Omeboix

Package leaflet: Information for the patient

Omeboix, 20 mg, hard enteric-coated capsules
Omeboix, 40 mg, hard enteric-coated capsules
Omeprazole
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts or questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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 package and other information

1. What is Omeboix and what is it used for

Omeboix contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced in the stomach.

Omeboix is used to treat the following conditions and disorders:

In adults:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or in the stomach (gastric ulcers).
• Ulcers infected with bacteria called Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eliminate the infection and allow ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Omeboix may also be used to prevent the development of ulcers during NSAID treatment.
• Excessive acid production in the stomach due to a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:
Children above 1 year of age and weighing ≥10 kg

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn. In children, symptoms may include regurgitation of stomach contents into the mouth (spitting up, vomiting), vomiting, and poor weight gain.

Children and adolescents above 4 years of age

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

2. Information before using Omeboix

When not to use Omeboix:

• if the patient has a known allergy to omeprazole or any of the other ingredients of this medicine Omeboix (listed in section 6).
• if the patient has a known allergy to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Omeboix if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Omeboix.

Warnings and precautions

Before taking Omeboix, talk to your doctor or pharmacist.

Severe skin reactions have been reported during treatment with Omeboix, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If any symptoms related to these severe skin reactions described in section 4 occur, discontinue use of Omeboix immediately and seek urgent medical help.

Omeboix may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Omeboix, inform your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Passing black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as use of omeprazole has been associated with a small increased risk of infectious diarrhoea.
• Severe liver problems.
• If the patient has ever had a skin reaction after taking a medicine similar to Omeboix that reduces stomach acid secretion.
• Prior to a specific blood test (chromogranin A levels).

If Omeboix is used long-term (longer than 1 year), the patient will likely require close and regular medical monitoring. During visits to the doctor, report any new or unusual symptoms or circumstances.

Taking proton pump inhibitors such as Omeboix, particularly for over one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If a skin rash develops, especially in areas exposed to sunlight, inform your doctor as soon as possible, as discontinuation of Omeboix may be necessary. Also report any other adverse effects such as joint pain.

During treatment with omeprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in urine and/or allergic reactions such as fever, rash, and joint stiffness. Such symptoms should be reported to the treating physician.

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. This medicine must not be given to children under 1 year of age or with body weight < 10 kg.

Omeboix with other medicines

Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken, including those available without a prescription. This is important because Omeboix may affect the action of certain other medicines, and some other medicines may affect the action of Omeboix.

Do not take Omeboix if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

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 disorders).
• Diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy).
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient's condition when starting or stopping Omeboix.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient's condition when starting or stopping Omeboix.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in organ transplant patients).
• 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 chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue Omeboix.

If your doctor has prescribed amoxicillin and clarithromycin together with Omeboix to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor about all other medicines being taken.

Omeboix with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, consult a doctor or pharmacist before starting this medicine.

Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. Whether a breastfeeding woman can take Omeboix will be decided by the doctor.

Driving and using machines

Omeboix does not affect the ability to drive or operate tools and machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If these occur, do not drive or operate machinery.

Omeboix contains sucrose and sodium

If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before starting this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Omeboix

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will inform you how many capsules to take and for how long. This will depend on your medical condition and age. Dosage recommendations are provided below.

Use in adults:

Treatment of GERD symptoms such as heartburn and regurgitation of stomach contents:

• If your doctor has determined that your oesophagus has been slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend continuing with a dose of 40 mg for an additional 8 weeks if the oesophagus has not healed.
• The recommended dose after healing of the oesophagus is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily (to administer a 10 mg dose, available products containing omeprazole at a strength of 10 mg should be used).

Treatment of ulcers in the upper part of the small intestine (duodenal ulcers):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing with the same dose for another 2 weeks if ulcers have not healed during this time.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcers):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing with the same dose for another 4 weeks if ulcers have not healed during this time.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence 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 administer a 10 mg dose, available products containing omeprazole at a strength of 10 mg should be used).

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

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

Prevention of recurrence of duodenal and gastric ulcers during use of NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by bacterial infection Helicobacter pylori 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 from the following: amoxicillin, clarithromycin, and metronidazole.

Treatment of excessive acid secretion in the stomach caused by a hyperplastic change in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and decide how long treatment with Omeboix should continue.

Use in children and adolescents

Treatment of GERD symptoms such as heartburn and regurgitation of stomach contents:

• Children aged over 1 year and weighing more than 10 kg may take Omeboix. The dose depends on the child's body weight and is individually determined by the treating physician.

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

• Children aged over 4 years may take Omeboix. The dose for children depends on body weight and is individually determined by the treating physician.
• Your doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take Omeboix capsules

• It is recommended to take the capsules in the morning.
• The capsules may 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 coated pellets designed to protect the medicine from breakdown by stomach acid. It is important that the pellets remain undamaged.

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

• If an adult or child has difficulty swallowing the capsules:
  • Open the capsule and swallow the contents directly with a glass of water, or mix the contents with a glass of still water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple sauce.
  • Always mix the preparation immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
  • To ensure the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

Taking more Omeboix than recommended

If you take more Omeboix than prescribed by your doctor, contact your doctor or pharmacist immediately.

Missing a dose of Omeboix

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

Stopping Omeboix

Do not stop taking Omeboix without first consulting your doctor or pharmacist.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 adverse reactions, you must stop taking Omeboix and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Skin redness with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Red, scaly, widespread rash with subcutaneous nodules 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 dysfunction. (rare)

Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people)

• Headache.
• Effects on stomach or intestines: diarrhoea, abdominal pain, constipation, gas (bloating).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or prickling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, nodular rash (urticaria), and skin itching.
• General malaise and lack of energy.

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

• Blood-related problems such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising, or increased risk of infection.
• Low sodium levels in blood. This may cause weakness, vomiting, and muscle cramps.
• Feeling of agitation, confusion or depression.
• Altered sense of taste.
• Vision problems, such as blurred vision.
• Sudden sensation of wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as "thrush", which may affect the intestines.
• Hair loss (alopecia).
• Skin rash occurring during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver dysfunction leading to liver failure and encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Inflammation of the intestines (causing diarrhoea).
• If Omeboix has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash which may be accompanied by joint pain.

In very rare cases, Omeboix may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by serious worsening of general condition, or fever with local infection symptoms such as neck, throat or mouth pain, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible white blood cell deficiency (agranulocytosis), based on blood test results. It is important that, in such a situation, the patient informs the doctor or pharmacist about the medicine being taken.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store the medicine Omeboix

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
• For Aluminium/Aluminium foil blisters: Store below 30°C. Keep in the original packaging to protect from moisture.
• For PVC/PVDC/Aluminium foil blisters: Store below 25°C. Keep in the original packaging to protect from moisture.
• For HDPE bottles: No special temperature storage requirements. Keep the bottle tightly closed to protect from moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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.
• Other ingredients are: sucrose, pellets (sucrose and maize starch), hypromellose, talc, titanium dioxide (E 171), disodium hydrogen phosphate dihydrate, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (methacrylic acid and ethyl acry游戏副本