Package Leaflet: Information for the User

Omeprazol Healthkern 20 mg Hard Capsules

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

Follow exactly the instructions for taking the medicine contained in this leaflet or those given by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

-You should consult a doctor if your symptoms worsen or do not improve after 14 days.

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

2.What you need to know before taking Omeprazol Healthkern

3.How to take Omeprazol Healthkern

4.Possible side effects

5Storage of Omeprazol Healthkern

6.Contents of the pack and additional information

Omeprazol Healthkerncontains omeprazole as its active ingredient. It belongs to a group of medications known as “proton pump inhibitors”. These medications work by reducing the amount of acid produced by the stomach.

Omeprazol Healthkernis indicated for adults for the short-term treatment of symptoms of acid reflux (e.g., heartburn, acid regurgitation).

Acid reflux is the backflow of acid from the stomach into the esophagus, which can become inflamed and painful. This can cause symptoms such as a burning sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2-3 consecutive days to achieve an improvement in symptoms.

You should consult a doctor if symptoms worsen or do not improve after 14 days.

Do not takeOmeprazol Healthkern:

• 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)

Do not take this medicine if you are in any of the above situations. If you are unsure, talk to your doctor or pharmacist before taking Omeprazol Healthkern.

Warnings and precautions

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

Do not take Omeprazol Healthkern for more than 14 days without consulting your doctor. If you do not experience relief, or if your symptoms worsen, consult your doctor.

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 the use of this medicine. Stop taking Omeprazol Healthkern and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

• you lose weight significantly without apparent reason and have difficulty swallowing.
• you have stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (hematochezia).
• you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcer or gastrointestinal surgery.
• you are receiving ongoing treatment for heartburn or stomach acid reflux for 4 weeks or more.
• you continuously experience heartburn or stomach acid reflux for 4 weeks or more.
• you have jaundice or severe liver disease.
• you are over 55 years old and your symptoms have changed recently or are new.
• you have ever had a skin reaction after treatment with a similar medicine to Omeprazol Healthkern for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranin A).

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 Healthkern. 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. You should inform your doctor of these signs.

Patients should not take omeprazole as a preventive medication.

Taking Omeprazol Healthkern with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. Omeprazole may affect the mechanism of action of some medicines, and some medicines may affect omeprazole.

Do not take omeprazole if you are taking a medicine that contains nelfinavir (used for HIV infection).

You should inform your doctor specifically if you are taking clopidogrel (used to prevent blood clots).

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

• ketoconazole, posaconazole, 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 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)
• erlotinib (used to treat cancer)
• methotrexate (chemotherapy 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 omeprazole.

Taking Omeprazol Healthkern with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

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 this time.

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 omeprazole while breastfeeding.

Driving and operating machinery

Omeprazole 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 use machines.

Omeprazol Healthkern contains Saccharose and sodium

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

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

The recommended dose is one 20 mg capsule once a day for 14 days. Contact your doctor if symptoms do not disappear after this time.

You may need to take the capsules for 2-3 consecutive days to achieve improvement of symptoms.

How to take this medication

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or with an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain granules coated with a substance that prevents the medication from breaking down by the action of stomach acid. It is essential not to spit out the granules. These granules contain omeprazole as the active ingredient and have a rich coating that protects them and prevents them from breaking down when they pass through the stomach. The granules release the active ingredient in the intestine, where it is absorbed by the body to produce an effect.

What to do if you have trouble swallowing the capsules

• If you 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 citrus fruit juice (e.g., apple, orange, or pineapple) or a cooked apple puree.
• 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 the halfway point, rinse it well, and drink the water. Do not use milk or carbonated water. The undissolved parts contain the medication; do not chew or crush them.

If you take moreOmeprazole Healthkernthan you should

If you have taken more omeprazole than recommended, consult your doctor or pharmacist immediately.

If you forget to takeOmeprazole Healthkern

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 Healthkern

Do not stop treatment with omeprazole 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 (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 omeprazole and consult your doctor immediately:

• Sudden hissing sounds while 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 formation of blisters or peeling. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. It may be a case of "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).

• Generalized rash, elevated body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare)
• A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema). (rare)

• Yellow discoloration of the skin, dark urine, and fatigue, which may be symptoms of liver problems (rare)

Other side effects are:

Frequent 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 polyps in the stomach.

Infrequent 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).
• Alterations in blood tests that check liver function.
• Rash on the skin, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare side 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 risk of infections.
• Low sodium concentration in the blood. It can cause weakness, vomiting, and muscle cramps. Agitation, confusion, or depression.
• Alterations 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.
• Loss of hair (alopecia).
• Rash on the skin with exposure to sunlight.
• Joint pain (arthritis) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Alterations in 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.

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

• Inflammation in the intestines (which causes diarrhea).
• Hypomagnesemia.
• Skin rash, possibly with joint pain.

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

Do not worry about this list of possible side effects. You may not experience any of them. If you consider that any of the side effects you are experiencing are severe or if you experience any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD. The expiration date is the last day of the month indicated.

Aluminum/Aluminum Blister:

Store below 86°F.

Store in the original packaging to protect it from moisture.

PVC-PVDC/Aluminum Blister:

Store below 77°F.

Store in the original packaging to protect it from moisture.

Bottle:

No special storage conditions are required.

Shelf life after the first opening of the bottle: 100 days.

Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be disposed of through the drains or trash.Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacisthow to dispose ofthe containers and medicines you no longerneed.By doing so, you will help protect the environment.

Composition ofOmeprazol Healthkern

-The active ingredient is omeprazole.Omeprazol Healthkernhard-gastrorresistant capsules contain 20 mg of omeprazole.

-The other components are sugar spheres (sucrose and cornstarch), hypromellose (E-464),talc (E-553b), titanium dioxide (E-171), dihydrogen phosphate disodium (E-339 ii), sodium lauryl sulfate, polisorbate 80,carboxymethylcellulose and ethyl acrylate copolymer,triethyl citrate (E-1505).Capsule:gelatin, titanium dioxide (E-171), printing ink (iron oxide black (E-172), potassium hydroxide, propylene glycol, ammonium hydroxide, and shellac). See section 2Omeprazol Healthkerncontains sucrose.

Appearance of the product and contents of the container

Omeprazol Healthkerncapsules are hard gelatin capsules of white opaque color that contain spherical granules.

HDPE bottle with cap and safety ring equipped with a desiccant agent: 7 and 14 capsules.

Alu/Alu blister: 7 and 14 capsules.

PVC-PVDC/Alu blister: 7 and 14 capsules.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer responsible

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Marti, 75-97

08107 - Martorelles (Barcelona)

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

Netherlands: Ometremp 20 mggastro-resistant capsules, hard

Spain: Omeprazol Healthkern 20 mghard-gastrorresistant capsules

Last review date of this leaflet:March 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/.