Bio-Losartan: Uses, Side Effects and Dosage

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:

Bio-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 Bio-LOSARTAN if you are allergic to losartan potassium or any of the non-medicinal ingredients (see the section What the non-medicinal ingredients are).

Do not take Bio-LOSARTAN if you are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.

What the medicinal ingredient is:

Each tablet contains losartan potassium.

What the non-medicinal ingredients are:

Bio-LOSARTAN tablets contain the following non-medicinal ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide.

Bio-LOSARTAN tablets 25 mg, 50 mg and 100 mg contain the following amounts of potassium: 2.12 mg (<1 mmol), 4.24 mg (<1 mmol), and 8.48 mg (<1 mmol) respectively.

Although Bio-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:

Bio-LOSARTAN tablets of 25 mg, 50 mg and 100 mg.

WARNINGS AND PRECAUTIONS

Serious Warning and Precautions

Bio-LOSARTAN® should not be used during pregnancy. If you discover that you are pregnant while taking Bio-LOSARTAN, stop the medication and please contactyour physician.

BEFORE you use Bio-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 a medicine that contains aliskiren, such as

  Rasilez, used to lower high blood pressure. The combination with Bio-LOSARTAN is not recommended.

• you are taking an angiotensin-converting-enzyme inhibitor

  (ACEI).

• 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 Bio-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 Bio-LOSARTAN, contact immediately your physician.

It is possible that Bio-LOSARTAN passes into breast milk. You should discuss with your physician about taking Bio-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 Bio-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 Bio-LOSARTAN every day exactly as your physician

  has instructed. It is important to continue taking Bio-LOSARTAN for as long as your physician prescribes it in order to maintain smooth control of your blood pressure.

• Bio-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 Bio-LOSARTAN works equally well and is equally well tolerated by most older and younger adult patients.

• For pediatric patients (6-16 years 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 Centre immediately, even if there are no symptoms.

Missed Dose:

Try to take Bio-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.

* 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 Bio-LOSARTAN, contact your physician or pharmacist.

HOW TO STORE IT

Store Bio-LOSARTAN tablets at room temperature (15°C to 30°C). 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 ww.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 the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Biomed Pharma.

Biomed Pharma

100-5950, Ch. de la Côte de Liesse

Mont-Royal

Qc, H4T 1E2

Phone# (514) 731-2003; Fax: (514) 731-2004

Date of Preparation: September 14, 2015