OMEPRAZOL KERN PHARMA 40 mg HARD GASTRORESISTENT CAPSULES

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:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers which are infected with bacteria 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.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn.
• In children, the symptoms of the disease may include the return of stomach contents into the mouth (regurgitation), vomiting and poor weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by bacteria 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 containing nelfinavir (used to treat HIV infection).

Do not take Omeprazole Kern Pharma if any of the above apply to you. 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 taking Omeprazole Kern Pharma.

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of omeprazole. If you get any of the following symptoms, stop taking Omeprazole Kern Pharma and contact your doctor immediately:

Omeprazole Kern Pharma may hide the symptoms of other diseases. Therefore, if you get any of the following symptoms, or if they get worse, you should see your doctor:

• Losing a lot of weight without reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomit blood.
• Having black stools (faeces) that look like tar.
• Having severe or persistent diarrhoea, as omeprazole has been associated with a slightly increased risk of infectious diarrhoea.
• Having 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 due to have a specific blood test (Chromogranin A).

If you take Omeprazole Kern Pharma for a long period of time (more than 1 year), your doctor will probably keep you under regular surveillance. You should report any new and unusual symptoms to your doctor, especially if you have been taking omeprazole for a long time.

Taking a proton pump inhibitor like Omeprazole Kern Pharma, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with Omeprazole Kern Pharma. Also remember to mention any other symptoms that you may have, such as joint pain.

Kidney inflammation has been reported with omeprazole. The signs and symptoms may include decrease in urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint pain. You should inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12. If you are taking omeprazole for a long time, you should contact your doctor if you notice any of the following symptoms, which could be signs of a vitamin B12 deficiency:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Pain in the tongue or mouth, mouth ulcers
• Muscle weakness
• Changes in vision
• Memory problems, confusion, depression

Children

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

Other medicines and Omeprazole Kern Pharma

Taking Omeprazole 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 Omeprazole Kern Pharma may affect the way some medicines work and some medicines may affect the way Omeprazole Kern Pharma works.

Do not take Omeprazole Kern Pharma if you are taking a medicine containing 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 taking omeprazole
• 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 taking 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 (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with Omeprazole Kern Pharma.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to take with Omeprazole Kern Pharma to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Taking Omeprazole Kern Pharma with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 recommended doses. Your doctor will decide whether you can take Omeprazole Kern Pharma if you are breast-feeding.

Driving and using machines

Omeprazole Kern Pharma is unlikely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If affected, you should not drive or operate machinery.

Omeprazole Kern Pharma contains sucrose

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

3. How to take Omeprazole Kern Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many capsules to take and for how long.

The recommended dose is described below.

Use in Adults

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

• If your doctor finds that you have mild inflammation of the oesophagus (oesophagitis), the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if the oesophagus has not healed.

• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If your oesophagus has not been damaged, the recommended dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if the ulcer has not yet healed.
• If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if the ulcer has not yet healed.
• If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and stomach 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 ulcers caused by NSAIDs:

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

Prevention of ulcers caused by NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

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

Treatment of Zollinger-Ellison syndrome:

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Use in children and adolescents

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

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

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

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

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 which 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 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, non-fizzy fruit juice (e.g. apple, orange or pineapple) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
  • To make sure that you have taken all the medicine, refill the glass with water, rinse the glass well and drink the water. The solid pieces contain the medicine; do not chew or crush them.

If you take more Omeprazole 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 contact the national poison centre, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Kern Pharma

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Omeprazole Kern Pharma

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

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

4. Possible Adverse Effects

Like all medicines, Omeprazol Kern Pharma can cause adverse effects, although not all people suffer from them.

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 Omeprazol Kern Pharma 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 syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread 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.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the likelihood of infections.
• 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 inside of the mouth.
• Infection called "candidiasis" that can affect the intestine 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 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.
• Erithema multiforme.
• Muscle weakness.
• Increased breast size in males.

Frequency Not Known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhea).
• If you are being treated with Omeprazol Kern Pharma 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.
• Rash, possibly with joint pain.

In very rare cases, omeprazol 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 does not appear in this prospectus. 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. Conservation of Omeprazol Kern Pharma

Keep this medication out of 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.

Bottle:

No special storage conditions are required.

Blister:

Do not store at a temperature above 25°C.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you 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 40 mg of omeprazol.
• The other components (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 methacrylic acid 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 40 mg. The capsules are formed by a body and a cap of white color and contain enteric-coated granules.

Package sizes:

• White HDPE bottle with cap and safety ring, equipped with silica gel as a desiccant: 28 capsules.
• Blister packs of 14 or 28 or 500 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 Prospectus: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/