• you have ever had a skin reaction after treatment with a similar medicine to omeprazole for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranin A).

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt omeprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Omeprazole may cause kidney inflammation. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• extreme fatigue or lack of energy,
• tingling,
• mouth pain or red tongue, ulcers in the mouth,
• muscle weakness,
• visual disturbances,
• memory problems, confusion, depression.

Patients should not take omeprazole as preventive medication.

Other medicines and Omeprazol Sandoz Care

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. Omeprazole may affect the mechanism of action of some medicines and some medicines may affect omeprazole.

Do not take omeprazole if you are taking a medicine withnelfinavir(used to treat HIV infection).

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

• ketoconazole, posaconazole, itraconazole, or voriconazole (used to treat fungal infections)
• digoxin (used to treat heart problems)
• diazepam (used to treat anxiety, relax muscles, or epilepsy)
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment
• medicines used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment
• rifampicin (used to treat tuberculosis)
• atazanavir (used to treat HIV infection)
• tacrolimus (in cases of organ transplantation)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)
• cilostazol (used to treat intermittent claudication)
• saquinavir (used to treat HIV infection),
• clopidogrel (used to prevent blood clots),
• erlotinib (used to treat cancer),
• methotrexate (chemotherapy used in high doses to treat cancer),
• if you are taking high doses of methotrexate, your doctor will need to temporarily stop omeprazole treatment.

Omeprazol Sandoz Care with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

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.

Omeprazole passes into breast milk but is unlikely to affect the baby when used in therapeutic doses. Your doctor will decideif you can take omeprazole if you arebreastfeeding.

Driving and operating machinery

Omeprazole is unlikely to affect your ability to drive or use tools or machines.

Severe side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Omeprazol Sandoz Care contains saccharose and sodium

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 than1 mmolof sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

The recommended dose is one 20 mg capsule once a day for 14 days. Contact your doctor if symptoms do not disappear after this time.

You may need to take the capsules for 2-3 consecutive days to achieve an improvement in symptoms.

How to take this medication

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules that prevent the medication from breaking down in the stomach's acid. It is essential not to damage the granules. These granules contain omeprazole as the active ingredient and have an enteric coating that protects them and prevents them from breaking down when they pass through the stomach. The granules release the active ingredient in the intestine, where it is absorbed by the body to produce an effect.

What to do if you have difficulty swallowing the capsules

• If you have problems swallowing the capsules:
• Open the capsule and swallow the contents directly with half a glass of water or pour the contents into a glass of water without gas, a sour fruit juice (e.g., apple, orange, or pineapple) or apple compote.
• Always shake the mixture just before drinking it (the mixture will not be transparent).Then, drink the mixture immediately or within 30 minutes.
• To ensure that all the medication has been taken, fill the glass with water up to the middle, rinse it well, and drink the water. Do not use milk or carbonated water. The solid parts contain the medication; do not chew or crush them.

What to do if you take more Omeprazol Sandoz Care than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

What to do if you forget to take Omeprazol Sandoz Care

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

What to do if you interrupt treatment with Omeprazol Sandoz Care

Do not stop treatment with omeprazole without first speaking with your doctor or pharmacist.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking omeprazole and consult your doctor immediately:

• sudden hissing sounds when breathing (sudden onset of stridor), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare),
• skin redness with blistering or peeling. Blisters may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare),
• generalized rash, high body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome) (rare),
• a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema) (rare),
• yellow discoloration of the skin, dark urine, and fatigue, which may be symptoms of liver problems (rare).

Other side effects are:

Frequent side effects (may affect up to 1 in 10 people):

• headache,
• gastrointestinal effects: diarrhea, stomach pain, constipation, and gas (flatulence),
• nausea or vomiting,
• benign stomach polyps.

Less frequent side effects (may affect up to 1 in 100 people):

• swelling of the feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling sensation, drowsiness,
• sensation of spinning (vertigo),
• abnormal blood test results that check liver function,
• skin rash, hives, and itching,
• general feeling of discomfort and lack of energy.

Rare side effects (may affect up to 1 in 1,000 patients/people):

• blood problems, such as a decrease in white blood cells or platelets. This can cause weakness, bruising, or an increased risk of infection,
• low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• agitation, confusion, or depression,
• alterations in taste,
• visual problems, such as blurred vision,
• sudden sensation of difficulty breathing (bronchospasm),
• dry mouth,
• inflammation of the inside of the mouth,
• infection called "candidiasis" that can affect the intestines and is caused by a fungus,
• hair loss (alopecia),
• skin rash with exposure to sunlight,
• joint pain (arthritis) or muscle pain (myalgia),
• serious kidney problems (interstitial nephritis),
• increased sweating.

Very rare side effects (may affect up to 1 in 10,000 patients/people):

• blood count alterations, such as agranulocytosis (lack of white blood cells).
• aggressiveness,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• serious liver problems that cause liver failure and brain inflammation,
• erythema multiforme,
• muscle weakness,
• enlargement of the breasts in men,

Side effects of unknown frequency (cannot be estimated from available data):

• inflammation in the intestine (which causes diarrhea),
• if you are taking omeprazole for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels,
• skin rash, possibly with joint pain.

In very rare casesomeprazolemay affect white blood cells in the blood and cause

immunodeficiency. If you experience an infection with symptoms such as fever with a verypoorgeneral condition or fever with local infection symptoms, such as neck pain, throat pain, or mouth pain ordifficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential that at thatmoment you provide information about the medication you are taking.

Do not worry about this list of possible side effects. You may not experience any of them. Ifyou consider any of the side effects you are experiencing to be serious or if you experience any side effectsnot mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

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

BlisterAluminum/Aluminum:

Store in the original packaging to protect it from moisture.

Store below 30 °C.

HDPE plastic containerwith screw cap and silica gel desiccant:

Store below 25 °C.

Keep the container perfectly closed to protect it from moisture.

After opening the containeruse within the first 3 months.

Medicines should not be disposed of through drains or in the trash.

Deposit the containers and medicines you no longer need at the SIGREpoint of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Omeprazol Sandoz Care

Appearance of the product and contents of the packaging

Yellow opaque hard gastro-resistant capsulecontaining white to cream-colored spherical microgranules.

Alu/Alu blister: 7, 14 capsules.

HDPE container with desiccant gel in the polypropylene lid: 7, 14 capsules.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Laboratorio Liconsa, S.A

Av. Miralcampo nº7,

Polígono Industrial Miralcampo

19200 Azuqueca de henares (Guadalajara)

Spain

Last review date of this leaflet:July 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gobes