Patient Medication Information: uses, side effects, how to take - AG-Olmesartan HCTZ
What the medication is used for:
AG-Olmesartan HCTZ lowers high blood pressure.
What it does:
AG-Olmesartan HCTZ contains a combination of two drugs, olmesartan medoxomil and hydrochlorothiazide:
- Olmesartan medoxomil 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 AG-Olmesartan HCTZ regularly even if you feel fine.
When it should not be used:
Do not take AG-Olmesartan HCTZ if you:
- Are allergic to olmesartan medoxomil, hydrochlorothiazide or to any non-medicinal ingredient in the formulation or components of the container.
- Are allergic to any sulphonamide-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 ARB (any drug in the same class as olmesartan medoxomil). 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 AG-Olmesartan HCTZ during pregnancy can cause injury and even death to your baby.
Are breastfeeding. AG-Olmesartan HCTZ passes into breast milk.
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
Have one of the following rare hereditary diseases
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose mal absorption
Because lactose is a non-medicinal ingredient in AG-Olmesartan HCTZ.
What the medicinal ingredients are:
Olmesartan medoxomil and hydrochlorothiazide
What the non-medicinal ingredients are:
Lactose monohydrate, microcrystalline cellulose, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, titanium dioxide and talc, iron oxide yellow and iron oxide red.
What dosage forms it comes in:
Tablets: 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.
BEFORE you use AG-Olmesartan 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.
- 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.
- Are taking a medicine that contains aliskirin, such as Rasilez, used to lower high blood pressure. The combination with AG-Olmesartan HCTZ is not recommended.
- Are taking an angiotensin converting enzyme inhibitor (ACEI). You can recognize ACEIs because their medicinal ingredient ends in “-PRIL”.
- 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.
ABOUT THIS MEDICATION
WARNING AND PRECAUTIONS
Serious Warnings and Precautions - Pregnancy
AG-Olmesartan HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking AG-Olmesartan HCTZ , stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
PrAG-Olmesartan HCTZ
IMPORTANT: PLEASE READ
- Are taking any medication including non-prescription or herbal products.
- You have to undergo any kind of surgery and general anesthesia
AG-Olmesartan HCTZ can cause severe chronic diarrhea with substantial weight loss (sprue-like enteropathy). It can take months to years for symptoms to develop.
Hydrochlorothiazide in AG-Olmesartan HCTZ 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 AG-Olmesartan HCTZ.
You may become sensitive to the sun while taking AG-Olmesartan 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 AG-Olmesartan HCTZ. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
Avoid alcoholic beverages until you have discussed their use with your physician. Alcohol consumption may alter your blood pressure.
If AG-Olmesartan HCTZ is taken with medicines to reduce pain and swelling (called Non-steroidal anti-inflammatory drugs (NSAIDs) or with COX-2 inhibitors), you may experience:
- decreased kidney function or sudden kidney failure. If you notice a decrease in the amount of urine you produce, generalized swelling, weakness, shortness of breath, or irregular heartbeats, loss of appetite, lethargy, and fatigue, contact your doctor or go to the emergency department of the hospital right away.
- A decreased ability of AG-Olmesartan HCTZ to lower your blood pressure. This means that AG-Olmesartan HCTZ may not be able to lower your blood pressure as it is expected to do. If this happens, speak with your doctor or pharmacist.
As with most medications, interaction 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 AG-Olmesartan 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.
- 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. When taken in combination with AG-Olmesartan HCTZ, they may cause excessively low blood pressure.
- Calcium or vitamin D supplements.
- Corticosteroids used to treat joint pain and swelling.
- Digoxin, a heart medicine.
- Drugs that slow down or speed up bowel function, including atropine, metoclopramide and domperidone.
- 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 for arthritis and to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
- Pressor amines such as norepinephrine.
- Sympathomimetics
- Anesthetics
- Amantadine
- Anticholonergic agents
- Cyclosporine
- Blood pressure-lowering drugs, including diuretics ("water pills"), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors (ACEIs).
Take AG-Olmesartan HCTZ exactly as prescribed. It is recommended to take your dose at about the same time everyday.
Dosage must be individualized. AG-Olmesartan HCTZ is not for initial therapy.
AG-Olmesartan HCTZ may be taken with or without food. If AG-Olmesartan HCTZ causes upset stomach, take it with food or milk.
INTERACTION WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
PrAG-Olmesartan HCTZ
IMPORTANT: PLEASE READ
Usual Adult dose:
One tablet daily.
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 dose.
Side effects may include:
- upper respiratory tract infection, cough.
- 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 the skin, rash, red patches on the skin.
- fatigue, drowsiness, insomnia
- reduced libido
If any of these affects you severely, tell your doctor, nurse or pharmacist.
AG-Olmesartan HCTZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| SERIOUS SIDE EFFECT, 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 medical help | ||
| 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 increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell. | √ | |||
| Chest Pain | √ | |||
| Edema: Swelling of the hands, ankles or feet | √ | |||
| Uncommon | Allergic Reaction: rash, | √ | ||
If you think you have taken too much AG-Olmesartan 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 EFFECT, 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 medical help | ||
| Only if severe | In all cases | |||
| hives, swelling of the lips, face, 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. | √ | |||
| Bronchitis: shortness of breath, weakness, high fever, coughing and fatigue. | √ | |||
| Rare | Sudden Kidney Failure (sudden decrease or absence of urine, generalized swelling, weakness, shortness of breath, or irregular heartbeats, loss of appetite, lethargy and fatigue). | √ | ||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine. | √ | |||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu- like symptoms. | √ | |||
| Decreased Platelets: bruising, bleeding, fatigue and weakness. | √ | |||
| Very Rare | Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes. | √ | ||
Eye disorders:
| √ | |||
PrAG-Olmesartan HCTZ
IMPORTANT: PLEASE READ
Stop taking drug and seek immediate medical help
SERIOUS SIDE EFFECT, HOW OFTEN THEY HAPPEN AND
WHAT TO DO ABOUT THEM
Symptom/effect
Talk with your doctor, nurse or pharmacist
Only if severe
Anemia: fatigue, loss of
energy, weakness, shortness of breath.
In
all cases
√
Inflammation of the
Pancreas: abdominal pain √ that lasts and gets worse
when you lie down, nausea, vomiting.
Palpitations:
heartbeats.
Sprue-like
Irregular
√
enteropathy:
√
severe chronic diarrhea
with substantial weight loss.
Angita Pharma Inc, 1310 rue Nobel Boucherville, Quebec J4B 5H3
Date of Revision: July 11, 2018
This is not a complete list of side effects. For any unexpected effects while taking AG-Olmesartan HCTZ, contact your doctor or pharmacist.
Store at 15°-30°C.
Keep out of reach and sight of children.
MORE INFORMATION
Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.
This document plus the full product monograph prepared for health professional can be obtained by contacting the sponsor, Angita Pharma Inc. at 1 866-399-9091.
HOW TO STORE IT
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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report- declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
PrAG-Olmesartan HCTZ
IMPORTANT: PLEASE READ