Losartan/HCT: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LOSARTAN/HCT lowers high blood pressure

What it does:

LOSARTAN/HCT contains a combination of 2 drugs, losartan component and hydrochlorothiazide:

• Losartan component 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 LOSARTAN/HCT regularly even if you feel fine.

When it should not be used:

Do not take LOSARTAN/HCT if you:

• are allergic to losartan potassium and hydrochlorothiazide or

  any of the non-medicinal ingredients (see the section What the non-medicinal ingredients are);

• are allergic to any sulfonamide-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. Be sure to tell your doctor, nurse, or pharmacist that his has happened to you.

• have been diagnosed with hereditary angioedema: an

  increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.

• have difficulty urinating or produce no urine.

• are already taking a blood-lowering medicine that contains

  aliskiren (such as Rasilez) and you have diabetes or kidney disease.

• are pregnant or intend to become pregnant. Taking

  LOSARTAN/HCT during pregnancy can cause injury and even death to your baby.

• are breastfeeding. LOSARTAN/HCT passes into breast milk.

• have one of the following rare hereditary diseases since lactose

  is a non-medicinal ingredient in LOSARTAN/HCT:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

What the medicinal ingredients are:

Losartan potassium and hydrochlorothiazide.

What the non-medicinal ingredients are:

LOSARTAN/HCT 50/12.5 mg tablets contains the following non-medicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and silicon dioxide. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and D&C Yellow #10 aluminum lake.

LOSARTAN/HCT 100/12.5 mg tablets contains the following non-medicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and silicon dioxide. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

LOSARTAN/HCT 100/25 mg tablets contains the following non-medicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and silicon dioxide. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and D&C Yellow #10 aluminum lake.

Although LOSARTAN/HCT 50/12.5 mg, 100/12.5 mg and 100/25 mg tablets contain very small amounts of potassium, they cannot replace potassium supplements. If your physician has prescribed potassium supplements, continue to follow his advice.

What dosage forms it comes in:

LOSARTAN/HCT is available as tablets: 50/12.5 mg, 100/12.5 mg and 100/25 mg.

WARNINGS AND PRECAUTIONS

Serious Warning and Precautions - Pregnancy LOSARTAN/HCT should not be used during pregnancy. If you discover that you are pregnant while taking LOSARTAN/HCT, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use LOSARTAN/HCT, talk to your doctor, nurse or pharmacist if:

• 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 recently received or are planning to get allergy shots for bee or wasp stings.
• have heart failure.
• have diabetes, liver or kidney disease.

• you are taking a medicine that contains aliskiren, such as

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

• you are taking an angiotensin-converting-enzyme inhibitor

  (ACEI).

• you 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.
• are receiving gold (sodium aurothiomalate) injections

• have to undergo any kind of surgery and general anesthesia (even at the dentist's office). Tell the physician or dentist that you are taking LOSARTAN/HCT, as there may

  be a sudden fall in blood pressure associated with general anesthesia.

• are hypersensitive to this drug or to any ingredient in the formulation.

Hydrochlorothiazide in LOSARTAN/HCT 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 LOSARTAN/HCT.

You may become sensitive to the sun while taking LOSARTAN/HCT. 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 LOSARTAN/HCT. Dizziness, light headedness, or fainting can especially occur after the first dose and when the dose is increased.

Taking LOSARTAN/HCT 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 LOSARTAN/HCT, contact immediately your physician.

It is possible that LOSARTAN/HCT passes into breast milk. You should discuss with your physician about taking

LOSARTAN/HCT while breastfeeding.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions 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 LOSARTAN/HCT:

• 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.
• Amphoterecin 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.
• Calcium or Vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Digoxin, a heart mediation.
• Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
• Drugs used to treat epilepsy, including carbamazepine and topiramate.
• Gout metidations, including allopurinol and probenecid.
• Glycyrrhizin (found in liquorice)
• Lithium used to treat bipolar disease.
• Medicines that may cause high blood pressure (adrenaline)
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
• Other blood pressure lowering drugs. When taken in combination with LOSARTAN/HCT, they may cause excessively low blood pressure.
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
• Sympathomimetics which may be found in some decongestants, cough/cold, hay fever, sinus medicines

PROPER USE OF THIS MEDICATION

Take LOSARTAN/HCT exactly as prescribed. It is recommended to take your dose at about the same time everyday.

LOSARTAN/HCT can be taken with or without food. If LOSARTAN/HCT causes upset stomach, take it with food or milk.

Usual Adult Dose:

• Take LOSARTAN/HCT every day exactly as your doctor has instructed. It is important to continue taking LOSARTAN/HCT for as long as your physician prescribes it in order to maintain smooth control of your blood pressure.
• The usual dose of LOSARTAN/HCT for most patients with high blood pressure is 1 tablet of LOSARTAN/HCT 50 mg/12.5 mg per day to control blood pressure over the 24-hour

period.

Overdose:

If you think you have taken too much LOSARTAN/HCT, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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 AND WHAT TO DO ABOUT THEM

Side effects may include:

• Back or leg pain, muscle cramps, spasms and pain, weakness, restlessness, joint pain
• 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
• Drowsiness, insomnia
• Erectile dysfunction / impotence
• Reduced libido
• Increased sensitivity to the sun
• A feeling of dizziness or lightheadedness due to a sudden drop in blood pressure when standing up quickly.
• Cramping
• Fatigue
• Hives, itch and bruising
• Taste alteration
• Seeing more of the colour yellow in your vision, or temporary blurred vision
• Dry cough, nasal congestion and upper respiratory infections
• Fever

If any of these affects you severely, tell your doctor, nurse or pharmacist.

LOSARTAN/HCT can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking LOSARTAN/HCT, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Keep container tightly closed and store LOSARTAN/HCT at room temperature (15°C-30°C). Protect from light. Protect from moisture.

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:

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• 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, 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company, at: 1-866-254-6111.

Actavis Pharma Company

6733 Mississauga Road, Suite 400

Mississauga ON

L5N 6J5

Last revised: November 3, 2014