Details for: ENALAPRIL MALEATE/HCTZ
Company: AA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02352923 | ENALAPRIL MALEATE/HCTZ | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5 MG; 12.5 MG | TABLET | ORAL |
| 02352931 | ENALAPRIL MALEATE/HCTZ | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10 MG; 25 MG | TABLET | ORAL |
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
ENALAPRIL MALEATE /HCTZ lowers high blood pressure.
What it does
ENALAPRIL MALEATE /HCTZ contains a
combination of 2 drugs, enalapril and
hydrochlorothiazide.
Enalapril 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 a
“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 ENALAPRIL MALEATE /HCTZ
regularly even if you feel fine.
When it should not be used
Do not take ENALAPRIL MALEATE /HCTZ if you:
- Are allergic to enalapril and hydrochlorothiazide or any non-medicinal ingredient in the formulation.
- Are allergic to sulphonamide-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 (any drug in the same class as enalapril maleate) 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.
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ) and you have diabetes or kidney disease
- Are pregnant or intend to become pregnant. Taking ENALAPRIL MALEATE /HCTZ during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. ENALAPRIL MALEATE /HCTZ passes into breast milk.
- Have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption because lactose is a non-medicinal ingredient in ENALAPRIL MALEATE /HCTZ.
What the medicinal ingredient is
enalapril maleate and hydrochlorothiazide.
What the non-medicinal ingredients are
Anhydrous lactose, zinc stearate
The tablets also contain:
5/12.5 mg tablets: FD&C Blue No. 2 and iron oxide
yellow
10/25 mg tablets: iron oxide red
What dosage form it comes in
Tablet 5/12.5 mg (green) and 10/25 mg (rust)
Warnings and precautions
Serious Warnings and Precautions
ENALAPRIL MALEATE /HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking ENALAPRIL MALEATE /HCTZ, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
BEFORE you use ENALAPRIL MALEATE/HCTZ talk to your doctor, nurse or pharmacist if you
- Are allergic to any drug used to lower blood pressure or penicillin.
- Have bronchial asthma.
- 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.
- Have lupus or gout.
- 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”).
- Are on a low-salt diet.
- Are taking a medicine that contains aliskiren, such as RASILEZ, used to lower high blood pressure. The combination with ENALAPRIL MALEATE /HCTZ is not recommended.
- Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “- SARTAN”.
- Are receiving gold (sodium aurothiomalate) injections.
- Are less than 18 years old.
- 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.
Risk of skin cancer:
ENALAPRIL MALEATE /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 ENALAPRIL
MALEATE /HCTZ for many years (more than 3) or at
a high dose.
While taking ENALAPRIL MALEATE /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 ENALAPRIL MALEATE /HCTZcan 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 ENALAPRIL MALEATE
/HCTZ.
You may become sensitive to the sun while taking
ENALAPRIL MALEATE /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 ENALAPRIL MALEATE /HCTZ.
Driving and using machines: Before you perform
tasks which may require special attention, wait until
you know how you respond to ENALAPRIL
MALEATE /HCTZ. Dizziness, lightheadedness, or
fainting can especially occur after the first dose and
when the dose is increased.
You should be aware that black patients are at
increased risk of angioedema types of reactions to
ACE inhibitors like ENALAPRIL MALEATE
/HCTZ.
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 ENALAPRIL MALEATE /HCTZ:
- Adrenocorticotropic hormone (ACTH) used to treat West Syndrome
- 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, and sertraline.
- 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.
- Gout medications (allopurinol, uricosurics, xanthine oxidase inhibitors, probenecid)
- Lithium used to treat bipolar disease. Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
- Potassium-containing medicines, potassium supplements or salt substitutes that contain potassium.
- Certain pain and arthritis medicines, including gold therapy.
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs).
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
Proper use of this medication
ENALAPRIL MALEATE /HCTZ is not for initial therapy. You must first be stabilized on the individual components (enalapril and hydrochlorothiazide) of ENALAPRIL MALEATE /HCTZ. If your dosage matches the dosages in ENALAPRIL MALEATE /HCTZ, your doctor may prescribe ENALAPRIL MALEATE /HCTZ taken once a day (instead of each component as a separate pill).
Take ENALAPRIL MALEATE /HCTZ exactly as prescribed. It is recommended to take your dose at about the same time every day. ENALAPRIL MALEATE /HCTZ can be taken with or without food. If ENALAPRIL MALEATE /HCTZ causes upset stomach, take it with food or milk.
Splitting of ENALAPRIL MALEATE /HCTZ 10 mg/25 mg tablets is not advised.
Usual Adult Dose
Maximum Dose:
- four tablets of ENALAPRIL MALEATE /HCTZ 5/12.5 mg a day
- two tablets of ENALAPRIL MALEATE /HCTZ 10/25 mg a day
OR
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
- Depression, confusion, nervousness, difficulty sleeping
- Cough
- Rash
- Headache
- Abdominal pain, upset stomach, decreased appetite, dry mouth, constipation, diarrhea, nausea, and vomiting
- Muscle pain
- Sore throat
- Impotenceerectile dysfunction
- Tingling of the skin
- Ringing in the ears (Tinnitus)
The initial dose may cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as faintness or dizziness and it may help to lie down.
If any of these affects you severely, tell your doctor, nurse or pharmacist.
ENALAPRIL MALEATE /HCTZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse or pharmacist only if severe | Talk with your doctor, nurse or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Common | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness may occur when you go from lying or sitting to standing up. | ✔ | ||
| Decreased or increased level of potassium in the blood: irregular heartbeats, muscle weakness, generally feeling unwell | ✔ | ||
| Chest pain | ✔ | ||
| Breathing problems, shortness of breath | ✔ | ||
| Non-melanoma 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. | ✔ | ||
| Uncommon | |||
| Allergic Reactions: rash, hives, swelling of the face, eyes, lips, tongue or throat, , difficulty swallowing or breathing | ✔ | ||
| Angioedema: itching, hives, swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing | ✔ | ||
| Kidney Disorder: decreased urination, nausea, vomiting, swelling of extremities, fatigue | ✔ | ||
| Liver Disorder: yellowing of the skin or eyes (jaundice), 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 | ✔ | ||
| Rare | |||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms (malaise, muscle pain, rash, itching, abdominal pain, nausea, vomiting, diarrhea, jaundice, or lack of appetite) | ✔ | ||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Very rare | |||
| Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes | ✔ | ||
| Unknown | |||
| Heart Attack: chest pain, shortness of breath | ✔ | ||
| Stroke: sudden face and arm weakness, abnormal speech | ✔ | ||
| Pulmonary Embolism: rapid and difficult breathing, chest pain or inspiration, and palpitations | ✔ | ||
| Fast, slow or irregular heart beats | ✔ | ||
| Eye disorders: -Myopia: sudden near sightedness or blurred vision -Glaucoma: increased pressure in your eyes, eye pain | ✔ | ||
| 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 ENALAPRIL MALEATE /HCTZ, contact your doctor, nurse or pharmacist.
How to store
Store at controlled room temperature (15°C to 30°C).
Protect from moisture.
Keep all medicines out of the reach and sight of
children.
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 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
Read this carefully before you start taking ENALAPRIL MALEATE /HCTZand each time you get a refill. This leaflet is a summary and will not tell you everything about ENALAPRIL MALEATE /HCTZ. Talk to your doctor, nurse, or pharmacist about your medical condition and treatment and ask if there is any new information about ENALAPRIL MALEATE /HCTZ.
If you want more information about ENALAPRIL MALEATE /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://health-products.canada.ca/dpdbdpp/index-eng.jsp; AA Pharma Inc.’s website www.aapharma.ca/en/, or by calling AA Pharma Inc. at 1-877-998-9097.
This leaflet was prepared by AA Pharma Inc.
Last revised: June 4, 2019