OMEPRAZOL KERN PHARMA 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Kern Pharma 20 mg Hard Gastro-Resistant Capsules EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. Contents of the pack and other information

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

Omeprazole Kern Pharma contains the active substance omeprazole. 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 used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (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 stomach (gastric ulcer).
• Ulcers caused by an infection with a bacterium called “Helicobacter pylori”. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• Omeprazole may also be used to prevent 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” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• In children, symptoms of the disease can include reflux of stomach contents into the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by an infection with a bacterium called “Helicobacter pylori”. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Omeprazole Kern Pharma

Do not take Omeprazole Kern Pharma

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

Do not take Omeprazole Kern Pharma if you are among any of the above cases. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Kern Pharma.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Omeprazole Kern Pharma.

There have been reports of severe skin reactions with Omeprazole Kern Pharma, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Stop taking Omeprazole Kern Pharma and contact 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 conditions before starting to take Omeprazol Kern Pharma or during treatment, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (stools stained with blood).
• If you have 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 medicine similar to Omeprazole Kern Pharma to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

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

Taking a proton pump inhibitor like Omeprazol Kern Pharma, especially for a period of more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can 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 Omeprazol Kern Pharma. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation can 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 inform your doctor of such 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 could indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression

Children

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

Other medicines and Omeprazol Kern Pharma

Taking Omeprazol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Omeprazol Kern Pharma may affect the way some medicines work and some medicines may affect Omeprazol Kern Pharma.

Do not take Omeprazol Kern Pharma if you are taking a medicine that contains nelfinavir(used to treat HIV infection).

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

• Ketoconazole, itraconazole, posaconazole, 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 Omeprazol Kern Pharma
• 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 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 (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 will need to temporarily stop treatment with Omeprazol Kern Pharma.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to take with Omeprazol Kern Pharma to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform your doctor of any other medicines 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole passes into breast milk but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide whether you can take Omeprazol Kern Pharma if you are breastfeeding.

Driving and using machines

Omeprazol Kern Pharma is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If this happens, do not drive or use machines.

Omeprazol Kern Pharma contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Omeprazol Kern Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 GORD, such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild esophageal damage, the recommended dose is 20 mg once daily 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 daily.
• If you do not have esophageal damage, the recommended dose is 10 mg once daily.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily 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 daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily 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 daily for 8 weeks.

Preventionof the recurrence of gastric and duodenal ulcers:

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

Treatment of gastric and duodenal ulcers caused by NSAIDs:

• The recommended dose is 20 mg once daily for 4-8 weeks.

Prevention of gastric and duodenal ulcersduring NSAID therapy:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• The recommended dose is 20 mg of omeprazole twice daily 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 daily.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Use in children and adolescents

Treatment of symptoms of GORD, 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 your doctor will decide the correct dose.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• Children over 4 years of age 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 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.

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, fruit juice (e.g. apple, orange, or pineapple), or apple sauce.
  • Always shake the mixture well just before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
  • To make sure you have taken all the medicine, fill the glass with water, rinse it well, and drink the water. The solid parts contain the medicine; 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, contact your doctor or pharmacist immediately. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Omeprazol Kern Pharma

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Omeprazol Kern Pharma can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Omeprazol Kern Pharma and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• • Reddening of the skin with blistering or peeling. Blisters in the mouth and eyes, 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 temperature, and enlargement of the lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
  • A widespread red, scaly, and crusty rash with small, raised, red bumps, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and tiredness, which can be symptoms of liver problems. (rare)

Other side effects are:

E

• Headache.
• Stomach or intestine effects: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign stomach polyps

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling of spinning (vertigo).
• Abnormal liver function blood tests.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

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 risk of infection.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count changes, 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.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in males.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).
• If you are treated with Omeprazol Kern Pharma for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as 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 lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, omeprazol can 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 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Omeprazol Kern Pharma

Keep this medication out of sight and reach of children.

Do not use Omeprazol Kern Pharma after the expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

Bottle:

No special storage conditions are required.

Blister:

Do not store above 25°C.

Keep this blister in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Omeprazol Kern Pharma

• The active ingredient is omeprazol. Each gastro-resistant capsule contains 20 mg of omeprazol.
• The other ingredients (excipients) are sugar spheres (sucrose and cornstarch), hypromellose (E-464), disodium hydrogen phosphate dihydrate, talc (E-533b), titanium dioxide (E171), 30% dispersion of ethyl acrylate and methyl methacrylate copolymer (1:1) and triethyl citrate (E-1505), gelatin capsule (containing titanium dioxide (E-171), water, and gelatin), printing ink (containing lacquer, ethanol, isopropanol, propylene glycol, n-butanol, ammonium hydroxide, potassium hydroxide, purified water, and black iron oxide (E172)).

Appearance of the product and package contents

• Omeprazol Kern Pharma 20 mg. The capsules consist of a white body and cap and contain enteric-coated granules.

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles - Barcelona

Spain

Date of the last revision of this leaflet:September 2024

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