OMEPRAZOL HEALTHKERN 20 mg HARD GASTRORESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Healthkern 20 mg Hard Gastro-Resistant Capsules

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet

1. What is Omeprazole Healthkern and what is it used for
2. What you need to know before taking Omeprazole Healthkern
3. How to take Omeprazole Healthkern
4. Possible side effects

5 Storage of Omeprazole Healthkern

1. Contents of the pack and further information

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

Omeprazole Healthkern 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 Healthkern is indicated in adults for the short-term treatment of symptoms of reflux (e.g., heartburn, acid regurgitation).

Reflux is the rise of acid from the stomach to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that rises 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 your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazole Healthkern

Do not takeOmeprazole 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 cases. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Healthkern.

Warnings and precautions

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

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

Serious skin reactions have been reported in relation to treatment with this medicine, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Omeprazole Healthkern and consult your doctor immediately if you experience any of these symptoms related to serious 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 conditions before starting to take omeprazole or during treatment:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (bloody stools).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have a history of stomach ulcers or gastrointestinal surgery.
• You are receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• You have persistent indigestion or heartburn 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Healthkern to reduce stomach acid.
• A specific blood test (Chromogranin A) is scheduled.

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 Omeprazole Healthkern. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation may occur. The 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 Omeprazole Healthkern with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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 to treat HIV infection).

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

Tell 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 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 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 treatment with 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 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 omeprazole

Taking Omeprazole 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 that time.

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

Driving and using machines

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.

Omeprazole Healthkern contains Sucrose and Sodium

Omeprazole Healthkern contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to Take Omeprazole Healthkern

Follow the instructions for administration of the medicine contained in this leaflet or as 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 your symptoms do not disappear after this time.

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

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. These granules contain omeprazole as the active substance and have an enteric coating that protects them and prevents them from breaking down when passing through the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to produce an effect.

What to do if you have problems swallowing the capsules

• If you 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, acidic 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 you have taken all the medicine, fill the glass with water to about half, rinse it well, and drink the water. Do not use milk or carbonated water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Healthkern than you should

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

If you forget to take Omeprazole Healthkern

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 the missed doses.

If you stop taking Omeprazole Healthkern

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice 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 wheezing, swelling of the lips, tongue, or throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Also, blisters and bleeding in the lips, eyes, mouth, nose, and genitals may appear. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare)

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. The 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 side effects are:

Common side 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.

Uncommon side 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).
• Changes in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general 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 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.
• An infection called “candidiasis” that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash with sun exposure.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count changes, such as agranulocytosis (lack of white blood cells). Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can 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 of the intestine (causing diarrhea).
• Hypomagnesemia
• Skin rash, possibly with joint pain.

In very rare cases, omeprazolemay 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 sore throat, 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 important that you provide information about the medicine you are taking at that time.

Do not worry about this list of possible side effects. You may not experience any of them. If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Healthkern

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Al/Al blister:

Store below 30°C.

Keep in the original packaging to protect from moisture.

PVC-PVDC/Al blister:

Store below 25°C.

Keep in the original packaging to protect from moisture.

Bottle:

No special storage conditions are required.

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

Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container contents and additional information

Composition ofOmeprazol Healthkern

• The active ingredient is omeprazole. Omeprazol Healthkern gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other components are sugar spheres (sucrose and corn starch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, and triethyl citrate (E-1505). Capsule: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide, propylene glycol, ammonium hydroxide, and shellac). See section 2 Omeprazol Healthkern contains sucrose.

Appearance of the product and container contents

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

White HDPE bottle with cap and security ring equipped with a desiccant: 7 and 14 capsules.

Alu/Alu blister: 7 and 14 capsules.

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

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 Marti, 75-97

08107 - Martorelles (Barcelona)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Ometremp 20 mg gastro-resistant hard capsules

Spain: Omeprazol Healthkern 20 mg gastro-resistant hard capsules

Date of the last revision of this leaflet:March 2023

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