Lansoprazole and Naproxen (Oral Route)

It is used for patients who have had stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis .

Lansoprazole is a proton pump inhibitor (PPI) that is used to treat certain conditions (e.g., duodenal and gastric ulcers) where there is too much acid in the stomach. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain and the symptoms of arthritis, such as inflammation, swelling, stiffness, and joint pain.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet


• Capsule, Delayed Release

Before Using

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 have not been performed on the relationship of age to the effects of lansoprazole and naproxen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lansoprazole and naproxen combination in the elderly. However, elderly patients may be more sensitive to the effects of lansoprazole and naproxen combination than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breastfeeding

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.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

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.

• Ketorolac

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.

• Ardeparin


• Atazanavir


• Beta Glucan


• Certoparin


• Clopidogrel


• Dalteparin


• Danaparoid


• Dasatinib


• Delavirdine


• Enoxaparin


• Erlotinib


• Ginkgo


• Methotrexate


• Mycophenolate Mofetil


• Nadroparin


• Nelfinavir


• Parnaparin


• Pemetrexed


• Reviparin


• Tacrolimus


• Tinzaparin


• Warfarin

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.

• Acenocoumarol


• Acetohexamide


• Alacepril


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Amiloride


• Azosemide


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Calcium Carbonate


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Citalopram


• Clopamide


• Clopidogrel


• Clovoxamine


• Cranberry


• Cyclopenthiazide


• Cyclosporine


• Cyclothiazide


• Delapril


• Desvenlafaxine


• Dicumarol


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Escitalopram


• Ethacrynic Acid


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Lisinopril


• Losartan


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Methyclothiazide


• Metolazone


• Milnacipran


• Moexipril


• Nefazodone


• Olmesartan Medoxomil


• Paroxetine


• Pentopril


• Perindopril


• Phenprocoumon


• Piretanide


• Polythiazide


• Quinapril


• Quinethazone


• Ramipril


• Sertraline


• Spirapril


• Spironolactone


• Tasosartan


• Telmisartan


• Temocapril


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Warfarin


• Xipamide


• Zimeldine


• Zofenopril

Other Interactions

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Anemia or


• Bleeding problems or


• Congestive heart failure or


• Crohn`s disease, history of or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease or


• Stomach ulcers or bleeding, history of or


• Stroke, history of or


• Ulcerative colitis, history ofa€”Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history ofa€”Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG])a€”Should not be used to relieve pain right before or after the surgery.

Proper Use

Use this medicine exactly as ordered by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor . Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is packaged as a kit. The kit contains two different medicines that are used together for 7 days or 28 days. Each daily dose consists of one PrevacidA® capsule and two NaprosynA® tablets.

It is best to take this medicine on an empty stomach, but take your medicine with a glass of water .

Swallow the PrevacidA® capsule whole. Do not break, crush, or chew it. If you are also taking sucralfate, take the PrevacidA® capsule 30 minutes before sucralfate.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules and tablets):
  
  
  
  • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
    
    
    
    • Adultsa€”One PrevacidA® capsule and one NaprosynA® tablet in the morning before eating . Take the second NaprosynA® tablet in the evening.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress 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 and urine tests may be needed to check for unwanted effects.

Naproxen may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

Naproxen may cause bleeding in your stomach or intestines. This problem can happen without warning signs . This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention . Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Using this medicine during late pregnancy can harm your unborn baby . If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment . Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.

This medicine may cause some people to become dizzy, drowsy, depressed, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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:

More common

• Abdominal or stomach pain, cramping, or burning


• Black, tarry stools


• Bruising


• Constipation


• Diarrhea


• Difficult or labored breathing


• Heartburn


• Indigestion


• Large, flat, blue, or purplish patches in the skin


• Nausea


• Pale skin


• Shortness of breath


• Skin blisters


• Swelling


• Tightness in the chest


• Troubled breathing with exertion


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting of blood or material that looks like coffee grounds


• Wheezing

Less common

• Irregular heartbeat


• Pinpoint red or purple spots on the skin


• Sweating


• Thirst

Rare

• Abdominal or stomach fullness


• Abdominal or stomach pain with gas


• Ankle, knee, or great toe joint pain


• Anxiety


• Arm, back, or jaw pain


• Back, leg, or stomach pains


• Bladder pain


• Bleeding from rectum or bloody stools


• Bleeding gums


• Blistering, burning, crusting, dryness, or flaking of the skin


• Blistering, peeling, or loosening of the skin


• Bloating or swelling of the face, arms, hands, lower legs, or feet


• Blood in the urine or stools


• Bloody nose


• Bloody or cloudy urine


• Blue lips and fingernails


• Blurred vision


• Body aches or pain


• Burning while urinating


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Canker sores


• Change in consciousness


• Changes in menstrual periods


• Chest pain, discomfort, or burning


• Chest tightness or heaviness


• Clay-colored stools


• Cold, clammy skin


• Cold sweats


• Confusion


• Congestion


• Cool, pale skin


• Cough increased


• Cough or hoarseness


• Cough producing mucus


• Coughing or spitting up blood


• Coughing that sometimes produces a pink frothy sputum


• Cracks in the skin


• Dark-colored urine


• Decrease in the amount of urine


• Decreased frequency or amount of urine


• Decreased sexual ability in males


• Decreased urination


• Decreased urine output


• Depression


• Difficult or troubled breathing


• Difficult, burning, or painful urination


• Difficult, fast, or noisy breathing, sometimes with wheezing


• Difficulty with swallowing


• Dilated neck veins


• Dizziness


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Dry cough


• Dry mouth


• Dry skin and hair


• Dry, puffy skin


• Dryness or soreness of the throat


• Extreme fatigue


• Fainting


• Fast, irregular, pounding, or racing heartbeat or pulse


• Fast, weak pulse feeling


• Feeling of warmth or heat


• Fever with or without chills


• Fluid-filled skin blisters


• Flushed, dry skin


• Flushing or redness of the skin, especially on the face and neck


• Frequent strong or increased urge to urinate


• Frequent urge to defecate or urinate


• Fruit-like breath odor


• General body swelling


• General feeling of discomfort or illness


• General feeling of tiredness or weakness


• Greatly decreased frequency of urination or amount of urine


• Hair loss


• Headache


• High blood pressure


• High fever


• Hives


• Inability to speak


• Increase in heart rate


• Increased blood pressure


• Increased clear or white vaginal discharge


• Increased hunger


• Increased need to urinate


• Increased sweating


• Increased thirst


• Increased urination


• Irregular, fast or slow, or shallow breathing


• Itching, scaling, severe redness, soreness, or swelling of the skin


• Joint or muscle pain


• Joint stiffness or swelling


• Kidney pain


• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• Light-colored stools


• Lightheadedness, dizziness, or fainting


• Loss of appetite


• Loss of consciousness


• Loss of heat from the body


• Lower back or side pain


• Muscle cramps and stiffness


• Neck pain


• Nervousness


• Nightmares


• Noisy breathing


• Nosebleeds


• Numbness or tingling in the hands, feet, or lips


• Pain


• Pain in the ankles or knees


• Pain in the groin or genitals


• Pain or burning in the throat


• Pain or discomfort in the arms, jaw, back, or neck


• Pain or tenderness around the eyes and cheekbones


• Pain with swallowing


• Painful, red lumps under the skin, mostly on the legs


• Pains in the stomach, side, or abdomen, possibly radiating to the back


• Pale or blue lips, fingernails, or skin


• Passing of gas


• Passing urine more often


• Pounding in the ears


• Rapid weight gain


• Rapid, shallow breathing


• Rash


• Rectal bleeding


• Recurrent fever


• Red skin lesions, often with a purple center


• Red, irritated eyes


• Red, swollen skin


• Redness, soreness, or itching skin


• Runny nose


• Scaly skin


• Seizures


• Sensitivity to the sun


• Severe and continuing nausea


• Severe or continuing stomach pain


• Severe or sudden headache


• Severe stomach pain, cramping, or burning


• Shakiness in the legs, arms, hands, or feet


• Sharp back pain just below ribs


• Shivering


• Skin thinness


• Slurred speech


• Sneezing


• Sore throat


• Sores, ulcers, or white spots on the lips or tongue or inside the mouth


• Sores, welting, or blisters


• Stiff neck or back


• Stomach pain, continuing


• Stomach pain, fullness, or discomfort


• Straining while passing stool


• Sudden decrease in amount of urine


• Sunken eyes


• Swelling of the face, fingers, feet, or lower legs


• Swelling of the front part of the neck


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Temporary blindness


• Tenderness


• Thirst


• Tiredness


• Trouble with sleeping


• Trouble with swallowing


• Troubled breathing with exertion


• Unexplained bleeding or bruising


• Unexplained weight loss


• Unpleasant breath odor


• Unusual weight gain or loss


• Upper right abdominal pain


• Voice changes


• Vomiting


• Watery or bloody diarrhea


• Weakness in the arm or leg on one side of the body, sudden and severe


• Weakness or heaviness of the legs


• Weight gain or loss


• Wrinkled skin


• Yellow eyes and skin

Incidence not known

• Change in mental status


• Clay colored stools


• Decrease in frequency of urination


• Decreased appetite


• Difficulty in passing urine (dribbling)


• Difficulty with speaking


• Difficulty with swallowing


• Greatly decreased frequency of urination or amount of urine


• Nosebleeds


• Pains in the stomach, side, or abdomen, possibly radiating to the back

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:

More common

• Absent missed or irregular menstrual periods


• Belching


• Continuing ringing or buzzing or other unexplained noise in the ears


• Excess air or gas in the stomach or intestines


• Hearing loss


• Pain in the chest below the breastbone


• Passing gas


• Sleepiness


• Stopping of menstrual bleeding

Less common

• Acid or sour stomach


• Change in hearing


• Disturbed color perception


• Double vision


• Feeling of constant movement of self or surroundings


• Loss of hearing


• Night blindness


• Overbright appearance of lights


• Seeing halos around lights


• Sensation of spinning


• Swelling or inflammation of the mouth


• Tunnel vision

Rare

• Abnormal dreams


• Abnormal menses


• Abnormal stools


• Bad breath


• Blemishes on the skin


• Bone deformity


• Breast enlargement, pain, or tenderness


• Breath odor


• Burning feeling in the chest or stomach


• Burning, dry, or itching eyes


• Change in ability to see colors, especially blue or yellow


• Change in color vision


• Change in hearing


• Changes in vision


• Cold sweats


• Coma


• Continuing ringing or buzzing or other unexplained noise in the ears


• Cool, pale skin


• Cramps


• Crying


• Deafness


• Decrease in height


• Decrease or change in vision


• Decreased interest in sexual intercourse


• Decreased vision


• Depersonalization


• Difficulty seeing at night


• Discharge, excessive tearing


• Discoloration of the fingernails or toenails


• Discouragement


• Double vision


• Drooping upper eyelids


• Dysphoria


• Earache


• Enlarged abdomen


• Euphoria


• Excessive muscle tone


• Eye pain


• Fear


• Fecal discoloration


• Feeling of constant movement of self or surroundings


• Feeling of unreality


• Feeling sad or empty


• Fruit-like breath odor


• Hair loss or thinning of the hair


• Headache, severe and throbbing


• Heavy bleeding


• Hiccup


• Hostility


• Hyperventilation


• Impaired vision


• Inability to concentrate


• Inability to have or keep an erection


• Inability to move the legs or arms


• Increase in body movements


• Increased in sexual ability, desire, drive, or performance


• Increased interest in sexual intercourse


• Increased salivation


• Increased sensitivity of the skin to sunlight


• Irritability


• Itching of the vagina or genital area


• Lack of appetite


• Lack of feeling or emotion


• Lack or loss of strength


• Leg cramps


• Longer or heavier menstrual periods


• Loss of interest or pleasure


• Loss of memory


• Loss of strength or energy


• Mood or mental changes


• Mouth ulceration


• Muscle aching or cramping


• Muscle or bone pain


• Muscle tension or tightness


• Muscle weakness


• Neck pain or rigidity


• Nightmares


• Pain during sexual intercourse


• Pain in the back, ribs, arms, or legs


• Paralysis of one side of the body


• Paranoia


• Passing gas


• Pelvic pain


• Persistent non-healing sore


• Pimples


• Poor insight and judgment


• Problems with memory or speech


• Quick to react or overreact emotionally


• Rapidly changing moods


• Rash with flat lesions or small raised lesions on the skin


• Red-green color blindness


• Reddish patch or irritated area


• Redness or other discoloration of the skin


• Redness or swelling in the arms or legs


• Redness or swelling in the ear


• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• Redness, swelling, or soreness of the tongue


• Restlessness


• Seeing double


• Seeing, hearing, or feeling things that are not there


• Seizures


• Sensation of spinning


• Sense of detachment from self or body


• Severe sunburn


• Shiny bump


• Skin disorder


• Sleep disorder


• Swelling of the breasts or breast soreness in both females and males


• Swelling or inflammation of the mouth


• Taste loss


• Tearing


• Thick, white vaginal discharge with no odor or with a mild odor


• Tiredness


• Transient, mild, pleasant aromatic odor


• Trouble performing routine tasks, recognizing objects, thinking and planning, or walking


• Uncaring


• Unexplained weight loss


• Urethral pain


• White patches with diaper rash


• White, yellow, or waxy scar-like area

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.