Package Leaflet: Information for the User

Omeprazol Kern Pharma 20 mg Hard Gastrorresistant Capsules EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Omeprazol Kern Pharma and what it is used for

2.What you need to know before you start taking Omeprazol Kern Pharma

3.How to take Omeprazol Kern Pharma

4.Possible side effects

1. Storage of Omeprazol Kern Pharma

6.Contents of the pack and additional information

Omeprazol Kern Pharma contains the active ingredient omeprazole. It belongs to a group of medications called “proton pump inhibitors”. These medications 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 to the stomach), causing pain, inflammation, and burning.
• 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 medications 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 burning.
• In children, the 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 Kern Pharma

• If you are allergic to omeprazole or any of the other components of this medication (listed in section 6).(including those 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).

Do not take Omeprazol Kern Pharma if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Omeprazol Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazol Kern Pharma.

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

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

• Significant weight loss without apparent reason and difficulty swallowing.
• Stomach pain or indigestion.
• Starting to vomit food or blood.
• Black stools (blood-stained stools).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a similar medication to Omeprazol Kern Pharma for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranin A).

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

Taking a proton pump inhibitor like Omeprazol Kern Pharma, especially for more than a year, may slightly increase the risk of fractures in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can 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 treatment with Omeprazol Kern Pharma. 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 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.
• Tickling.
• Pain or redness in the tongue or mouth, 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>

Other medications and Omeprazol Kern Pharma

Taking Omeprazol Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications that can be purchased without a prescription. This is because Omeprazol Kern Pharma may affect the mechanism of action of some medications, and some medications may affect Omeprazol Kern Pharma.

Do not take Omeprazol Kern Pharma if you are taking a medication that contains nelfinavir (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).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol Kern Pharma.
• 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 treatment with Omeprazol Kern Pharma.
• 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 Omeprazol Kern Pharma.

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

Taking Omeprazol Kern Pharma 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 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 Kern Pharma while breastfeeding.

Driving and operating machinery

Omeprazol Kern Pharma 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, patients should not drive or use machines.

Omeprazol Kern Pharma contains saccharose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 dose is described below:

Use in adults

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

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

• The recommended dose once the esophagus has healed is 10mg once a day.
• If you do not have damage to the esophagus, the recommended dose is 10mg once a day.

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

• Therecommended 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 20mg 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 40mg once a day for 8 weeks.

Preventionof the recurrenceofstomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40mg 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 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 for how long you should take the medication.

Use in children and adolescents

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

• Children over 1 year of age who weigh more than10 kgmay take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years old may 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 containcoated granulesthat prevent the medication from breaking down in the stomach acid. It is essential not to damage thegranules.

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.

If you take more Omeprazol Kern Pharma than you should

If you have taken more omeprazole 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 take Omeprazol Kern Pharma

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 Omeprazol Kern Pharma

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, Omeprazol Kern Pharma 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 Omeprazol Kern Pharma 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. 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".(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 (acute generalized pustular psoriasis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. (rare)

Other side effects are:

Side effects that are frequent(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 polyps in the stomach

Side effects that are infrequent (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 help check liver function.
• Rash on the skin, hives, and itching.
• General feeling of discomfort and lack of energy.

Side effects that are rare (may affect up to 1 in 1,000 people)

• 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.
• Agitation, confusion, or depression.
• Changes 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).
• Rash on the skin with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Side effects that are very rare (may affect up to 1 in 10,000 people)

• 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.
• Stevens-Johnson syndrome.
• Muscle weakness.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking Omeprazol Kern Pharma 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 decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

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 poor 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 Pharmacovigilance of Medicines for Human Use: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 Omeprazol Kern Pharma after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Container:

No special storage conditions are required.

Blister:

Do not store above 25°C.

Store this blister in the original packaging to protect it from moisture

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

Composition of Omeprazol Kern Pharma

• The active ingredient is omeprazole. Each capsulegastro-resistantcontains 20mg of omeprazole.
• The other components (excipients) are sugar spheres (sucrose and cornstarch), hypromellose (E-464), dihydrogen phosphate of disodium dihydrate, talc (E-533b), titanium dioxide (E171), dispersion at 30% of methacrylic acid copolymer and ethyl acrylate (1:1) and triethylcitrate (E-1505), gelatin capsule (containing titanium dioxide (E-171), water and gelatin), printing ink (containing lacquer, ethanol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water and iron oxide black (E172)).

Appearance of the product and content of the packaging

• Omeprazol Kern Pharma 20mg. The capsules are formed by a body and a white-colored cap, and contain granules with enteric coating.

Size of the packaging:

• HDPE white bottle with cap and safety ring, equipped with silica gel, a drying agent: 28 capsules.
• Blister packs of 14, 28 or 56 capsules.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles - Barcelona

Spain

Last review date of this leaflet:September 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/