OMEPRAZOL SANDOZ CARE 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Omeprazole Sandoz Care 20 mg Hard Gastro-Resistant Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet:

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

1. Contents of the pack and further information

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

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

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

Reflux is the rise of acid from the stomach to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that rises 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 your symptoms worsen or do not improve after 14 days.

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

Do not take Omeprazole Sandoz Care

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

Do not take this medicine if you are in any of the above cases. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole 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 your symptoms worsen, consult your doctor.

Severe skin reactions have been reported in relation to treatment with omeprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). 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 conditions before starting to take omeprazole or during treatment:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (bloody stools).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have a history of stomach ulcers or gastrointestinal surgery.
• You are receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• You have persistent indigestion or heartburn for 4 weeks or more. You have jaundice or severe liver disease.
• You are over 55 years old and your symptoms have changed recently or are new.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A).

If you suffer from 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 omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation may occur. The 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. You should report these signs to your doctor.

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 could indicate low levels of vitamin B12:

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

Patients should not take omeprazole as a preventive medication.

Other medicines and Omeprazole Sandoz Care

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Omeprazole may affect the action of some medicines, and some medicines may affect omeprazole.

Do not take omeprazole 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:

• Ketoconazole, posaconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with omeprazole
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment with omeprazole
• 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 (thrombi)),
• Erlotinib (used to treat cancer),
• Methotrexate (chemotherapy medicine used in high doses to treat cancer),
• If you are taking a high dose of methotrexate, your doctor may decide to temporarily stop treatment with omeprazole.

Omeprazole 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 it is unlikely to affect the baby when used at therapeutic doses. Your doctor will decide whether you can take omeprazole if you are breastfeeding.

Driving and using machines

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

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

Omeprazole Sandoz Care contains sucrose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Omeprazole Sandoz Care

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 your 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 medicine

• 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 medicine from being broken down by the acid in the stomach. It is important 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 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 still water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.
• 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 you have taken all the medicine, fill the glass with water, rinse it well, and drink the water. Do not use milk or carbonated water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Sandoz Care than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested

If you forget to take Omeprazole Sandoz Care

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you stop taking Omeprazole Sandoz Care

Do not stop taking omeprazole without talking to your doctor or pharmacist first.

If you have any further questions 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 everybody gets them.

If you notice 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 wheezing, swelling of the lips, tongue, throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare),
• redness of the skin with blistering or peeling. Blisters or bleeding in the lips, eyes, mouth, nose, or genitals may also appear. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare),
• widespread skin rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome) (rare),
• a red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) (rare),
• yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems (rare).

Other side effects are:

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

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

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

• swelling of the feet and ankles,
• sleep disorders (insomnia),
• dizziness, tingling, drowsiness,
• feeling that everything is spinning (vertigo),
• changes in blood tests that check liver function,
• skin rash, hives, and itching,
• feeling of general discomfort and lack of energy.

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

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

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

• changes in blood cell count, such as agranulocytosis (lack of white blood cells).
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• severe liver problems that can cause liver failure and brain inflammation,
• erythema multiforme,
• muscle weakness,
• breast enlargement in men,

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

• inflammation of the intestine (which can cause diarrhea),
• skin rash, possibly with joint pain.

In very rare cases, omeprazolecan affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as sore throat, or difficulty 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 important that you provide information about the medicine you are taking at that time.

Do not worry about this list of possible side effects. You may not get any of them. If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Sandoz Care

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

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

Aluminum/Aluminum Blister:

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 tightly closed to protect it from moisture.

After opening the container, use within the first 3 months.

Medicines should not be disposed of via wastewater or household waste.

Deposit the containers and medicines you no longer need in the SIGRE Point of your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Sandoz Care

• The active ingredient is omeprazole. Each gastro-resistant capsule contains 20 mg of omeprazole.
• The other components (excipients) are: sugar spheres (contains sucrose and corn starch), sodium lauryl sulfate, disodium phosphate, mannitol (E-421), hypromellose type 2910, macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), and 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1). The hard gelatin capsule is composed of: gelatin, quinoline yellow (E-104), and titanium dioxide (E-171).

Product Appearance and Package Contents

Gastro-resistant hard capsule of opaque yellow color containing spherical microgranules of white to off-white color.

Alu/Alu blister pack: 7, 14 capsules.

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

Only some package 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:

Laboratorio Liconsa, S.A.

Av. Miralcampo nº7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus:July 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/