OMEBOIX 20 mg Capsules

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Omeboix, 20 mg, gastro-resistant hard capsules
3. Omeboix, 40 mg, gastro-resistant hard capsules
   1. Table of contents of the leaflet
4. What is Omeboix and what is it used for
5. Important information before taking Omeboix
   1. When not to take Omeboix:
   2. Warnings and precautions
   3. Children
   4. Omeboix and other medicines
   5. Omeboix with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Omeboix contains sugar and sodium
6. How to take Omeboix
   1. Adult dosage:
   2. Paediatric use:
   3. Method of administration of Omeboix
   4. What to do if you have difficulty swallowing the capsules (in adults or children)
   5. What to do if you take more Omeboix than you should
   6. What to do if you forget to take Omeboix
   7. What to do if you stop taking Omeboix
7. Possible side effects
   1. If you notice any of the following serious side effects, stop taking Omeboix and contact your doctor immediately:
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1,000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
   6. Frequency not known (cannot be estimated from the available data)
   7. Reporting side effects
8. How to store Omeboix
9. Contents of the packaging and other information
   1. What Omeboix contains
   2. What Omeboix looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: 01.03.2023

Leaflet included in the packaging: patient information

Omeboix, 20 mg, gastro-resistant hard capsules

Omeboix, 40 mg, gastro-resistant hard capsules

Omeprazole
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed to you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Omeboix and what is it used for
• 2. Important information before taking Omeboix
• 3. How to take Omeboix
• 4. Possible side effects
• 5. How to store Omeboix
• 6. Contents of the packaging and other information

1. What is Omeboix and what is it used for

Omeboix contains the active substance omeprazole. It belongs to a group of medicines called proton pump inhibitors. Their action is to reduce the amount of acid produced in the stomach.

Omeboix is used to treat the following diseases and disorders:

In adults:

• Gastroesophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers caused by bacteria called Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Omeboix can also be used to prevent ulcers from developing while taking NSAIDs.
• Excessive acid production in the stomach due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

• Gastroesophageal reflux disease (GERD). This condition can cause symptoms such as regurgitation of stomach contents into the mouth, vomiting, and poor weight gain in children.

In children and adolescents over 4 years of age:

• Ulcers caused by Helicobacter pylori bacteria. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcers to heal.

2. Important information before taking Omeboix

When not to take Omeboix:

• If you are allergic to omeprazole or any of the other ingredients of Omeboix (listed in section 6).
• If you are allergic to other 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 Omeboix if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Omeboix.

Warnings and precautions

Before taking Omeboix, you should talk to your doctor or pharmacist.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with Omeboix. If you notice any symptoms related to these serious skin reactions, you should stop taking Omeboix and seek medical help immediately.

Omeboix may mask the symptoms of other diseases. Therefore, if you experience any of the following, you should inform your doctor before or during treatment with Omeboix:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole is associated with a slight increase in the risk of diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction with a medicine that reduces stomach acid.
• If you are due to have a specific blood test (chromogranin A).

If you have been taking Omeboix for a long time (more than 1 year), you will likely be kept under regular medical supervision. During these visits, you should report any new or unusual symptoms and circumstances.

Taking proton pump inhibitors like Omeboix, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis). If you experience a rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Omeboix. You should also report any other side effects, such as joint pain.

While taking omeprazole, kidney inflammation can occur. Symptoms may include decreased urine output or blood in the urine and (or) allergic reactions, such as fever, rash, and stiffness. You should report these symptoms to your doctor.

Children

Some children with chronic diseases 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.

Omeboix and other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking, recently taken, or plan to take. This includes medicines available without a prescription. It is essential because Omeboix can affect how some other medicines work, and some other medicines can affect how Omeboix works.

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

You should inform 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 rhythm disorders).
• Diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Omeboix.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping Omeboix.
• 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).
• Clopidogrel (used to prevent blood clots).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Omeboix.

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin, as well as Omeboix, to treat ulcers caused by Helicobacter pylori bacteria, it is crucial that you inform your doctor about any other medicines you are taking.

Omeboix with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Omeprazole passes into breast milk, but its effect on the baby is unlikely when the medicine is used at therapeutic doses. Whether you can take Omeboix while breastfeeding will be decided by your doctor.

Driving and using machines

Omeboix does not affect the ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) can occur. If you experience these symptoms, do not drive or operate machinery.

Omeboix contains sugar and sodium

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

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

3. How to take Omeboix

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, consult 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.

Adult dosage:

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

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4-8 weeks. Your doctor may prescribe a dose of 40 mg for a further 8 weeks if the esophagus does not heal.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus has not been damaged, the usual dose is 10 mg once daily (to use a 10 mg dose, you should use a suitable product containing omeprazole 10 mg).

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for a further 2 weeks if the ulcers do not heal within this time.
• 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 a further 4 weeks if the ulcers do not heal within this time.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily (to use a 10 mg dose, you should use a suitable product containing omeprazole 10 mg).

Treatment of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of duodenal and gastric ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori bacteria and prevention of their recurrence:

• The recommended dose of Omeboix is 20 mg twice daily for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

Treatment of excessive acid production in the stomach due to a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose according to your individual needs and decide how long you need to take Omeboix.

Paediatric use:

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

• Omeboix can be given to children over 1 year of age and weighing more than 10 kg. The dose depends on the child's weight and will be determined by your doctor.

Treatment of ulcers caused by Helicobacter pylori bacteria and prevention of their recurrence:

• Children over 4 years of age can take Omeboix. The dose for children will depend on their weight and will be determined by your doctor.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

Method of administration of Omeboix

• Omeboix should be taken in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is essential to keep the pellets intact.

What to do if you have difficulty swallowing the capsules (in adults or children)

• If you or your child have difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, or mix the contents with water, non-fizzy fruit juice (e.g., apple, orange, or grapefruit), or apple sauce.
• Always mix the contents immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that you or your child have taken the entire dose, rinse the glass with half a glass of water and drink it.

What to do if you take more Omeboix than you should

If you have taken more Omeboix than prescribed, you should contact your doctor or pharmacist immediately.

What to do if you forget to take Omeboix

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

What to do if you stop taking Omeboix

Do not stop taking Omeboix without consulting your doctor or pharmacist first. If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

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

• Sudden swelling of the face, lips, tongue, or throat, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling, possibly with mouth sores, and fever. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity reaction). (rare)
• Red, blistering, and peeling skin rash, possibly with fever, and joint pain. This could be acute generalized exanthematous pustulosis (AGEP). (rare)
• Yellowing of the skin or eyes, dark urine, and tiredness, which can be signs of liver problems. (rare)

Other side effects include:

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

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Nausea or vomiting.
• Mild stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Feeling dizzy, tingling, or sleepy.
• Feeling of spinning (vertigo).
• Changes in liver function tests.
• Rash, hives, or itching.
• General feeling of being unwell and lacking energy.

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

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, bruising, or increased risk of infection.
• Low levels of sodium in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• Fungal infections (thrush).
• Hair loss (alopecia).
• Skin rash in reaction to sunlight.
• 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)

• Changes in blood cell counts, including agranulocytosis (a potentially life-threatening decrease in white blood cells).
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).
• Severe liver problems, which can lead to liver failure and encephalopathy.
• Severe skin rash (erythema multiforme).
• Muscle weakness.
• Breast enlargement in men (gynaecomastia).

Frequency not known (cannot be estimated from the available data)

• Colitis (inflammation of the colon, which can cause diarrhea).
• If you have taken Omeboix for more than three months, it is possible that you may experience a deficiency of magnesium in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, and a rapid heartbeat. If you experience any of these symptoms, you should inform your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash that can occur with joint pain.

In very rare cases, Omeboix can affect the number of white blood cells in the blood, leading to a lack of immunity. If you experience an infection with symptoms such as fever and a serious deterioration in general health or fever with local signs of infection, such as pain in the neck, throat, or mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on a blood test. It is essential to inform your doctor or pharmacist that you are taking Omeboix.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system via the website [insert website]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omeboix

• 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 stated.
• For blisters with Aluminum/Aluminum foil: Store in a temperature not exceeding 30°C. Store in the original packaging to protect from moisture.
• For blisters with PVC/PVDC/Aluminum foil: Store in a temperature not exceeding 25°C. Store in the original packaging to protect from moisture.
• For HDPE bottles: No special storage temperature requirements. Store the bottle tightly closed to protect from moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the packaging and other information

What Omeboix contains

• The active substance is omeprazole. Omeboix 20 mg gastro-resistant hard capsules contain 20 mg of omeprazole. Omeboix 40 mg gastro-resistant hard capsules contain 40 mg of omeprazole.
• The other ingredients are: sugar spheres (sugar and corn starch), hypromellose, talc, titanium dioxide (E 171), disodium phosphate dihydrate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% (methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulfate, and polysorbate 80), triethyl citrate. Capsule shell:gelatin, titanium dioxide (E 171), purified water, and printing ink (iron oxide, black, potassium hydroxide, and shellac). See section 2 Omeboix contains sugar.

What Omeboix looks like and contents of the pack

Omeboix 20 mg capsules are white, opaque, hard gelatin capsules, marked with "OM 20", containing spherical pellets.

Omeboix 40 mg capsules are white, opaque, hard gelatin capsules, marked with "OM 40", containing spherical pellets.

A white HDPE bottle containing a desiccant, with a PP cap and a tamper-evident ring: 14, 28, 90, and 100 capsules, in a cardboard box.

Aluminum/Aluminum blister: 14 and 28 capsules, in a cardboard box.

PVC/PVDC/Aluminum blister: 14, 28, 30, and 100 capsules, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles, Barcelona

Spain

Manufacturer:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles, Barcelona

Spain

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

France:

Omeprazole Alter 20 mg gastro-resistant capsule

Spain:

Omeprazol cinfa 40 mg hard gastro-resistant capsule

Netherlands:

Omecat 20, 40 mg gastro-resistant hard capsule

Poland:

Omeboix

Portugal:

Omeboix 20 & 40 mg gastro-resistant capsule

Romania:

Omez 20, 40 mg gastro-resistant capsule

Italy:

Omeprazolo Aristo Pharma

Date of last revision of the leaflet: 01.03.2023