Septa-Losartan HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Septa-Losartan HCTZ lowers high blood pressure.

What it does:

Septa-Losartan HCTZ contains a combination of 2 drugs, losartan component HCTZ:

• 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 Septa-Losartan HCTZ regularly even if you feel fine.

When it should not be used:

Do not take Septa-Losartan HCTZ if you:

• are allergic to Septa-Losartan HCTZ or any of the

  non-medicinal ingredients in the formulation.

• 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 this 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 pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.

  • are pregnant or intend to become pregnant. Taking

    Septa-Losartan HCTZ during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. Septa-Losartan HCTZ passes into breast milk.

  • Have one of the following rare hereditary diseases since lactose is a non-medicinal ingredient in Septa-Losartan HCTZ tablets:

    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption Because lactose is a non-medicinal ingredient in Septa-Losartan HCTZ tablets.

What the medicinal ingredients are:

Losartan potassium Hydrochlorothiazide

What the non-medicinal ingredients are:

Septa-Losartan HCTZ 50 mg/12.5 mg and 100 mg/25 mg contain the following non-medicinal ingredients: cellulose microcrystalline, lactose monohydrate, pregelatinised starch, magnesium stearate, titanium dioxide, hypromellose, hydroxypropyl cellulose and quinoline yellow aluminum lake.

Septa-Losartan HCTZ 50 mg/12.5 mg contains 4.24 mg (<1 mmol) of potassium, as losartan potassium. Septa-Losartan HCTZ 100 mg/25 mg contains 8.48 mg (<1 mmol) of potassium, as losartan potassium.

Although Septa-Losartan HCTZ 50 mg/12.5 mg, and 100 mg/25 mg contain a very small amount 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:

Septa-Losartan HCTZ 50 mg/12.5 mg, and 100 mg/25 mg tablets.

WARNINGS AND PRECAUTIONS

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

BEFORE you use Septa-Losartan 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 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 Septa-Losartan HCTZ is not recommended.

• you are taking an angiotensin-converting-enzyme

  inhibitor (ACEI).

• 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 Septa-Losartan HCTZ 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 Septa-Losartan 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 Septa-Losartan HCTZ.

You may become sensitive to the sun while taking Septa-Losartan 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 Septa-Losartan HCTZ. Dizziness,

lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Taking Septa-Losartan HCTZ 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 Septa-Losartan HCTZ, contact immediately your physician.

It is possible that Septa-Losartan HCTZ passes into breast milk. You should discuss with your physician about taking Septa-Losartan HCTZ 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 Septa-Losartan 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.

• 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 medication.
• 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.
• Glycyrrhizin (found in liquorice)
• Lithium used to treat bipolar disease.

• Medicines 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 Septa-Losartan HCTZ, 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 Septa-Losartan HCTZ exactly as prescribed. It is recommended to take your dose at about the same time everyday.

Septa-Losartan HCTZ can be taken with or without food. If Septa-Losartan HCTZ causes upset stomach, take it with food or milk.

Usual Adult dose:

• Take Septa-Losartan HCTZ every day exactly as

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

• The usual dose of Septa-Losartan HCTZ for most

  patients with high blood pressure is 1 tablet of Septa-Losartan HCTZ 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 Septa-Losartan HCTZ, 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.

Septa-Losartan HCTZ 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 Septa-Losartan HCTZ, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store Septa-Losartan HCTZ 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 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^TM 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 professional can be obtained by contacting the distributor Septa Pharmaceuticals, Inc. 905.564.5665.

or by email, at: info@septapharmaceuticals.com

Septa Pharmaceuticals, Inc.

7490 Pacific Circle, #1

Mississauga, ON L5T 2A3

Canada

Date of Preparation: August 13, 2014