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Details for: JAMP-MYCOPHENOLATE

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02380382JAMP-MYCOPHENOLATEMYCOPHENOLATE MOFETIL500 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
  • Jamp-MYCOPHENOLATE is used after kidney, heart and liver transplantation to help prevent organ rejection.
  • Jamp-MYCOPHENOLATE belongs to a family of drugs known as “ immunosuppressants”. These drugs work to "suppress" or reduce the body's immune response.
  • Jamp-MYCOPHENOLATE must be given with other drugs such as cyclosporine (Sandimmune® or Neoral®) and corticosteroids (e.g., prednisone, prednisolone, methylprednisolone, prednisolone acetate, methylprednisolone acetate) which also suppress your immune system. Together these drugs help prevent the rejection of your transplanted organ
What it does

Your body's immune system works to protect you from infections and other foreign material. When you receive a transplant, your immune system recognizes the new organ as foreign, and will try to reject it. JampMYCOPHENOLATE works to reduce this reaction, so that your body is more likely to accept the transplanted organ.

When it should not be used

When it should not be used:

  • Jamp-MYCOPHENOLATE should not be used in patients allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or to any component of the drug product (see section titled “What the nonmedicinal ingredients are”).
  • Jamp-MYCOPHENOLATE should not be used if you are pregnant or breastfeeding.
  • Jamp-MYCOPHENOLATE should not be used if you can become pregnant and are not using highly effective birth control.
  • Jamp-MYCOPHENOLATE should not be used unless you have a pregnancy test result showing that you are not pregnant.
What the medicinal ingredient is

mycophenolate mofetil

What the non-medicinal ingredients are

Jamp-MYCOPHENOLATE film-coated tablets contain the following nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, FD&C blue #2 aluminum lake, iron oxide black, iron oxide red, magnesium stearate, purified talc, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

What dosage form it comes in

Jamp-MYCOPHENOLATE is available as a purple colored, capsule shaped, biconvex, film-coated tablets debossed ‘AHI’ on one side and ‘500’ on other side. Ten tablets are contained in each blister pack.

Warnings and precautions

Serious Warnings and Precautions

  • If you use mycophenolate mofetil in combination with other medicines used to prevent organ rejection when you are pregnant; you are likely to have early pregnancy loss and infant birth defects (see Special Note for Female Patients).
  • Because Jamp-MYCOPHENOLATE suppresses your immune system, you are more likely to get infections and have a greater chance of developing cancer. The chances of developing either are similar to the chances seen in patients taking other immunosuppressants.

Special Note For Female Patients

  • Women must not take JampMYCOPHENOLATE while they are pregnant as Jamp- MYCOPHENOLATE may cause an increased risk of first trimester pregnancy loss or damage to the unborn baby (affecting development of ears, limbs, face, heart, brain for example). For this reason it is recommended that you discuss with your doctor if you are pregnant or become pregnant or plan on becoming pregnant while taking JampMYCOPHENOLATE. You will want t o discuss the possible benefits and risks of continuing with this drug.
  • If you think you may be pregnant tell your doctor straight away. However, keep taking Jamp- MYCOPHENOLATE until you see him or her. Your doctor will talk to you about other medicines you can take to prevent rejection of your transplant organ
  • Women (who have the potential of becoming pregnant) should have two negative serum (blood) or urine pregnancy tests . The second test should be performed 8-10 later. You can only start JampMYCOPHENOLATE if the tests are negative Repeat pregnancy tests should be performed during routine follow- up visits.
  • You must always use two reliable methods of birth control:
    • Before you start taking JampMYCOPHENOLATE,
    • During your entire treatment with JampMYCOPHENOLATE and
    • For 6 weeks after stopping your treatment with Jamp- MYCOPHENOLATE.

    Talk to your doctor about the most suitable methods of contraception for you. This will depend on your individual situation.

  • If you take oral contraceptives (birth control pills) while using Jamp- MYCOPHENOLATE you must also use another form of birth control method as Jamp- MYCOPHENOLATE may adversely affect the efficacy of an oral contraceptive.
  • Do not breastfeed your baby if you are taking Jamp- MYCOPHENOLATE as it may pass into breast milk and may harm your baby.
  • Be sure to keep all appointments at your transplant clinic. During these visits, pregnancy tests may be administered by your doctor.

Special Note For Male Patients

  • Sexually active male patients and/or their female partners are recommended to use effective birth control while taking Jamp- MYCOPHENOLATE and for at least 90 days after stopping treatment. If pregnancy occurs, talk to your doctor. (See Special Note For Female Patients, above.)
  • Men should not donate semen during therapy and for 90 days after taking of Jamp- MYCOPHENOLATE.

All Patients

  • Tell all health professionals you see (doctor, dentist, nurses, pharmacists) that you are taking JampMYCOPHENOLATE.
  • Be sure to keep all appointments at your transplant clinic. During these visits, complete blood counts will need to be measured weekly in the first month, twice monthly for the second and third months of treatment, and then monthly for the remainder of the first year. Your doctor may sometimes order additional blood tests.
  • Patients should not donate blood during therapy and for at least 6 weeks after taking JampMYCOPHENOLATE.
  • Jamp- MYCOPHENOLATE reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
    • wearing protective clothing which also covers your head, neck, arms and legs. o using a sunscreen with a high sun protection factor (SPF).
  • Patients should use caution when driving or using machines.

BEFORE you use Jamp-MYCOPHENOLATE talk to your doctor or pharmacist:

  • If you have had a bad, unusual or allergic reaction to Jamp-MYCOPHENOLATE, mycophenolic acid, or mycophenolate sodium;
  • If you are pregnant, plan to become pregnant, or are breastfeeding a baby; or plan to breastfeed.
  • About all other health conditions you have now, or have had in the past, especially problems with your stomach or bowel movements;
  • About all other medicines or treatments you have used or are using, including any products you buy at a pharmacy, supermarket or health food store;
Interactions with this medication
  • Tell your doctor if you are taking medicines containing telmisartan, rifampicin or azathioprine.
  • Do not take any other drugs without asking your doctor or pharmacist first.
  • Taking antacids at the same time as JampMYCOPHENOLATE may affect the way JampMYCOPHENOLATE works for you and therefore should not be taken simultaneously.
  • Taking proton pump inhibitors, such as lansoprazole and pantoprazole, at the same time as Jamp- MYCOPHENOLATE may affect the way Jamp- MYCOPHENOLATE works for you.
  • Taking Renagel® (sevelamer), or other calcium free phosphate binders at the same time as JampMYCOPHENOLATE mg may affect the way Jamp- MYCOPHENOLATE works for you and therefore should not be taken at the same time.
  • Taking combinations of antibiotics at the same time as Jamp-MYCOPHENOLATE may affect the way Jamp-MYCOPHENOLATE works for you. Do not take any other drugs without asking your doctor or pharmacist first.
  • During treatment with Jamp-MYCOPHENOLATE, vaccinations may be less effective and live vaccines should not be given. Do discuss this with your doctor before you get any vaccinations or immunizations.
  • Do not take cholestyramine, which is used to treat high blood cholesterol
Proper use of this medication
  • Your doctor has decided the dose you should take based on your medical condition and response to the drug
  • The initial dose of Jamp-MYCOPHENOLATE should be taken as soon as possible following transplantation. If you are not sure of your dose, or when to take it, ask your doctor, pharmacist or nurse.
  • Space your two doses of JampMYCOPHENOLATE as evenly as you can throughout the day leaving about 12 hours between each dose.
  • 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 the drug as prescribed.
  • Jamp-MYCOPHENOLATE must be taken with other immunosuppressive medicines (such as cyclosporine and corticosteroids). Discuss with your doctor if you are to stop, or to continue, the other immunosuppressant drugs you had been taking.
  • Try to take your doses at the same times each day. Taking your medicine at the same time each day will also help you remember each dose.
  • Vomiting or diarrhea may prevent JampMYCOPHENOLATE from being taken up into your body. Always call your doctor if you have either of these episodes.
  • Do not change the dose on your own, no matter how you are feeling. Call your doctor.
  • Do not stop taking Jamp-MYCOPHENOLATE on your own even if you have been taking it for several years.

Tablets:
It is important to leave the tablets in the blister pack until you need a dose. When you are ready to take a dose, remove the number of tablets you need to make up the dose your doctor prescribed. Swallow the tablets whole with plenty of water; do not crush them. Avoid contact with any powder, including accidental inhalation, from damaged tablets. Wash any powder from your skin with soap and water; rinse eyes with plain water.

Usual Dose

Jamp-MYCOPHENOLATE should be taken on an empty stomach


Kidney Transplant Patients Adults:
A dose of 1 g taken twice a day (daily dose of 2 g) is recommended after kidney transplantation.

Pediatric Patients:

  • Jamp-MYCOPHENOLATE is not indicated for use in children.

Heart Transplant Patients Adults:
A dose of 1.5 g twice a day (daily dose of 3 g) is recommended after heart transplantation in adults.


Liver Transplant Patients Adults:
A dose of 1.5 g taken twice a day (daily dose of 3g) is recommended after liver transplantation in adults.



Overdose

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



Missed Dose

  • Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time. That way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.
  • If you ever do miss a dose of JampMYCOPHENOLATE, do not catch up on your own; 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. Do not double dose.
Side effects and what to do about them
  • Like all medicines, along with the beneficial effects of treatment, Jamp-MYCOPHENOLATE may cause side effects in people.
  • Because Jamp-MYCOPHENOLATE and the other medicines to be taken suppress your immune system, you are more likely to get infections. To help reduce complications from infections, tell your doctor about any cold or flu-like symptoms (such as fever or sore throat), any boils on your skin, or pain when you urinate (pass your water).
  • The following symptoms are some possible warning signs of cancer. To help detect any cancers as soon as possible, report any of these symptoms to your doctor right away:
    • a change in your bowel or bladder habits;
    • any sore that doesn't 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;
    • an obvious change in a wart or a mole;
    • a nagging cough or hoarseness;
    • night sweats;
    • persistent and severe headaches
  • Patients taking Jamp-MYCOPHENOLATE in combination therapy with cyclosporine and corticosteroids may experience an increase in blood pressure.
  • Serious common and uncommon side-effects which have been reported with Mycophenolate moftale when used in combination with cyclosporine and corticosteroids, are provided in the following table. Tell your doctor right away if you notice any of these symptoms. Do not stop taking this drug on your own.
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Very Common
Abdominal, pain Blood in urine, Constipation, Increased cough, Diarrhea, Fever, Laboured breathing, Headache, Hypertension, Swelling of parts of your body, Vomiting, Weakness   ✔  
Common
Chest, or back pain, Dizziness, Heart Burn, Involuntary trembling, Muscle weakness Nausea, Nosebleed, Sleeplessness, Stomach pain   ✔  
Uncommon
Blood or black tarrystools   ✔  

†Do not stop your medicines unless you have discussed this with your doctor first.

This is not a complete list of side effects. For any unexpected effects you have while taking JampMYCOPHENOLATE contact your doctor or pharmacist.

How to store
  • Keep Jamp-MYCOPHENOLATE out of reach of children. A child who accidentally takes the drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
  • Jamp-MYCOPHENOLATE should be stored at room temperature (15ºC-30ºC). The tablets should be protected from light. Remember to keep each tablet in its original package until you need to take it.
  • Jamp-MYCOPHENOLATE should not be used after the expiry date (EXP) shown on the package.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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

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


If you want more information about JAMPMYCOPHENOLATE:


This leaflet was prepared by:
Jamp Pharma Corporation
1310 rue Nobel, Boucherville, Québec
J4B 5H3


Last Revised: March 20, 2019

Date modified: