Ramipril-HCTZ (Sanis Health): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for

RAMIPRIL-HCTZ lowers high blood pressure.

What it does

RAMIPRIL-HCTZ contains a combination of 2 drugs, ramipril and hydrochlorothiazide:

• Ramipril is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’. 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 RAMIPRIL-HCTZ regularly even if you feel fine

When it should not be used

Do not take RAMIPRIL-HCTZ if you:

• Are allergic to ramipril, hydrochlorothiazide, or to any

  of the non-medicinal ingredient 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 ACE inhibitor or without a known cause. 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.

• Are pregnant or intend to become pregnant. Taking

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

• Are breastfeeding. Ramipril and hydrochlorothiazide

  passes into breast milk.

  • Have narrowing of the arteries to one or both kidneys

    (renal artery stenosis).

  • Have difficulty urinating or produce no urine.
  • Have hypotension (low blood pressure).
  • Are already taking a blood pressure-lowering medicine that contains aliskiren and you have diabetes and/or kidney disease.

What the medicinal ingredients are

ramipril and hydrochlorothiazide.

What the nonmedicinal ingredients are

Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Lactose, Microcrystalline Cellulose, and Sodium Stearyl Fumarate. The 5 mg/12.5 mg, 10 mg/12.5 mg & 10 mg/25 mg strengths also contain Red Iron Oxide. The 10 mg/12.5 mg strength also contains Yellow Iron Oxide.

What dosage forms it comes in

RAMIPRIL-HCTZ is available in tablets of the following strengths.

• 5 mg ramipril/12.5 mg hydrochlorothiazide
• 10 mg ramipril/12.5 mg hydrochlorothiazide
• 5 mg ramipril/25 mg hydrochlorothiazide
• 10 mg ramipril/25 mg hydrochlorothiazide

WARNINGS AND PRECAUTIONS

Serious Warning and Precautions - Pregnancy

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

BEFORE you use RAMIPRIL-HCTZ talk to your doctor, nurse or pharmacist if you:

• Have had a heart attack or stroke.
• Have heart failure.
• Have narrowing of an artery or a heart valve.
• Have diabetes, liver or kidney disease.
• Are on dialysis or LDL apheresis (a treatment to remove LDL cholesterol from the blood);
• Are allergic to any drug used to lower blood pressure or penicillin.
• Have recently received or are planning to get allergy shots for bee/wasp stings.
• Have lupus or gout.
• Have Raynaud’s phenomenon (a condition resulting from poor circulation in the extremities, such as fingers and toes). It may begin or worsen.

•

• Have scleroderma (disease that can cause thickening, hardening, or tightening of the skin, blood vessels and

internal organs);

• 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 receiving gold (sodium aurothiomalate)

  injections.

• Are less than 18 years old.

• Are taking a medicine that contains aliskiren used to

  lower high blood pressure. The combination with ALTACE HCT is not recommended.

• Are taking an angiotensin receptor blocker (ARB).

  You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

Your doctor may order regular blood tests or blood pressure checks, to monitor your health, liver and kidney function.

Hydrochlorothiazide in RAMIPRIL-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 RAMIPRIL-HCTZ.

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

If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking pmg-RAMIPRIL-HCTZ.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to RAMIPRIL-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 RAMIPRIL-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.
  • Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
  • Bile acid resins used to lower cholesterol.
  • Calcium or vitamin D supplements
  • Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.

  • Diuretics (water pills), potassium retaining diuretics

    (such as spironolactone, triamterene or amiloride)

  • Digoxin, a heart medication
  • Lithium used to treat bipolar disease
  • Antidiabetic drugs, including insulin and oral medicines
  • Acetylsalicylic acid
  • Sympathomimetics which may be found in some decongestants, cough/cold medicines
  • Nitrates
  • Heparin
  • Procainamide, cytostatics and other substances that may change the normal results expected to be measured on a routine blood test.
  • Gout medications, including allopurinol and probenecid
  • Corticosteroids used to treat joint pain and swelling or for other conditions.
  • Anticancer drugs, including cyclophosphamide and methotrexate
  • Carbenoxolone, large amount of liquorice, table salt or laxatives
  • Drugs used to treat epilepsy, including carbamazepine and topiramate.
  • 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 RAMIPRIL-HCTZ, they may cause excessively low blood pressure.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.

  • Blood pressure-lowering drugs, including diuretics

    (“water pills”), aliskiren-containing products, or angiotensin receptor blockers (ARBs).

PROPER USE OF THIS MEDICATION

RAMIPRIL-HCTZ is not for initial therapy. You must first be stabilized on the individual medicinal ingredients (ramipril and hydrochlorothiazide) of RAMIPRIL-HCTZ. If your dosage matches the dosages in RAMIPRIL-HCTZ, your doctor may prescribe RAMIPRIL-HCTZ taken once a day (instead of each medicinal ingredient as a separate pill).

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

Generally, it is recommended that the daily dose be administered in the morning.

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

Swallow your tablet whole with sufficient amount of water (approximately ½ glass). Do not chew or crush the tablets.

Usual adult dose

The usual daily dose is RAMIPRIL-HCTZ 2.5mg/12.5 mg. The maximum daily dose of RAMIPRIL-HCTZ is 10 mg/50 mg.

Overdose

In case of overdosage, contact a health care practitioner, hospital emergency department or regional Poison Control center 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:

• dizziness, difficulty in maintaining your balance

  while standing

• drowsiness, fatigue, weakness
• cough
• rash
• headache

• abdominal pain, upset stomach, decreased

  appetite, constipation

• muscle pain
• flushing

• nasal or sinus congestion, bronchitis, swollen

  lymph nodes

• mouth ulcer, tongue pain
• unusual tiredness
• attention disturbances
• problems with sleeping

• sexual difficulties, impotence, reduced libido,

  breast enlargement in men

  • vision, hearing, taste or smell changes
  • loss of hair
  • eye modification (pink eye, less tearing,, yellow vision)
  • inflammation or enlargement of salivary glands
  • muscular weakness or stiffness

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

RAMIPRIL-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 RAMIPRIL-HCTZ, contact your doctor, nurse or pharmacist

HOW TO STORE IT

Store between 15°C and 25°C. Protect from heat and humidity.

Keep out of 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 found by contacting the sponsor, Sanis Health Inc., at:

Phone: 1-866-236-4076;

Fax: 905-689-1465;

or quality @sanis.com

Sanis Health Inc.

Dieppe, New Brunswick

Canada, E1A 1P2

Last revised: July 28 2014