Jamp Quinapril / HCTZ: Uses, Side Effects and Dosage

What is JAMP Quinapril / HCTZ used for?

JAMP Quinapril / HCTZ lowers high blood pressure.

How does JAMP Quinapril / HCTZ work?

JAMP Quinapril / HCTZ contains a combination of 2 drugs, quinapril hydrochloride and hydrochlorothiazide:

• Quinapril hydrochloride 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 JAMP Quinapril / HCTZ regularly even if you feel fine.

What are the ingredients in JAMP Quinapril / HCTZ?

Medicinal ingredients: Quinapril (as quinapril hydrochloride) and hydrochlorothiazide

Non-medicinal ingredients: Basic magnesium carbonate, crospovidone, hydroxypropylcellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, povidone K-30 and titanium dioxide.

JAMP Quinapril / HCTZ comes in the following dosage forms:

Tablets:

1. 10 mg quinapril (as 10.8 mg quinapril hydrochloride) and 12.5 mg hydrochlorothiazide

20 mg quinapril (as 21.7 mg quinapril hydrochloride) and 25 mg hydrochlorothiazide

JAMP Quinapril / HCTZ is NOT available in 20 mg / 12.5 mg strength. For 20 mg / 12.5 mg strength, please refer to another quinapril and hydrochlorothiazide tablet product.

Do not use JAMP Quinapril / HCTZ if you:

• Are allergic to quinapril hydrochloride or hydrochlorothiazide or to any non-medicinal ingredients in the formulation
• Have a condition causing your body's immune system to attack your own tissues (collagen vascular disease)
• 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 healthcare professional 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 taking Entresto (sacubitril / valsartan), due to the increased risk of serious allergic reaction which causes swelling of the face or throat (angioedema) when taken with JAMP Quinapril / HCTZ.
• Have difficulty urinating or produce no urine

• Are pregnant or intend to become pregnant. Taking JAMP Quinapril / HCTZ during pregnancy can cause injury and even death to your baby

• Are breastfeeding. JAMP Quinapril / HCTZ passes into breast milk.

• Are taking aliskiren-containing medicines, such as Rasilez, and have one of the following conditions:

  • Diabetes
  • Kidney disease
  • High levels of potassium
  • Congestive heart failure combined with hypotension

• Are taking an angiotensin receptor blocker (ARB), another medicine to treat your high blood pressure, and have one of the following conditions:

  • Diabetes with end organ damage
  • Kidney disease
  • High levels of potassium
  • Congestive heart failure combined with hypotension.

You can recognize ARBs because their medicinal ingredient ends in “-SARTAN”

• Have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in JAMP Quinapril / HCTZ.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Quinapril / HCTZ. Talk about any health conditions or problems you may have, including if you:

• Are allergic to any drug used to lower blood pressure or penicillin
• Have a condition causing your body's immune system to attack your own tissues (collagen vascular disease)
• 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 problems
• Have lupus or gout
• Are on dialysis or receiving LDL apheresis (treatment to remove “bad 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”)
• Are taking an antibiotic containing trimethoprim
• Are on a low-salt diet
• Are receiving gold (sodium aurothiomalate) injections
• Are less than 18 years old
• Are taking a neutral endopeptidase inhibitor. The combination with JAMP Quinapril / HCTZ is not recommended.
• Are taking an aliskiren-containing medicine, such as Rasilez, used to lower high blood pressure. The combination with JAMP Quinapril / HCTZ is not recommended.
• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”
• Are taking a medicine that contains aliskiren, such as Rasilez, or an angiotensin receptor blocker (ARB). The combination with JAMP Quinapril / HCTZ is not recommended.
• Are currently taking anticancer (temsirolimus, everolimus), anti-rejection (sirolimus) or antidiabetic (gliptins) drugs. Use of ACE inhibitors, such as JAMP Quinapril / HCTZ, with these drugs may increase the chance of having an allergic reaction.
• Have had skin cancer or have a family history of skin cancer.
• Have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.
• Have a medical history or family history of psoriasis (rash with itchy, scaly patches usually on the knees, elbows, trunk and scalp).

• Have had breathing or lung problems (including inflammation or fluid in the lungs) in the past

  • the use of medication containing hydrochlorothiazide. If you experience any severe shortness of breath or difficulty breathing after taking JAMP Quinapril / HCTZ, stop the medication and seek medical attention immediately.

Other warnings you should know about:

Risk of skin cancer:

• JAMP Quinapril / HCTZ contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking JAMP Quinapril / HCTZ for many years (more than 3) or at a high dose.

• While taking JAMP Quinapril / HCTZ:

  • Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
  • Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
  • Talk to your healthcare professional immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during the treatment

Hydrochlorothiazide in JAMP Quinapril / HCTZ can cause sudden eye disorders:

• Choroidal effusion: an abnormal buildup of liquid behind the white outer layer of your eye that may result in vision changes.
• Myopia: sudden nearsightedness or blurred vision
• Glaucoma: an increased pressure in your eye, eye pain. Untreated, it may lead to permanent vision loss

If your vision changes, stop taking JAMP Quinapril / HCTZ and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting JAMP Quinapril / HCTZ.

You may become sensitive to the sun while taking JAMP Quinapril / 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 healthcare professional or dentist that you are taking JAMP Quinapril / HCTZ.

Driving and using machines: before you perform tasks, which may require special attention, wait until you know how you respond to JAMP Quinapril / HCTZ. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.

Hydrochlorothiazide in JAMP Quinapril / HCTZ can cause sudden respiratory toxicity, called Acute Respiratory Distress Syndrome (ARDS)

• Treatment with hydrochlorothiazide can lead to pulmonary edema, accumulation of fluid

  • the medicine.
• Talk to your healthcare professional immediately if you experience sudden onset in difficulty or laboured breathing, fever, and low blood pressure (e.g. dizziness or lightheadedness). Stop taking JAMP Quinapril / HCTZ and seek immediate medical help.

Development or worsening symptoms of psoriasis:

JAMP Quinapril / HCTZ can cause or worsen psoriasis. Speak to your healthcare professional if you experience symptoms of psoriasis or worsening psoriasis.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with JAMP Quinapril / HCTZ:

• Adrenocorticotropic hormone (ACTH) used to treat West Syndrome
• Alcohol, narcotics (strong pain medications) or barbiturates (sleeping pills). They may cause low blood pressure and dizziness when you go from lying down or sitting to standing up.
• Amphotericin B, an antifungal drug
• Anticancer drugs, including cyclophosphamide, methotrexate, temsirolimus and everolimus
• Anti-rejection drugs, such as sirolimus (Rapamune)
• Antidepressants, in particular monoamine oxidase inhibitors (MAOI) or selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline
• Antidiabetic drugs including insulin and oral medicines (e.g. metformin, gliptins, sulfonylureas)
• Bile acid resins used to lower cholesterol
• Calcium or vitamin D supplements
• Corticosteroids used to treat joint pain and swelling
• Chronic heart failure drugs such as Entresto (sacubitril / valsartan)
• Digoxin, a heart medication
• Drugs known to increase the potassium level in the blood such as a salt substitute that contains potassium, potassium supplements, potassium-sparing diuretic (a specific kind of “water pill”) (e.g. spironolactone, triamterene, amiloride, sulfamethoxazole/trimethoprim).
• Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone
• Drugs used to treat epilepsy, including carbamazepine and topiramate
• Drugs that lower blood sugar such as DDP-IV inhibitors (linagliptin, saxagliptin, sitagliptin).
• Gold for the treatment of rheumatoid arthritis
• Gout medications, including allopurinol and probenecid
• Lithium used to treat bipolar disease
• Neutral endopeptidase (NEP) inhibitors used to treat heart failure
• 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

  • blockers (ARBs).
• Pressor amines (drugs which increase blood pressure, such as adrenaline)
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare
• Tetracycline (a type of antibiotic)

How to take JAMP Quinapril / HCTZ:

JAMP Quinapril / HCTZ is not for initial therapy. You must first be stabilized on the individual medicinal ingredients (quinapril hydrochloride and hydrochlorothiazide) of JAMP Quinapril / HCTZ. If your dosage matches the dosages in JAMP Quinapril / HCTZ, your healthcare professional may prescribe JAMP Quinapril / HCTZ taken once a day (instead of each medicinal ingredient as a separate pill).

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

JAMP Quinapril / HCTZ can be taken with or without food.

If JAMP Quinapril / HCTZ causes upset stomach, take it with food or milk.

Usual adult dose:

The recommended starting dose is one 10 mg / 12.5 mg tablet daily

Overdose:

Missed Dose:

If you have forgotten to take your dose during the day, take it as soon as you remember. If it is almost time for the next dose, the missed dose should be skipped. Carry on with the next dose at the usual time. Do NOT double dose.

What are possible side effects from using JAMP Quinapril / HCTZ?

These are not all the possible side effects you may have when taking JAMP Quinapril / HCTZ. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Dizziness, headache, trouble sleeping
• Drowsiness, fatigue, weakness
• Cough
• Rash, itching
• Abdominal pain, upset stomach, decreased appetite, constipation,
• Muscle pain, spasms, back pain, restlessness
• Pins and needles in your fingers
• Nausea, vomiting, diarrhea
• Sore throat
• Stuffy, runny nose
• Reduced libido

JAMP Quinapril / HCTZ can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store at 15-25°C. Protect from moisture. Keep in well-closed container. Keep out of reach and sight of children.

If you want more information about JAMP Quinapril / HCTZ:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); or by calling 1-866-399-9091

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last revised: MAY 03, 2024