Patient Medication Information: uses, side effects, how to take - PHL-Losartan
ABOUT THIS MEDICATION
What the medication is used for:
Adults
- lowering high blood pressure
providing kidney protection by delaying the worsening of
kidney disease in type 2 diabetic patients with protein in the urine (proteinuria) and high blood pressure.
Children (6-16 years)
- lowering high blood pressure
What it does:
phl-LOSARTAN belongs to a class of drugs known as angiotensin II receptor antagonists. Its action is to lower blood pressure by relaxing the blood vessels.
When it should not be used:
Do not take phl-LOSARTAN if you are allergic to losartan potassium or any of the nonmedicinal ingredients (see the section What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Losartan potassium.
What the non-medicinal ingredients are:
Each tablet contains the following non-medicinal ingredients: Magnesium Stearate Kosher; Microcrystalline Cellulose; Povidone; Sodium Starch Glycolate. Coating contains: Hypromellose, Hydroxypropyl Cellulose, Titanium Dioxide.
phl-LOSARTAN 25, 50 and 100 mg tablets contain the following amounts of potassium: 2.12 mg (<1 mmol), 4.24 mg (<1 mmol), and 8.48 mg (<1 mmol) respectively.
Although phl-LOSARTAN tablets contain potassium; this amount is too small to replace potassium supplements. If your
physician has prescribed potassium supplements, continue to follow his advice.
What dosage forms it comes in:
Tablets: 25 mg, 50 mg and 100 mg.
WARNINGS AND PRECAUTIONS
Serious Warning and Precautions phl-LOSARTAN should not be used during pregnancy. If you discover that you are pregnant while taking phl-LOSARTAN, stop the medication and please contact your physician.
BEFORE you use phl-LOSARTAN talk to your physician or pharmacist if:
You perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery). Almost all patients can, but you should not perform these tasks until you know how you respond to your medicine.
- You have or have had any medical problems, and about any allergies.
- You are taking potassium supplements, potassium-sparing agents or salts substitutes containing potassium.
- You are taking any medication including non-prescription and herbal products.
- You have recently suffered from excess vomiting or diarrhea.
- You have liver, kidney, heart or heart valve disease.
- You are allergic to this drug or to any ingredient in the formulation.
You are pregnant, breast feeding or thinking of becoming pregnant?
Taking phl-LOSARTAN during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking phl-LOSARTAN, contact immediately your physician
It is possible that losartan passes into breast milk. You should discuss with your physician about taking phl-LOSARTAN while breastfeeding.
Remember that your physician has prescribed this medicine only for you. Never give it to anyone else.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interaction with other drugs is possible. Therefore, do not take any other medicines unless you have discussed the matter with your physician or your pharmacist. It is important to tell your physician if you are taking:
- Lithium salts
- Digitalis
- Warfarin
- Rifampin
- Erythromycin
- Fluconazole
- Phenobarbital
- Cimetidine
- Non-steroidal anti-inflammatory drugs (such as indomethacin)
Diuretics (water pills)-patients on diuretics may occasionally
experience an excessive reduction of blood pressure after initiation of therapy with phl-LOSARTAN
Potassium supplements or salt substitutes containing
potassium
- Other blood pressure medicines
Certain medicines tend to increase your blood pressure, for example, some, but not all, non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.
PROPER USE OF THIS MEDICATION
Usual Dose:
Take phl-LOSARTAN every day exactly as your physician
has instructed. It is important to continue taking phl-LOSARTAN for as long as your physician prescribes it in order to maintain smooth control of your blood pressure.
phl-LOSARTAN may be taken with or without food, but it should be taken consistently with respect to food intake, at about the same time every day.
Hypertension
For adult patients, the usual starting dose is 50 mg once daily.
The usual dose range is 50 to 100 mg once daily.
Most older patients require the same dose as younger patients,
since phl-LOSARTAN works equally well and is equally well tolerated by most older and younger adult patients.
For pediatric patients (6-16years of age) who can swallow
tablets, the recommended dose is 25 mg once daily in patients between 20 and 49 kg. The dose can be increased to a maximum of 50 mg once daily. In patients greater or equal to 50 kg, the starting dose is 50 mg once daily. The dose can be increased to a maximum of 100 mg once daily.
Type 2 diabetes patients with proteinuria and hypertension
For adults, the usual starting dose is 50 mg once daily. The
dose may be increased to 100 mg once daily.
Overdose:
In case of an overdose, contact a physician, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
Missed Dose:
Try to take phl-LOSARTAN daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Any medicine may have unintended or undesirable effects, so-called side effects. Some patients may experience fatigue, hives, taste alteration or vomiting. Tell your physician or pharmacist promptly about these or any other unusual symptoms.
Some patients, especially those with type 2 diabetes with protein in the urine, may also develop increased levels of potassium in their blood.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
Allergic reactions involving swelling of the face, lips, throat, and/or tongue which may cause difficulty in breathing or swallowing. | T | |||
| Rash | T | |||
| Light-Headedness/ Dizziness | T | |||
| Low blood pressure | T | |||
| Muscle pain | T | |||
Muscle tenderness or weakness or dark/brown urine (sign of rhabdomyolysis*) | T | |||
* Rhabdomyolysis is a muscle-wasting disease which in rare cases can lead to kidney failure.
This is not a complete list of side effects. For any unexpected effects while taking phl-LOSARTAN, contact your physician or pharmacist.
HOW TO STORE IT
Store phl-LOSARTAN at room temperature between 15°C and 30°C. Keep container tightly closed. Protect from light.
Keep all medicines out of the reach of children.
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, Ontario
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.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmel Inc. at 1-888-550-6060.
Pharmel Inc.
Montreal Quebec
H4P 2T4