PriLOSEC OTC

In the U.S.

• First - Omeprazole
• PriLOSEC
• PriLOSEC OTC

Available Dosage Forms:

• Tablet, Delayed Release
• Capsule, Delayed Release
• Powder for Suspension
• Packet

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of omeprazole in children 1 to 16 years of age. Safety and efficacy have not been established in children younger than 1 month of age. .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omeprazole in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Bendamustine
• Bosutinib
• Cilostazol
• Citalopram
• Clopidogrel
• Clorazepate
• Conivaptan
• Dasabuvir
• Dasatinib
• Delavirdine
• Erlotinib
• Escitalopram
• Eslicarbazepine Acetate
• Gefitinib
• Indinavir
• Ketoconazole
• Ledipasvir
• Methotrexate
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Netupitant
• Nilotinib
• Ombitasvir
• Paritaprevir
• Pazopanib
• Ritonavir
• Saquinavir
• Tacrolimus
• Velpatasvir
• Vismodegib
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Armodafinil
• Carbamazepine
• Digoxin
• Disulfiram
• Fluconazole
• Ginkgo Biloba
• Iron
• Levothyroxine
• Raltegravir
• St John's Wort
• Tipranavir
• Triazolam
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (bone problem) or
• Seizures, history of or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, check with your doctor.

Tell your doctor if you or your child have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine to treat erosive esophagitis.

Do not use omeprazole if you are also using medicines containing rilpivirine (Edurant®, Complera®). Using these medicines together may cause unwanted side effects.

This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you or your child together with omeprazole.

Omeprazole may cause a serious type of allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor right away if you or your child has itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Check with your doctor right away if you or your child has a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after receiving this medicine. These could be symptoms of acute interstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you or your child have concerns about vitamin B12 deficiency.

Serious stomach conditions may occur while taking this medicine alone or together with antibiotics. Check with your doctor immediately if you or your child is having more than one of these symptoms: abdominal or stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than 1 year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Back, leg, or stomach pain
• bleeding or crusting sores on the lips
• blisters
• bloody or cloudy urine
• chills
• continuing ulcers or sores in the mouth
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches or cramps
• pain
• red or irritated eyes
• redness, tenderness, itching, burning, or peeling of the skin
• skin rash or itching
• sore throat
• sores, ulcers, or white spots on the lips, in the mouth, or on the genitals
• unusual bleeding or bruising
• unusual tiredness or weakness

• Drowsiness
• fast, racing, or uneven heartbeat
• mood or mental changes
• muscle spasms (tetany) or twitching seizures
• nausea or vomiting
• trembling

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• confusion
• dryness of the mouth
• flushing
• headache
• increased sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• chest pain
• constipation
• cough
• diarrhea or loose stools
• difficulty with breathing
• dizziness
• ear congestion
• gas
• heartburn
• loss of voice
• muscle pain
• nasal congestion
• runny nose
• sneezing
• unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat heartburn.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Prilosec OTC.
• Call your doctor if you have throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
• Take calcium and vitamin D as you were told by your doctor.
• This medicine may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take this medicine in high doses or for longer than a year, or if you are older than 50 years old. Talk with your doctor.
• Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. You will need to have your blood work checked if you will be taking Prilosec OTC for a long time or if you take certain other drugs like digoxin or water pills. Talk with your doctor.
• Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Lupus has happened with Prilosec OTC, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Very bad pancreas, liver, and white blood cell problems have happened in people who were taking this medicine. Rarely, these have been fatal. Talk with the doctor if you have questions.
• If you are of Asian descent, use Prilosec OTC with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Very bad dizziness or passing out.
• Very bad belly pain.
• Bone pain.
• Fever or chills.
• Sore throat.
• A big weight loss.
• This medicine may raise the chance of a very bad form of diarrhea called Clostridium difficile (C diff)-associated diarrhea. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Prilosec OTC or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prilosec OTC. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to omeprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet delayed release

Along with its needed effects, omeprazole (the active ingredient contained in Prilosec OTC) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking omeprazole:

• Back, leg, or stomach pain
• bleeding or crusting sores on the lips
• blisters
• bloody or cloudy urine
• chills
• continuing ulcers or sores in the mouth
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches or cramps
• pain
• red or irritated eyes
• redness, tenderness, itching, burning, or peeling of the skin
• skin rash or itching
• sore throat
• sores, ulcers, or white spots on the lips, in the mouth, or on the genitals
• unusual bleeding or bruising
• unusual tiredness or weakness

• Drowsiness
• fast, racing, or uneven heartbeat
• mood or mental changes
• muscle spasms (tetany) or twitching seizures
• nausea or vomiting
• trembling

Get emergency help immediately if any of the following symptoms of overdose occur while taking omeprazole:

• Blurred vision
• confusion
• dryness of the mouth
• flushing
• headache
• increased sweating

Some side effects of omeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• chest pain
• constipation
• cough
• diarrhea or loose stools
• difficulty with breathing
• dizziness
• ear congestion
• gas
• heartburn
• loss of voice
• muscle pain
• nasal congestion
• runny nose
• sneezing
• unusual drowsiness