Omeprazole Healthkern 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol Healthkern 20 mg gastro-resistant hard capsules

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

Follow exactly the instructions for use provided 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 side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 14 days.

Contents of the leaflet

1. What Omeprazol Healthkern is and what it is used for
2. What you need to know before taking Omeprazol Healthkern
3. How to take Omeprazol Healthkern
4. Possible side effects
5. How to store Omeprazol Healthkern
6. Contents of the pack and other information

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

Omeprazol Healthkern contains the active substance omeprazol. It belongs to a group of medicines called "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

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

Reflux is the backflow of acid from the stomach into the esophagus, which may become inflamed and cause pain. This can lead to symptoms such as a painful burning sensation in the chest rising 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 symptom improvement.

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

2. What you need to know before taking Omeprazol Healthkern

Do not take Omeprazol Healthkern:

• if you are allergic to omeprazole or to 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 for HIV infection).

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

Warnings and precautions

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

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

Serious skin adverse reactions have been reported 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 Omeprazol Healthkern and contact your doctor immediately if you experience any of these symptoms related to serious skin reactions described in section 4.

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

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your bowel movements are black (bloody stools).
• 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 have been receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• You have had 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 recently changed or are new.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazol Healthkern used to reduce stomach acidity.
• You are scheduled to have a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol Healthkern. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation may occur. 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 report these signs to your treating doctor.

Patients should not take omeprazole as preventive medication.

Taking Omeprazol Healthkern with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Omeprazole may affect the way some medicines work, and some medicines may affect omeprazole.

Do not take omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

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 in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment
• Medicines used to prevent blood clot formation, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in 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 (a 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 omeprazole treatment

Taking Omeprazol Healthkern with food and drink

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 whether you can take omeprazole during this time.

Omeprazole passes into breast milk but is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether 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, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

Omeprazol Healthkern contains sucrose and sodium

Omeprazol Healthkern contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him 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 Omeprazol Healthkern

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 20 mg capsule once daily for 14 days. Contact your doctor if symptoms do not resolve after this period.

You may need to take the capsules for 2-3 consecutive days before experiencing symptom improvement.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may 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 enteric-coated granules that prevent the medicine from breaking down due to stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active substance and are protected by an enteric coating that prevents them from dissolving in the stomach. The granules release the active substance in the intestine, where it is absorbed into the body to produce its effect.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules:
• Open the capsule 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 puree.
• Always shake the mixture well just before drinking (the mixture will not be transparent). Then drink the mixture immediately or within 30 minutes.
• To ensure you have taken the full dose, fill the glass halfway with water, swirl it well, and drink the water. Do not use milk or carbonated water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Healthkern than you should

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

If you forget to take Omeprazol Healthkern

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 forgotten doses.

If you stop taking Omeprazol Healthkern

Do not stop treatment with omeprazol without first talking to your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences 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 and throat, or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Reddening of the skin with blistering or peeling. Severe 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).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems (rare).

Other adverse effects are:

Common adverse effects (may affect up to 1 in 10 people)

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

Uncommon adverse 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).
• Abnormalities in blood tests used to assess liver function.
• Skin rash, hives, and itching.
• General feeling of malaise and lack of energy.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood problems, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps. Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells). Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in males.

Adverse effects with unknown frequency (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhea).
• Hypomagnesemia.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole may affect the white blood cells in the blood and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a very poor general condition, or fever with signs of localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicines you are taking at that time.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol Healthkern

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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.

Validity period after first opening of the bottle: 100 days.

Keep the bottle tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If in doubt, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Omeprazol Healthkern

• The active substance 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 and ethyl acrylate copolymer, 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.

Nature of the product and contents of the container

Omeprazol Healthkern capsules are white, opaque, gelatin hard capsules containing 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 certain 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)
Spain

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

Netherlands: Ometremp 20 mg maagsapresistente capsules, hard
Spain: Omeprazol Healthkern 20 mg gastro-resistant hard capsules

Date of latest revision of this leaflet: March 2023

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