Patient Medication Information: uses, side effects, how to take - Septa-Candesartan HCTZ
What the medication is used for:
SEPTA-CANDESARTAN HCTZ lowers high blood pressure.
What it does:
SEPTA-CANDESARTAN HCTZ contains a combination of 2 drugs, candesartan cilexetil and hydrochlorothiazide.
Candesartan is an angiotensin receptor blocker (ARB). You
can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. 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 SEPTA-CANDESARTAN HCTZ regularly even if you feel fine.
When it should not be used:
Do not take SEPTA-CANDESARTAN HCTZ if you:
are allergic candesartan cilexetil, hydrochlorothiazide or to any
non-medicinal ingredient in the formulation.
Are allergic to any sulphonamide-derived drugs (sulfa drugs);
most of them have a medicinal ingredient that ends in “-MIDE”.
Are already taking a blood pressure-lowering medicine that
contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
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 (any drug in the same class as candesartan cilexetil). Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
- Have difficulty urinating or produce no urine.
Are pregnant or intend to become pregnant. Taking SEPTA-
CANDESARTAN HCTZ during pregnancy can cause injury and even death to your baby.
Are breastfeeding. SEPTA-CANDESARTAN HCTZ passes into
breast milk.
Have one of the following rare hereditary diseases:
o Galactose intolerance
o Lapp lactase deficiency
o Glucose-galactose malabsorption
Because lactose is a non-medicial ingredient in SEPTA-
CANDESARTAN HCTZ.
What the medicinal ingredients are:
Candesartan cilexetil and hydrochlorothiazide.
What the non-medicinal ingredients are:
Lactose monohydrate, corn starch, carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, iron oxide yellow (32 mg / 12.5 mg), iron oxide red (32 mg / 25 mg) and polyethylene glycol.
What dosage forms it comes in:
Tablets in two strengths:
candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg candesartan cilexetil/hydrochlorothiazide 32 mg/25 mg
BEFORE you use SEPTA-CANDESARTAN HCTZ talk to your doctor, nurse or pharmacist if you:
- Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
- Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with SEPTA-CANDESARTAN HCTZ is not recommended.
Are taking an angiotensin converting enzyme inhibitor (ACEI).
You can recognize ACEIs because their medicinal ingredient ends in ‘-PRIL’.
- Have narrowing of an artery or a heart valve.
- Have heart failure.
- Have diabetes, liver, heart or kidney disease.
- Have lupus or gout.
- 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”).
- Are on a low-salt diet.
- Are less than 18 years old.
- Are having any kind of surgery or dental procedure with anesthesia.
- Have had a heart attack or stroke.
Hydrochlorothiazide in SEPTA-CANDESARTAN HCTZ can cause Sudden Eye Disorders:
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions-Pregnancy
SEPTA-CANDESARTAN HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking SEPTA-CANDESARTAN HCTZ, stop taking the medication and contact your physician, nurse or pharmacist as soon as possible.
- 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 SEPTA-CANDESARTAN HCTZ.
You may become sensitive to the sun while taking SEPTA-CANDESARTAN HCTZ. Exposure to sunlight should be minimized until you know how you respond.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to SEPTA-CANDESARTAN HCTZ. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
As with most medicines, interactions with other drugs are possible. Tell your doctor or 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 SEPTA-CANDESARTAN HCTZ:
Adrenocorticotropic hormone (ACTH) used to treat West
Syndrome.
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.
- Amphotericin B, an antifungal drug.
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.
Other blood pressure lowering drugs, including diuretics
(“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors (ACEIs). When taken in combination with ATACAND PLUS, they may cause excessively low blood pressure.
- Calcium or vitamin D supplements.
- Corticosteroids used to treat joint pain and swelling.
- Cyclosporine.
- 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.
- Gout medications, including allopurinol and probenecid.
- Lithium used to treat bipolar disease.
Nonsteroidal anti-inflammatory drugs (NSAIDs), used to
reduce pain and swelling. Examples include ibuprofen, naproxen and celecoxib.
Pressor amines such as norepinephrine.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
Take SEPTA-CANDESARTAN HCTZ exactly as prescribed. It is recommended to take your dose at about the same time everyday.
SEPTA-CANDESARTAN HCTZ can be taken with or without food but it should be taken the same way each day. Swallow SEPTA-CANDESARTAN HCTZ with a glass of water.
If SEPTA-CANDESARTAN HCTZ causes upset stomach, take it with food or milk.
The blister package protects each tablet. 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 SEPTA-CANDESARTAN HCTZ to other pill containers. To protect your SEPTA-CANDESARTAN HCTZ tablets, keep them in the container received from your farmacist.
Remember to get a new prescription from your doctor or a refill from your pharmacy a few days before all your tablets are taken.
Usual Adult Dose:
Usual maintenance dose is: 1 tablet daily
The dosage of SEPTA-CANDESARTAN HCTZ is individualized.
SEPTA-CANDESARTAN HCTZ is not for initial therapy. You must first be stabilized on the individual components (candesartan cilexetil and hydrochlorothiazide) of SEPTA-CANDESARTAN HCTZ.
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
Overdose:
Missed dose:
If you miss a dose of SEPTA-CANDESARTAN HCTZ 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. Do not double dose.
Side effects may include:
- back or leg pain, muscle cramps, spasms and pain, weakness, restlessness
- dizziness, pins and needles in your fingers, headache
- constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth
- bleeding under skin, rash, red patches on the skin
- drowsiness, insomnia
- reduced libido
- throat infections
If any of these affects you severely, tell your doctor, nurse or pharmacist.
SEPTA-CANDESARTAN HCTZ 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 / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate emergency medical assistance | ||||
Only if severe | In all cases | |||||
| Common | Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up | |||||
| Decreased or | ||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
Symptom / effect increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell Tachycardia: increased heart beats Edema: swelling of hands, ankles or feet | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek | ||||
| Un-common | Allergic reactions: 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 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 | ||||||
| Rare | Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | |||||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains | ||||||
If you think you have taken too much SEPTA-CANDESARTAN HCTZ contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
Symptom / effect and flu-like symptoms Decreased Platelets: bruising, bleeding, fatigue and weakness | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek | ||||
| Very rare | Toxic Epidermal Necrolysis: severe skin peeling, especially in the mouth and eyes | |||||
| Unknown | Eye 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 | ||||||
This is not a complete list of side effects. For any unexpected effects while taking SEPTA-CANDESARTAN HCTZ, contact your doctor, nurse or pharmacist.
Although SEPTA-CANDESARTAN HCTZ tablets are
protected in their package, it is best to store them at normal room temperature between 15 and 30°C and in a dry place. Do not keep SEPTA-CANDESARTAN HCTZ in the bathroom.
Keep SEPTA-CANDESARTAN HCTZ out of reach of
children. Never take medicine in front of small children as they will want to copy you.
Do not keep or use SEPTA-CANDESARTAN HCTZ 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.
This document, plus the full Product Monograph prepared for health professionals, can be found at: www.septapharmaceuticals.com / or by contacting the sponsor, Septa Pharmaceuticals Inc, at: 1-905-564-5665 or by email, at: info@septapharmaceuticals.com
Please check our website to see if more up-to-date information has been posted.
Septa Pharmaceuticals Inc.
7490 Pacific Circle, #1
Mississauga, ON L5T 2A3
Canada
.
Date of Preparation : April 22, 2015
HOW TO STORE IT
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, ON 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.