Apo-Nifed Pa: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-NIFED PA is used for:

High Blood Pressure

APO-NIFED PA may be used in patients to manage mild to moderate high blood pressure.

What it does:

APO-NIFED PA manages high blood pressure. It is called a “calcium channel blocker”. Although the mechanism by which APO-NIFED PA reduces blood pressure is not fully known, it is believed to be brought about as a result of the ability of APO-NIFED PA to widen and relax blood vessels.

When it should not be used:

You should not use APO-NIFED PA if you:

• are allergic to nifedipine, or to any of the

nonmedicinal ingredients

• have allergies to other drugs that are

  similar to APO-NIFED PA (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 any liver disease
  • have severe narrowing in your stomach or intestines

What the medicinal ingredient is:

Nifedipine

What the nonmedicinal ingredients are:

carnauba wax, hydroxypropyl methylcellulose, polyethylene glycol, red ferric oxide, stearic acid and titanium dioxide.

What dosage forms it comes in:

Nifedipine Prolonged Action Tablets: 10 mg and 20 mg

WARNING AND PRECAUTIONS

Before you use APO-NIFED PA, 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 APO-NIFED PA. 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 APO-NIFED PA:

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

You must swallow APO-NIFED PA tablets 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 80 mg a day are not recommended.

The recommended initial dose is 10 to 20 mg twice daily. The usual adult dose is 20 mg twice daily.

Overdose

In case of accidental overdose call your healthcare professional or poison control centre immediately, even if there are no symptoms.

In case of drug overdose, contact a health care practitioner, 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.

APO-NIFED PA can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

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

HOW TO STORE IT

Tablets should be stored between 15°C to 30°C. Protect from light. Broken tablets should not be used.

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/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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

If you want more information about APO-NIFED PA:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Date of Revision: October 30, 2018