Famotidine and ibuprofen

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Famotidine and ibuprofen is usually taken 3 times each day. Follow your doctor's instructions.

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of famotidine and ibuprofen needed to get relief from your pain, swelling, or fever.

Do not crush, chew, or break a famotidine and ibuprofen tablet. Swallow it whole.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to famotidine / ibuprofen: oral tablet

Along with its needed effects, famotidine / ibuprofen 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 famotidine / ibuprofen:

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or black, tarry stools
• blurred vision
• chills
• clay-colored stools
• cloudy urine
• constipation
• cough
• dark-colored urine
• diarrhea
• difficult, burning, or painful urination
• dizziness
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• general feeling of tiredness or weakness
• headache
• heartburn
• indigestion
• itching or rash
• joint pain
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• nervousness
• pale skin
• pounding in the ears
• rapid weight gain
• runny nose
• severe stomach pain
• shivering
• slow or fast heartbeat
• sore throat
• stomach pain, continuing
• stomach pain, cramping, or burning
• sweating
• tingling of the hands or feet
• trouble sleeping
• troubled breathing with exertion
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

• Blistering, peeling, or loosening of the skin
• change in consciousness
• confusion as to time, place, or person
• cracks in the skin
• darkening of the skin
• depression
• dry mouth
• fainting
• hallucinations
• holding false beliefs that cannot be changed by fact
• loss of consciousness
• loss of heat from the body
• pain in the lower back or side
• pain in the chest, groin, or legs, especially calves of the legs
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• seizures
• severe headaches of sudden onset
• sores, ulcers, or white spots in the mouth or on the lips
• stiff neck or back
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• thirst
• unusual excitement, nervousness, or restlessness

Some side effects of famotidine / ibuprofen 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:

• Back pain
• belching
• body aches or pain
• cough producing mucus
• difficulty having a bowel movement
• difficulty with moving
• ear congestion
• loss of voice
• muscle stiffness
• pain or tenderness around the eyes and cheekbones
• sneezing
• stuffy nose

CrCl less than 50 mL/min: Not recommended.

Data not available

Administration advice:
-Swallow whole; do not break, crush, or chew
-Missed dose: If a dose is missed, take as soon as possible; however, if next scheduled dose is due, do not take the missed dose and instead take the next dose on time; do not take 2 doses at one time.
-Do not substitute with single-ingredient products of famotidine and ibuprofen.

General:
-Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
-The shortest duration consistent with individual patient treatment goals should be used.
-Clinical trials primarily included patients less than 65 years without prior history of gastrointestinal ulcer.
-There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.

Monitoring:
-Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
-Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
-Hematological: Monitor CBC and chemistry profile periodically in patients receiving long-term therapy.
-Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.

Patient advice:
-Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
-Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
-Patients should talk to their health care provider if they are pregnant or planning to become pregnant; this drug is not recommended for use during pregnancy.