Details for: JAMP CANDESARTAN-HCT
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02473240 | JAMP CANDESARTAN-HCT | HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL | 12.5 MG; 16 MG | TABLET | ORAL |
| 02473259 | JAMP CANDESARTAN-HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32 MG; 12.5 MG | TABLET | ORAL |
| 02473267 | JAMP CANDESARTAN-HCT | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32 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
JAMP Candesartan-HCT lowers high blood pressure.
What it does
JAMP Candesartan-HCT contains a combination of 2 drugs, candesartan cilexetil and hydrochlorothiazide:
- Candesartan is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. It lowers blood pressure.
- Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This lowers blood pressure.
When it should not be used
Do not take JAMP Candesartan-HCT if you:
- Are allergic to candesartan cilexetil, hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
- Have severe liver disease.
- Have severe kidney disease.
- Are allergic to any sulphonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
- 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 ARB (any drug in the same class as candesartan cilexetil). Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
- Have difficulty urinating or produce no urine.
- Are pregnant or intend to become pregnant. Taking JAMP Candesartan-HCT during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. JAMP Candesartan-HCT passes into breast milk.
- Are less than 1 year old.
- Have gout.
- Have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactosemalabsorption
Because lactose monohydrate is a non-medicinal ingredient in JAMP Candesartan-HCT.
What the medicinal ingredient is
Candesartan cilexetil and hydrochlorothiazide.
What the non-medicinal ingredients are
Carboxymethyl cellulose Calcium, corn starch, hydroxypropyl cellulose, iron oxide red (as colorant in 16 mg/12.5 mg and 32 mg/25 mg strengths), iron oxide yellow (as colorant in 32 mg/12.5 mg), lactose monohydrate, magnesium stearate and polyethylene glycol.
What dosage form it comes in
Tablets in three strengths: candesartan cilexetil/hydrochlorothiazide: 16 mg / 12.5 mg; candesartan cilexetil/hydrochlorothiazide: 32 mg / 12.5 mg; candesartan cilexetil/hydrochlorothiazide: 32 mg / 25 mg.
Warnings and precautions
Serious Warnings and Precautions- Pregnancy
JAMP Candesartan-HCT should not be used during pregnancy. If you discover that you are pregnant while taking JAMP Candesartan-HCT, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
Before you use JAMP Candesartan-HCT talk to your doctor, nurse or pharmacist if you:
- Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
- Have a liver disorder.
- Have a kidney disorder.
- Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with JAMP Candesartan-HCT is not recommended.
- Are taking an angiotensin converting enzyme inhibitor (ACEI). You can recognize ACEIs because their medicinal ingredient ends in ‘- PRIL’.
- Have narrowing of an artery or a heart valve.
- Have heart failure.
- Have diabetes, liver, heart or kidney disease.
- Have lupus.
- Are on dialysis.
- Are dehydrated or suffer from excessive vomiting, diarrhea or sweating.
- Are taking a salt substitute that contains potassium, potassium supplements, a potassium-sparing diuretic (a specific kind of “water pill”) or other drugs that may increase potassium levels (e.g., heparin, cotrimoxazole).
- Are on a low-salt diet.
- Are less than 18 years old.
- Are having any kind of surgery or dental procedure with anesthesia.
- Have had a heart attack or stroke.
- 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:
JAMP Candesartan-HCT 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 CandesartanHCT for many years (more than 3) or at a high dose.
While taking JAMP Candesartan-HCT:
- 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 JAMP Candesartan-HCT 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 JAMP Candesartan-HCT.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to JAMP CandesartanHCT. 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 or 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 JAMP Candesartan HCT:
- 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.
- Amantadine.
- 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.
- Other blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme inhibitors (ACEIs). When taken in combination with JAMP Candesartan-HCT, they may cause excessively low blood pressure.
- Calcium or vitamin D supplements.
- Corticosteroids used to treat joint pain and swelling.
- Cyclosporine.
- Digoxin, a heart medication.
- Drugs that slow down or speed up bowel function, including atropine, biperiden, domperidone and metoclopramide.
- Drugs used to treat epilepsy, including carbamazepine and topiramate.
- 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.
- Pressor amines such as norepinephrine.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurarine.
Proper use of this medication
Take JAMP Candesartan-HCT exactly as prescribed. It is recommended to take your dose at about the same time everyday.
JAMP Candesartan-HCT can be taken with or without food but it should be taken the same way each day. Swallow JAMP Candesartan-HCT with a glass of water.
If JAMP Candesartan-HCT causes upset stomach, take it with food or milk.
Do not transfer JAMP Candesartan-HCT to other pill containers. To protect your JAMP Candesartan-HCT tablets, keep them in the original package
Remember to get a new prescription from your doctor or a refill from your pharmacy a few days before all your tablets are taken.
Usual adult dose:
Usual maintenance dose is: 1 tablet daily
The dosage of JAMP Candesartan-HCT is individualized.
JAMP Candesartan-HCT is not for initial therapy. You must first be stabilized on the individual components (candesartan cilexetil and hydrochlorothiazide) of JAMP Candesartan-HCT.
Overdose:
Missed Dose:
If you miss a dose of JAMP Candesartan-HCT and remember within 12 hours, you should take your usual dose as soon as possible. Then go back to your regular schedule. But if it is more than 12 hours when you remember, do not take the missed dose. Just take the next dose on time. Do not double dose.
Side effects and what to do about them
Side effects may include:
- back or leg pain, muscle cramps, spasms and pain, weakness,restlessness
- dizziness, pins and needles in your fingers, headache
- constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth
- bleeding under skin, rash, red patches on the skin, itching
- drowsiness, insomnia
- reduced libido
- throat infections
- cough
If any of these affects you severely, tell your doctor, nurse or pharmacist.
JAMP Candesartan-HCT 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 or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up | ✔ | ||
| Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
| Tachycardia: increased heart beats | ✔ | ||
| Edema: swelling of hands, ankles or feet | ✔ | ||
| 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, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| 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 heart beat | ✔ | ||
| Rare | |||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✔ | ||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains and flulike symptoms | ✔ | ||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Very Rare | |||
| Toxic Epidermal Necrolysis: severe skin peeling, especially in the mouth and eyes | ✔ | ||
| Not Known | |||
|
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 | ✔ | ||
| Lupus: Conditions may be activated or made worse. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking JAMP CandesartanHCT, contact your doctor, nurse or pharmacist.
How to store
- Although the JAMP Candesartan-HCT tablets are protected in their package, it is best to keep the package at normal room temperature (15°C to 30°C) and in a dry place. Do not keep JAMP Candesartan-HCT in the bathroom.
- Keep out of sight and reach of children. Never take medicine in front of small children as they will want to copy you.
- Do not keep or use JAMP Candesartan-HCT after the expiry date indicated on the package. Unused medicines, which you know you will no longer need, should be carefully discarded. You may wish to seek advice from your pharmacist.
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 here . 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 JAMP Candesartan-HCT:
- 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) ; or by contacting the sponsor, JAMP Pharma Corporation, at: 1-866-399-9091
This leaflet was prepared by
JAMP Pharma Corporation
1310 rue Nobel, Boucherville,
Québec, J4B 5H3
Last Approved: March 13, 2020