OMEPRAZOL SANDOZ 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Omeprazole Sandoz Pharmaceutical 20 mg Hard Gastro-Resistant Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

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

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

Omeprazole Sandoz Pharmaceutical contains the active substance omeprazole. It belongs to a group of medications called "proton pump inhibitors". These medications work by reducing the amount of acid produced by the stomach.

Omeprazole is used to treat the following diseases:

In adults:

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacterium called "Helicobacter pylori". If you have this disease, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medications called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazole can be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacterium called "Helicobacter pylori". If your child has this disease, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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

Do not take Omeprazole Sandoz Pharmaceutical

• if you are allergic to omeprazole or any of the other ingredients of this medication (listed in section 6),
• if you are allergic to medications that contain proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if you are taking a medication that contains nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole.

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.

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

• you have ever had a skin reaction after treatment with a medication similar to omeprazole to reduce stomach acid,
• you lose weight without any apparent reason and have difficulty swallowing,
• you have stomach pain or indigestion,
• you start vomiting food or vomiting blood,
• your stools are black (blood-stained stools),
• you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea,
• you have severe liver problems,
• a specific blood test (Chromogranin A) is scheduled.

If you take this medication for a long period (more than 1 year), your doctor will likely perform regular check-ups. You should report any new or unusual symptoms and circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like omeprazole, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If you experience 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 output 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 medication 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.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not give this medication to children under 1 year of age or weighing less than 10 kg.

If you experience 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.

If you take this medication for a long period (more than 1 year), your doctor will likely perform regular check-ups. You should report any new or unusual symptoms and circumstances whenever you visit your doctor.

Other medications and Omeprazole Sandoz Pharmaceutical

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Omeprazole may affect the mechanism of action of some medications, and some medications may affect omeprazole.

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

Tell your doctor or pharmacist if you are taking any of the following medications:

• ketoconazole, 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,
• medications 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),
• erlotinib (used to treat cancer),
• methotrexate (chemotherapy medication used in high doses to treat cancer), if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with omeprazole.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform them of any other medications you are taking.

Taking Omeprazole Sandoz Pharmaceutical with food and drinks

You can take your capsules with food or on an empty stomach.

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 medication.

Before taking omeprazole, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take omeprazole during that time.

Your doctor will decide if you can take this medication if you are breastfeeding.

Driving and using machines

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

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

Omeprazole Sandoz Pharmaceutical contains sucrose and sodium

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Omeprazole Sandoz Pharmaceutical

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The recommended doses are described below.

Use in adults

Treatment of symptoms of GERD, such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild esophageal damage, the recommended dose is 20 mg once a day for 4 to 8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have esophageal damage, the recommended dose is 10 mg once a day.

Treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof the recurrence of stomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of stomach and duodenal ulcers caused by NSAIDs(non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once a day for 4 to 8 weeks.

Prevention of stomach and duodenal ulcersduring the administration of NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• The recommended dose is 20 mg of omeprazole twice a day for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

Treatment of excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medication.

Use in children and adolescents

Treatment of symptoms of GERD, such as heartburn and acid regurgitation

• Children over 1 year of age who weigh more than 10 kg can take omeprazole. The dose for children is based on body weight, and the doctor will decide the correct dose.

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• Children over 4 years of age can take omeprazole. The dose for children is based on body weight, and the doctor will decide the correct dose.
• The doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

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 due to the action of stomach acid. It is essential not to damage the granules.

What to do if you or your child have problems swallowing the capsules

If you or your child have problems swallowing the capsules:

• Open the capsules 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 applesauce.
• 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 medication, fill the glass with water to about half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Omeprazole Sandoz Pharmaceutical than you should

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

If you forget to take Omeprazole Sandoz Pharmaceutical

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 interrupt treatment with Omeprazole Sandoz Pharmaceutical

Do not interrupt treatment with omeprazole without talking to your doctor or pharmacist first.

If you have any other questions about the use of this medication, 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.

Adverse effects can occur with certain frequencies, which are defined as follows:

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

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• Widespread rash, elevated body temperature, and inflammation of the lymph nodes (DRESS or drug hypersensitivity syndrome) (rare).
• A widespread red, scaly, and generalized rash with bumps under the skin and blisters, accompanied by fever. 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 adverse effects are:

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

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

Infrequent adverse effects(may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.
• Hip, wrist, and spine fractures.*

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

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the likelihood of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alterations.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count alterations, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance of an intense rash, blistering, or peeling of the skin. It can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

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

• Inflammation in the intestine (which causes diarrhea).
• If you are being treated with omeprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have 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 periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

If you are taking omeprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

*If you are taking proton pump inhibitors like omeprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

In very rare cases, omeprazole can affect the white blood cells in the blood 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 neck, throat, or mouth pain, 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 essential that you provide information about 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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Omeprazol Sandoz Farmacéutica

Keep this medicine out of sight and reach of children.

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

Blister:

Store in the original packaging to protect it from moisture.

Store below 25°C.

HDPE capsule container with screw cap and silica gel desiccant:

Do not store at a temperature above 30°C.

Keep the bottle perfectly closed to protect it from moisture.

Keep the container perfectly closed after use.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. In case of 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. Package contents and additional information

Composition of Omeprazol Sandoz Farmacéutica

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components (excipients) are: sugar spheres (consisting of cornstarch and sucrose), magnesium hydroxide, sodium lauryl sulfate, disodium hydrogen phosphate, mannitol (E-421), hypromellose type 2910, sodium carboxymethyl cellulose (type A, potato), macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), and a 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1). The hard gelatin capsule is composed of: gelatin, indigotine FD&C Blue 2 (E132), and titanium dioxide (E-171).

Appearance of the product and package contents

Omeprazol Sandoz Farmacéutica 20 mg is presented in the form of hard gastric-resistant gelatin capsules of size "4" with a white body and blue cap, which contain white to cream-colored spherical granules. It is presented in blisters containing 14, 28, or 56 gastric-resistant capsules or in HDPE containers with a screw cap and silica gel desiccant containing 28 or 56 gastric-resistant capsules.

Only some package sizes may be commercialized.

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

Liconsa, S.A.

Avda. Miralcampo, nº 7,

Polígono Industrial Miralcampo,

Azuqueca de Henares, (Guadalajara),

Spain

Date of the last revision of this prospectus:July 2024

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