Consumer Information for: TEVA-CANDESARTAN
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
TEVA-CANDESARTAN is used to treat
- High blood pressure in adults
- High blood pressure in children (6 to 17 years of age)
- Heart failure in adults
What it does
TEVA-CANDESARTAN is an angiotensin receptor blocker (ARB).You can recognize an ARB because its medicinal ingredient ends in ‘-SARTAN’.
This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking TEVA-CANDESARTAN regularly even if you feel fine.
Its main action is to relax the arteries, letting the blood flow more freely, thereby lowering the blood pressure.
When it should not be used
Do not take TEVA-CANDESARTAN if you:
- Are allergic to candesartan cilexetil or to any non-medicinal ingredients in the formulation.
- 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 ARB. 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.
- Are pregnant or intend to become pregnant. Taking TEVA-CANDESARTAN during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. It is possible that TEVA-CANDESARTAN passes into breast milk.
- Are less than 1 year old.
- Have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
because lactose is a non-medicinal ingredient in TEVA-CANDESARTAN.
What the medicinal ingredient is
Candesartan cilexetil
What the non-medicinal ingredients are
carmellose calcium, microcrystalline cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, poloxamer 188, povidone, red iron oxide.
What dosage form it comes in
TEVA-CANDESARTAN is available as 8 mg, 16 mg and 32 mg tablets.
Warnings and precautions
Serious Warnings and Precautions - Pregnancy
TEVA-CANDESARTAN should not be used during pregnancy. If you discover that you are pregnant while taking TEVA-CANDESARTAN, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
WARNINGS AND PRECAUTIONS
Before you use TEVA-CANDESARTAN talk to your doctor, nurse or pharmacist if you:
- Have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors
- Have narrowing of an artery or a heart valve
- Have had a heart attack or stroke
- Have heart failure
- Have diabetes, heart, liver or kidney disease
- Are on dialysis
- 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’ that makes your body keep potassium) or other drugs that may increase potassium levels (e.g., heparin, co-trimoxazole
- Are on a low salt diet
- Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with TEVA-CANDASARTAN is not recommended.
- Are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.
- Are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptor antagonists (for example, spironolactone, eplerenone). These medicines are for the treatment of heart failure.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to TEVA-CANDESARTAN. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
If you are currently taking TEVA-CANDESARTAN and are going to have an operation, be sure to tell your doctor or dentist about your medication before you are given an anesthetic.
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 TEVA-CANDESARTAN:
- Agents increasing serum potassium, such as salt substitutes that contain potassium, potassium supplements or a potassium-sparing diuretic (a specific kind of ‘water pill’, or other drugs that may increase potassium levels (e.g., heparin, co-trimoxazole),
- Lithium used to treat bipolar disease,
- Nonsteroidal anti-inflammatory drugs (NSAIDs) used to reduce pain and swelling. Examples include ibuprofen, naproxen and celecoxib;
- Blood pressure-lowering drugs, including diuretics (water pills), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme (ACE) inhibitors.
- Mineralocorticoid receptor antagonists (for example, spironolactone, eplerenone) and ACE inhibitors used in Heart failure.
Proper use of this medication
The dosage of TEVA-CANDESARTAN is individualized.
Take TEVA-CANDESARTAN exactly as prescribed. It is recommended to take your dose at about the same time every day.
TEVA-CANDESARTAN is taken once a day. Even if your doctor has prescribed 2 tablets a day, both should be taken at the same time, unless otherwise indicated.
TEVA-CANDESARTAN may be taken with food or on an empty stomach but it should be taken consistently the same way each day.
Swallow TEVA-CANDESARTAN with a glass of water.
Usual Dose
Lower doses may be required based on the other medications you take and the presence of other disease conditions.
High Blood Pressure in Adults:
Recommended Initial Dose: 16 mg once a day
Total Daily Dose: 8 mg to 32 mg once a day
High Blood Pressure in Children (6 to 17 years of age):
- For children who weigh less than 50 kg:
Recommended Starting Dose: 4 mg once a day
Maximum Dose: 8 mg once a day - For children who weigh 50 kg or more:
Recommended Starting Dose: 8 mg once a day
Maximum Dose: 16 mg once a day
TEVA-CANDESARTAN must not be given to children under 1 year of age due to the potential risk to the developing kidneys.
Heart Failure in Adults:
Usual Recommended Initial Dose: 4 mg once a day
If tolerated by the patient, this dose is gradually doubled (approximately every 2 weeks) until the target dose is reached.
Target Dose: 32 mg once a day
Overdose
Missed Dose
If you miss a dose of TEVA-CANDESARTAN and remember within 12 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. But if it is more than 12 hours when you remember, do not take the missed dose. Just take the next dose on time.
Never take a double dose of TEVA-CANDESARTAN to make up for missed tablets. If you are still unsure, check with your doctor or pharmacist to see what you should do.
Side effects and what to do about them
Side effects may include:
- Dizziness, falls
- Drowsiness, insomnia
- Rash
- Diarrhea, vomiting
- Headache
- Back or leg pain, muscle cramps
- Cough
- Sore throat
- Dry mouth
- Cold symptoms
- Pneumonia
- Fainting spells
- Confusion
Side effects in adults and children are similar, but may occur more often in children.
If any of these affects you severely, tell your doctor, nurse or pharmacist.
TEVA-CANDESARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Common | |||
| Low blood pressure: dizziness, fainting, lightheadedness | ✔ | ||
| Fast, slow or irregular heart beat | ✔ | ||
| Increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
| Uncommon | |||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat; difficulty swallowing or breathing | ✔ | ||
| Kidney disorder: change in frequency of urination, nausea, vomiting, swelling of the extremities, fatigue. | ✔ | ||
| Hematuria (blood in urine) | ✔ | ||
| Liver disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Shortness of breath, difficulty breathing (Dyspnea, Pulmonary edema) | ✔ | ||
| Rare | |||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✔ | ||
| Very rare | |||
| Decreased platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Unknown | |||
| Inflammation of the pancreas: abdominal pain that lasts and gets worse when you lie down, nausea and vomiting | ✔ | ||
| Chest pain | ✔ | ||
| Stroke (cerebrovascular accident): face or arm weakness, abnormal speech and blurred vision, loss of consciousness | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA-CANDESARTAN, contact your doctor, nurse or pharmacist.
How to store
- 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.
- TEVA-CANDESARTAN tablets are protected in their package, it is best to keep the tablets in the original package at normal room temperature and in a dry place. Do not keep TEVA-CANDESARTAN in the bathroom.
- Keep out of sight and reach of children. Never take medicine in front of small children as they will want to copy you.
- Do not keep or use TEVA-CANDESARTAN 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 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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 by contacting Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Last revised: May 2, 2016
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|---|---|---|---|
| TEVA-SALBUTAMOL HFA | 02326450 | TEVA CANADA LIMITED | SALBUTAMOL (SALBUTAMOL SULFATE) 100 MCG / ACT |