August 20, 2014
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Apo-Diclo

(diclofenac)

DIN (Drug Identification Number)

00839175 APO-DICLO 25MG ENTERIC-COATED TABLET
02243433 APO-DICLO RAPIDE 50 MG TABLETS
00839183 APO-DICLO 50MG ENTERIC-COATED TABLET
02091194 APO-DICLO SR 100MG EXTENDED RELEASE TABLET
02162814 APO-DICLO SR 75MG EXTENDED RELEASE TABLET

What side effects are possible with Apo-Diclo?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal or stomach cramps, pain, or discomfort (mild to moderate)
  • diarrhea
  • dizziness, drowsiness, or lightheadedness
  • headache (mild to moderate)
  • heartburn, indigestion, nausea, or vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bladder pain
  • bleeding from cuts or scratches that lasts longer than usual
  • bleeding from rectum (with suppositories)
  • bleeding or crusting sores on lips
  • bloody or cloudy urine or any problem with urination, such as difficult, burning, or painful urination
  • burning feeling in throat, chest, or stomach
  • change in urine colour or odour
  • confusion, forgetfulness, mental depression, or other mood or mental changes
  • cough or hoarseness
  • decreased hearing, any other change in hearing, or ringing or buzzing in ears
  • difficulty swallowing
  • eye pain, irritation, dryness, redness, or swelling
  • frequent urge to urinate
  • hallucinations
  • headache (severe), throbbing, or with stiff neck or back
  • increased blood pressure
  • light-coloured stools
  • muscle cramps, pain, or weakness
  • numbness, tingling, pain, or weakness in hands or feet
  • pain in lower back or side (severe)
  • sudden, large increase or decrease in the amount of urine or loss of bladder control
  • swelling of face, feet, or lower legs
  • swelling of lips or tongue
  • swelling or tenderness in upper abdominal or stomach area
  • swollen or painful glands (especially in the neck or throat area)
  • thirst (continuing)
  • unexplained runny nose or sneezing
  • unexplained, unexpected, or unusually heavy vaginal bleeding
  • unusual tiredness or weakness
  • weight gain (rapid)
  • yellow eyes or skin

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • abdominal or stomach pain, cramping, or burning (severe)
  • bloody or black, tarry stools
  • blurred vision or any change in vision
  • chest pain
  • convulsions (seizures)
  • difficulty speaking
  • fever with or without chills
  • fainting
  • fast or irregular breathing
  • fast, irregular heartbeat or pulse
  • hive-like swellings (large) on face, eyelids, mouth, lips, or tongue
  • hives, itching of skin, or any other skin problem, such as blisters, redness or other colour change, tenderness, burning, peeling, loosening or splitting of fingernails
  • nausea, heartburn, or indigestion (severe and continuing)
  • pinpoint-sized red spots on skin
  • puffiness or swelling of the eyelids or around the eyes
  • shortness of breath, troubled breathing, wheezing, or tightness in chest
  • sores, ulcers, or white spots on lips or in mouth
  • spitting up of blood
  • unexplained nosebleeds
  • unusual bleeding or bruising
  • vomiting of blood or material that looks like coffee grounds

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Apo-Diclo?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking this medication. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined how this medication affects you.

Fluid and electrolyte balance: Fluid retention and edema have been reported with use of this medication. People with the following medical conditions should be closely monitored by their doctor while taking diclofenac:

  • any other condition that might lead to fluid retention
  • certain heart conditions (e.g., congestive heart failure)
  • high blood pressure
  • kidney disease or reduced kidney function
  • recovering from a surgical operation under general anesthesia

There is a risk of high blood potassium with NSAID treatment. Those most at risk include seniors, those with conditions such as diabetes or kidney failure, and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills).

Heart problems: Like other NSAID medications, diclofenac may increase the risk of heart attacks, strokes, and blood clots. The risk is greater with higher doses and long-term use. People at risk of heart problems, such as those with high blood pressure, high cholesterol, diabetes, peripheral arterial disease, heart failure, or coronary artery disease, should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: This medication may mask the signs of an infection, such as a fever.

Kidney function: Long-term use of diclofenac may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who are take diuretics (water pills); and for seniors.

Liver function: This medication may cause liver problems. If you have a liver condition, you may need more frequent checkups with your doctor. If you develop signs of a liver problem (such as yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), stop taking the medication and see your doctor as soon as possible.

Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with diclofenac. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding are increased for people taking higher doses of NSAIDs for longer periods of time.

Diclofenac should be taken under close medical supervision by people prone to irritation of the stomach and intestines, particularly those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn's disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.

Sun sensitivity: This medication may make your skin more sensitive to the sun. While you are using this medication, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience sunburn with itching, swelling, and blistering, stop using this medication and contact your doctor.

Pregnancy: This medication is not recommended for use during pregnancy as its safety has not been established.

Breast-feeding: This medication should not be used by breast-feeding mothers.

Children: Diclofenac is not recommended for children under 16 years of age. The safety, effectiveness, and dosage of this medication for this age group have not been established.

Seniors: Seniors appear to have a higher risk of side effects with this medication. The lowest effective dosage should be used under close medical supervision.

What other drugs could interact with Apo-Diclo?

There may be an interaction between diclofenac and any of the following:

  • acetaminophen
  • alcohol
  • angiotensin II receptor blockers (ARBs; e.g., candesartan, irbesartan)
  • angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril)
  • antidiabetes medication (e.g., glyburide, gliclazide)
  • beta-blockers (e.g., metoprolol, atenolol)
  • bisphosphonates (e.g., alendronate, etidronate, pamidronate, risedronate, zoledronic acid)
  • cholestyramine
  • colestipol
  • corticosteroids (e.g., prednisone)
  • cyclosporine
  • desmopressin
  • digoxin
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, spironolactone)
  • fluoroquinolone antibiotics (e.g., ofloxacin, ciprofloxacin)
  • herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine)
  • lithium
  • medications that affect blood clotting (e.g., acetylsalicylic acid (ASA, aspirin), clopidogrel, enoxaparin, dalteparin, heparin, lepirudin, tinzaparin, or warfarin)
  • medications used to treat stomach or intestinal ulcers, reflux, or excessive acidity (e.g., ranitidine, omeprazole, esomeprazole, pantoprazole)
  • methotrexate
  • other NSAIDs (e.g., naproxen, indomethacin)
  • other products containing diclofenac
  • pemetrexed
  • pentoxifylline
  • phenytoin
  • potassium supplements
  • probenecid
  • SSRIs (e.g., paroxetine, fluoxetine, citalopram, sertraline)
  • sulfinpyrazone
  • tacrolimus
  • tricyclic antidepressants (e.g., amitriptyline, doxepin, imipramine)
  • voriconazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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