• What is Byraza Plus?
A prescription medicine called a proton pump inhibitor (PPI) is used to reduce the amount of acid in your stomach.

What is Byraza Plus used for?
Byraza Plus Hard Capsules is used in adults for:
• Up to 8 weeks for the healing of duodenal ulcers.
• Up to 8 weeks for the healing of stomach ulcers.
• Up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
• Up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 4 weeks of Byraza Plus in patients whose EE does not heal.
• Maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD. It is not known if omeprazole/sodium bicarbonate is safe and effective when used for longer than 12 months for this purpose.

It is not known if omeprazole/sodium bicarbonate is safe and effective in children.

Do not take Byraza Plus if you are:
• Allergic to omeprazole, any other PPI medicine, or any of the ingredients in Byraza Plus. See the end of this leaflet for a complete list of ingredients in Byraza Plus.
• Taking a medicine that contains rilpivirine, used to treat HIV-1 (Human Immunodeficiency Virus).

Warnings and precautions
Before taking Byraza Plus, tell your doctor about all of your medical conditions, including if you:
• Have low magnesium, calcium, or potassium levels in your blood.
• Have problems with the acid-base (pH) balance in your body.
• Have liver problems.
• Have heart failure.
• Are on a low-sodium diet.
• Have Bartter’s syndrome (a rare kidney problem).
• Are of Asian descent and have been told that your body’s ability to break down (metabolize) omeprazole is poor or if your genotype called CYP2C19 is not known.
• Are pregnant or plan to become pregnant. It is not known if omeprazole/sodium bicarbonate will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. Omeprazole/sodium bicarbonate can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take omeprazole/sodium bicarbonate.

Children and adolescents
It is not known if omeprazole/sodium bicarbonate is safe and effective in children.

Other medicines and Byraza Plus
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take:
• Digoxin.
• Clopidogrel.
• St. John’s wort (Hypericum perforatum).
• Rifampin.
• Methotrexate.
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Pregnancy and breast-feeding
Before taking Byraza Plus, tell your doctor if you:
• Are pregnant or plan to become pregnant. It is not known if omeprazole/sodium bicarbonate will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. Omeprazole/sodium bicarbonate can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take omeprazole/sodium bicarbonate.

Byraza Plus contains sodium
Byraza Plus contains sodium. Each 20 mg and 40 mg Byraza Plus Hard Capsule contains 1100 mg (13 mEq) of sodium bicarbonate.

• Take Byraza Plus exactly as prescribed by your doctor.
• Do not change your dose or stop taking Byraza Plus without talking to your doctor.
• Swallow Byraza Plus Hard Capsules whole with water. Do not use other liquids. Do not crush or chew the capsule. Do not open the capsule and sprinkle
contents into food.
• Take Byraza Plus Hard Capsules on an empty stomach at least 1 hour before a meal.
• Do not substitute two 20 mg capsules for one 40 mg capsule of Byraza Plus because you will receive twice the amount of sodium bicarbonate. Talk to your doctor if you have questions.

Dosage regimen
The recommended dosage regimen by indication in adults of Byraza Plus Hard Capsules is summarized in Table 1. All recommended dosages are based upon omeprazole content.

Table 1: Recommended dosage regimen of Byraza Plus Hard Capsules in adults by indication

Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

The efficacy of omeprazole/sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Byraza Plus may be considered.

If you take more Byraza Plus than you should

If you take too much Byraza Plus, call your doctor right away or go to the nearest hospital emergency room.

If you forget to take Byraza Plus

If you miss a dose of Byraza Plus, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to make up for a missed dose.

What is the most important information I should know about Byraza Plus?

Byraza Plus may help your acid-related symptoms, but you could still have serious stomach problems. Talk to your doctor.

Omeprazole/sodium bicarbonate can cause serious side effects, including:

•   A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including omeprazole/sodium bicarbonate, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with omeprazole/sodium bicarbonate. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

•   Byraza Plus contains sodium bicarbonate. Long-term use of bicarbonate with calcium or milk can cause a condition called “milk-alkali syndrome”. Long-term use of sodium bicarbonate can cause a condition called “systemic alkalosis”. Talk to your doctor about any questions you may have. Too much sodium can cause swelling and weight gain. Tell your doctor if you are on a low-sodium diet or if you have Bartter’s Syndrome (a rare kidney disorder). Tell your doctor right away if you have confusion, shaking hands, dizziness, muscle twitching, nausea, vomiting, and numbness or tingling in the face, arms, or legs.

•   Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.

•   Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have bone fracture, especially in the hip, wrist, or spine.

•   Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including omeprazole/sodium bicarbonate, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

•   Low vitamin B-12 levels in your body can happen in people who have taken omeprazole/sodium bicarbonate for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.

•   Low magnesium levels in your body can happen in people who have taken omeprazole/sodium bicarbonate for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

•   Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growth called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

•   Severe skin reactions. Omeprazole/sodium bicarbonate can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:

-   Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).

-   You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

Stop taking omeprazole/sodium bicarbonate and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

•   The most common side effects of omeprazole/sodium bicarbonate include:

-   Headache.

-   Abdominal pain.

-   Nausea.

-   Diarrhea.

-   Vomiting.

-   Gas.

These are not all the possible side effects of omeprazole/sodium bicarbonate. Call your doctor for medical advice about side effects.

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

Store below 30°C.

Store in the original package in order to protect from light and moisture.

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

Do not use this medicine if you notice any visible signs of deterioration.

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.