Accel-Mycophenolate Mofetil Capsules: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Accel-Mycophenolate Mofetil Capsules 250 mg are used

  after kidney, heart and liver transplantation to help prevent organ rejection.

• Accel-Mycophenolate Mofetil Capsules 250 mg belongs

  to a family of drugs known as "immunosuppressants". These drugs work to "suppress" or reduce the body's immune response.

• Accel-Mycophenolate Mofetil Capsules 250 mg 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. Accel-Mycophenolate Mofetil Capsules 250 mg, works to reduce this reaction, so that your body is more likely to accept the transplanted organ.

When it should not be used:

• Accel-Mycophenolate Mofetil Capsules 250 mg 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”).

What the medicinal ingredient is:

• mycophenolate mofetil

What the nonmedicinal ingredients are:

Accel-Mycophenolate Mofetil Capsules 250 mg capsules contain the following nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone and talc. The capsule shells contain black iron oxide, FD & C Blue 2, gelatin, potassium hydroxide, iron oxide red, iron oxide yellow, shellac, sodium lauryl sulfate and titanium dioxide.

What dosage forms it comes in:

Accel-Mycophenolate Mofetil Capsules 250 mg are available as a light blue/peach size ‘1’ hard gelatin capsule imprinting with ‘MMF’ on cap and ‘250’ on body, containing white to off white powder. Ten capsules are contained in each blister pack.

WARNINGS AND PRECAUTIONS

Warning Because Accel-Mycophenolate Mofetil Capsules 250 mg 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 avoid pregnancy while taking Accel-

  Mycophenolate Mofetil Capsules 250 mg as it may cause an increased risk of first trimester pregnancy loss or damage to the unborn baby. For this reason it is recommended that you discuss with your doctor if you are pregnant or become pregnant while taking Accel-Mycophenolate Mofetil Capsules 250 mg. You will want to discuss the possible benefits and risks of continuing with this drug.

• Women (who have the potential of becoming pregnant)

  should have a negative serum (blood) or urine pregnancy test within 1 week prior to beginning therapy.

• Before, during your treatment and for 6 weeks after stopping your treatment with Accel-Mycophenolate Mofetil Capsules 250 mg, you must use two reliable methods of birth control.
• It is recommended that you do not breastfeed your baby if you are taking Accel-Mycophenolate Mofetil Capsules 250 mg as it may pass into breast milk and may harm your baby.

All Patients

• Tell all health professionals you see (doctor, dentist, nurses, pharmacists) that you are taking Accel-Mycophenolate Mofetil Capsules 250 mg.
• 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.

BEFORE you use Accel-Mycophenolate Mofetil Capsules 250 mg talk to your doctor or pharmacist if:

• If you have had a bad, unusual or allergic reaction to

  Accel-Mycophenolate Mofetil Capsules 250 mg, mycophenolic acid, or mycophenolate sodium;

• If you are pregnant, plan to become pregnant, or are breastfeeding a baby;
• 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

• Do not take any other drugs without asking your doctor or

  pharmacist first.

• Taking antacids at the same time as Accel-Mycophenolate

  Mofetil Capsules 250 mg may affect the way Accel-Mycophenolate Mofetil Capsules 250 mg works for you and therefore should not be taken simultaneously.

• Taking proton pump inhibitors, such as lansoprazole and

  pantoprazole, at the same time as Mycophenolate Mofetil Capsules 250 mg may affect the way Mycophenolate Mofetil Capsules 250 mg works for you

• Taking Renagel^® (sevelamer), or other calcium free

  phosphate binders at the same time as Accel-Mycophenolate Mofetil Capsules 250 mg may affect the way Accel-Mycophenolate Mofetil Capsules 250 mg works for you and therefore should not be taken at the same time.

• Taking combinations of antibiotics at the same time as

  Accel-Mycophenolate Mofetil Capsules 250 mg may affect the way Accel-Mycophenolate Mofetil Capsules 250 mg works for you. Do not take any other drugs without asking your doctor or pharmacist first.

• During treatment with Accel-Mycophenolate Mofetil

  Capsules 250 mg, 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 Accel-Mycophenolate Mofetil

  Capsules 250 mg 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 Accel-Mycophenolate Mofetil

  Capsules 250 mg 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.

• Accel-Mycophenolate Mofetil Capsules 250 mg 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 Accel-Mycophenolate

    Mofetil Capsules 250 mg 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 Accel-Mycophenolate Mofetil

    Capsules 250 mg on your own even if you have been taking it for several years.

Usual dose:

Accel-Mycophenolate Mofetil Capsules 250 mg 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:

• Pediatric patients with a body surface area** of 1.25 to

  1.5 m² may be dosed with Accel-Mycophenolate Mofetil Capsules at a dose of 750 mg twice a day (1.5 g daily dose). Pediatric patients with a body surface area** greater than 1.5 m² may be dosed with mycophenolate mofetil capsules or tablets at a dose of 1 g twice a day (2 g daily dose).

**Body surface area is the total surface area of the body, and is represented as square meters (m²). It is calculated from your weight and height. Body surface area is used in many measurements in medicine, such as determining the amount of drug you need to take.

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 3 g) is recommended after liver transplantation in adults.

How Do I Take Accel-Mycophenolate Mofetil Capsules 250 mg?

Capsules:

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

Overdose:

In case of overdose or suspected overdose, contact the poison control centre or your physician immediately, or go to the emergency room of the nearest hospital.

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 Accel-Mycophenolate

  Mofetil Capsules 250 mg, 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, Accel-Mycophenolate Mofetil Capsules 250 mg may cause side effects in people.

• Because Accel-Mycophenolate Mofetil Capsules 250 mg

  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 Accel-Mycophenolate Mofetil Capsules

  250 mg 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 Accel-Mycophenolate Mofetil Capsules 250 mg, 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.

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 while taking Accel-Mycophenolate Mofetil Capsules 500 mg, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep Accel-Mycophenolate Mofetil Capsules 250 mg 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.
• Accel-Mycophenolate Mofetil Capsules 250 mg should be stored at room temperature (15ºC-30ºC). Protected from light. Remember to keep each capsule in its original package until you need to take it.
• Accel-Mycophenolate Mofetil Capsules 250 mg should not be used after the expiry date (EXP) shown on the package.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

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

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

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

http://www.accelpharma.com

or by contacting the sponsor, Accel Pharma Inc., at: 1-877-827-1306

Manufactured By

Intas Pharmaceuticals Limited,

Plot No.: 457, 458

Village – Matoda,

Bavla Road, Ta.-Sanand

Dist.-Ahmedabad – 382 210

INDIA

Neoral^® (cyclosporine) is a registered Trade-Mark of Novartis AG

Sandimmune^® (cyclosporine) is a registered Trade-Mark of Novartis AG

Renagel^® (sevelamar) is a registered Trade-Mark of Genzyme Corporation

Last revised: January 28, 2013