Teva-Ramipril/HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-RAMIPRIL/HCTZ lowers high blood pressure.

What it does:

TEVA-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 TEVA-RAMIPRIL/HCTZ regularly even if you feel fine.

When it should not be used:

Do not take TEVA-RAMIPRIL/HCTZ if you:

• are allergic to ramipril, hydrochlorothiazide or to any 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 TEVA-RAMIPRIL/HCTZ during pregnancy can cause injury and even death to your baby.

  • are breastfeeding. TEVA-RAMIPRIL/HCTZ 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 on dialysis or LDL apheresis (a treatment to remove LDL cholesterol from the blood).
  • have diabetes or kidney disease and are already taking:
  • a blood pressure-lowering medicine that contains aliskiren (such as Rasilez^®)
  • an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

What the medicinal ingredients are:

Ramipril and hydrochlorothiazide

What the important nonmedicinal ingredients are:

Microcrystalline cellulose, magnesium hydroxide and sodium stearyl fumarate.

What dosage forms it comes in:

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

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

WARNINGS AND PRECAUTIONS

BEFORE you use TEVA-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 or 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”). Use of TEVA-RAMIPRIL/HCTZ with these medicines is not recommended.
• 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, such as Rasilez, used to lower high blood pressure. The combination with TEVA-RAMIPRIL/HCTZ is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. The combination with TEVA-RAMIPRIL/HCTZ is not recommended.

Hydrochlorothiazide in TEVA-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 TEVA-RAMIPRIL/HCTZ.

You may become sensitive to the sun while taking TEVA-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 TEVA-RAMIPRIL/HCTZ.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to TEVA-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 TEVA-RAMIPRIL/HCTZ:

• Adrenocorticotropic hormone (ACTH) used to treat West Syndrome.
• Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”). Use of TEVA-RAMIPRIL/HCTZ with these medicines is not recommended.
• 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.
• Gold for the treatment of rheumatoid arthritis.
• Antidiabetic drugs, including insulin and oral medicines, in particular vildagliptin.
• Acetylsalicylic acid (aspirin)
• Sympathomimetics which may be found in some decongestants, cough/cold medicines.
• Nitrates used to treat angina (chest pain)
• Heparin used to prevent and treat blood clots
• Immunosuppressants used to lower the body’s ability to reject a transplanted organ.
• Procainamide used to treat irregular heartbeats.
• Cytostatic medicines used to treat certain types of cancer.
• 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.
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
• Blood pressure-lowering drugs, including diuretics (“water pills”), methyldopa, aliskiren-containing products (e.g. Rasilez^®), or angiotensin receptor blockers (ARBs).
• mTOR inhibitors (e.g. temsirolimus) used to lower the body’s ability to reject a transplanted organ or to treat certain types of cancer.

PROPER USE OF THIS MEDICATION

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

Take TEVA-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.

TEVA-RAMIPRIL/HCTZ can be taken with or without food. If TEVA-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 one tablet of TEVA-RAMIPRIL/HCTZ 2.5 mg/12.5 mg. The maximum daily dose of TEVA-RAMIPRIL/HCTZ is 10 mg/50 mg.

Overdose:

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.

TEVA-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 TEVA-RAMIPRIL/HCTZ, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store TEVA-RAMIPRIL/HCTZ in original container at room temperature, between 15 and 25ºC and not beyond the date indicated on the container.

Keep out of reach of children.

Reporting Side Effects

MORE INFORMATION

This document plus the full Product Monograph prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 1255005 (English);

1-877-777-9117 (French); or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada

M1B 2K9

Last revised: November 13, 2014