Patient Medication Information: uses, side effects, how to take - Dom-Irbesartan-HCTZ
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What the medication is used for:
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE is used to treat hypertension (high blood pressure).
What it does:
The irbesartan ingredient of Dom-IRBESARTAN-HYDROCHLOROTHIA- ZIDE lowers blood pressure by specifically blocking a naturally occurring substance called angiotensin II, which normally narrows your blood vessels. The irbesartan ingredient of Dom-IRBESARTAN-HYDROCHLOROTHIA- ZIDE allows the blood vessels to relax. The hydrochlothiazide ingredient of Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE works by making your kidneys pass more water and salt. Together irbesartan and hydrochlorothia-. zide lower high blood pressure. Although your doctor will be able to tell you that the medicine is working by measuring your blood pressure, you will probably feel no different while you are taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE.
If your blood pressure remains too high after an adequate trial period, your doctor may decide to increase the dose of either irbesartan or hydrochlorothiazide.
When it should not be used:
Do not take Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE:
- If you are allergic to any of its ingredients or to sulfonamide. (See What the nonmedicinal ingredients are)
- If you have difficulty in producing urine
If you are not sure whether you should start taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE contact your doctor or your pharmacist.
Pregnancy and Breast-feeding: It is not recommended that you use Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE while you are pregnant or breast-feeding. If you are pregnant or planning to become pregnant while taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE talk to your doctor as soon as possible.
Children: Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE should not be given to children.
What the medicinal ingredient is:
Each tablet of Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE contains irbesartan and hydrochlorothiazide.
What the nonmedicinal ingredients are:
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg /25 mg tablets contain the following nonmedicinal ingredients: Colloidal Silicon Dioxide, Copovidone, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate. The coating of 150 mg/12.5 mg and 300 mg/12.5 mg strengths contain: Hypromellose 6cP, Titanium Dioxide, Macrogol, Iron Oxide Yellow, Iron Oxide Red and Iron Oxide Black. The coating of the 300 mg/25 mg strength contains: Hypromellose 3cP, Hypromellose 6cP, Titanium Dioxide, Macrogol, Iron Oxide Red, Iron Oxide Yellow and Iron Oxide Black JPE.
What dosage forms it comes in:
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE tablets are available in three different strengths. Tablets which contain 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide come in the form of peach coloured, film-coated, oval, biconvex tablets debossed with “P” on one side and “150-12.5” on the other side. The next strength contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. These come in a similar form and colour, with “P” on one side and “300-12.5” on the other side. The highest strength tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide. These tablets come in the form of pink coloured, film-coated, biconvex, oval tablets debossed with “P” on one side and “300-25”on the other.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE should not to be used during pregnancy.
If you discover that you are pregnant while taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE stop the medication and please contact your physician.
BEFORE you use Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE talk to your doctor or pharmacist about any medical problems you have or have had, and about any allergies. Tell your doctor if you have recently suffered from excess vomiting or diarrhea.
- It is particularly important to tell your doctor if you have liver or kidney disease, gout, diabetes, lupus erythematosus, or if you are being treated with other diuretics (water pills). In these cases, your doctor may need to adjust the dose of your medications.
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- Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE as there may be a sudden fall in blood pressure associated with general anesthesia.
- You are pregnant, breast-feeding or thinking of becoming pregnant? Taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE during pregnancy can cause injury and even death to your baby. This medication should not be used during pregnancy. If you are planning to become pregnant while taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE, contact immediately your doctor.
It is possible that Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE passes into breast milk. You should discuss with your doctor about taking Dom-IRBESARTASN-HYDROCHLOROTHIAZIDE while breast-feeding.
Wait until you know how you respond to your medication before performing tasks that require special attention (for example, driving an automobile or operating dangerous machinery).
INTERACTIONS WITH THIS MEDICATION
You should have informed your doctor of any medicines you are taking. These include medicines obtained without prescription.
The diuretic agent, hydrochlorothiazide, contained in Dom-IRBESARTAN- HYDROCHLOROTHIAZIDE may interact with other medicines.
Preparations containing lithium should not be taken with Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE without close supervision by your doctor.
Special precautionary measures (e.g., blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium sparing medicines, other diuretics (water pills), warfarin, digoxin, antidiabetic drugs, alcohol, barbiturates, narcotics, pressor amines, skeletal muscle relaxants, cholestyramine and colestipol resins.
If calcium or a calcium sparing drug (e.g., vitamin D therapy) is prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.
It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, or if you are taking steroids, or anti-inflammatory medicines used in arthritis.
PROPER USE OF THIS MEDICATION
Usual dose:
Take Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE every day exactly as your doctor has instructed.
It is important to continue taking Dom-IRBESARTAN-HYDROCHLORO- THIAZIDE for as long as your doctor prescribes it in order to maintain control of your blood pressure.
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE may be taken with or without food, however it should be taken consistently with respect to food intake.
Overdose:
For management of a suspected drug overdose, or in case of an actual
overdose, contact your Regional poison Center or your doctor immediately, so that medical attention may be given promptly.
Missed Dose:
Try to take Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your normal schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its intended action, any medication, including Dom-IRBE- SARTAN-HYDROCHLOROTHIAZIDE may cause side effects. In most patients, Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE is well tolerated. Side effects may include:
- Headache
- Dizziness
- Fatigue
- Muscle pain
Side effects such as myalgia (muscle pain), myasthenia (muscle weakness), myositis (muscle inflammation) and rhabdomyolysis (a muscle-wasting disease), in rare cases leading to kidney failure, have been reported with the use of angiotensin II receptor blockers, the class of drugs to which a component of Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE belongs. You should contact your physician promptly if you experience muscle pain that you cannot explain, muscle tenderness or weakness, generalised weakness, or when you notice dark/brown urine.
Your physician or pharmacist has a more complete list. Tell your physician or pharmacist promptly about these or any other unusual symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptoms / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Uncommon | Low blood pressure associated with dizziness/light headedness, (hypotension) | √ | |||
| Fainting (syncope) | √ | √ | |||
| Muscle pain you cannot explain | √ | ||||
| Muscle tenderness or weakness | √ | ||||
| Generalized weakness | √ | ||||
Dark/brown urine | √ | ||||
This is not a complete list of side effects. If you have any
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unexpected effects while taking Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE contact your doctor or pharmacist.
HOW TO STORE IT
Store Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE tablets at om temperature (15 to 30 °C). Keep this medication out of the reach of children.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Dominion Pharmacal, at: 1-888-550-6060
Last revised: August 23, 2011
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:
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Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345 or
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 lebels, Canada Vigilance Reporting form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web aite at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.