Details for: APO-CILAZAPRIL/HCTZ
Company: APOTEX INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02284987 | APO-CILAZAPRIL/HCTZ | CILAZAPRIL (CILAZAPRIL MONOHYDRATE); HYDROCHLOROTHIAZIDE | 5 MG; 12.5 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-CILAZAPRIL/HCTZ lowers high blood pressure.
What it does
APO-CILAZAPRIL/HCTZ contains a combination of 2 drugs: cilazapril and hydrochlorothiazide.
- Cilazapril 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 APO-CILAZAPRIL/HCTZ regularly even if you feel fine.
When it should not be used
Do not take APO-CILAZAPRIL/HCTZ if you:
- Are allergic to cilazapril or hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
- Are allergic to any other blood pressure medicines of the same class (called ACE inhibitors).
- 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.
- Have difficulty urinating or produce no urine.
- Have a build up of fluid in your abdomen (ascites).
- Are taking a medicine containing a neprilysin inhibitor (e.g., sacubitril/valsartan), as the risk of angioedema is increased. Do not take APOCILAZAPRIL/HCTZ for at least 36 hours before or after you take sacubitril/valsartan, a medicine used to treat heart failure.
- Are pregnant or intend to become pregnant. Taking APO-CILAZAPRIL/HCTZ during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. APO-CILAZAPRIL/HCTZ passes into breast milk.
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ) and you have diabetes or kidney disease.
What the medicinal ingredient is
Cilazapril and hydrochlorothiazide
What the non-medicinal ingredients are
APO-CILAZAPRIL/HCTZ tablets contain the following inactive ingredients: corn starch, ferric oxide red, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide.
What dosage form it comes in
Warnings and precautions
Serious Warnings and Precautions - Pregnancy
APO-CILAZAPRIL/HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking APO-CILAZAPRIL/HCTZ, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use APO-CILAZAPRIL/HCTZ talk to your doctor, nurse or pharmacist if you:
- Are allergic to any drug used to lower blood pressure.
- Are allergic to penicillin.
- 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.
- Have lupus or gout.
- 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 collagen disease (skin disease) such as lupus (systemic lupus erythematosus) or scleroderma (a skin condition leading to hardening or thickening of the skin).
- Are on LDL apheresis (a treatment to lower the LDL cholesterol in the blood).
- Are dehydrated or recently suffered 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 drugs that may increase serum potassium (e.g., trimethoprimcontaining products).
- Are on a low-salt diet.
- Are receiving gold (sodium aurothiomalate) injections.
- Are less than 18 years old. APOCILAZAPRIL/HCTZ is not recommended for use in children.
- Are taking a medicine that contains aliskiren, such as RASILEZ, used to lower high blood pressure. The combination with APOCILAZAPRIL/HCTZ is not recommended.
- Are taking any of the following medicines, the
risk of angioedema may be increased:
- Medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus).
- DPP-IV inhibitors (e.g. alogliptin, linagliptin, saxagliptin and sitagliptin, medicines used to treat diabetes).
- Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
Risk of skin cancer:
APO-CILAZAPRIL/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 APOCILAZAPRIL/HCTZ for many years (more than 3) or at a high dose.
While taking APO-CILAZAPRIL/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 doctor 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 APOCILAZAPRIL/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 APOCILAZAPRIL/HCTZ.
You may become sensitive to the sun while taking APO-CILAZAPRIL/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 APO-CILAZAPRIL/HCTZ.
Driving and using machines: Before you perform tasks, which may require special attention, wait until you know how you respond APO CILAZAPRIL/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 APOCILAZAPRIL/HCTZ
- Adrenocorticotropic hormone (ACTH) used to treat West Syndrome.
- Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, potassium-sparing diuretics (a specific kind of “water pill,” e.g. spironolactone, triamterene, amiloride and eplerenone) or other drugs that may increase serum potassium (e.g. trimethoprimcontaining products and co-trimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots).
- 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.
- Anticancer drugs, including cyclophosphamide and methotrexate.
- Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, sertraline, and tricyclic antidepressants (e.g. amitriptyline, clomipramine, imipramine).
- Antipsychotics.
- Antidiabetic drugs, including insulin and oral medicines.
- Bile acid resins used to lower cholesterol.
- Calcium or vitamin D supplements.
- Corticosteroids used to treat joint pain and swelling.
- Digoxin, a heart medication.
- Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
- Drugs used to treat epilepsy, including carbamazepine and topiramate.
- Drugs used to treat irregular heartbeat
- Gout medications, including allopurinol and probenecid.
- 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. When taken in combination with APOCILAZAPRIL/HCTZ, they may cause excessively low blood pressure.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
- Gold salts for the treatment of rheumatoid arthritis.
- Tetracycline, an antibiotic
- Amantadine, an antiviral
- Iodine containing contrast media
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs).
- mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus)
- DPP-IV inhibitors (e.g. alogliptin, linagliptin, saxagliptin and sitagliptin)
Proper use of this medication
APO-CILAZAPRIL/HCTZ is not for initial therapy. You must first be stabilized on the individual components (cilazapril and hydrochlorothiazide) of APO-CILAZAPRIL/HCTZ. If your dosage matches the dosages in APO-CILAZAPRIL/HCTZ, your doctor may prescribe APO-CILAZAPRIL/HCTZ taken once a day (instead of each component as a separate pill).
Take APO-CILAZAPRIL/HCTZ exactly as prescribed. It is recommended to take your dose at about the same time every day.
APO-CILAZAPRIL/HCTZ tablets must not be chewed or crushed and should always be taken with a full glass of water.
APO-CILAZAPRIL/HCTZ can be taken with or without food. If APO-CILAZAPRIL/HCTZ causes upset stomach, take it with food or milk.
Overdose
If you think you have taken too much APOCILAZAPRIL/HCTZ contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effects and what to do about them
Side effects may include:
- Dizziness, headache, trouble sleeping
- Drowsiness, feeling tired, weakness
- Dry cough, dry or swollen mouth
- Runny or blocked nose, sneezing
- Rash, itching
- Abdominal pain, upset stomach, decreased appetite
- Diarrhea, constipation, nausea, vomiting
- Change in the way things taste
- Muscle cramps and/or joint pain, pins and needles sensation
- Sweating more than usual, flushing
If any of these affects you severely, tell your doctor, nurse or pharmacist.
APO-CILAZAPRIL/HCTZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
Common | |||
Low blood pressure: Dizziness, fainting, lightheadednes s May occur when you go from lying or sitting to standing up. | ✔ | ||
Nonmelanoma skin cancer: Lump or discoloured patch on the skin that stays after a few weeks and slowly changes. Cancerous lumps are red/pink and firm and sometimes turn into ulcers. Cancerous patches are usually flat and scaly. | ✔ | ||
Decreased or increased levels of potassium in the blood: Irregular heartbeats, muscle weakness and generally feeling unwell. | ✔ | ||
Uncommon | |||
Angioedema and Severe Allergic Reaction (anaphylaxis): Swelling of the face, eyes, lips, tongue or throat, difficulty swallowing or breathing, wheezing, rash, hives, itching, fever, abdominal cramps, chest discomfort or tightness | ✔ | ||
Heart Attack: Chest pain and pressure (can be radiating from the left arm), heart palpitations, nausea, vomiting, trouble breathing, sweating, anxiety. | ✔ | ||
Kidney Disorder: Change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue. | ✔ | ||
Liver Disorder: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | ✔ | ||
Increased blood sugar: Frequent urination, thirst, and hunger. | ✔ | ||
Electrolyte Imbalance: Weakness, drowsiness, muscle pain or cramps, irregular heartbeat. | ✔ | ||
Fast or irregular heartbeat | ✔ | ||
Chest pain (Angina) | ✔ | ||
Lupus-Like Syndrome: Fever, fatigue, joint and muscle pain, generally feeling unwell. | ✔ | ||
Breathing problems, including shortness of breath, trouble breathing, tightness in the chest, cough, wheezing | ✔ | ||
Rare | |||
Decreased Platelets: Bruising, bleeding, fatigue and weakness | ✔ | ||
Decreased White Blood Cells: Infections, ( e. g. sor throat, fever), fatigue, , aches, pains, and flu-like symptoms | ✔ | ||
Decreased White Blood Cells: Infections, ( e. g. sor throat, fever), fatigue, , aches, pains, and flu-like symptoms | ✔ | ||
Very Rare | |||
Serious skin reactions (StevensJohnson Syndrome, Toxic Epidermal Necrolysis): Any combination of itchy skin rash, redness, blistering and severe peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine. | ✔ | ||
Unkno wn | |||
Eye disorders: -Myopia: Sudden near sightedness or blurred vision - Glaucoma: increased pressure in your eyes, eye pain |
✔ | ||
Stroke: Weakness, blurred vision, trouble speaking, slurred speech, face drooping, dizziness, headache | ✔ | ||
Anemia: Fatigue, loss of energy, weakness, shortness of breath | ✔ | ||
Inflammation of the Pancreas: Abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking APOCILAZAPRIL/HCTZ, contact your doctor, nurse, or pharmacist.
How to store
All medicines should be kept out of the reach and sight of children. The expiry date of this medicine is printed on the package label. Do not use the medicine after this date. If your doctor tells you to stop taking APO-CILAZAPRIL/HCTZ or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.
Store at 15°C to 30°C. Keep container tightly closed.
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/healthcanada/services/drugs-health-products/medeffectcanada/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.
More information
If you want more information about APOCILAZAPRIL/HCTZ:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 12, 2020