Package Insert: Information for the Patient

Omeprazole Sandoz Pharmaceutical 20 mg Hard Gastroresistant Capsules EFG

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

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Omeprazol Sandoz Pharmaceutical contains the active ingredient omeprazole. 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 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 with the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Omeprazole can also 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 with the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Omeprazol Sandoz Farmacéutica

• 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 that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if you are taking a medicine that contains nelfinavir (used for HIV infection).

If you are unsure, talk to your doctor or pharmacist before taking this medicine

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole

Severe skin reactions have been reported in relation to omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and generalized acute pustular psoriasis (PEGA). 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 medicine may mask the symptoms of other diseases. Therefore, if you experience any of the following complaints before starting to take omeprazole or during treatment, consult your doctor immediately if:

• you have ever had a skin reaction after treatment with a similar medicine to omeprazole for reducing stomach acid,
• you are losing weight without apparent reason and have problems swallowing,
• you have stomach pain or indigestion,
• you start vomiting food or 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,
• you are scheduled to have a specific blood test (Cromogranin A).

If you take this medicine for a long period (more than 1 year), your doctor will probably perform regular check-ups. You must inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

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

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.

When taking omeprazole, kidney inflammation may occur. 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 must 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 B12levels:

• extreme fatigue or lack of energy,
• tingling,
• pain or redness in the tongue or mouth, ulcers in the mouth,
• 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 administer this medicine to children under 1 year of age or <10>

Consult your doctor as soon as possible if you experience a skin rash, especially in sun-exposed areas, as it may be necessary to interrupt omeprazole treatment.

Remember to mention any other symptoms you may notice, such as joint pain.

If you take this medicine for a long period (more than 1 year), your doctor will probably perform regular check-ups. You must inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

Other medicines and Omeprazol Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Omeprazole may affect the mechanism of action of some medicines and some medicines may affect omeprazole.

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

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

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

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor of any other medicines you are taking.

Taking Omeprazol Sandoz Farmacéutica 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 medicine if you are breastfeeding.

Driving and operating machinery

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

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

Omeprazol Sandoz Farmacéutica contains saccharose and sodium

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, 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 gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, 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 damage to the esophagus, the recommended dose is 10 mg once a day.

Treatment ofulcers in the upper part of the small 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 ofstomach 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 ofstomach 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 bynonsteroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The recommended dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• The recommended dose is 20 mg of omeprazole twice a day for a week.
• Your doctor will also tell you to take two antibiotics, amoxicillin, clarithromycin, and metronidazole.

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

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

Use in children and adolescents

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation

• Children over one year of age who weigh more than10 kgcan take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years old can take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.
• Your 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 in the stomach acid. It is essential not to damage the granules.

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

If you or your child have trouble 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 water without gas, a sour fruit juice (e.g., apple, orange, or pineapple), or a compote of apple.
• 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 of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

What to do if you take more Omeprazol Sandoz Farmacéutica 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 Farmacéutica

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 the treatment with Omeprazol Sandoz Farmacéutica

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects may occur with certain frequencies, which are defined as follows:

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

• Sudden hissing sounds when breathing (sudden sibilance), 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. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• Generalized rash, elevated body temperature, and lymph node inflammation (DRESS syndrome or pharmacological hypersensitivity syndrome) (rare).
• Generalized red, scaly rash with subcutaneous nodules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular psoriasis) (rare).
• Yellow skin discoloration, dark urine, and fatigue, which may be symptoms of liver problems (rare).

Other side effects are:

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

• Headache.
• Effects on the stomach or intestines: 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 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.
• Fracture of the hip, wrist, and spine.*

Rare side 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 risk of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and sibilance.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult 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.
• Liver problems, such as jaundice, which can cause yellow skin discoloration, 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 side effects (may affect up to 1 in 10,000 people)

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

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

• Inflammationin the intestine (causing diarrhea).
• 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, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood 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, or increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

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

In very rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very deteriorated general condition or fever with local infection symptoms, such as neck pain, throat pain, 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 to provide information about the medication you are taking at that time.

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 Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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.

Blister:

Store in the original packaging to protect it from moisture.

Store below 25ºC.

HDPE capsule container with screw cap and silica gel desiccant:

Do not store at a temperature above 30ºC.

Store the bottle perfectly closed to protect it from moisture.

Keep the container perfectly closed after use.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Omeprazol Sandoz Pharmaceutical

• 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 carboxymethylcellulose (type A, from potato), macrogol 6000, talc, poloxamer 80, titanium dioxide (E-171), and a copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion. The hard gelatin capsule is composed of: gelatin, indigotin FD&C Blue 2 (E132), and titanium dioxide (E-171).

Appearance of the product and content of the container

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for Manufacturing

Liconsa, S.A.

Avda. Miralcampo, nº 7,

Polígono Industrial Miralcampo,

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.gob.es