PATIENT INFORMATION LEAFLET

Omeprazol SUN 20 mg Hard Gastrorresistant Capsules EFG

Omeprazol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others. Although they may have the same symptoms, it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

1. What Omeprazol SUN is and what it is used for

2. What you need to know before taking Omeprazol SUN

3. How to take Omeprazol SUN

4. Possible side effects

5. Storage of Omeprazol SUN

6. Contents of the pack and other information.

Omeprazol SUN 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.

Omeprazol SUN 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 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). Omeprazol SUN 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 to 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 SUN

• 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 for HIV infection).

Do not take Omeprazol SUN if you fall into any of the above categories.If you are unsure, speak with your doctor or pharmacist before taking Omeprazol SUN.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazol SUN.

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 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.

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

- You are losing weight without apparent reason and have trouble swallowing.

- You have stomach pain or indigestion.

- You start vomiting food or blood.

- Your stools are black (blood-stained stools).

- If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.

- You have severe liver problems.

- If you have ever had a skin reaction after treatment with a similar medication to Omeprazol SUN for reducing stomach acid.

- If you are scheduled to have a specific blood test (Cromogranin A).

If you take Omeprazol SUN for a long period (more than 1 year), your doctor will likely perform regular check-ups. Inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

If you are taking proton pump inhibitors such as Omeprazol SUN, especially for more than a year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. 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 sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue Omeprazol SUN treatment. Remember to mention any other symptoms you may notice, such as joint pain.

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 may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy
• Tingling
• Pain or redness in the tongue or mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medication to children under 1 year of age or <10>

Taking Omeprazol SUN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Omeprazol SUN may affect the mechanism of action of some medications, and some medications may affect Omeprazol SUN.

Do not take Omeprazol SUN if you are taking a medication that containsnelfinavir(used to treat HIV infection).

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

- Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)

- Digoxin (used to treat heart problems)

- Diazepam (used to treat anxiety, relax muscles, or epilepsy)

- Phenobarbital (used in epilepsy). If you are taking phenobarbital, your doctor will need to monitor you when starting or stopping Omeprazol SUN treatment

- Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping Omeprazol SUN 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)

-Metotrexato (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 Omeprazol SUN treatment.

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

Omeprazol SUN and food and beverages

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.Omeprazole passes into breast milk but is unlikely to affect the baby when used in therapeutic doses.Your doctor will decide if you can take Omeprazol SUN during this time.

Driving and operating machinery

Omeprazol SUN is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or operate machinery.

Omeprazol SUN contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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 indicated below.

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 4-8 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 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 reappearance 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 by NSAIDs (nonsteroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

- The recommended dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their reappearance:

- The recommended dose is 20 mg of Omeprazole SUN twice a day for a week.

- Your doctor will also indicate that you take two antibiotics from the following: 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 for how long you should take the medication.

Use in children:

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 SUN. The dose for children is based on body weight, and your doctor will decide on the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their reappearance:

- Children over 4 years old can take Omeprazole SUN. The dose for children is based on body weight, and your doctor will decide on the correct dose.

- Your doctor will also prescribe two antibiotics for your child, amoxicillin, and clarithromycin.

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 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 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.

If you take moreOmeprazole SUNthan you should

If you have taken more Omeprazole SUN than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeOmeprazole SUN

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.

If you interrupt the treatment with Omeprazole SUN

Do not interrupt the treatment with Omeprazole SUN 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 medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop takingOmeprazol SUNand consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden onset of bronchospasm), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Generalized rash, elevated body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome).
• A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Other side effects are:

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

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

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

• 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)

• Blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Restlessness, 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.
• 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 patients)

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Unknown side effects (their frequency cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking Omeprazol SUN for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol SUN may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a severely 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.

Do not worry about this list of possible side effects. You may not experience any of them.

Reporting side effects

If you experience any type of side effect, consultyour doctororpharmacist,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 Pharmacovigilance of Medicines for Human Use: https://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. The expiration date is the last day of the month indicated.

Blister: Do not store at a temperature above25°C. Store this blister in the original packaging to protect it from moisture.

Bottle: Do not store at a temperature above25°C. Keep the bottle perfectly closed to protect it from moisture. After the first opening, it must be used within the next 100 days.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Omeprazol SUN

The active ingredient is omeprazole. Omeprazol SUN capsules contain 20 mg of omeprazole.

The other components are mannitol, anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, dihydrogen phosphate of disodium dihydrate, sodium lauryl sulfate, hypromellose, copolymer of methacrylic acid-ethyl acrylate, macrogol, magnesium stearate, gelatin, iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), printing ink (shellac, propylene glycol, iron oxide black, potassium hydroxide).

Appearance of the product and contents of the package

Omeprazol SUN 20 mg capsules are formed by a pink body and a brown cap marked with 20/O.

Package sizes: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 or 100 capsules;

The bottle contains two desiccant packets with silica gel. DO NOT CONSUME the contents of the packets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.: +34 93 342 78 90

This product is authorized in the member states of the European Economic Area with the following names:

Germany:OMEPRAZOL BASICS 10 mg/20 mg/40 mg enteric-coated hard capsules

Spain:Omeprazol SUN 20 mg hard gastro-resistant capsules EFG

France:OMEPRAZOLECRISTERS LAB 10 mg/20 mg, gastro-resistant gel capsule

Italy:Omeprazolo SUN 10 mg/20 mg rigid gastro-resistant capsules

Revision date of this leaflet: September 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/