IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
Pr
APO-CILAZAPRIL
Cilazapril Tablets
This leaflet is part III of a three-part “Product
Monograph” published when APO-CILAZAPRIL
was approved for sale in Canada and is designed
specifically for Consumers. This leaflet is a
summary and will not tell you everything about
APO-CILAZAPRIL. Contact your doctor or
pharmacist if you have any questions about the
drug.
ABOUT THIS MEDICATION
What the medication is used for:
APO-CILAZAPRIL is used to treat raised blood
pressure.
What it does:
APO-CILAZAPRIL blocks natural chemicals produced
by the body which cause raised blood pressure. This
inhibition leads to reduction of blood pressure.
When it should not be used:
Do not take APO-CILAZAPRIL if you have had an
allergic reaction to APO-CILAZAPRIL or any of the
ingredients listed at the end of this information.
APO-CILAZAPRIL is also contraindicated in patients
with history of angioedema related to previous
treatment with an ACE inhibitor and in patients with
ascites.
What the medicinal ingredient is:
APO-CILAZAPRIL tablets contain the active
ingredient called cilazapril.
What the important nonmedicinal ingredients are:
APO-CILAZAPRIL tablets contain the following
inactive ingredients: microcrystalline cellulose, starch,
sodium stearyl fumarate, hydroxypropyl
methylcellulose, hydroxypropyl cellulose, polyethylene
glycol, titanium dioxide (1 mg and 2.5 mg only),
yellow ferric oxide (1 mg only) and red ferric oxide
(2.5 mg and 5 mg only).
What dosage forms it comes in:
APO-CILAZAPRIL tablets are available in 1 mg, 2.5
mg and 5 mg strengths.
WARNINGS AND PRECAUTIONS
Pregnancy: Since the use of ACE inhibitors during
pregnancy can cause injury and even death of the
developing fetus, patients should be advised to stop the
medication and report promptly to their physician if
they become pregnant.
Before starting APO-CILAZAPRIL and to get the best
possible treatment, be sure to tell your doctor if you:
•
are on a salt restricted diet
•
have a heart, liver or kidney condition
•
are undergoing dialysis
•
are pregnant or plan to become pregnant
•
are breast-feeding or plan to breast-feed
•
are taking other medicines
•
plan to have surgery that requires anesthetic
•
are using desensitization therapy
Angioedema: Angioedema, including laryngeal
edema, may occur especially following the first dose of
cilazapril. Patients should be so advised and told to
report immediately any signs or symptoms suggesting
angioedema (swelling of face, extremities, eyes, lips,
tongue, difficulty in breathing) and to take no more
drug until they have consulted with the prescribing
physician. Should the tongue and/or larynx be
involved, the physician should be consulted
immediately.
Hypotension: Patients should be cautioned to report
light-headedness, especially during the first few days
of APO-CILAZAPRIL therapy. If actual syncope
occurs, the patients should be told to discontinue the
drug until they have consulted with the prescribing
physician.
All patients should be cautioned that excessive
perspiration and dehydration may lead to an excessive
fall in blood pressure because of reduction in fluid
volume. Other causes of volume depletion such as
vomiting or diarrhea may also lead to a fall in blood
pressure; patients should be advised to consult with
their physician.
Neutropenia: Patients should be advised to report
promptly any indication of infection (e.g., sore throat,
fever) since this may be an early sign of neutropenia.
Impaired Liver Function: Patients should be advised
to return to the physician if he/she experiences any
symptoms possibly related to liver dysfunction. This
would include “viral-like symptoms” in the first weeks
to months of therapy (such as fever, malaise, muscle
pain, rash or adenopathy which are possible indicators
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of hypersensitivity reactions), or if abdominal pain,
nausea or vomiting, loss of appetite, jaundice, itching
or any other unexplained symptoms occur during
therapy.
Hyperkalemia: Patients should be advised not to use
potassium supplements or salt substitutes containing
potassium without consulting their physician.
Surgery: Patients planning to undergo surgery and/or
anesthesia should be told to inform their physician that
they are taking an ACE inhibitor.
Monotherapy: The recommended initial dose of APOCILAZAPRIL is 2.5 mg once daily. Dosage should be
adjusted according to the blood pressure response,
generally at intervals of at least two weeks. The usual
dose range for APO-CILAZAPRIL is 2.5 to 5 mg once
daily. A dose of 10 mg should not be exceeded.
Overdose:
If you take too much, immediately contact your doctor
or go to your nearest hospital emergency department.
Nursing Mothers: Patients should be advised not to
breast feed if they are taking APO-CILAZAPRIL.
Missed Dose:
The dose should always be taken at about the same
time each day. If you miss a dose, wait until your next
scheduled dose. Do not take 2 doses at once. In case
of doubt contact your doctor or pharmacist.
INTERACTIONS WITH THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT
THEM
Tell all doctors, dentists and pharmacists who are
treating you that you are taking APO-CILAZAPRIL.
Tell your doctor or pharmacist that you are taking
APO-CILAZAPRIL before you start taking any new
medicines.
The medicines may interfere with APO-CILAZAPRIL:
•
ACE inhibitors and diuretics
•
lithium salts
•
digoxin
•
non-steroidal anti-inflammatory drugs
•
agents increasing serum potassium
Only take other medicines while you are on APOCILAZAPRIL if your doctor tells you that you can.
DO NOT give APO-CILAZAPRIL to anyone else.
Your doctor has prescribed it for you and your
condition.
Like other medicines, APO-CILAZAPRIL can cause
some side effects. The most common side effects of
APO-CILAZAPRIL are:
•
•
•
•
•
•
•
headache
dizziness
fatigue
cough
nausea
asthenia
palpitation
This is not a complete list of side effects. For any
unexpected effects while taking APO-CILAZAPRIL,
contact your doctor or pharmacist.
Elevation of liver enzymes and/or serum bilirubin have
been reported for APO-CILAZAPRIL.
PROPER USE OF THIS MEDICATION
Usual dose:
Dose must be individualized.
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HOW TO STORE IT
MORE INFORMATION
All medicines should be kept out of the reach of
children. APO-CILAZAPRIL should be stored in its
original package at room temperature (15-30°C), in a
dry place. Keep container tightly closed and protect
from moisture. The expiry date of this medicine is
printed on the package label. Do not use the medicine
after this date.
For more information, please contact your doctor,
pharmacist or other healthcare professional. This
document, plus the full product monograph, prepared
for health professional can be found at
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Date of Revision: January 23, 2007
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects
information on serious and unexpected effects of drugs.
If you suspect you have had a serious or unexpected
reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: [email protected]
By regular mail:
Canadian Adverse Drug Reaction Monitoring Program
(CADRMP)
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9
NOTE: Before contacting Health Canada, you should
contact your physician or pharmacist.
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