Consumer Information for: M-NIFEDIPINE ER

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

M-NIFEDIPINE ER is used for:

Chronic Stable Angina

M-NIFEDIPINE ER may be used in patients to manage chronic stable angina.

High Blood Pressure

M-NIFEDIPINE ER may be used in patients to manage mild to moderate high blood pressure.

What it does

M-NIFEDIPINE ER manages high blood pressure and chronic stable angina. It is called a “calcium channel blocker”. Although the mechanism by which MNIFEDIPINE ER reduces blood pressure and relieves angina is not fully known, it is believed to be brought about as a result of the ability of M-NIFEDIPINE ER to widen and relax blood vessels.

When it should not be used

You should not use M-NIFEDIPINE ER if you:

  • are allergic to nifedipine, or to any of the nonmedicinal ingredients
  • have allergies to other drugs that are similar to MNIFEDIPINE ER (dihydropyridines calcium antagonists)
  • are pregnant, breastfeeding, or a woman of childbearing age
  • have severe low blood pressure or are in shock
  • are taking the medicine rifampicin
  • have a Kock pouch (a pouch or reservoir created inside the abdomen with a portion of large bowel for which a tube or catheter can be inserted through the abdominal wall to drain the reservoir)
  • have moderate to severe liver disease
  • have severe narrowing in your stomach or intestines
What the medicinal ingredient is

Nifedipine

What the non-medicinal ingredients are

Butylated hydroxytoluene , cellulose acetate, Hypromellose, iron oxide red, magnesium stearate, Polyethylene oxide, Povidone, Polyethylene Glycol , sodium chloride

In addition, to the above non medicinal ingredients of 60 mg tablets, are film coating system and imprinting ink.

The non-volatile components of the Film Coating System are Hypromellose, Hydroxypropyl cellulose, iron oxide red, talc, titanium dioxide, and the nonvolatile components of the black Imprinting ink are Ammonium hydroxide, iron oxide black, Propylene Glycol, shellac glaze

What dosage form it comes in

The medication in M-NIFEDIPINE ER is packed within a nonabsorbable shell that has been specially designed to slowly release the drug at a constant rate over time so that the body can absorb it. The shell will pass into your stool after your body has absorbed the medicine. This is normal and is nothing to worry about.

Extended release tablets 60 mg

Warnings and precautions

Before you use M-NIFEDIPINE ER, talk to your doctor or pharmacist if you:

  • are pregnant or breastfeeding
  • have heart failure, liver disease, kidney disease, or coronary artery disease
  • have unstable angina (sudden chest pain that occurs at rest and gets increasingly worse)
  • have recently had a heart attack or you have a heart condition called aortic stenosis (narrowing of a valve in your heart)
  • have pre-existing gastrointestinal narrowing disease
  • have diabetes
  • have a history of poor blood circulation in the brain.
  • are scheduled for surgery with a general anaesthetic
  • are a man and have been repeatedly unsuccessful at fathering a child by in vitro fertilization

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to M-NIFEDIPINE ER. Your ability to drive or to operate machinery may be impaired particularly at the start of treatment, when changing the medication, or in combination with alcohol.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your healthcare professional about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with M-NIFEDIPINE ER:

Drug-Drug interactions

  • Azole antifungals (ketoconazole, itraconazole or fluconazole)
  • cyclosporine
  • carbamazepine
  • cimetidine, ranitidine
  • diltiazem
  • digoxin
  • erythromycin, clarithromycin
  • fluoxetine
  • HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir, or amprenavir)
  • nefazodone
  • phenobarbital
  • phenytoin
  • quinidine
  • quinupristin/dalfopristin
  • tacrolimus
  • rifampicin
  • valproic acid
  • blood pressure lowering drugs including beta blockers
  • benzodiazepines
  • cisapride
  • coumarin anticoagulants
  • warfarin
  • imipramine
  • propafenone
  • terfenadine

Drug-Food interactions

DO NOT eat grapefruit or drink grapefruit juice while you are using this medicine.

Drug-Herb Interactions

Saint John’s Wort

Proper use of this medication

PROPER USE OF THIS MEDICATION

You must swallow M-NIFEDIPINE ER whole. Do not bite, chew, divide or crush the tablets. This can result in a large immediate release of the drug.

You can take this medication with or without food.

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Follow your doctor's treatment plan exactly so that you reach and maintain your blood pressure targets, and get relief from angina. Do not use more medicine or use it more often than your doctor tells you to.

Do not discontinue a medication on your own. If you have a problem with a drug, always tell your doctor. Dosage should be individualised.

Usual Dose:

Doses greater than 90 mg a day are not recommended. Chronic Stable Angina

  • Starting Dose: 30 mg once a day

High Blood Pressure

  • Starting Dose: 30 mg once a day
  • Usual Maintenance Dose: 30 mg to 60 mg once a day.

Overdose:

In case of accidental overdose call your healthcare professional or poison control centre immediately,

If you think you have taken too much M-NIFEDIPINE ER, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose unless instructed by your doctor.

Side effects and what to do about them

Side effects may include:

  • headaches, anxiety, numbness and/or pins and needles (hypoesthesia), confusion, insomnia, nervousness, weakness, excessive muscle movement
  • dizziness, fatigue
  • nausea, upset stomach, indigestion, dry mouth
  • enlargement of the gums
  • muscle or joint pain, leg cramps, back pain
  • rash, itch, sensitivity to the sun
  • impotence, breast enlargement in men, menstrual disorder for women
  • abnormally large production of urine, the need to urinate at night, lack of urine or incontinence
  • eye pain

If any of these affects you severely, tell your doctor, nurse or pharmacist.

M-NIFEDIPINE ER can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Wheezing or trouble breathing ✔    
Angina Pectoris: chest tightness, chest pain      
Edema: swelling of tissues of the hands, ankles, feet or legs      
Abdominal cramps      
Vomiting      
Diarrhea      
Irregular heartbeat      
Fast heartbeat      
Uncommon
Constipation      
Allergic Reactions: difficulty breathing or swallowing, rash or hives (redness, intense itching and burning), swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs      
Low Blood Pressure: dizziness, fainting, light headedness      
Uncommon
Liver Disorder (hepatitis and cholestasis): yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite      
Myocardial Infarction: heart attack      
Toxic Epidermal Necrolysis: severe skin peeling, especially in the mouth and eyes      
Intestinal (bowel) Obstruction: swollen, hard or painful abdomen, vomiting, and constipation/ no stools.      

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

How to store

Store at room temperature (15 to 30°C). Protect from light and humidity.

Keep out of reach and sight of children.

Never share your medicine with anyone.

Ask your healthcare professional about the best way to dispose of any outdated medicine or medicine no longer needed.

Reporting side effects

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

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-healthproducts/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

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

MORE INFORMATION

For more information, please contact your health professional or pharmacist first, or Mantra Pharma Inc. at: medinfo@mantrapharma.ca

The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.

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