Jamp-Tacrolimus (Jamp Pharma, 0.5 mg): Uses, Side Effects and Dosage

What the medication is used for:

Jamp-Tacrolimus is the brand name for tacrolimus immediate-release capsules (twice daily). You may have also heard it called FK506. Jamp-Tacrolimus is an immunosuppressant that is used concomitantly with adrenal corticosteroids to prevent or treat rejection of your transplanted organ.

What it does:

Your body’s immune system is your defence system. Immunity is the way your body protects itself from infections and other foreign material. When you receive a transplant, your immune system recognizes the transplanted organ as foreign and will try to reject it. Tacrolimus is an anti-rejection drug that helps your body accept your transplanted organ(s).

When it should not be used:

Jamp-Tacrolimus should not be used if you are hypersensitive (allergic) to tacrolimus or to any of the ingredients in the formulation, including castor oil [intravenous formulation only] (see “What the nonmedicinal ingredients are”).

What the medicinal ingredient is:

• Tacrolimus

What the nonmedicinal ingredients are:

Jamp-Tacrolimus (immediate release capsules) contains croscarmellose sodium, hypromellose 6 cps, lactose anhydrous and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains shellac, propylene glycol, strong ammonia, iron oxide black and potassium hydroxide.

What dosage forms it comes in:

Jamp-Tacrolimus is available in 0.5 milligram immediate release capsules. Light yellow/ Light yellow hard gelatin capsules, size “4” imprinted with ‘TCR’ on cap & ‘CAN 0.5’ on body containing white to off white granular powder.

BEFORE you use Jamp-Tacrolimus be sure you have told your doctor the following:

• If you have taken Jamp-Tacrolimus, FK506 or tacrolimus before and had a bad, unusual or allergic reaction. • About all other medicines or treatments you use, including any products you buy off the shelf such as over-the-counter drugs and herbal or home remedies. • If you have the heart problem: congenital or acquired QT prolongation.
• About all other health conditions you have now, or have had in the past.

• If you are pregnant, plan to become pregnant, or are breastfeeding a baby. Jamp-Tacrolimus may cause fetal abnormalities and malformations. Pregnancy should be avoided while taking Jamp-Tacrolimus because its effect on pregnancy or on an unborn baby is not known. You must use a reliable method of birth control before, during your treatment and for 6 weeks after stopping your treatment with Jamp-Tacrolimus. Breast-feeding is not recommended while taking Jamp-Tacrolimus. It is important to notify your doctor right away if you become pregnant or father a child while taking Jamp-Tacrolimus. It is recommended that you do not take Jamp-Tacrolimus if you are, or become, pregnant. However, never stop taking Jamp-Tacrolimus without first consulting your doctor.

• It is not known what effect Jamp-Tacrolimus has on the effectiveness of vaccinations and on the risk of getting an illness from vaccination with a live vaccine. Do discuss this with your doctor before you get any vaccinations or immunizations.

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

• If you have a rare hereditary disease of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption, because the capsules contain lactose

• Jamp-Tacrolimus may cause new onset diabetes in

  kidney transplant patients. Your doctor may order tests to monitor your blood glucose levels.

Precautions

• Jamp-Tacrolimus is often given with other

  medications. Make sure you know if you are to stop, or continue, other immunosuppressive drugs you had been taking.

• Be sure that you are taking the correct dose and correct

  formulation of Jamp-Tacrolimus (immediate release capsules) prescribed by your doctor.

• Be sure to keep all appointments at your transplant

  clinic. This is very important to help ensure that you receive the maximum benefit from your medications • As with other immunosuppressive agents, owing to the

  potential risk of malignant skin changes, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using sunscreen with a high protection factor

• Tell all health professionals you see that you are

  taking Jamp-Tacrolimus. It is also a good idea to wear a Medic-Alert bracelet

Tell your doctor, dentist, nurse, and pharmacist about all the drugs that you are taking. Jamp-Tacrolimus blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Jamp-Tacrolimus, which may require an increase or decrease in Jamp-Tacrolimus dose. In particular, you should tell your doctor if you are taking or have recently taken medicines such as:

• Antacids: magnesium aluminum hydrochloride • Antiarythmic: amiodarone

• Antifungals: clotrimazole, fluconazole, ketoconazole,

  itraconazole, voriconazole

• Calcium channel blockers: diltiazem, nicardipine,

  nifedipine, verapamil

• Gastrointestinal prokinetic agents: cisapride^*,

  metoclopramide

• Macrolide antibiotics: erythromycin, clarithromycin,

  troleandomycin

• Proton pump inhibitors: lansoprazole, omeprazole • Other drugs: bromocriptine, cimetidine,

  chloramphenicol, cyclosporine, danazol, ethinyl estradiol, methylprednisolone, nefazodone • Protease inhibitors: boceprevir, nelfinavir, ritonavir,

  saquinavir, telaprevir

• Anticonvulsants: carbamazepine, phenobarbital,

  phenytoin

• Anti-infectives: rifampin, rifabutin, capsofungin • Calcineurin inhibitor: sirolimus

• Potassium sparing diuretics

  *no longer marketed in Canada

  Do not take any other drugs without asking your doctor first. This includes anything you can buy off the shelf such as over-the-counter drugs and herbal, especially St. John’s Wort (Hypericum perforatum), Schisandra sphenanthera extracts, or home remedies.

  A high intake of potassium should be avoided during Jamp-Tacrolimus treatment.

  Jamp-Tacrolimus should not be taken with grapefruit or grapefruit juice.

Usual dose:

Your doctor will give you specific instructions about how much Jamp-Tacrolimus you should take each day. Your doctor has decided the dose you should take based on your medical condition and response to the drug. It is very important to take the exact amount of Jamp-Tacrolimus that your doctor has told you.

Once your doctor has told you when and how many times a day to take Jamp-Tacrolimus:

• Try to take your doses at the same time every day.

  This will help keep the same amount of Tacrolimus in your body so it can continue to protect your transplanted organ

• Space your doses of Jamp-Tacrolimus as evenly as you can throughout the day. For example, if you take Jamp-Tacrolimus twice a day, doses should be 12 hours apart. Ask your transplant nurse or pharmacist about a dosing schedule that best fits your lifestyle • Jamp-Tacrolimus may be taken with or without food.

  But it is best to be consistent. Once you decide when you are going to take it in relation to food, do it the same way each time

• Swallow the capsules whole. Do not cut, crush, or chew the Jamp-Tacrolimus
• Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine. If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine

Blood tests are one of the ways your doctor decides how much Jamp-Tacrolimus you need. Based on these tests and your response to Jamp-Tacrolimus, your doctor may change your dose from time to time. Do not change your dose on your own.

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

Overdose:

Missed Dose:

Missing even a few doses of Jamp-Tacrolimus may cause your body to reject your transplanted organ. That is why it is very important to take each dose as your doctor prescribed. If you have trouble remembering doses, or if you are uncertain about how to take them, talk to your doctor, nurse or pharmacist and be sure to discuss any concerns you have about taking Jamp-Tacrolimus as prescribed.

If you do miss a dose of Jamp-Tacrolimus do not try to catch up on your own (do not take twice your dose); instead call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses.

Never allow your medication to run out between refills and be sure to take enough medication with you when you will be away from home for any extended period of time.

Like other medicines, Jamp-Tacrolimus may cause side effects in some people. If you think that you are having side effects, talk to your doctor right away. DO NOT stop taking Jamp-Tacrolimus on your own.

• Because Jamp-Tacrolimus decreases the function of

  your immune system you may be more likely to get an infection. Tell your doctor right away about any cold or flu-like symptoms (such as fever or sore throat), any mouth sores or burning discomfort with urination • Be sure to tell your doctor right away if you notice any

  of these symptoms, and especially if they continue, bother you in any way, or seem to increase in intensity ➢ diarrhea, nausea, constipation, vomiting, loss of

  appetite, stomach pain

  • headache, tremors, convulsions, tiredness or

    fatigue, difficulty sleeping, nightmares ➢ urinary tract infection, weakness

  • decreased or increased urine volumes, kidney or

    liver problems

  • diabetes/increased blood sugar, swelling or

    tingling in your hands and feet

  • palpitations, abnormal heart rhythms, chest pain,

    high blood pressure

  • fever, back pain, changes in mood or emotions,

    difficulty in breathing

  • progressive weakness on one side of the body,

    clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes, which could be symptoms of a rare brain infection called progressive multifocal

    leukoencephalopathy (PML)

    • headache, seizures, visual disturbances or altered mental state, which could be symptoms of posterior encephalopathy syndrome (PRES)

    • Immunosuppressive drugs including t acrolimus may also increase your chances of developing certain types of cancer. The following are possible warning signs of cancer and should be reported to your doctor as soon as possible:

      • any sore that does not heal
      • unusual bleeding or discharge
      • the appearance of a lump or thickened areas in your breast or anywhere else on your body ➢ unexplained stomach upset or any trouble with swallowing
      • any noticeable change in a wart or a mole ➢ a nagging cough or hoarseness
      • night sweats
      • persistent and severe headaches
      • swollen lymph nodes
      • a change in your bowel or bladder habits • Cases of pure red cell aplasia (PRCA- bone marrow stops producing red blood cells) have occurred in patients taking tacrolimus. Contact your doctor immediately if you suffer symptoms such as fatigue, malaise, weakness, dizziness, fainting, shortness of breath, rapid heartbeat, pallor (paleness of skin), pale stool.
    • Cases of gastrointestinal perforation (hole in the stomach or intestine) have occurred in patients taking tacrolimus. If you suffer symptoms such as severe abdominal pain, burning pain, nausea, vomiting and later possibly chills or fever, get medical attention immediately.

Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate or extended release tacrolimus oral formulations, have been observed. This has led to serious adverse events, including graft rejection, or other side effects which could be a consequence of either under- or over- exposure to tacrolimus. You should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist.

It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking Jamp-Tacrolimus.

If you think you have taken too much Jamp-Tacrolimus, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

*Unable to determine frequency since this is a post- marketing event

This is not a complete list of side effects. For any unexpected effects while taking Jamp-Tacrolimus, contact your doctor or pharmacist.

Keep Jamp-Tacrolimus out of the reach, sight and away from children. A child who accidentally takes Jamp-Tacrolimus may be seriously harmed. All drugs should be kept in a locked drawer or cupboard if there are children who may accidentally take your drugs. Should anyone accidentally or mistakenly take Jamp-Tacrolimus, contact your physician immediately.

Always store Jamp-Tacrolimus at room temperature (15°C to 30°C), protect from moisture in the container or package that was dispensed by your pharmacist until use.

If you have additional questions or would like to talk with someone to explain something you are worried about, ask your doctor, nurse, pharmacist, or other members of the Transplant Team. They are your best resource for guidance and information.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,at:

Jamp Pharma Corporation

1310, rue Nobel

Boucherville, Quebec

J4B 5H3

Last revised: January 03, 2017

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information:

3 ways to report:

• online at MedEffect (http://hc-sc.gc.ca/dhp-

  mps/medeff/index-eng.php);

• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc- sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

HOW TO STORE IT

MORE INFORMATION

PART III: CONSUMER INFORMATION

RHEUMATOID ARTHRITIS

^Pr Jamp-Tacrolimus (Immediate release capsules)

This leaflet is part III of a three-part "Product Monograph" published when Jamp-Tacrolimuswas approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Jamp-Tacrolimus. Contact your doctor or pharmacist if you have any questions about the drug.

What the nonmedicinal ingredients are:

Jamp-Tacrolimus (immediate release capsules) contains croscarmellose sodium, hypromellose 6 cps, lactose anhydrous and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains shellac, propylene glycol, strong ammonia, iron oxide black and potassium hydroxide.

What dosage forms it comes in:

Jamp-Tacrolimusis available in 0.5 milligram immediate release capsules. Light yellow/ Light yellow hard gelatin capsules, size “4” imprinted with ‘TCR’ on cap & ‘CAN 0.5’ on body containing white to off white granular powder.

IT IS VERY IMPORTANT that you read the following information carefully. Your doctor, nurse, and pharmacist have explained Jamp-Tacrolimusto you, and this information will answer some of the questions you may have about your new medication. The success of treatment with this drug depends on how carefully you follow your doctor’s instructions. As you review this information, write down any questions that you may have. Then, talk with your doctor, nurse or pharmacist. This information should not replace your doctor’s or pharmacist’s advice.

What the medication is used for:

Jamp-Tacrolimusis the brand name for tacrolimus immediate-release capsules (twice daily). You may have also heard it called FK506. Jamp-Tacrolimusis an immunosuppressant that is used alone or in combination with other drugs to reduce the symptoms experienced by patients with rheumatoid arthritis.

What it does:

Rheumatoid arthritis is an autoimmune disorder of unknown cause in which the bone joint lining (synovium) is attacked by the immune system. The mechanism of action of tacrolimus in rheumatoid arthritis is not known. Approximately 8 weeks of treatment with Jamp-Tacrolimus may be required before any significant improvement is noted in your symptoms of rheumatoid arthritis.

When it should not be used:

Jamp-Tacrolimus should not be used if you are hypersensitive (allergic) to tacrolimus or to any of the ingredients in the formulation (see “What the nonmedicinal ingredients are”).

What the medicinal ingredient is:

• Tacrolimus

  have told your doctor the following:

  • If you have taken Jamp-Tacrolimus, FK506 or tacrolimus before and had a bad, unusual or allergic reaction
  • About all other medicines or treatments you use, including any products you buy off the shelf such as over-the-counter drugs and herbal or home remedies • If you have the heart problem: congenital or acquired QT prolongation
  • About all other health conditions you have now, or have had in the past
  • If you are pregnant, plan to become pregnant, or are breastfeeding a baby. Jamp-Tacrolimus may cause fetal abnormalities and malformations. Pregnancy should be avoided while taking Jamp-Tacrolimusbecause its effect on pregnancy or on an unborn baby is not known. You must use a reliable method of birth control before, during your treatment and for 6 weeks after stopping your treatment with Jamp-Tacrolimus. Breast-feeding is not recommended while taking Jamp-Tacrolimus. It is important to notify your doctor right away if you become pregnant or father a child while taking Jamp-Tacrolimus. It is recommended that you do not take Jamp-Tacrolimus if you are, or become, pregnant. However, never stop taking Jamp-Tacrolimus without first consulting your doctor
  • It is not known what effect Jamp-Tacrolimus has on the effectiveness of vaccinations and on the risk of getting an illness from vaccination with a live vaccine. Do discuss this with your doctor before you get any vaccinations or immunizations
  • If you have a rare hereditary disease of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption, because the capsules contain lactose

ABOUT THE MEDICATION Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

BEFORE you use Jamp-Tacrolimusbe sure you WARNINGS AND PRECAUTIONS

Precautions

• Jamp-Tacrolimusis often given with other medications. Make sure you know if you are to stop, or continue, other drugs you had been taking
• As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using sunscreen with a high protection factor
• Be sure that you are taking the correct dose of Jamp-Tacrolimus prescribed by your doctor
• Tell all health professionals you see that you are taking Jamp-Tacrolimus. It is also a good idea to wear a Medic-Alert bracelet

Usual dose:

Your doctor will decide the dosage. The usual adult dosage is 3 mg taken once daily.

Make sure that you receive the same tacrolimus medicine every time you collect your prescription. If the appearance of this medicine is not the same as usual, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.

Jamp-Tacrolimusmay be taken with or without food. But it is best to be consistent. Once you decide when you are going to take it in relation to food, do it the same way each time.

Swallow the capsules whole. Do not cut, crush, or chew the Jamp-Tacrolimus.

Try to take your doses at the same time every day.

Tell your doctor, dentist, nurse, and pharmacist about all the drugs that you are taking. Jamp-Tacrolimus blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Jamp-Tacrolimus, which may require an increase or decrease in Jamp-Tacrolimusdose. In particular, you should tell your doctor if you are taking or have recently taken medicines such as:

• Antacids: magnesium aluminum hydrochloride • Antiarythmic: amiodarone

• Antifungals: clotrimazole, fluconazole,

  ketoconazole, itraconazole, voriconazole • Calcium channel blockers: diltiazem, nicardipine,

  nifedipine, verapamil

• Gastrointestinal prokinetic agents: cisapride*,

  metoclopramide

• Macrolide antibiotics: erythromycin,

  clarithromycin, troleandomycin

• Proton pump inhibitors: lansoprazole, omeprazole • Other drugs: bromocriptine, cimetidine,

  chloramphenicol, cyclosporine, danazol, ethinyl estradiol, methylprednisolone, nefazodone • Protease inhibitors: boceprevir, nelfinavir,

  ritonavir, saquinavir, telaprevir

• Anticonvulsants: carbamazepine, phenobarbital,

  phenytoin

• Anti-infectives: rifampin, rifabutin, capsofungin • Calcineurin inhibitor: sirolimus

*no longer marketed in Canada

Do not take any other drugs without asking your doctor first. This includes anything you can buy off the shelf such as over-the-counter drugs and herbal, especially St. John’s Wort (Hypericum perforatum), Schisandra sphenanthera extracts, or home remedies.

Jamp-Tacrolimusshould not be taken with grapefruit or grapefruit juice.

Missed Dose:

If you do miss a dose of Jamp-Tacrolimus, skip this dose and take the next one at the regular scheduled time; do not take twice your dose. Call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses.

Do not allow your medication to run out between refills and be sure to take enough medication with you when you will be away from home for any extended period of time.

Like other medicines, Jamp-Tacrolimus may causes side effects in some people. If you think that you are having side effects, talk to your doctor right away.

• Because Jamp-Tacrolimusdecreases the function of your immune system you may be more likely to get an infection. Tell your doctor right away about any cold or flu-like symptoms (such as fever or sore throat), any mouth sores or burning discomfort with urination

• Be sure to tell your doctor right away if you notice any of these symptoms, and especially if they continue, bother you in any way, or seem to increase in intensity:

  • diarrhea, nausea, vomiting, stomach pain ➢ headache, tremors, convulsions, difficulty sleeping
  • pain and /or burning during urination which may be signs of a urinary tract infection ➢ decreased or increased urine volumes, dark coloured urine which may be a sign of SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Overdose:

If you think you have taken too much Jamp-Tacrolimus, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

PROPER USE OF THIS MEDICATION

INTERACTIONS WITH THIS MEDICATION Jamp-Tacrolimus-Product Monograph Page 68 of 69

kidney problems or yellowing of the skin or eyes or back pain which may be a sign of liver problems

• diabetes/increased blood sugar, swelling or

  tingling in your hands and feet

• palpitations, abnormal heart rhythms, chest

  pain, high blood pressure, fever

• progressive weakness on one side of the body,

  clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes, which could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML)

• headache, seizures, visual disturbances or

  altered mental state, which could be symptoms of posterior encephalopathy syndrome (PRES) • Immunosuppressive drugs including tacrolimus may

also increase your chances of developing certain types of cancer. The following are possible warning signs of cancer and should be reported to your doctor as soon as possible:

• any sore that does not heal
• unusual bleeding or discharge

• the appearance of a lump or thickened areas

  in your breast or anywhere else on your body

• unexplained stomach upset or any trouble

  with swallowing

• any noticeable change in a wart or a mole ➢ a nagging cough or hoarseness
• night sweats
• persistent and severe headaches
• swollen lymph nodes
• a change in your bowel or bladder habits

• Cases of pure red cell aplasia (PRCA- bone marrow

  stops producing red blood cells) have occurred in patients taking tacrolimus. Contact your doctor immediately if you suffer symptoms such as fatigue, malaise, weakness, dizziness, fainting, shortness of breath, rapid heartbeat, pallor (paleness of skin), pale stool

It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking Jamp-Tacrolimus.

*Unable to determine frequency since this is a post- marketing event

This is not a complete list of side effects. For any unexpected effects while taking Jamp-Tacrolimus, contact your doctor or pharmacist.

Keep Jamp-Tacrolimus out of the reach, sight and away from children. A child who accidentally takes Jamp-Tacrolimus may be seriously harmed. All drugs should be kept in a locked drawer or cupboard if there are children who may accidentally take your drugs. Should anyone accidentally or mistakenly take Jamp-Tacrolimus, contact your physician immediately.

Always store Jamp-Tacrolimus at room temperature (15°C to 30°C), protect from moisture in the container or package that was dispensed by your pharmacist until use. HOW TO STORE IT

Jamp-Tacrolimus-Product Monograph Page 69 of 69 If you have additional questions or would like to talk with someone to explain something you are worried about, ask your doctor, nurse, pharmacist. They are your best resource for guidance and information.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, at:

Jamp Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3

Last revised: January 03, 2017

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information:

3 ways to report:

• online at MedEffect (http://hc-sc.gc.ca/dhp-

  mps/medeff/index-eng.php);

• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc- sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION