Patient Medication Information: uses, side effects, how to take - Van-Mycophenolate (Vanc Pharmaceuticals, 500 mg)
ABOUT THIS MEDICATION
What the medication is used for:
VAN-Mycophenolate tablets are used after kidney,
heart and liver transplantation to help prevent organ rejection.
VAN-Mycophenolate tablets belongs to a family of
drugs known as "immunosuppressants". These drugs work to "suppress" or reduce the body's immune response.
VAN-Mycophenolate tablets 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. VAN-Mycophenolate tablets, works to reduce this reaction, so that your body is more likely to accept the transplanted organ.
When it should not be used:
VAN-Mycophenolate tablets 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:
VAN-Mycophenolate tablets 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 forms it comes in:
VAN-Mycophenolate tablets are 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
Warning Because VAN-Mycophenolate tablets 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 VAN-
Mycophenolate tablets 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 VAN-Mycophenolate tablets. 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 VAN-Mycophenolate tablets, you must use two reliable methods of birth control.
- It is recommended that you do not breastfeed your baby if you are taking VAN-Mycophenolate tablets 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 VAN-Mycophenolate tablets.
- 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 VAN-Mycophenolate tablets talk to your doctor or pharmacist:
If you have had a bad, unusual or allergic reaction to
VAN-Mycophenolate tablets, 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 VAN-
Mycophenolate tablets may affect the way VAN-Mycophenolate tablets works for you and therefore should not be taken simultaneously.
Taking proton pump inhibitors, such as lansoprazole
and pantoprazole, at the same time as VAN-Mycophenolate tablets may affect the way VAN-Mycophenolate tablets works for you.
Taking Renagel® (sevelamer), or other calcium free
phosphate binders at the same time as VAN-Mycophenolate tablets may affect the way VAN-Mycophenolate tablets works for you and therefore should not be taken at the same time.
Taking combinations of antibiotics at the same time
as VAN-Mycophenolate tablets may affect the way VAN-Mycophenolate tablets works for you. Do not take any other drugs without asking your doctor or pharmacist first.
During treatment with VAN-Mycophenolate tablets,
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 VAN-Mycophenolate tablets
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 VAN-Mycophenolate
tablets 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.
VAN-Mycophenolate tablets 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 VAN-
Mycophenolate tablets 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 VAN-Mycophenolate tablets on your own even if you have been taking it for several years.
Usual Dose:
VAN-Mycophenolate tablets 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.
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 VAN-Mycophenolate tablets? 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.
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 VAN-Mycophenolate
tablets, 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, VAN-Mycophenolate tablets may cause side effects in people.
Because VAN-Mycophenolate tablets 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 VAN-Mycophenolate tablets 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 mofetil, 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 to your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention† | ||
Only if severe | In all cases | |||
| Common | Abdominal, chest, or back pain, Blood in urine, Constipation, Diarrhea, Fever, Headache, Heart Burn, Laboured breathing, Nausea, Nosebleed, Swelling of parts of your body, Vomiting, Weakness | √ | ||
| Uncommon | Blood or black tarry stools, Dizziness, Increased cough, Involuntary trembling, Sleeplessness, Stomach pain | √ | ||
†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 VAN-Mycophenolate tablets, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep VAN-Mycophenolate tablets 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.
- VAN-Mycophenolate tablets 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.
- VAN-Mycophenolate tablets 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:
- 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: CanadaVigilance Program
Health Canada
Postal Locator 0701E Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 by contacting the manufacturer and distributer, Vanc Pharmaceuticals Inc. at:
Manufacturer and Distributor:
Vanc Pharmaceuticals Inc. Building 152, 11782 River Road
Richmond, BC V6X 1Z7
www.vancpharm.com
Last revised: October 22, 2014
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