Ramipril Capsules (Ranbaxy Pharmaceuticals Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

High Blood Pressure (Hypertension)

RAMIPRIL CAPSULES lowers high blood pressure. It can be used alone or together with a diuretic (“water pill”).

Managing your lifestyle

Keeping your blood pressure controlled

It takes more than just medication to reduce blood pressure. Discuss the risk factors, and how they apply to your lifestyle, with your doctor. You may have to modify some of your daily habits to keep your blood pressure down.

Exercise regularly. It will help to keep your weight down, make you feel more energetic and is a good way to deal with stress. If you are not exercising regularly, be sure to discuss a fitness plan with your doctor.

Remember, hypertension is a long-term disease without symptoms. Just because you feel fine does not mean you can stop taking your medication. If you stop, serious complications of the disease may occur. Therefore, you should continue to take RAMIPRIL CAPSULES regularly, as prescribed by your doctor.

The "lifestyle" part of your treatment is as important as your medication. By working as a team with your doctor, you can help reduce the risk of complications to maintain the style of life you are accustomed to.

• Alcohol: Avoid alcoholic beverages until you have discussed their use with your doctor. Alcohol consumption may alter your blood pressure and/or increase the possibility of dizziness or fainting.

• Diet: Generally, avoid fatty foods and food that is high in salt or cholesterol.
• Smoking: Avoid it completely.

What it does:

RAMIPRIL CAPSULES is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking RAMIPRIL CAPSULES regularly even if you feel fine.

When it should not be used:

Do not take RAMIPRIL CAPSULES if you:

• Are allergic to ramipril or to any non-medicinal ingredient in the formulation.
• 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 CAPSULES during pregnancy can cause injury and even death to your baby.

• Are breastfeeding. Ramipril passes into breast milk.
• Have narrowing of the arteries to one or both kidneys (renal artery stenosis).
• Have hypotension (low blood pressure).
• Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes and/or kidney disease.

What the medicinal ingredient is:

ramipril

What the nonmedicinal ingredients are:

Non-medicinal ingredients in all capsules include: black iron oxide, gelatin, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide.

In addition, RAMIPRIL CAPSULES 1.25 mg contains: iron oxide yellow RAMIPRIL CAPSULES 2.5 mg contains: D&C Yellow 10 and FD&C Red 40 RAMIPRIL CAPSULES 5 mg contains: FD&C Blue 1 and FD&C Red 40 RAMIPRIL CAPSULES 10 mg contains: D&C Yellow 10, FD&C Blue 2 and FD&C Red 3.

What dosage forms it comes in:

Capsules 1.25 mg, 2.5 mg, 5.0 mg, and 10.0 mg.

WARNINGS AND PRECAUTIONS

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

• Are allergic to any drug used to lower blood pressure.
• Have recently received or are planning to get allergy shots for bee or wasp stings.
• Have narrowing of an artery or a heart valve.
• Have heart failure.
• Have diabetes, liver or kidney disease.
• 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”). Use of RAMIPRIL CAPSULES 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 RAMIPRIL CAPSULES is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

You may become sensitive to the sun while taking RAMIPRIL CAPSULES. 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 RAMIPRIL CAPSULES.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to RAMIRPIL CAPSULES. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Raynaud's phenomenon is a condition resulting from poor circulation in the extremities (i.e., fingers and toes). It may begin or get worse.

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 CAPSULES:

• 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 RAMIPRIL CAPSULES with these medicines is not recommended.

• Allopurinol used to treat gout.

  • Antidiabetic drugs, including insulin and oral medicines.
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Other blood pressure lowering drugs, including diuretics (“water pills”). When taken in combination with RAMIPRIL CAPSULES, they may cause excessively low blood pressure.
  • Nitrates
  • ASA (aspirin)
  • Heparin
  • Immunosuppressants
  • Corticosteroids
  • Procainamide
  • Cytostatics.
  • Other substances that may change the normal results expected to be measured on a routine blood test.
  • Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs).

PROPER USE OF THIS MEDICATION

Take RAMIPRIL CAPSULES exactly as prescribed. It is recommended to take your dose at about the same time everyday.

Usual adult dose:

High Blood Pressure: The recommended initial dosage of RAMIPRIL CAPSULES is 2.5 mg once daily. Your doctor will determine the appropriate dosage.

For patients taking diuretics (“water pills”) or with impaired kidney function: The recommended initial dosage of RAMIPRIL CAPSULES is 1.25 mg daily.

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
• drowsiness, fatigue, weakness
• cough
• rash, itching, flushing
• headache
• abdominal pain
• sad mood

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

Other side effects may include: difficulty in maintaining your balance while standing, nasal or sinus congestion, swollen lymph nodes, bronchitis, loss of hair, impotence/reduced libido, difficulty with sleep, restlessness, inflammation of the eye (pink eye), taste modifications or loss of taste, vision or hearing modifications, attention disturbances, skin inflammation or red skin, burning sensation, inflammation of the mouth or tongue, aggravated asthma, breast enlargement in males.

RAMIPRIL CAPSULES 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 CAPSULES, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store in original container at room temperature, between 15° C - 30º C. Protect from light and moisture.

Keep out of reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

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

RANBAXY

Ranbaxy Pharmaceuticals Canada Inc.,

2680 Matheson Blvd. E., Suite 200

Mississauga, Ontario

L4W 0A5

Last revised: November 28, 2013

MORE INFORMATION