Patient Medication Information: uses, side effects, how to take - Auro-Azilsartan Medoxomil
Serious warnings and precautions box
What Auro-Azilsartan Medoxomil is used for:
Auro-Azilsartan Medoxomil is used in adults to lower high blood pressure. It can be used alone or together with a thiazide diuretic (“water pill”) or a calcium channel blocker.
How Auro-Azilsartan Medoxomil works:
Auro-Azilsartan Medoxomil is an angiotensin receptor blocker (ARB). It lowers blood pressure. This medicine does not cure your disease. It helps control it. Therefore, it is important to continue taking Auro-Azilsartan Medoxomil regularly even if you feel fine.
The ingredients in Auro-Azilsartan Medoxomil are:
Medicinal ingredients: azilsartan medoxomil
Non-medicinal ingredients: Croscarmellose sodium, HPMC 2910 / Hypromellose, hydroxy propyl cellulose, iron oxide yellow, macrogol/PEG, magnesium aluminometa silicate, magnesium stearate, mannitol, microcrystalline cellulose, talc and titanium dioxide.
Auro-Azilsartan Medoxomil comes in the following dosage forms:
Tablets: 40 mg and 80 mg
Do not use Auro-Azilsartan Medoxomil if:
Auro-Azilsartan Medoxomil should not be used during pregnancy. Taking Auro-Azilsartan Medoxomil during pregnancy can cause injury or even death to your baby.
- If you discover that you are pregnant while taking Auro-Azilsartan Medoxomil, stop the medication and contact your healthcare professional as soon as possible.
- you are allergic to azilsartan medoxomil or to any other ingredients in Auro-Azilsartan Medoxomil.
you have had an allergic reaction (angioedema) to any ARB. Signs of an allergic reaction include:
- swelling of the hands, feet, ankles, face, lips, tongue and throat
- suddenly having trouble breathing or swallowing
Make sure that you tell your healthcare professional that this has happened to you before.
- you have diabetes or kidney disease and are already taking a blood pressure-lowering medicine that contains aliskiren.
- you are pregnant or intend to become pregnant. Taking Auro-Azilsartan Medoxomil during pregnancy can cause injury and even death to your baby.
- you are breastfeeding. It is possible that Auro-Azilsartan Medoxomil passes into breastmilk.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Azilsartan Medoxomil. Talk about any health conditions or problems you may have, including if you:
- have experienced an allergic reaction to any medicine used to lower blood pressure.
- have narrowing of an artery or a heart valve.
- have had a heart attack or stroke.
- have heart failure.
- have liver or kidney diseases.
- have diabetes.
- are on dialysis.
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- are on a low-salt diet.
- are taking a medicine that contains aliskiren.
- are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.
- are 75 years of age or older. You are at a higher risk of experiencing low blood pressure while taking Auro-Azilsartan Medoxomil. Your healthcare professional will decide if Auro-Azilsartan Medoxomil is right for you.
Other warnings you should know about:
Auro-Azilsartan Medoxomil can cause serious side effects, including:
Hypotension (low blood pressure): You may feel dizzy or light-headed:
- Particularly in the first few days after you start taking Auro-Azilsartan Medoxomil or when your dose is increased.
- When you exercise or when the weather is hot.
You should lie down if this happens. If you faint, talk to your healthcare professional right away.
- Allergic reactions (angioedema): Some patients have reported experiencing allergic reactions (angioedema) while taking angiotensin receptor blockers (ARBs) such as azilsartan medoxomil. If you experience signs or symptoms of an allergic reaction while taking Auro-Azilsartan Medoxomil, stop taking it and tell your healthcare professional right away.
- Kidney Disorder: Auro-Azilsartan Medoxomil may cause kidney problems. Some patients experienced a decrease in urination, kidney injury or failure while taking ARBs such as azilsartan medoxomil. Some cases have resulted in death. If you experience signs or symptoms of kidney problems, tell your healthcare professional right away.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Driving and using machines: Before doing tasks that require special attention, wait until you know how you respond to Auro-Azilsartan Medoxomil. Dizziness, light-headedness, or fainting can occur, particularly in the first few days after you start taking Auro-Azilsartan Medoxomil or when your dose is increased.
Surgery: Tell your healthcare professional you are taking Auro-Azilsartan Medoxomil before undergoing any surgeries that require general anesthesia. This includes dental surgery. General anesthesia may cause a sudden fall in blood pressure.
Laboratory tests and monitoring: Your healthcare professional may do blood tests before you take Auro-Azilsartan Medoxomil and/or during treatment. This is to make sure your kidneys are working properly.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Auro-Azilsartan Medoxomil:
Medicines that can increase the levels of potassium in your blood. These include:
- potassium-sparing diuretics (a specific kind of “water pill”)
- potassium supplements
- salt substitutes that contain potassium
Medicines that lower your blood pressure. These include:
- Angiotensin-Converting Enzyme (ACE) inhibitors
- aliskiren-containing medicines
- diuretics (“water pills”)
- Amlodipine – used to treat high blood pressure and manage a type of chest pain called angina
- Lithium – used to treat bipolar disease
- Fluconazole, ketoconazole – used to treat fungal infections
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, naproxen and celecoxib – used to reduce pain and swelling
How to take Auro-Azilsartan Medoxomil:
- Take Auro-Azilsartan Medoxomil every day exactly as prescribed.
- It is recommended to take your dose at about the same time every day.
Auro-Azilsartan Medoxomil may be taken with or without food.
Usual dose:
- 40 mg tablet once a day.
- Your healthcare professional can increase the dosage to 80 mg once daily if required.
Overdose:
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 the dose.
Possible side effects from using Auro-Azilsartan Medoxomil:
These are not all the possible side effects you may have when taking Auro-Azilsartan Medoxomil. If you experience any side effects not listed here, tell your healthcare professional.
Side effects include:
- Dizziness
- Fatigue
- Rash
- Itchy skin
- Hives
- Diarrhea
- Constipation
- Feeling sick
- Vomiting
- Headache
- Back pain
- Pain in your arms or legs
- Muscle pain or spasms
- Joint pain
- Vertigo
- Abdominal discomfort or pain
- Dry mouth
- Heartburn
- Toothache
- Anxiety
- Cough
- Sore throat
- Sinus congestion
- Excessive sweating
- Frequent urination
- Inflammation of the nose and throat
- Impotence (not able to have an erection)
If you think you, or a person you are caring for, have taken too much Auro-Azilsartan Medoxomil, contact a healthcare professional, hospital emergency department regional poison control centre or Health Canada’s toll free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Auro-Azilsartan Medoxomil can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Hyperkalemia (increased levels of potassium in the blood): irregular heartbeats, muscle weakness and generally feeling unwell | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | ||
| Irregular heartbeat | √ | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | √ | ||
| Uncommon | |||
| Allergic reactions (angioedema): difficulty swallowing or breathing; swollen face, hands and feet, genitals, tongue, throat; wheezing; hives or rash; swelling of the digestive tract causing diarrhea, nausea or vomiting | √ | ||
| Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | √ | ||
| Liver Disorder: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | √ | ||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | √ | ||
| Rare | |||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | √ | ||
| Very rare | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | √ | ||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | √ | ||
| Leukopenia (decreased white blood cells) – infections, fatigue, fever, aches, pains and flu-like symptoms | √ | ||
| Unknown | |||
| Intestinal angioedema (swelling of the intestine): colicky abdominal pain, diarrhea, nausea or vomiting | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store Auro-Azilsartan Medoxomil tablets between 15 to 30oC.
- Keep container tightly closed.
- Protect from light and moisture.
- Keep tablets in original packaging. Do not transfer Auro-Azilsartan Medoxomil tablets to a different container.
- Keep out of reach and sight of children.
If you want more information about Auro-Azilsartan Medoxomil:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.auropharma.ca, or by calling 1-855-648-6681.