What Zestoretic is used for and how to use it
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Zestoretic - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Heart Failure (Congestive Heart Failure), High Blood Pressure (Hypertension)
Class: ACE inhibitors with thiazides
Form: Tablets
Ingredients: lisinopril, hydrochlorothiazide, calcium hydrogen phosphate dihydrate, corn starch, magnesium stearate, mannitol, pregelatinized starch

lisinopril and hydrochlorothiazide tablets

About this Medication

What the medication is used for

ZESTORETIC lowers high blood pressure.

What it does

ZESTORETIC contains a combination of 2 drugs, lisinopril and hydrochlorothiazide:

  • Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in '-PRIL'. It lowers blood pressure;
  • Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This lowers blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking ZESTORETIC regularly even if you feel fine.

When it should not be used

Do not take ZESTORETIC if you:

  • Are allergic to lisinopril, hydrochlorothiazide, or to any non-medicinal ingredient in the formulation.
  • Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in "-MIDE".
  • Have experienced an allergic reaction (angioedema) with swelling of the hands, feet, or ankles, face, lips, tongue, throat or sudden difficulty breathing or swallowing, to any ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
  • Have been diagnosed with hereditary angioedema: an increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors such as surgery, flu, or dental procedures.
  • Have certain kidney diseases or have difficulty urinating or produce no urine.
  • Are pregnant or intend to become pregnant. Taking ZESTORETIC during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. ZESTORETIC passes into breast milk.

What the medicinal ingredients are

lisinopril and hydrochlorothiazide.

What the non-medicinal ingredients are

Calcium hydrogen phosphate dihydrate, corn starch, magnesium stearate, mannitol, pregelatinized starch. The 10/12.5 mg and 20/25 mg tablets also contain red iron oxide and yellow iron oxide.

What dosage forms it comes in

lisinopril and hydrochlorothiazide tablets: 10/12.5 mg, 20/12.5 mg, and 20/25 mg.

Warnings and Precautions

Serious Warnings and Precautions - Pregnancy
ZESTORETIC should not be used during pregnancy. If you discover that you are pregnant while taking ZESTORETIC, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use ZESTORETIC talk to your doctor, nurse, or pharmacist if you:

  • Have experienced an allergic reaction to any drug used to lower blood pressure or penicillin.
  • Have recently received or are planning to get allergy shots for bee or wasp stings or have an allergy.
  • Have narrowing of an artery or a heart valve.
  • Have had a heart attack or stroke.
  • Have heart failure.
  • Have diabetes, liver or kidney disease.
  • Have lupus, gout, or asthma.
  • Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
  • Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of "water pill").
  • Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with ZESTORETIC is not recommended.
  • Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in "-SARTAN".
  • Are on a low-salt diet.
  • Are on dialysis.
  • Are receiving gold (sodium aurothiomalate) injections.
  • Are less than 18 years old.
  • Are on LDL Apheresis (a treatment to lower the LDL cholesterol in the blood).

Hydrochlorothiazide in ZESTORETIC can cause Sudden Eye Disorders:

  • Myopia: sudden nearsightedness or blurred vision.
  • Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.

These eye disorders are related and can develop within hours to weeks of starting ZESTORETIC.

You may become sensitive to the sun while taking ZESTORETIC. Exposure to sunlight should be minimized until you know how you respond.

If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking ZESTORETIC.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ZESTORETIC. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Interactions with this Medication

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

The following may interact with ZESTORETIC:

  • Adrenocorticotropic hormone (ACTH) may be used to treat nephrotic syndrome and in diagnostic tests.
  • Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
  • Amantadine used to treat the flu and reduce symptoms of Parkinson's disease.
  • Amphotericin B, an antifungal drug.
  • Antacids.
  • Anticancer drugs, including cyclophosphamide and methotrexate.
  • Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
  • Antidiabetic drugs, including insulin and oral medicines.
  • Bile acid resins used to lower cholesterol.
  • Blood pressure-lowering drugs, including diuretics ("water pills"), aliskiren-containing products (e.g. Rasilez), diazoxide, methyldopa and beta blockers such as atenolol, metoprolol, propranolol, calcium channel blockers such as felodipine, amlodipine, nifedipine, and angiotensin II receptor blockers such as candesartan, valsartan, losartan. When taken in combination with ZESTORETIC may cause excessively low blood pressure.
  • Calcium or vitamin D supplements.
  • Capsaicin, an ingredient in some creams used to relieve arthritis pain.
  • Corticosteroids used to treat joint pain and swelling.
  • Cyclosporine used to treat autoimmune diseases.
  • Digoxin, a heart medication.
  • Drugs that slow down or speed up bowel function, including atropine, biperiden, domperidone and metoclopramide.
  • Drugs used to treat epilepsy, including carbamazepine and topiramate.
  • Gold (sodium aurothiomalate), used to treat autoimmune conditions such as rheumatoid arthritis and psoriatic arthritis.
  • Gout medications, including allopurinol and probenecid.
  • Lithium, a medicine to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Rituximab used to treat cancer, transplant rejection, and some autoimmune diseases.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
  • Tetracycline antibiotics.

Proper use of this Medication

Take ZESTORETIC exactly as prescribed.

It is recommended to take your dose at about the same time everyday.

ZESTORETIC can be taken with or without food. If ZESTORETIC causes upset stomach, take it with food or milk.

Usual adult dose

The dosage of ZESTORETIC is individualized and taken once a day.
It may be prescribed as follows:
One tablet of 10/12.5mg
Or,
One or two tablets of 20/12.5mg,
One or two tablets of 20/25mg

Overdose

If you think you have taken too much ZESTORETIC contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed dose

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

Side Effects and what to do about them

Side effects may include:

  • dizziness
  • headache
  • cough
  • drowsiness, fatigue, weakness
  • rash
  • abdominal pain, upset stomach, decreased appetite, constipation
  • muscle pain or cramps

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

ZESTORETIC can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Serious side effects, how often they happen and what to do about them

Symptom/effectTalk with your
doctor, nurse
of pharmacist
Stop
taking
drug and
seek
immediate
medical
help
Only
if
severe
In all
cases
CommonLow Blood
Pressure:

dizziness,
fainting,
lightheadedness
May occur when
you go from
lying or sitting
to standing up
Decreased or
increased levels
of potassium in
the blood:

irregular
heartbeats,
muscle
weakness and
generally
feeling unwell
UncommonAllergic
Reaction:
rash,
hives, swelling
of the face, lips,
tongue or throat,
difficulty
swallowing or
breathing
Kidney
Disorder:

decreased
urination,
nausea,
vomiting,
swelling of
extremities,
fatigue
Liver
Disorder:

yellowing of the
skin or eyes,
dark urine,
abdominal pain,
nausea,
vomiting, loss
of appetite
Increased
blood sugar:

frequent
urination, thirst,
and hunger
Electrolyte
Imbalance:

weakness,
drowsiness,
muscle pain or
cramps,
irregular
heartbeat
RareDecreased
Platelets:

bruising,
bleeding, fatigue
and weakness
Decreased
White Blood
Cells:

infections,
fatigue, fever,
aches, pains,
and
flu-like
symptoms
Very RareToxic
Epidermal
Necrolysis:

severe skin
peeling,
especially in
mouth and eyes
UnknownEye disorders:
- Myopia:

sudden near
sightedness or
blurred vision
- Glaucoma:
increased
pressure in your
eyes, eye pain
Anemia:
fatigue, loss of
energy,
weakness,
shortness of
breath
Inflammation
of the
pancreas:

abdominal pain
that lasts and
gets worse when
you lie down,
nausea,
vomiting
Hallucinations:
sensation of
seeing or
hearing things
Lupus-like
reactions:

associated with
fever, malaise,
joint pains,
myalgias,
fatigues etc.
May be
activated, or
lupus status may
worsen

This is not a complete list of side effects. For anyunexpected effects while taking ZESTORETIC, contact your doctor, nurse or pharmacist.

How to Store it

  • Keep in the original package at room temperature (15°C to 30°C), tightly closed and protected from light.
  • When you first open the package, if you find any damage to the plastic seal or foil which exposes the tablet, ask your pharmacist to check the package.
  • Do not transfer ZESTORETIC to other pill containers.
  • Keep out of reach and sight of children. Never take medicine in front of small children as they will want to copy you.
  • Do not keep or use ZESTORETIC after the expiry date indicated on the package. Unused medicines, which you know you will no longer need, should be carefully discarded. You may wish to seek advice from your pharmacist.
  • Remember to get a new prescription from your doctor or a refill from your pharmacy a few days before all your tablets are taken.

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
      K1A 0K9

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

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.astrazeneca.ca,

or by contacting the sponsor, AstraZeneca Canada Inc., at:

1-800-668-6000.