Serious Warnings and Precautions

TYKERB should be prescribed and managed by a doctor experienced in anticancer drugs. Serious side effects of TYKERB include:

• Liver toxicity can be severe and deaths have happened (harmful effect on the liver)
• Decreased left ventricular ejection fraction (decreased pumping of blood from the left ventricle of the heart)
• Abnormal heartbeat (QT prolongation)
• Severe diarrhea, which can be life-threatening

BEFORE you use TYKERB, talk to your doctor or pharmacist if:

• You have or have had heart problems, such as abnormal heartbeat (arrhythmias or dysrhythmias) or fainting spells
• You have electrolyte disturbances, such as low blood potassium, low blood magnesium, low blood calcium, or conditions that could lead to electrolyte disturbances such as eating disorder, vomiting, diarrhea, dehydration, diabetes (with nerve disorders)
• You have a family history of sudden cardiac death at younger than 50 years of age
• You have lung problems
• You have liver problems
• You have diarrhea or any changes in bowel patterns
• You are pregnant, or are planning to become pregnant
• You are breastfeeding or are planning to do so.

TYKERB may cause harm to your unborn baby. Therefore, you should use effective methods of contraception while taking TYKERB. If you become pregnant during treatment with TYKERB, tell your doctor immediately. It is not known whether TYKERB passes into breast milk, therefore breastfeeding is not recommended while you are taking TYKERB.

TYKERB has an effect on the electrical activity of the heart known as QT/QTc prolongation. This may lead to disturbances in the heartbeat (heart rhythm) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting (syncope) or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart problems, taking medicines that affect the heart, being female or being over 65 years of age. It is important to follow the instructions of your doctor with regard to dosing or any special tests. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention. Safety and efficacy of TYKERB have not been established in children.

TYKERB can make you feel drowsy or sleepy.

• Don’t drive or use machines unless you are sure you are not affected.

Severe Skin Reactions:

Severe skin reactions have been seen with TYKERB. Symptoms may include skin rash, blisters and skin peeling. Tell your doctor as soon as possible if you get any of these symptoms. As severe skin reactions can be life threatening, your doctor may tell you to stop TYKERB.

Like all medicines, TYKERB can cause side effects. Most of the side effects are mild to moderate. Tell your doctor or pharmacist if any of the side effects listed becomes severe or bothers you, or if you notice any side effects not listed in this leaflet.

Side effects of TYKERB in combination with capecitabine (XELODA) or letrozole (FEMARA) include:

Very common side effects:

These side effects may affect more than 10 in every 100 patients:

• Diarrhea (which if severe can be life-threatening), contact your doctor immediately at the first sign of diarrhea (loose stool), to treat it right away. Also tell your doctor immediately if your diarrhea worsens.
• Loss of appetite
• Indigestion or stomach/abdominal pain
• Feeling or being sick (nausea or vomiting)
• Constipation
• Tiredness
• Unusual hair loss or thinning
• Nose bleed
• Difficulty breathing
• Sore mouth or mouth ulcers
• Trouble sleeping (insomnia)
• Back pain or pain in extremities
• Rash or dry skin
• A skin reaction or pain on the palms of the hands or soles of the feet (including tingling, numbness, pain, swelling or reddening)

Supportive skin care regimens are available. Please talk to your healthcare provider for guidance. Before you go out in the sun, use a sun protection product with a high protection factor (SPF 30 or higher).

Common side effects:

These side effects may affect between 1 to 10 in every 100 people:

• An effect on how your heart works—this may cause an irregular heartbeat and shortness of breath
• Headache
• Fever
• Swelling in extremities
• Pain in joints or bones
• Nosebleed
• Nail disorders—such as tender infection and swelling of the cuticles

If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations, fainting, or seizures, you should seek immediate medical attention.

Uncommon side effects:

These side effects may affect up to 1 in every 100 people:

• Liver problems—this may cause itching, yellow eyes or skin (jaundice), dark urine or pain or discomfort in the right upper area of the stomach.
• Swelling or inflammation of the lungs—this may cause coughing or shortness of breath.

Tell your doctor immediately if you get any of these symptoms. These symptoms may persist after you stop taking TYKERB.

Rare side effects:

These side effects may affect up to 1 in every 1000 people:

• Severe allergic reactions—symptoms may include: skin rash (including itchy, bumpy rash); unusual wheezing or difficulty in breathing; swollen eyelids, lips or tongue; pains in muscles or joints; collapse or blackout.

There are certain groups of medicines that interact with TYKERB. The following list includes some, but not all, medicines that interact with TYKERB. Tell your doctor or pharmacist if you're taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes non-prescription medicines, vitamins, and natural health products.

• drugs used to treat infections (antibiotics and antifungals)
• drugs used to treat HIV (AIDS)
• drugs used to treat chronic inflammation or asthma (steroids)
• drugs used to treat seizures (anticonvulsant drugs)
• drugs used to treat certain heart disorders and high blood pressure (calcium channel blockers)
• water pills (diuretics)
• opioids (e.g. methadone)
• antidepressants
• antipsychotics
• drugs that decrease stomach acidity (used to treat stomach ulcers or indigestion)
• herbal products (St. John's Wort)

You should also avoid grapefruit juice or products containing grapefruit juice.

Because TYKERB is given with another drug, either capecitabine or letrozole, you should also discuss with your doctor any medicines that should be avoided when taking capecitabine (Xeloda) or letrozole.

Ask your health professional for advice before taking any medicine if you are unsure.

How to take:

Swallow the tablets whole with water.

TYKERB should be taken at least one hour before or at least one hour after a low fat meal.

TYKERB tablets should be taken at about the same time each day.

Do not drink grapefruit juice while you are taking TYKERB.

If you have any problems/questions regarding the use of TYKERB, please consult with your health professional.

Overdose:

Dosage directions should be followed carefully. Never exceed the prescribed dose.

If you have accidentally taken more TYKERB tablets than you should, contact your doctor, or poison control centre, or go to the emergency room of the nearest hospital.

Missed dose:

Do not take a double dose to make up for a forgotten dose on a given day, simply resume your dosing with the next scheduled dose the following day. If you have further questions on the use of TYKERB, ask your health professional.

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Your doctor may have suggested this medication for conditions other than those listed in this drug information. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

Do not use this medication if you:

• are allergic to betamethasone, gentamicin, or any ingredients of the medication
• have chickenpox
• have herpes simplex
• have tuberculosis of the skin
• have vaccinia
• have viral skin lesions

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.

Tell all health professionals involved in your care that you have been using a topical (skin applied) corticosteroid.

Absorption: Gentamicin and betamethasone are known to be absorbed through the skin into the bloodstream by people using these medications for a long period of time or over a large area of the body, increasing the risk of side effects. It is advisable to only use VALISONE-G for brief periods and to stop using it as soon as the problem clears.

Eyes: Use this medication with caution on lesions close to the eye. Take care to ensure that it does not enter the eye, as glaucoma may result. Cataracts have been reported following internal use of corticosteroids.

Thinning of skin: Using topical corticosteroid medications such as betamethasone valerate for a long period of time can cause skin to thin or soften or cause stretch marks. Your doctor may recommend you stop using this medication once in a while or to apply to one area of the body at a time. Suddenly stopping corticosteroid medication may cause psoriasis to return.

Yeast infections: Gentamicin is not effective against fungi, yeasts, or viruses. People with fungal, yeast, or viral infections must also receive specific treatment for those conditions as prescribed by your doctor. If you believe that an affected area is not responding to topical VALISONE-G, contact your doctor as soon as possible.

Pregnancy: VALISONE-G should not be used during pregnancy unless the benefits outweigh the risks. Topical corticosteroids should not be used by pregnant women over large areas of the body, in large amounts, or for prolonged periods of time. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if betamethasone valerate passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Betamethasone valerate belongs to the family of medications known as corticosteroids. Children may be more likely to experience the side effects encountered by using large amounts of this class of medication for long periods of time (e.g., slowing down of growth, delayed weight gain).

The use of this medication by children should be limited to the smallest amount that will be effective. Discuss with your doctor the risks and benefits of the use of this medication by children.

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.

• burning, irritation, itching, redness, or dryness of the skin (usually mild and temporary)
• increased redness or scaling of the skin sores (usually mild and temporary)
• skin rash (usually mild and temporary)

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

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

• blood-containing blisters on the skin
• burning and itching of the skin
• increased skin sensitivity
• lack of healing of the skin condition
• painful, red or itchy, pus-containing blisters in hair follicles
• raised, dark red, wart-like spots on the skin, especially when used on the face
• skin discoloration
• skin infection
• "spider veins" or blood vessels visible through the skin
• thinning of the skin with easy bruising

 Additional side effects may occur if this medication is used for long periods of time. Check with your doctor as soon as possible if any of the following side effects occur:

• acne or oily skin
• backache
• blurring or loss of vision (occurs gradually if certain products have been used near the eye)
• burning and itching of the skin with pinhead-sized red blisters
• changes in skin colour
• depression
• eye pain (if certain products have been used near the eye)
• filling or rounding out of the face
• increased blood pressure
• irregular heartbeat
• irregular menstrual periods
• irritability
• irritation of the skin around mouth
• loss of appetite
• muscle cramps, pain, or weakness
• nausea
• rapid weight gain or loss
• reddish purple lines (stretch marks) on the arms, face, legs, trunk, or groin
• redness and scaling around mouth
• softening of the skin
• swelling of feet or lower legs
• tearing of the skin
• unusual bruising
• unusual decrease in sexual desire or ability (in men)
• unusual increase in hair growth, especially on the face
• unusual loss of hair, especially on the scalp
• unusual tiredness or weakness
• vomiting
• weakness of the arms, legs, or trunk (severe)
• worsening of infections

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.

There may be an interaction between VALISONE-G and any of the following:

• other topical medications that contain corticosteroids, antibiotics, or that have irritating effects

If you are using any medications that fit this description, 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 that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.

Apply a small amount on the affected area 2 or 3 times daily, or as directed by your doctor. Enough medication should be applied to completely cover the affected area with a thin film. The medication should be gently and thoroughly massaged into the affected area.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the one above, do not change the way that you are using the medication without consulting your doctor.

For some cases of psoriasis and certain other conditions, your doctor may advise you to cover the area with an occlusive dressing (a dressing that doesn't breathe) such as a plastic wrap for more effective treatment. Do not cover the area unless directed to do so by your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, apply it as soon as possible and continue with your regular schedule. If it is almost time for the next application, skip the missed dose and continue with your regular schedule. Do not apply a double application to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Before using VISUDYNE, tell your doctor if you:

• are pregnant or planning to become pregnant. Fetal malformations were seen in animal studies for one species (rat) when VISUDYNE was administered during pregnancy. Your doctor will decide with you whether the product should be used.
• are breastfeeding or intend to breastfeed. VISUDYNE appears in human breast milk. You and your doctor should discuss whether nursing should be interrupted or treatment postponed. You should not nurse for at least 96 hours after VISUDYNE administration.
• have liver or gall bladder problems.
• are using any other medications.

Patients receiving VISUDYNE will become temporarily sensitive to light for 2 days. Therefore you must:

• protect all parts of your skin and eyes from direct sunlight and bright indoor light. This includes tanning salons, bright halogen lighting, high power lighting used in surgical operating rooms and dental offices, and light-emitting medical devices.
• wear protective clothing and dark sunglasses when going outdoors. UV sunscreens are NOT effective in protecting against light sensitivity.
• wear a temporary wristband to remind yourself and others that you are light sensitive.

However, you should not stay in the dark, but you should expose your skin to normal indoor lighting, because this helps break down the drug in the skin.

Accidental spills of VISUDYNE (e.g., on skin) should be wiped up immediately to avoid later photosensitivity reactions when this tissue is exposed to light. Contact with the skin and eyes should be avoided.

Following VISUDYNE therapy, you may develop a short-term disturbance in your vision. You should not attempt to drive or use machines until it goes away.

Changes in vision (including blurring, decreased sharpness, flashes of light and gaps or ‘spider webs' in vision) were among the most frequently reported side effects. If these occur, or if “floaters” or persistent changes in visual field appear, contact your doctor (see Table). These may be signs of a serious condition.

Temporary musculoskeletal pain commonly occurs, during or after infusion, often as chest and back pain which can radiate to other areas including the pelvis, shoulder girdle or ribs.

Other common side effects include weakness, nausea, constipation, hypertension, elevated blood cholesterol or urinary glucose, dry, itchy or painful eyes, aversion to light, decrease in pain or touch sensitivity, sunburn or increased sensitivity to the sun.

Injection site reactions (e.g. pain, swelling, blisters and discolouration) may occur, and can be serious.

Some drugs increase light sensitivity and could increase the potential for skin reactions or affect VISUDYNE activity. These include some antibiotics (tetracyclines, sulfonamides, polymyxin B) and antifungals (griseofulvin), oral diabetes drugs (sulfonylurea antihyperglycemic drugs), and drugs for mental disorders (phenothiazines).

Other drugs that may interact with VISUDYNE include drugs for heart or circulation conditions (calcium channel blockers, blood thinners or anti-clotting drugs, diuretics).

Antioxidant such as beta-carotene or drugs that scavenge free radicals (such as dimethylsulfoxide (DMSO), formate, mannitol, and alcohol) may interact with VISUDYNE.

Radiation therapy may also interact with VISUDYNE.

Make sure your doctor knows all the medications you are taking before starting VISUDYNE therapy.

Usual adult dose:

Your doctor will calculate the correct dose to give you, based on your body surface area. VISUDYNE should only be administered by a qualified health professional in an ophthalmology practice.

Overdose:

If your doctor tells you that you've had an overdose, you will have to protect your skin and eyes from bright light for a longer time than normal. Follow your doctor's instructions.

If you feel you have been given an overdose, consult with your doctor or healthcare practitioner administering the product immediately following the procedure, even if there are no symptoms.

Take VOLTAREN or VOLTAREN SR only as directed by your health care 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 health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much VOLTAREN or VOLTAREN SR may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly and frail or if you have a low body weight, have other diseases or take other medications.

If you will be using VOLTAREN or VOLTAREN SR for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

Swallow the tablet whole with water, do not chew or divide the tablet. It is best to take your dose at the same time each day.

To help reduce the possibility of stomach upset you should take VOLTAREN or VOLTAREN SR tablets 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. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor.

Using Suppositories:

VOLTAREN suppositories (50 and 100 mg) are wrapped in a plastic film. Make sure that the plastic wrapping is fully removed before inserting the suppository into the rectum. It is best to take the suppositories after emptying your bowels.

Do not take suppositories by mouth.

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.

Overdose:

If you have accidentally taken more than the prescribed dose of VOLTAREN tablets, suppositories or VOLTAREN SR tablets, contact your doctor, pharmacist or poison control centre immediately or go to the hospital emergency unit at once. You may require medical attention.

Missed dose:

If you forget to take your scheduled dose, you should not double the next scheduled dose to make up for the missed dose.

VOLTAREN or VOLTAREN SR may cause some side effects, 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 health care provider.

VOLTAREN or VOLTAREN SR 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 taking VOLTAREN or VOLTAREN SR, do NOT drive or operate machinery.

VOLTAREN or VOLTAREN SR 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 a reaction from the sun, check with your health care provider.

Check with your health care 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 have, or previously had, any of the following conditions, see your health care provider to discuss treatment options other than VOLTAREN or VOLTAREN SR:

• Heart Attack or Angina
• Stroke or Mini-stroke
• Loss of Vision
• Current Pregnancy (less than 28 weeks)
• Congestive Heart Failure
• High Blood Pressure
• Diabetes
• High Levels of Fats in Your Blood
• Smoking

It is important to take the lowest dose of VOLTAREN and VOLTAREN SR that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk of side effects on the heart and blood vessels as small as possible.

Use of NSAIDS, such as VOLTAREN and VOLTAREN SR can result in increased blood pressure and/or worsening of congestive heart failure.

Use of NSAIDs, such as VOLTAREN and VOLTAREN SR, may cause stomach and bowel problems (such as ulceration, perforation, obstruction and bleeding).

Before taking this medication, tell your health care provider 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 VOLTAREN and VOLTAREN SR 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
• 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, flurbiprofen, 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

Also, before taking this medication, tell your health care provider if you are pregnant or you are planning to get pregnant.

While taking this medication:

• Tell any other doctor, dentist, pharmacist or other health care professional that you 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;
• Fertility may be decreased. The use of VOLTAREN or VOLTAREN SR is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping VOLTAREN or VOLTAREN SR 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 VOLTAREN or VOLTAREN SR.
• Your doctor will monitor your kidney function, your liver function and your blood count to decide if VOLTAREN or VOLTAREN SR needs to be discontinued or if the dose needs to be changed.

If, at any time while taking VOLTAREN or VOLTAREN SR 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.

Long-term use of VOLTAREN or VOLTAREN SR might increase the risk of heart attacks or strokes.

VOLTAREN or VOLTAREN SR is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been established.

Take VOLTAREN or VOLTAREN SR only as directed by your health care 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 health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much VOLTAREN or VOLTAREN SR may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly and frail or if you have a low body weight, have other diseases or take other medications.

If you will be using VOLTAREN or VOLTAREN SR for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

Swallow the tablet whole with water, do not chew or divide the tablet. It is best to take your dose at the same time each day.

To help reduce the possibility of stomach upset you should take VOLTAREN or VOLTAREN SR tablets 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. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor.

Using Suppositories:

VOLTAREN suppositories (50 and 100 mg) are wrapped in a plastic film. Make sure that the plastic wrapping is fully removed before inserting the suppository into the rectum. It is best to take the suppositories after emptying your bowels.

Do not take suppositories by mouth.

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.

Overdose:

If you have accidentally taken more than the prescribed dose of VOLTAREN tablets, suppositories or VOLTAREN SR tablets, contact your doctor, pharmacist or poison control centre immediately or go to the hospital emergency unit at once. You may require medical attention.

Missed dose:

If you forget to take your scheduled dose, you should not double the next scheduled dose to make up for the missed dose.

VOLTAREN or VOLTAREN SR may cause some side effects, 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 health care provider.

VOLTAREN or VOLTAREN SR 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 taking VOLTAREN or VOLTAREN SR, do NOT drive or operate machinery.

VOLTAREN or VOLTAREN SR 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 a reaction from the sun, check with your health care provider.

Check with your health care 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 have, or previously had, any of the following conditions, see your health care provider to discuss treatment options other than VOLTAREN or VOLTAREN SR:

• Heart Attack or Angina
• Stroke or Mini-stroke
• Loss of Vision
• Current Pregnancy (less than 28 weeks)
• Congestive Heart Failure
• High Blood Pressure
• Diabetes
• High Levels of Fats in Your Blood
• Smoking

It is important to take the lowest dose of VOLTAREN and VOLTAREN SR that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk of side effects on the heart and blood vessels as small as possible.

Use of NSAIDS, such as VOLTAREN and VOLTAREN SR can result in increased blood pressure and/or worsening of congestive heart failure.

Use of NSAIDs, such as VOLTAREN and VOLTAREN SR, may cause stomach and bowel problems (such as ulceration, perforation, obstruction and bleeding).

Before taking this medication, tell your health care provider 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 VOLTAREN and VOLTAREN SR 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
• 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, flurbiprofen, 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

Also, before taking this medication, tell your health care provider if you are pregnant or you are planning to get pregnant.

While taking this medication:

• Tell any other doctor, dentist, pharmacist or other health care professional that you 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;
• Fertility may be decreased. The use of VOLTAREN or VOLTAREN SR is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping VOLTAREN or VOLTAREN SR 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 VOLTAREN or VOLTAREN SR.
• Your doctor will monitor your kidney function, your liver function and your blood count to decide if VOLTAREN or VOLTAREN SR needs to be discontinued or if the dose needs to be changed.

If, at any time while taking VOLTAREN or VOLTAREN SR 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.

Long-term use of VOLTAREN or VOLTAREN SR might increase the risk of heart attacks or strokes.

VOLTAREN or VOLTAREN SR is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been established.