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Microsoft word - lozide_final ci_april 8, 2013_english

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
What the medicinal ingredient is:
Pr Lozide®
(indapamide tablets)
What the non-medicinal ingredients are:
Read this carefully before you start taking
glycerol, hydroxypropylmethyl cellulose, lactose Lozide® and each time you get a refill. This leaflet
monohydrate, macrogol 6000, magnesium stearate, is a summary and will not tell you everything
about Lozide®. Talk to your doctor, nurse, or
pregelatinized starch, sunset yellow S aluminium pharmacist about your medical condition and
treatment and ask if there is any new information
about Lozide®.
colloidal silica, corn starch, ethylcellulose, FD&C Red No. 3 lake, FD&C Yellow No. 6 lake and ABOUT THIS MEDICATION
glycerol monooleate, lactose, magnesium stearate, polysorbate, povidone, pregelatinized corn starch, What the medication is used for:
sodium benzoate, sodium carboxymethylcellulose, Lozide® is used to treat mild to moderate high blood sucrose, talc, titanium dioxide, white beeswax. Lozide® can be used by itself or with other medicines What dosage forms it comes in:
What it does:
Lozide® is a diuretic often called a “water pill”. It
WARNINGS AND PRECAUTIONS
increases urination. This lowers blood pressure. Lozide® affects the kidney’s ability to reabsorb BEFORE you use Lozide® talk to your doctor, nurse, This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking Lozide® regularly even if you feel When it should not be used:
• Are allergic to indapamide or any other sulfonamide or to any non-medicinal ingredient • Have severe liver disease or suffer from a condition called hepatic encephalopathy (a • Have low potassium levels in your blood • Are taking drugs to treat heart rhythm disturbances (antiarrhythmics) that might cause severe cardiac Lozide® is not recommended for use in children. • Are breastfeeding. Lozide® passes into breast milk You may become sensitive to the sun while taking • Are pregnant. Lozide® should not be used during Lozide®. Exposure to sunlight should be minimized. pregnancy. If you become pregnant, discontinue use immediately and discuss with your doctor Athletes should be aware that Lozide® contains an • Have lactose intolerance or have hereditary active ingredient, which may give a positive reaction malabsorption or the Lapp lactase deficiency because Lozide® contains lactose IMPORTANT: PLEASE READ
Driving and using machines: Before you perform
Potassium-sparing diuretics (e.g. amiloride, tasks which may require special attention, wait until you know how you respond to Lozide®. Dizziness, Stimulant laxatives such as bisacodyl and senna lightheadedness, or fainting can especially occur after the first dose or when another antihypertensive agent is added. PROPER USE OF THIS MEDICATION
INTERACTIONS WITH THIS MEDICATION
Take Lozide® exactly as prescribed. It is recommended to take your dose at about the same As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, Lozide® is for oral use: swallow the tablet whole with including drugs prescribed by other doctors, Usual Adult dose:
The following may interact with Lozide®: ACTH (e.g. tetracosactide) for treatment of Maximum dose:
Alcohol, barbiturates (sleeping pills), or Your doctor may increase the dose to a maximum of narcotics (strong pain medications). They may 2.5 mg daily depending on your response to treatment cause low blood pressure and dizziness when you go from lying or sitting to standing up. Recommended dose for the elderly: 1.25 mg tablet a Antibiotics such as moxifloxacin, erythromycin This dose may be adjusted depending on your kidney Antifungal medications such as amphotericin B Antimicrobial medications such as pentamidine Overdose:
Calcium tablets or other calcium supplements If you think you have taken too much Lozide® contact Ciclosporin, tacrolimus or other medications to your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms. Drugs to treat heart rhythm disturbances (e.g. Missed Dose:
disopyramide, amiodarone, sotalol, ibutilide, If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do Drugs to treat high blood pressure, including angiotensin converting enzyme (ACE) inhibitors Drugs used to treat anxiety and schizophrenia (e.g. clozapine, risperidone, pimozide) SIDE EFFECTS AND WHAT TO DO ABOUT
Drugs used to treat depression, in particular selective serotonin reuptake inhibitors (SSRIs eg. paroxetine, sertraline, citalopram) and tricyclic Headache
Pains in the stomach, back, chest
Metformin, an oral medication for diabetes Dizziness
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen or celecoxib or high Fatigue, weakness
doses of acetylsalicylic acid (more than 3 g/day) Burning or prickling feeling in hands, arms,
legs or feet
Oral corticosteroids for treatment of asthma Muscle cramps
IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN
Constipation, diarrhea, nausea, vomiting
THEY HAPPEN AND WHAT TO DO ABOUT
Cough, dry mouth
Swelling
Symptom / effect
Talk with your
Rash, itching
If any of these symptoms affects you severely, tell doctor, nurse,
or pharmacist
immedia-
Lozide® can cause abnormal blood test results. Your te medical
doctor will decide when to perform blood tests and Increased
SERIOUS SIDE EFFECTS, HOW OFTEN
sugar:
frequent
THEY HAPPEN AND WHAT TO DO ABOUT
Symptom / effect
Talk with your
doctor, nurse,
Low blood
or pharmacist
pressure:
immedia-
te medical
Electrolyte
disturbance
s (low levels
of sodium,
potassium
Decreased
chloride):
Disorders:
Changes in
heart rate:
Hyperurica
Rhabdomy
emia: high
IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN
SERIOUS SIDE EFFECTS, HOW OFTEN
THEY HAPPEN AND WHAT TO DO ABOUT
THEY HAPPEN AND WHAT TO DO ABOUT
Symptom / effect
Talk with your
Symptom / effect
Talk with your
doctor, nurse,
doctor, nurse,
or pharmacist
or pharmacist
immedia-
immedia-
te medical
te medical
Decreased
Inflammati
Platelets:
pancreas:
Decreased
Red Blood
Allergic
(anemia):
Reaction/
Angioedem
a (swelling
disorder
Hypercalca
emia: high
disorder:
Torsade de
pointes:
IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN
SERIOUS SIDE EFFECTS, HOW OFTEN
THEY HAPPEN AND WHAT TO DO ABOUT
THEY HAPPEN AND WHAT TO DO ABOUT
Symptom / effect
Talk with your
Symptom / effect
Talk with your
doctor, nurse,
doctor, nurse,
or pharmacist
or pharmacist
immedia-
immedia-
te medical
te medical
Severe skin
reactions:
Possible
worsening
existing
Hepatitis a
This is not a complete list of side effects. For any
unexpected effects while taking Lozide®, contact
your doctor, nurse, or pharmacist.
HOW TO STORE IT
Keep out of reach and sight of children. Store at room temperature (15°C-30°C). Do not use after the expiry date stated on the carton IMPORTANT: PLEASE READ
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: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
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
Please consult your doctor, nurse or pharmacist with any questions or concerns you may have regarding your individual condition. This document plus the full product monograph, prepared for health professionals can be found at: http://www.servier.ca or by contacting the sponsor, Servier Canada Inc., at: 1-800-363-6093 This leaflet was prepared by Servier Canada Inc. SERVIER CANADA INC. 235, Boulevard Armand Frappier Laval, Québec H7V 4A7 Last revised: April 8, 2013

Source: http://www.servier.ca/PDF/Products/EN/EN-LOZIDE-CI.pdf