PRV-Ramipril: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

High Blood Pressure (Hypertension)

prv-RAMIPRIL 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 prv-RAMIPRIL 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:

prv-RAMIPRIL 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 prv-RAMIPRIL regularly even if you feel fine.

When it should not be used:

Do not take prv-RAMIPRIL 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 prv-RAMIPRIL 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 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 ingredient is:

ramipril

What the nonmedicinal ingredients are:

prv-RAMIPRIL 2.5 mg: contains gelatin, methyl paraben, propyl paraben, carmoisine, ponceau 4R, sunset yellow and titanium dioxide.

prv-RAMIPRIL 5 mg: contains gelatin, methyl paraben, propyl paraben, brilliant blue, carmoisine, ponceau 4R, and titanium dioxide.

prv-RAMIPRIL 10 mg: contains gelatin, methyl paraben, propyl paraben, brilliant blue, carmoisine, erythrosine, and titanium dioxide.

prv-RAMIPRIL is available in hard gelatin capsules in the following potencies:

2.5 mg: Orange/white coloured hard gelatin capsules, size 4; with ‘2.5’ imprinted in black on body, filled with a homogenous white to off white powder.

5.0 mg: Maroon/white coloured hard gelatin capsules, size 4; with ‘5’ imprinted in black on body, filled with a homogenous white to off white powder.

10.0 mg: Blue/white coloured hard gelatin capsules, size 4; with ‘10’ imprinted in black on body, filled with a homogenous white to off white powder.

What dosage forms it comes in:

Capsules 2.5 mg, 5.0 mg and 10.0 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use prv-RAMIPRIL 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 had a heart attack or stroke.
• Have heart failure.
• Have diabetes, liver or kidney disease.
• Are on dialysis or LDL apheresis (a treatment to remove LDL cholesterol from the blood).
• 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”) or other medicinal products that may increase potassium.. Use of prv-RAMIPRIL 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 prv-RAMIPRIL 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 prv-RAMIPRIL is not recommended.

  You may become sensitive to the sun while taking prv-RAMIPRIL. 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 prv-RAMIPRIL.

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

• Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, a potassium-sparing diuretic (a specific kind of “water pill”) or other medicinal products that may increase potassium. Use of prv-RAMIPRIL with these medicines is not recommended.
• Alcohol
• Allopurinol used to treat gout.
• Antidiabetic drugs, including insulin and oral medicines, in particular vildagliptin.
• Lithium used to treat bipolar disease.
• Gold for the treatment of rheumatoid arthritis.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
• Blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs).
• Nitrates used to treat angina (chest pain)
• Acetylsalicylic acid (aspirin)
• Heparin used to prevent and treat blood clots.
• Immunosuppressants used to lower the body’s ability to reject a transplanted organ.
• Corticosteroids used to treat joint pain and swelling or for other conditions.
• Procainamide used to treat irregular heartbeat
• Cytostatic-medicines used to treat certain types of cancer
• mTOR inhibitors (e.g. temsirolimus) used to lower the body’s ability to reject a transplant or to treat certain types of cancer.

PROPER USE OF THIS MEDICATION

Take prv-RAMIPRIL exactly as prescribed. It is recommended to take your dose at about the same time every day. Capsules should be swallowed whole. DO NOT open, divide, crush or chew the capsules.

Usual adult dose:

High Blood Pressure: The recommended initial dosage of prv-RAMIPRIL 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 prv-RAMIPRIL 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, difficulty in maintaining your balance while standing
• drowsiness, fatigue, weakness
• cough, nasal or sinus congestion, swollen lymph nodes, bronchitis, aggravated asthma
• rash, itching, flushing, inflammation of the eye (pink eye), skin inflammation or red skin, burning sensation, inflammation of the mouth or tongue.
• headache
• abdominal pain
• sad mood, difficulty with sleep, restlessness, attention disturbances.
• loss of hair
• taste modifications or loss of taste, vision or hearing modifications.
• Impotence/reduced libido, breast enlargement in males

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

prv-RAMIPRIL 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 prv-RAMIPRIL, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store in original container at room temperature (15- 30ºC). Protect from light and moisture, and not beyond the date indicated on the container.

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 found by contacting:

Pharmapar Inc.

1565 boul. Lionel-Boulet

Varennes (QC)

J3X 1P7

Phone# (514) 731-2003; Fax: (514) 731-2004

or by e-mail, at: info@pharmapar.ca

Date of Preparation: September 5, 2017

RASILEZ^® is a trade-mark of Novartis AG, Switzerland.