Ran-Irbesartan HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RAN-IRBESARTAN HCTZ lowers high blood pressure.

What it does:

RAN-IRBESARTAN HCTZ is a combination of 2 drugs, irbesartan and hydrochlorothiazide:

• Irbesartan 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 RAN-IRBESARTAN HCTZ regularly even if you feel fine.

When it should not be used:

• Do not take RAN-IRBESARTAN HCTZ if you are allergic to irbesartan or hydrochlorothiazide or to any 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 (any drug in the same class as irbesartan). Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
• have difficulty in urinating or produce no urine;

• Have diabetes or kidney disease and are already taking:

  • a blood pressure-lowering medicine that contains aliskiren
  • an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’

• are pregnant or intend to become pregnant; Taking RAN-IRBESARTAN HCTZ during pregnancy can cause injury and even death to your baby.

  • are breast-feeding. RAN-IRBESARTAN HCTZ passes into breast milk.

  • have one of the following rare hereditary diseases:

    o Galactose intolerance

    o Lapp lactase deficiency

    o Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in RAN-IRBESARTAN HCTZ

RAN-IRBESARTAN HCTZ is not recommended for use in children and adolescents (under the age of 18 years).

What the medicinal ingredients are:

Irbesartan and hydrochlorothiazide.

What the nonmedicinal ingredients are:

Croscarmellose sodium, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silica colloidal anhydrous, polyethylene glycol, titanium dioxide, talc.

RAN-IRBESARTAN HCTZ 150/12.5 mg and 300/12.5 mg also contain ferric oxide red and ferric oxide yellow.

RAN-IRBESARTAN HCTZ 300 mg/25 mg also contains ferric oxide red and ferric oxide black.

What dosage forms it comes in:

RAN-IRBESARTAN HCTZ tablets are oval biconvex film-coated tablet, available in three dosage strengths:

150 mg/12.5 mg

300 mg/12.5 mg

300 mg/25 mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy

RAN-IRBESARTAN HCTZ should not to be used during pregnancy. If you discover that you are pregnant while taking RAN-IRBESARTAN HCTZ stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use RAN-IRBESARTAN HCTZ tell 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 heart failure.
• have diabetes, liver or kidney disease.
• have gout, or lupus erythematosus.
• Have psoriasis or a history of psoriasis.
• 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” that makes your body keep potassium).
• Are on a low-salt diet.
• are taking a medicine that contains aliskiren, used to lower high blood pressure. The combination with RAN-IRBESARTAN HCTZ is not recommended.
• are taking an angiotensin converting enzyme (ACE) inhibitor. The combination with RAN-IRBESARTAN HCTZ is not recommended.
• are less than 18 years old.

Hydrochlorothiazide in RAN-IRBESARTAN 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 RAN-IRBESARTAN HCTZ.

You may become sensitive to the sun while taking RAN-IRBESARTAN HCTZ Exposure to sunlight should be minimized until you know how you respond.

Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking RAN-IRBESARTAN HCTZ, as there may be a sudden fall in blood pressure associated with general anesthesia.

Hypersensitivity reactions (angioedema, urticarial, anaphylactic reactions including anaphylactic shock) have been reported.

Driving and using machines: Before you perform tasks which

may require special attention, wait until you know how you

respond to RAN-IRBESARTAN HCTZ. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

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 RAN-IRBESARTAN 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.

• Amphotericin 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.
  • Beta-blockers (medications for heart disease)
  • Bile acid resins used to lower cholesterol.
  • Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products or angiotensin converting enzyme (ACE) inhibitors.
  • Calcium or vitamin D supplements.
  • Corticosteroids used to treat joint pain and swelling and other conditions.
  • 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.
  • Hyperglycemic agent, such as diazoxide.
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes.
  • Pressor amines such as norepinephrine.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
  • Warfarin.

PROPER USE OF THIS MEDICATION

Take RAN-IRBESARTAN HCTZ every day exactly as prescribed. It is recommended to take your dose at about the same time every day.

RAN-IRBESARTAN HCTZ can be taken with or without food but it should be taken the same way each day. If RAN-IRBESARTAN HCTZ causes upset stomach, take it with food or milk.

Usual Adult dose:

Patients should be individually titrated for each component separately.

Usual maintenance dose is: 1 tablet daily.

Overdose:

If you think you have taken too much RAN- IRBESARTAN 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
• dizziness, pins and needles in your fingers, headache and fatigue
• 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
• reduced libido

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

RAN-IRBESARTAN 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 RAN-IRBESARTAN HCTZ, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store RAN-IRBESARTAN HCTZ tablets at room temperature (15 to 30°C)

Keep out of reach and sight of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document, plus the full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc., at: 1 866-840-1340

Last revised: December 7, 2018