Omeprazol 40mg/sod Bicarb 1100mg CP

Omeprazole is a proton pump inhibitor (PPI) that irreversibly binds to and inhibits the H+/K+-ATPase (proton pump) in the secretory canaliculi of gastric parietal cells, thereby blocking the final step in gastric acid secretion. Sodium bicarbonate is an antacid that neutralizes existing gastric acid and, in this formulation, protects omeprazole from acid degradation in the stomach, allowing for rapid dissolution and absorption.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
Kidney Problems: Inability to pass urine, change in urine output, blood in the urine, or sudden weight gain.
High Blood Sugar: Confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
High or Low Blood Pressure: Severe headache or dizziness, fainting, or changes in vision. Confusion, shakiness, dizziness, or fainting. Twitching. Abnormal sensations such as burning, numbness, or tingling. Bone pain. Fever, chills, or sore throat; unexplained bruising or bleeding; or feeling extremely tired or weak. Swelling. Weight gain.
C. diff-Associated Diarrhea (CDAD): Stomach pain or cramps, very loose or watery stools, or bloody stools. Do not attempt to treat diarrhea without consulting your doctor first.
Vitamin B12 Deficiency: Shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs. This can occur with long-term treatment (more than 3 years).
Lupus: If you have lupus, inform your doctor. Call your doctor immediately if you experience a rash on the cheeks or other body parts, changes in skin color, easy sunburning, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Side Effects

Most people do not experience side effects or only have mild side effects. However, if you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Headache
Stomach pain or diarrhea
Gas
* Upset stomach or vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Bartter's syndrome
+ Low calcium or potassium levels
+ Acid-base problems in the blood
Symptoms of other health issues, such as:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food
A history of kidney problems caused by this medication or similar drugs
* If you are taking any of the following medications:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
Note: This is not an exhaustive list of interacting medications.

To ensure your safety, it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Always verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effect of this drug may not be apparent for a few days. Be sure to follow your doctor's instructions regarding the duration of treatment, as taking this medication for longer than prescribed can have adverse effects.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are on a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.

If you have diabetes, you will need to closely monitor your blood sugar levels, as this medication may increase the risk of elevated blood sugar. Additionally, this medication may increase the risk of hip, spine, and wrist fractures in individuals with osteoporosis (weak bones). This risk may be higher if you take high doses of this medication, use it for more than a year, or are over 50 years old.

If you have risk factors for osteoporosis, such as a family history of the condition, alcohol consumption, smoking, steroid use, or seizure medication use, exercise caution and discuss your risks with your doctor. Rarely, long-term use of this medication (at least 3 months, often after 1 year of treatment) can lead to low magnesium levels, which may cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels.

In rare cases, this medication has been associated with severe pancreas, liver, and white blood cell problems, which can be fatal. If you have questions or concerns, discuss them with your doctor. Long-term use of this medication (more than 1 year) may also increase the risk of stomach growths called fundic gland polyps. If you have questions, consult with your doctor.

Individuals of Asian descent should use this medication with caution, as they may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.

• Rilpivirine (due to significant reduction in rilpivirine absorption)

• Clopidogrel (reduced antiplatelet effect)
• Atazanavir, Nelfinavir (reduced absorption, risk of virologic failure)
• Methotrexate (increased methotrexate levels and potential toxicity)
• Dasatinib, Erlotinib, Pazopanib (reduced absorption)
• Mycophenolate Mofetil (reduced exposure of mycophenolic acid)

• Warfarin (increased INR, bleeding risk)
• Diazepam (increased diazepam levels)
• Phenytoin (increased phenytoin levels)
• Digoxin (increased digoxin levels)
• Iron salts, Ketoconazole, Itraconazole, Posaconazole (reduced absorption due to increased gastric pH)
• Tacrolimus (increased tacrolimus levels)
• Cilostazol (increased cilostazol levels)
• Citalopram (increased citalopram levels)
• Voriconazole (increased omeprazole exposure)

• Sucralfate (may delay omeprazole absorption; administer omeprazole at least 30 minutes before sucralfate)

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Black or tarry stools (melena)
• Coffee-ground emesis
• New or worsening abdominal pain
• Severe or persistent diarrhea (may indicate C. difficile infection)
• Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)

Omeprazole is generally considered in Pregnancy Category C. While animal studies have shown some adverse effects, human data are limited. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sodium bicarbonate is also Category C.

Omeprazole is excreted in human breast milk. While the amount is small and generally considered compatible with breastfeeding, caution is advised. Monitor the infant for any adverse effects (e.g., gastrointestinal upset). Sodium bicarbonate is also excreted in milk.

Safety and effectiveness of Omeprazole/Sodium Bicarbonate capsules have not been established in pediatric patients. The sodium load from sodium bicarbonate may be a concern in very young children. Use of omeprazole alone in pediatric patients is established for certain indications, but this combination product is generally not recommended.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Consider age-related decline in renal and hepatic function. Elderly patients may be at increased risk for C. difficile infection and bone fractures with long-term PPI use.

• This immediate-release formulation of omeprazole with sodium bicarbonate is designed for rapid onset of action, unlike enteric-coated omeprazole.
• Always take on an empty stomach, at least 1 hour before a meal, for optimal absorption.
• Do not chew or crush the capsules; swallow them whole.
• Long-term use (typically >1 year) of PPIs, including this combination, has been associated with increased risks of C. difficile-associated diarrhea, hypomagnesemia, vitamin B12 deficiency, and bone fractures (hip, wrist, spine).
• Carefully review concomitant medications for potential drug interactions, especially with clopidogrel, HIV antivirals (atazanavir, nelfinavir), and methotrexate.
• Patients should be advised to seek medical attention if they experience severe or persistent diarrhea, unexplained weight loss, difficulty swallowing, or signs of gastrointestinal bleeding.

• Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole)
• H2-receptor antagonists (e.g., Famotidine, Ranitidine [if available])
• Antacids (e.g., Calcium Carbonate, Aluminum Hydroxide/Magnesium Hydroxide)
• Prokinetic agents (e.g., Metoclopramide, for motility issues)
• Sucralfate (for ulcer protection)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.