Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not use TARKA together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

You should not use this medicine if you are allergic to trandolapril or verapamil, or if you have:

• certain serious heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);
• a heart rhythm disorder;
• low blood pressure; or
• if you are allergic to any other ACE inhibitor, such as benazepril, captopril, fosinopril, enalapril, lisinopril, moexipril, perindopril, quinapril, or ramipril.

If you have diabetes, do not use TARKA together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

You may also need to avoid taking TARKA with aliskiren if you have kidney disease.

To make sure TARKA is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);
• liver disease;
• congestive heart failure;
• diabetes;
• a nerve-muscle disease such as muscular dystrophy; or
• a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. TARKA can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

TARKA can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using TARKA.

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms;
• upper stomach pain, and jaundice (yellowing of the skin or eyes);
• chest pain, fast, slow, or uneven heart rate;
• lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;
• high potassium--nausea, slow or unusual heart rate, weakness, loss of movement; or
• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• headache, dizziness;
• chest pain, back pain;
• constipation;
• feeling tired; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

If you also take disopyramide, avoid taking it within 48 hours before or 24 hours after you take TARKA.

Do not use potassium supplements or salt substitutes while you are taking TARKA, unless your doctor has told you to.

Many drugs can interact with TARKA. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• colchicine;
• a diuretic or "water pill";
• gold injections to treat arthritis;
• insulin or oral diabetes medicine;
• lithium;
• St. John's wort;
• cholesterol-lowering medicine--atorvastatin, lovastatin, simvastatin, and others;
• an antibiotic--clarithromycin, erythromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;
• heart or blood pressure medicine--digoxin, digitalis, disopyramide, flecainide, metoprolol, propranolol, quinidine;
• antiviral medicine to treat hepatitis or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, ritonavir, and others;
• medicine to prevent organ transplant rejection--cyclosporine, everolimus, sirolimus, tacrolimus, temsirolimus;
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
• seizure medicine--carbamazepine, phenytoin; or
• tuberculosis medicine--isoniazid, rifampin.

This list is not complete and many other drugs can interact with TARKA. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

TARKA works best if you take it with food.

Your blood pressure will need to be checked often.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking TARKA. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

If you need surgery, tell the surgeon ahead of time that you are using TARKA. You may need to stop using the medicine for a short time.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help.

Overdose symptoms may include slow heart rate, weak pulse, muscle weakness, tingly feeling, seizure (convulsions), feeling light-headed, or fainting.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

There is an evidence of fetal risk based on adverse reaction data, but potential benefits may allow the drug to be used in pregnant women despite risks.

Abdominal pain, fatigue, nausea, constipation, lack of appetite, insomnia, drowsiness, palpitations, muscular or joint pain, headache, vertigo, tremor, dry mouth and hepatitis (rare cases).

interactions info....

It comes as a tablet to take by mouth, on an empty stomach.

There are several important warnings you should know about before taking ORACEA.

You should take this medication only to treat bacterial infections, and it's important to take it exactly as your doctor prescribes.

Using ORACEA or other antibiotics incorrectly or using them to treat infections caused by other types of germs, such as viruses, contributes to the development of drug-resistant bacteria.

Every time you take an antibiotic, it kills the sensitive bacteria. Resistant germs, however, can grow and multiply, and then surviving bacteria can become resistant.

It's also important to understand that taking antibiotics, including ORACEA, alters the normal balance of bacteria in your body.

In addition to killing harmful bacteria, the medication can also reduce the amount of good bacteria that help keep other germs in check.

As a result, some people taking ORACEA develop yeast infections and antibiotic-related diarrhea.

Taking ORACEA could make oral birth control pills less effective. If you are on oral contraceptives, you should use other forms of birth control while you take this antibiotic.

Before taking ORACEA, let your doctor know if you're going to have any kind of surgery, including dental surgery.

Your doctor also needs to know if you've ever had liver or kidney disease.

Also tell your doctor if you have diabetes. Taking ORACEA can interfere with tests for sugar in the urine.

Talk with your doctor before changing your diet or your diabetes treatment plan.

Pregnancy and ORACEA

Pregnant women should not take ORACEA because the drug can be harmful to an unborn baby.

Tetracyclines, including ORACEA, also pass into breast milk, so women who are breastfeeding should not take this drug.

If you're a woman, let your doctor know if you are pregnant, plan to become pregnant, or are breastfeeding.

It's also important to note that unborn babies exposed to ORACEA or children younger than 8 years old who take the drug may have permanently stained teeth.

Children younger than 8 should not take ORACEA except as treatment for inhalational anthrax or if a doctor decides it's necessary.

ORACEA for Dogs and Cats

ORACEA is often used to treat bacterial infections in dogs, cats, and other animals.

ORACEA may be prescribed to treat several bacterial infections, such as leptospirosis, urinary tract infections (UTI), toxoplasmosis, erlichiosis, or mycoplasma.

It's also used to treat tick-borne diseases, including Lyme disease and Rocky Mountain spotted fever.

Because ORACEA can cause severe side effects in dogs and cats (such as nausea and diarrhea), it should be used only under the care and direction of a veterinarian.

Common Side Effects of ORACEA

• Diarrhea
• Itching of the rectum or vagina
• Sore mouth

Serious Side Effects of ORACEA

If you have any of these side effects, stop taking ORACEA and call your doctor right away:

• Severe headache
• Blurry vision
• Rash or hives
• Trouble breathing or swallowing
• Sunburn
• Yellowing of the skin or eyes
• Dark-colored urine
• Light-colored bowel movements
• Loss of appetite
• Nausea or vomiting
• Stomach pain
• Extreme tiredness or weakness
• Confusion
• Less frequent urination

Certain drugs may affect the way ORACEA works. This antibiotic could also interact with other medications.

It's very important to let your doctor know about everything you're taking, including street drugs as well as any over-the-counter (OTC) medications, herbs, or supplements.

Types of drugs that interact with ORACEA include:

• Antacids
• Calcium supplements
• Iron supplements and laxatives that contain magnesium
• Penicillin
• Blood thinners, such as warfarin (Coumadin)
• Barbiturates and anti-seizure drugs, such as carbamazepine (Tegretol) and phenytoin (Dilantin)
• Oral birth control pills

Other ORACEA Interactions

ORACEA could upset your stomach.

Taking the drug with milk or food might help, but that may reduce the amount of medication your body can absorb from your stomach.

If you experience an upset stomach while taking ORACEA, talk with your doctor about the best way to take this drug.

Taking ORACEA could also make your skin more sensitive to sunlight. While you are on the medication, be sure to avoid sun exposure whenever possible.

If you do need to be outside, take precautions to protect your skin from the sun, such as:

• Wearing protective clothing,
• Wearing sunglasses
• Applying sunscreen

If you're taking ORACEA to prevent malaria, it's important to understand that the drug does not fully protect you from this infection.

While you are on the drug, you must still take additional preventative measures, including:

• Applying effective insect repellent
• Using mosquito nets
• Wearing clothing that covers your whole body

ORACEA and Alcohol

It's possible to drink alcohol while taking ORACEA, but use of alcohol may increase your risk of side effects, including stomach upset.

Talk with your doctor about the risks of combining alcohol and ORACEA.

ORACEA comes in tablet, capsule, or liquid form. A doctor also can inject it under your skin.

Tablets come in varying strengths including 50, 75, 100, and 150 mg.

Don't crush or break a delayed-release capsule.

If you're taking an oral form of the drug, drink a full glass of water with each dose.

For adults, the normal dose of oral ORACEA is 200 mg on the first day of treatment.

Usually you take that as two 100-mg doses, 12 hours apart. After this initial dose, people usually take a maintenance dose of 100 mg daily for seven to 10 days.

For more severe infections, such as chronic infections of the urinary tract, the recommended dose is 100 mg every 12 hours.

In some cases, people may need to take higher doses, 300 mg a day for 10 days.

For inhalational anthrax, the usual adult prescription is 100 mg of ORACEA twice a day for 60 days.

For the prevention of malaria, you should start taking ORACEA up to two days before traveling.

Continue taking the drug for four weeks after you leave an area where malaria is a risk.

Do not take ORACEA to prevent malaria for more than four months.

The correct dosage for children older than 8 will depend on the child's weight.

Continue to take ORACEA until your course of treatment is finished, even if you feel good.

Don't stop taking the medication unless directed by your doctor.

ORACEA Overdose

Don't take more ORACEA than your doctor prescribed.

Taking too much of the medication can increase your risk for developing side effects.

If you or someone else has symptoms of an overdose, call a poison control center.

If someone collapses or isn't breathing, call 911.

Missed Dose of ORACEA

Be sure to take ORACEA exactly as your doctor prescribed.

Skipping doses or not completing the full course of therapy could make the drug less effective.

It could also lead to the development of drug-resistant bacteria ("superbugs") that will not respond to antibiotics in the future.

If you forget to take a dose of ORACEA, take the missed dose as soon as you remember it.

If it's almost time for your next regular dose, however, skip the missed one.

Don't take twice as much ORACEA at one time to make up for a missed dose.

There are several important warnings you should know about before taking VIBRAMYCIN.

You should take this medication only to treat bacterial infections, and it's important to take it exactly as your doctor prescribes.

Using VIBRAMYCIN or other antibiotics incorrectly or using them to treat infections caused by other types of germs, such as viruses, contributes to the development of drug-resistant bacteria.

Every time you take an antibiotic, it kills the sensitive bacteria. Resistant germs, however, can grow and multiply, and then surviving bacteria can become resistant.

It's also important to understand that taking antibiotics, including VIBRAMYCIN, alters the normal balance of bacteria in your body.

In addition to killing harmful bacteria, the medication can also reduce the amount of good bacteria that help keep other germs in check.

As a result, some people taking VIBRAMYCIN develop yeast infections and antibiotic-related diarrhea.

Taking VIBRAMYCIN could make oral birth control pills less effective. If you are on oral contraceptives, you should use other forms of birth control while you take this antibiotic.

Before taking VIBRAMYCIN, let your doctor know if you're going to have any kind of surgery, including dental surgery.

Your doctor also needs to know if you've ever had liver or kidney disease.

Also tell your doctor if you have diabetes. Taking VIBRAMYCIN can interfere with tests for sugar in the urine.

Talk with your doctor before changing your diet or your diabetes treatment plan.

Pregnancy and VIBRAMYCIN

Pregnant women should not take VIBRAMYCIN because the drug can be harmful to an unborn baby.

Tetracyclines, including VIBRAMYCIN, also pass into breast milk, so women who are breastfeeding should not take this drug.

If you're a woman, let your doctor know if you are pregnant, plan to become pregnant, or are breastfeeding.

It's also important to note that unborn babies exposed to VIBRAMYCIN or children younger than 8 years old who take the drug may have permanently stained teeth.

Children younger than 8 should not take VIBRAMYCIN except as treatment for inhalational anthrax or if a doctor decides it's necessary.

VIBRAMYCIN for Dogs and Cats

VIBRAMYCIN is often used to treat bacterial infections in dogs, cats, and other animals. 

VIBRAMYCIN may be prescribed to treat several bacterial infections, such as leptospirosis, urinary tract infections (UTI), toxoplasmosis, erlichiosis, or mycoplasma. 

It's also used to treat tick-borne diseases, including Lyme disease and Rocky Mountain spotted fever. 

Because VIBRAMYCIN can cause severe side effects in dogs and cats (such as nausea and diarrhea), it should be used only under the care and direction of a veterinarian.

Common Side Effects of VIBRAMYCIN

Common side effects of VIBRAMYCIN include:

• Diarrhea
• Itching of the rectum or vagina
• Sore mouth

Serious Side Effects of VIBRAMYCIN

Serious side effects of VIBRAMYCIN can also occur.

If you have any of these side effects, stop taking VIBRAMYCIN and call your doctor right away:

• Severe headache
• Blurry vision
• Rash or hives
• Trouble breathing or swallowing
• Sunburn
• Yellowing of the skin or eyes
• Dark-colored urine
• Light-colored bowel movements
• Loss of appetite
• Nausea or vomiting
• Stomach pain
• Extreme tiredness or weakness
• Confusion
• Less frequent urination

Certain drugs may affect the way VIBRAMYCIN works. This antibiotic could also interact with other medications.

It's very important to let your doctor know about everything you're taking, including street drugs as well as any over-the-counter (OTC) medications, herbs, or supplements.

Types of drugs that interact with VIBRAMYCIN include:

• Antacids
• Calcium supplements
• Iron supplements and laxatives that contain magnesium
• Penicillin
• Blood thinners, such as warfarin (Coumadin)
• Barbiturates and anti-seizure drugs, such as carbamazepine (Tegretol) and phenytoin (Dilantin)
• Oral birth control pills

Other VIBRAMYCIN Interactions

VIBRAMYCIN could upset your stomach.

Taking the drug with milk or food might help, but that may reduce the amount of medication your body can absorb from your stomach.

If you experience an upset stomach while taking VIBRAMYCIN, talk with your doctor about the best way to take this drug.

Taking VIBRAMYCIN could also make your skin more sensitive to sunlight. While you are on the medication, be sure to avoid sun exposure whenever possible.

If you do need to be outside, take precautions to protect your skin from the sun, such as:

• Wearing protective clothing,
• Wearing sunglasses
• Applying sunscreen

If you're taking VIBRAMYCIN to prevent malaria, it's important to understand that the drug does not fully protect you from this infection.

While you are on the drug, you must still take additional preventative measures, including:

• Applying effective insect repellent
• Using mosquito nets
• Wearing clothing that covers your whole body

VIBRAMYCIN and Alcohol

It's possible to drink alcohol while taking VIBRAMYCIN, but use of alcohol may increase your risk of side effects, including stomach upset. 

Talk with your doctor about the risks of combining alcohol and VIBRAMYCIN.

VIBRAMYCIN comes in tablet, capsule, or liquid form. A doctor also can inject it under your skin.

Tablets come in varying strengths including 50, 75, 100, and 150 mg.

Don't crush or break a delayed-release capsule.

If you're taking an oral form of the drug, drink a full glass of water with each dose.

For adults, the normal dose of oral VIBRAMYCIN is 200 mg on the first day of treatment.

Usually you take that as two 100-mg doses, 12 hours apart. After this initial dose, people usually take a maintenance dose of 100 mg daily for seven to 10 days.

For more severe infections, such as chronic infections of the urinary tract, the recommended dose is 100 mg every 12 hours.

In some cases, people may need to take higher doses, 300 mg a day for 10 days.

For inhalational anthrax, the usual adult prescription is 100 mg of VIBRAMYCIN twice a day for 60 days.

For the prevention of malaria, you should start taking VIBRAMYCIN up to two days before traveling.

Continue taking the drug for four weeks after you leave an area where malaria is a risk.

Do not take VIBRAMYCIN to prevent malaria for more than four months.

The correct dosage for children older than 8 will depend on the child's weight.

Continue to take VIBRAMYCIN until your course of treatment is finished, even if you feel good.

Don't stop taking the medication unless directed by your doctor.

VIBRAMYCIN Overdose

Don't take more VIBRAMYCIN than your doctor prescribed.

Taking too much of the medication can increase your risk for developing side effects.

If you or someone else has symptoms of an overdose, call a poison control center. If someone collapses or isn't breathing, call 911.

Missed Dose of VIBRAMYCIN 

Be sure to take VIBRAMYCIN exactly as your doctor prescribed.

Skipping doses or not completing the full course of therapy could make the drug less effective.

It could also lead to the development of drug-resistant bacteria ("superbugs") that will not respond to antibiotics in the future.

If you forget to take a dose of VIBRAMYCIN, take the missed dose as soon as you remember it.

If it's almost time for your next regular dose, however, skip the missed one.

Don't take twice as much VIBRAMYCIN at one time to make up for a missed dose.

SYNVISC is injected directly into the knee joint by a healthcare professional. It's usually given once every week for three weeks.

SYNVISC-One is given as a single injection.

Your doctor may tell you to apply ice to your knee after you receive your injection of SYNVISC.

SYNVISC Overdose

A healthcare professional typically administers SYNVISC in a medical setting, so you're unlikely to experience an overdose.

But if you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of SYNVISC

Call your healthcare provider if you miss an appointment to receive your SYNVISC injection.

Common Side Effects of SYNVISC

Tell your doctor if any of the following side effects become severe or don't go away:

• Mild pain, warmth, swelling, stiffness, or puffiness at the injection site
• Itching or skin irritation around the knee
• Muscle pain or trouble walking
• Fever, chills, or nausea
• Numbness or tingly feeling
• Tiredness
• Headache
• Dizziness

Serious Side Effects of SYNVISC

Tell your doctor right away if you experience any of the following serious side effects:

• Signs of an allergic reaction, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat
• Fast, pounding heartbeat
• Severe headache

You shouldn't receive an injection of SYNVISC if you have an infection in your knee or on the skin surrounding your knee.

Before receiving this treatment, tell your doctor if you have or have had:

• Blood clots
• Circulation problems in your legs
• Skin infections
• An allergy to hylan G-F 20, birds, feathers, or egg products

Call your doctor immediately if you experience severe pain or swelling around the knee after receiving an injection of SYNVISC.

You'll need to avoid strenuous activities such as jogging or high-impact sports for at least two days after your treatment with SYNVISC. You should also avoid standing for longer than one hour at a time for at least 48 hours after your injection.

SYNVISC should only be injected in the knee. The safety and effectiveness of the treatment in other areas of the body hasn't been established.

This treatment typically isn't used in people under age 21. 

Pregnancy and SYNVISC

It's not known whether SYNVISC could harm an unborn baby.

Tell your doctor if you're pregnant or plan to become pregnant before receiving this therapy.

It's also not known whether SYNVISC could pass into breast milk.

Don't breastfeed a baby while receiving SYNVISC injections without first talking to your physician.

Other medications may interact with SYNVISC.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking.

Don't take TAPAZOLE if you're allergic to the drug or any of its ingredients.

Women should avoid taking TAPAZOLE while breastfeeding.

Talk to your doctor before taking TAPAZOLE if you:

• Are pregnant
• Have low counts of red blood cells, white blood cells, or platelets
• Are taking Clozaril (clozapine) or Propyl-Thyracil (propylthiouracil, or PTU)
• Are receiving radiation treatment

Pregnancy and TAPAZOLE

Studies show that TAPAZOLE may cause birth defects.

Manufacturers of the drug state that it's not safe to take during pregnancy.

But your doctor may feel that the benefits of taking the drug during pregnancy outweigh the risks in certain situations.

TAPAZOLE is passed into breast milk, and its safety for nursing babies has been a topic of debate. Talk to your doctor before taking the drug while breastfeeding.

It's always a good idea to talk to your doctor about all medications you're taking if you're pregnant, planning a pregnancy, or breastfeeding.

TAPAZOLE for Cats

Veterinarians prescribe TAPAZOLE for overactive thyroids in cats, and treatment success rates are as high as 95 percent in cats.

Your veterinarian may ask you to give your cat TAPAZOLE twice a day for up to a year.

TAPAZOLE for cats comes in pill and liquid forms, and as a paste that you apply to the inside of your cat's outer ear.

Common Side Effects

Tell your doctor if any of the following side effects are severe or don't go away:

• Itching, hives, or a rash
• Darkening of the skin or jaundice (yellowing of the skin, nails, and whites of the eyes)
• Nausea and vomiting
• Altered taste and heartburn
• Headache, drowsiness, or dizziness
• Joint pain, inflamed nerves, and swelling
• Swelling of lymph nodes or salivary glands

Serious Side Effects

The following serious side effects require urgent medical attention:

• Low platelet, white blood cell, or red blood cell count
• Lack of new blood cell production by bone marrow
• Liver damage
• Kidney infection or inflammation
• Poor or slow blood clotting
• Inflammation of the lining of the arteries

Tell your doctor(s) and pharmacist about all prescription, over-the-counter, illegal, recreational, herbal, nutritional, or vitamin-containing drugs and supplements you're taking.

Fortunately, TAPAZOLE doesn't interact with many drugs.

But talk to your doctor or pharmacist about TAPAZOLE if you're taking Coumadin or Jantoven (warfarin).

You may need to get your blood tested, or your warfarin dose adjusted, when you start taking TAPAZOLE.

Also, be careful with TAPAZOLE if you're taking herbal supplements like kava or black cohosh.

TAPAZOLE and Alcohol

Try to avoid or limit drinking alcohol while taking TAPAZOLE.

TAPAZOLE and Grapefruit Juice

Avoid eating grapefruit and drinking grapefruit juice while taking TAPAZOLE.

Grapefruit slows down the body's breakdown of TAPAZOLE, which could result in dangerously high levels of the drug in the bloodstream.

Always take TAPAZOLE with food. Don't take more than your doctor tells you to take.

TAPAZOLE Overdose

If you suspect an overdose of TAPAZOLE, contact an emergency room or poison control center right away.

Missed Dose of TAPAZOLE

If you miss a dose of TAPAZOLE, take it as soon as you remember.

But if it's almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Don't double up on doses to make up for a missed one.

Serious Warnings and Precautions

TAFINLAR should only be prescribed by a doctor who is experienced in the use of anti-cancer drugs.

• Taking TAFINLAR may cause severe fever
• TAFINLAR can harm an unborn baby
• Birth control using hormones (pills, injections, or patches) may not work as well while you are taking TAFINLAR
• TAFINLAR has not been studied in patients with moderate or severe liver problems
• Patients taking TAFINLAR have reported second cancers

TAFINLAR in combination with MEKINIST

In addition to the above events:

• Serious bleeding
• Blood clots

TAFINLAR should only be used to treat melanomas with a change (mutation) in the BRAF gene. Your doctor will take a tumour tissue sample, to test whether TAFINLAR is suitable for you.

TAFINLAR is not recommended for children and adolescents (<18 years of age).

Fever (high temperature >38.5°C):

Taking TAFINLAR may cause fever. Fever may happen more often or may be more severe when TAFINLAR is taken with MEKINIST. Stop taking TAFINLAR and tell your doctor immediately if you get a fever.

In some cases, people with fever may develop chills, low blood pressure, dizziness and kidney problems. If the fever is severe, your doctor may recommend that you stop taking TAFINLAR while they treat the fever with other medicines. Once the fever is controlled, your doctor may recommend that you start taking TAFINLAR again.

Bleeding Problems:

TAFINLAR, when taken with MEKINIST, can cause serious bleeding problems, including in your brain, stomach, or bowel, and can lead to death. Call your doctor and get medical help right away if you have any unusual signs of bleeding including:

• headaches, dizziness, or feeling weak
• coughing up blood or blood clots
• vomiting blood or your vomit looks like “coffee grounds”
• red or black stools that look like tar

Blood Clots:

TAFINLAR, when taken with MEKINIST, can cause blood clots in your arms and legs, which can travel to your lungs and can lead to death. Get medical help right away if you have any of the following symptoms:

• chest pain
• sudden shortness of breath or trouble breathing
• pain in your legs with or without swelling
• swelling in your arms or legs, especially one larger than the other
• a cool or pale arm or leg

Changes in your skin:

If you notice any skin lesions while taking this medicine, talk to your doctor as soon as possible.

Up to 1 in 10 people taking TAFINLAR may develop a different type of skin cancer called cutaneous squamous cell carcinoma. Usually, this remains local and can be removed with surgery and people can continue treatment.

Some people taking TAFINLAR also may notice that new melanomas have appeared. These are usually removed by surgery and people can continue treatment.

Your doctor will check your skin for any new cancers before you start taking TAFINLAR, and every 2 months while you take TAFINLAR. Your doctor will check your skin again every 2 or 3 months for 6 months after you stop taking TAFINLAR.

Check your skin regularly while taking TAFINLAR for any of the following:

• new wart
• skin sore or reddish bump that bleeds or does not heal
• change in size or colour of a mole

Tell your doctor as soon as possible if you get any of these symptoms—either for the first time or if they get worse.

Eye Problems:

TAFINLAR can cause an eye problem called uveitis which could damage your vision if it is not treated. Uveitis may develop rapidly; symptoms include:

• eye redness and irritation
• blurred vision
• eye pain
• increased sensitivity to light
• floating spots in front of your eyes

Contact your doctor immediately if you get these symptoms. It is very important to tell your doctor immediately if you develop these symptoms, especially if you have a painful, red eye that does not clear up quickly. They may arrange for you to see a specialist eye doctor for a complete eye examination.

Liver Problems:

TAFINLAR, when taken with MEKINIST, can cause problems with your liver which may develop into serious conditions such as hepatitis and liver failure, which may be fatal. Your doctor will monitor you periodically. Signs that your liver may not be working properly may include:

• Loss of appetite
• Feeling sick (nausea)
• Being sick (vomiting)
• Pain in your stomach (abdomen)
• Yellowing of your skin or the whites of your eyes (jaundice)
• Dark-coloured urine
• Itching of your skin

Decrease in White Blood Cells (neutropenia):

TAFINLAR, when taken with MEKINIST, can cause a decrease in a certain kind of white blood cells that may lead to infection which can be life-threatening, or to unexpected bruising or bleeding. Your doctor will monitor you periodically. Signs that certain white cell counts are low may include:

• Symptoms of infection (fever, chills, sore throat)
• Bruise or bleed easily
• Cold

Non-Skin Cancers:

Have been reported in patients receiving TAFINLAR. Your doctor will monitor you periodically.

Heart Problems:

TAFINLAR has an effect on the electrical activity of the heart known as QT prolongation.

Diabetes:

TAFINLAR may cause an elevation in blood sugars or worsening of diabetes. If you are diabetic your blood sugar may be monitored more frequently while on TAFINLAR.

Driving and Using Machines:

TAFINLAR can have side effects that may affect your ability to drive or use machines.

Avoid driving or using machines if you have problems with your vision or if you feel tired or weak, or if your energy levels are low.

Discuss with your doctor, pharmacist or nurse if you are unsure about anything. Even your disease, symptoms and treatment situation may affect your ability to drive or use machines.

BEFORE you use TAFINLAR either by itself or with MEKINIST talk to your doctor if you:

• are pregnant, think you may be pregnant or are planning to become pregnant. You must use reliable non-hormonal birth control while receiving TAFINLAR and for 4 weeks after you stop the treatment. Pills, patches and injections are not effective in preventing pregnancies because they may not work as well while you are taking TAFINLAR; therefore you should use an alternative method. You must make sure that you do not get pregnant while receiving TAFINLAR, but if you do, inform your doctor immediately. TAFINLAR can harm an unborn baby.
• are breastfeeding. Do not breastfeed if you are taking TAFINLAR. If you wish to restart breastfeeding after TAFINLAR treatment, you must discuss this with your doctor, who will tell you when it is safe to do so.
• are a male. Men who take TAFINLAR may have a reduced count of sperm that may not return to normal levels after you stop taking TAFINLAR.
• have or have had a heart rhythm disorder such as irregular heartbeat, prolongation of the QT interval or any risk factors for Torsade de Pointes (dangerous rapid fluttering of the heart) such as diabetes, low potassium, magnesium or calcium levels, or a history of low heart rate, fainting, or loss of consciousness.
• have heart valve problems.
• have elevated blood sugar levels (diabetes).
• have any liver problems. Your doctor may take blood samples to monitor your liver function while you are taking TAFINLAR.
• have or have ever had any kidney problems.
• plan to have surgery, dental or other medical procedures.
• have any other medical conditions.

BEFORE you use TAFINLAR with MEKINIST also talk to your doctor if you have:

• had bleeding problems or blood clots.
• heart problems such as heart failure or problems with the way your heart beats.
• eye problems including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the eye which may be caused by fluid leakage.
• any skin problems including rash or acne-like rash.
• high blood pressure (hypertension).
• a low number of white blood cells (neutropenia).
• any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue (pneumonitis).

Side effects that can occur when you take TAFINLAR are:

Very common side effects—these may affect more than 1 in 10 people:

• Thickening of the outer layers of the skin
• Skin effects such as rash, dryness, wart-like growths, or redness and swelling of the palms, fingers and soles of the feet
• Headache
• Nausea, vomiting, or diarrhoea
• Decreased appetite
• Chills
• Feeling weak
• Lack of energy
• Fever
• Joint pain, muscle pain, or pain in the hands or feet
• Cough
• Unusual hair loss or thinning
• Itching
• Constipation
• Nasal inflammation

Common side effects—affects less than 1 in 10 but more than 1 in 100 people:

• Flu-like illness
• Skin effects including rough scaly patches of skin, brown or yellowish thickening of the skin, skin tags or redness of the skin
• Inflammation of the fatty layer underneath the skin (panniculitis)

Common side effects that may show up in your blood tests:

• Low phosphorus
• Increase in sugar (glucose)

Uncommon side effects— affects less than 1 in 100 but more than 1 in 1000 people:

• Inflammation of the eye (uveitis)
• Inflammation of the kidney (nephritis)
• Kidney disorder that may result in decreased urine output (kidney failure)

Refer to the MEKINIST Consumer Information leaflet for possible side effects when TAFINLAR is taken with MEKINIST including heart problems, eye problems and rash.

In addition to the above, other side effects that can occur when you take TAFINLAR with MEKINIST are:

Very common side effects—these may affect more than 1 in 10 people:

• Swelling of the hands or feet
• Stomach ache
• High blood pressure
• Urinary tract infections
• Acne-like problem
• Dizziness
• Bleeding (haemorrhage)

Very common side effects that may show up in your blood tests:

• Abnormal blood test results related to the liver
• Low levels of a type of white blood cells (neutropenia)

Common side effects—affects less than 1 in 10 but more than 1 in 100 people:

• Night sweats
• Shortness of breath
• Muscle spasms
• Heart pumping less efficiently
• Low blood pressure (hypotension)
• Slow heart rate
• Eyesight problems
• Dry mouth
• Sore mouth or mouth ulcers
• Inflammation of the mucous membranes
• Swelling of the face, localized tissue swelling
• Low levels of water or fluid (dehydration)
• Infection of the skin (cellulitis)
• Papilloma (a type of skin cancer)
• Inflammation of the follicles in the skin
• Nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
• Skin rash with pus-filled blisters
• Excessive sweating (hyperhidrosis)
• Skin cracking

Common side effects that may show up in your blood tests:

• Low levels of red blood cells (anaemia) and a type of white blood cells (leukopenia)
• Increase in creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle
• Increase in some substances (enzymes) produced by the liver
• Decrease in the number of blood platelets (cells that help blood clot)
• Low sodium

Uncommon side effects—affects less than 1 in 100 but more than 1 in 1000 people:

• Lung inflammation (pneumonitis)
• Swelling around the eyes
• Swelling in the eye caused by fluid leakage (chorioretinopathy)
• Separation or tear of the lining of the back part of the eye (retinal detachment or tear)

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Tell your doctor if you have any side effect that bothers you or that does not go away.

Tell your doctor, nurse or pharmacist about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not start, stop or change any medicine without talking to your doctor, nurse or pharmacist first.

Some medicines may affect how TAFINLAR works, or make it more likely that you will have side effects. TAFINLAR can also affect how some other medicines work. These include:

• birth control using hormones such as pills, injections, or patches
• warfarin, to thin the blood
• medicines to treat fungal infections, such as ketoconazole
• some antibiotic medicines, such as clarithromycin or rifampin
• dexamethasone
• some medicines to treat HIV, such as ritonavir
• medicines to treat seizures, such as phenytoin, phenobarbital, or carbamazepine
• the anti-depressant medicine nefazodone
• the lipid lowering medicine gemfibrozil
• medicines that reduce stomach acid (e.g. esomeprazole, ranitidine, magnesium hydroxide)
• the herbal product, St John’s wort
• medicines known to cause heart rhythm changes

Tell your doctor if you are taking any of these. Your doctor may decide to adjust your dose. Keep a list of the medicines you take, so you can show it to your doctor when you get a new medicine.

It is important to take TAFINLAR on an empty stomach, because food may affect the way TAFINLAR is absorbed into your body and how effective it works.

The usual dose of TAFINLAR is two 75 mg capsules (150 mg), twice a day. (a total of four capsules equalling 300 mg).

Taking TAFINLAR with MEKINIST:

The usual dose is two 75 mg capsules of TAFINLAR (150 mg) twice a day with 2 mg of MEKINIST once a day.

How to take TAFINLAR either by itself or with MEKINIST:

Take TAFINLAR on an empty stomach at least one hour before or at least two hours after food.

Swallow the TAFINLAR capsules whole with a full glass of water, one after the other.

Take TAFINLAR at about the same time two times each day.

If you take TAFINLAR with MEKINIST, take MEKINIST with either the morning or the evening dose of TAFINLAR. Take MEKINIST at about the same time each day.

Your doctor may decide that you should take a lower dose if you get side effects.

Take TAFINLAR for as long as your doctor recommends.

Do not take the morning and evening doses of TAFINLAR at the same time, and do not take more than one dose of MEKINIST a day.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you take too much TAFINLAR or MEKINIST, call your doctor or poison control centre, or go to the nearest hospital emergency room right away. Take TAFINLARcapsules and MEKINIST tablets with you when possible.

Missed dose:

If the missed dose is less than 6 hours late, take it as soon as you remember. If the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time. Then continue to take your capsules at regular times as usual. Do not take a double dose to make up for a missed dose.