Arthrotec (Diclofenac/Misoprostol)

(℞) Prescription Required

    Arthrotec (Diclofenac/Misoprostol) Dosage and Side Effects

    ARTHROTEC (diclofenac plus misoprostol), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling. It helps to relieve joint pain, swelling, and stiffness by reducing the production of certain substances (prostaglandins) and by helping to control inflammation. ARTHROTEC, as a non-steroidal anti-inflammatory drug (NSAID) does NOT cure your illness or prevent it from getting worse.

    Proper Use of this medication

    Usual dose for Patients 18 Years of Age and Older:

    ARTHROTEC should be swallowed whole.

    To lessen stomach upset, take ARTHROTEC immediately after a meal or with food or milk. Also, you should remain standing or sitting upright (i.e. do not lie down) for about 15-30 minutes after taking the medicine. This helps to prevent irritation that may lead to trouble swallowing.

    Take ARTHROTEC only as directed by your healthcare provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your healthcare provider ordered. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much ARTHROTEC may increase the chance of unwanted and sometimes dangerous side effects, especially if you are an elderly patient, have other disease or take other medications.

    If you will be using ARTHROTEC for more than 7 days, see your healthcare provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects. Be sure to take ARTHROTEC regularly as prescribed. In some types of arthritis, up to two weeks may pass before you feel the full effects of this medicine. During treatment, your doctor may decide to adjust the dosage according to your response to the medication.

    This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

    ARTHROTEC is NOT recommended for use in patients under 18 years of age since safety and effectiveness have NOT been established.

    Overdose:

    Symptoms of overdose may include stomach pain, confusion, drowsiness, low muscle tone, shaking hands that you cannot control, seizures, shortness of breath, diarrhea, fever, rapid or pounding heartbeat, slow heartbeat, dizziness or fainting.

    Seek immediate medical attention if you think that you or anyone else may have taken too much ARTHROTEC. Do this even if there are no signs of discomfort or poisoning.

    Missed dose:

    If you miss a dose of ARTHROTEC, take the next dose at the regular time. It is important that ARTHROTEC be taken as prescribed. Try to remember to take ARTHROTEC at the appropriate time. Having a regular routine associated with taking your medicine will help.

    Do not take a double dose.

    Side Effects

    ARTHROTEC may cause some undesirable reactions especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your healthcare provider.

    ARTHROTEC may cause you to become drowsy or tired. Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after ARTHROTEC, do NOT drive or operate machinery.

    ARTHROTEC may cause you to become more sensitive to sunlight. Any exposure to sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have reaction from the sun, check with your health care provider.

    Check with your healthcare provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

    If you are not getting any relief of your arthritis or if any problems develop, check with your doctor.

    Elderly, frail, or debilitated patients often seem to experience more frequent or more severe side effects.

    Stomach upset is one of the common problems with NSAIDs. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor.

    Because misoprostol increases mucus production some patients experience diarrhea. Keep taking your ARTHROTEC. It is just a sign that the drug is working. Usually the diarrhea goes away in two to three days. If it is not gone after a week, check with your doctor.

    While your body gets used to misoprostol you may feel a crampy pain in your stomach. Like the diarrhea it usually goes away in a few days. If it doesn't, check with your doctor.

    Warnings and Precautions

    BEFORE you use ARTHROTEC talk to your doctor or pharmacist if you have any of the following:

    • Disease of the heart or blood vessels (also called cardiovascular disease, including uncontrolled high blood pressure, congestive heart failure, established ischemic heart disease, or peripheral arterial disease), as treatment with GD-diclofenac/misoprostol in these cases is not recommended.

    • Risk factors for cardiovascular disease (see above) such as high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in your blood, diabetes, or if you smoke.

    • Diabetes mellitus or on a low sugar diet

    • Atherosclerosis

    • Poor circulation to your extremities

    • Smoker or ex-smoker

    • Kidney disease or urine problems

    • Previous ulcer or bleeding from the stomach or gut

    • Previous bleeding in the brain

    • Bleeding problems

    • Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, fluribiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)

    • Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives

    • you are on any special diet, such as a low sodium

    • you drink alcohol

    ARTHROTEC may cause sensitivity to sunlight.

    Fertility may be decreased. The use of ARTHROTEC is not recommended in women who have difficulty conceiving.

    WHILE taking ARTHROTEC:

    • tell any other doctor, dentist, pharmacist or other health care professional that you consult or see, that you are taking this medication, especially if you are planning to have heart surgery;

    • do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;

    • some NSAIDs may cause drowsiness or fatigue in some people taking them; be cautious about driving or participating in activities that require alertness if you are drowsy, dizzy or lightheaded after taking this medication;

    • your regular medical checkups are essential;

    • do not give ARTHROTEC to anyone else. It has been prescribed for your specific condition. ARTHROTEC may not be the correct treatment for another person, and would be dangerous if the other person were pregnant.

    • fertility may be decreased. The use of ARTHROTEC is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping ARTHROTEC should be considered.

    • if you have cardiovascular disease or risks for cardiovascular disease, your doctor will periodically re-evaluate whether you should continue treatment with ARTHROTEC.

    If, at any time while taking GD-diclofenac/misoprostol you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.

    Interactions with this medication

    Talk to your healthcare provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):

    • Acetylsalicylic Acid (ASA) or other NSAIDs (e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen)

    • Antacids

    • Antidepressants

      • Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. citalopram, fluoxetine, paroxetine, sertraline)

    • Blood pressure medications

      • Diuretics (e.g. furosemide, hydrochlorothiazide)

      • ACE (Angiotensin converting enzyme) inhibitors (e.g. enalapril, lisinopril, perindopril, ramipril)

      • ARBs (angiotensin II receptor blockers) (e.g. candesartan, irbesartan, losartan, valsartan)

      • Beta-blockers

    • Blood thinners (e.g. warfarin, ASA, clopidogrel)

    • Corticosteroids (including glucocorticoids) (e.g. prednisone)

    • Cyclosporin

    • Digoxin

    • Lithium

    • Methotrexate

    • Oral contraceptives

    • Oral hypoglycemics (diabetes medications)

    • Phenytoin (a medicine used to treat seizures)

    • Tacrolimus

    • Sulfinpyrazone (a medicine used to treat gout)

    • Voriconazole (a medicine used to treat fungal infections)

    Do not take ASA (acetylsalicylic acid), ASA-containing compounds, ibuprofen or other drugs used to relieve symptoms of arthritis while taking ARTHROTEC unless directed to do so by your physician.

    Your healthcare provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking ARTHROTEC. Take only the amount of ASA prescribed by your healthcare provider. You are more likely to upset or damage your stomach if you take both ARTHROTEC and ASA than if you took ARTHROTEC alone.

    Using ARTHROTEC with a blood-thinner increases the risk of bleeding. This can occur in the stomach or anywhere.

    Using ARTHROTEC with blood pressure drugs may increase your risk of kidney failure. This is more likely if you are elderly or dehydrated.

    Do not take antacids that contain magnesium (because they can cause diarrhea) while you are taking ARTHROTEC. Ask your pharmacist to help you select a suitable brand.

    Stomach problems may be more likely to occur if you drink alcoholic beverages. Therefore, do not drink alcoholic beverages while taking this medication.

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    The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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