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Details for: ACH-TELMISARTAN HCTZ

Company: ACCORD HEALTHCARE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02419114ACH-TELMISARTAN HCTZTELMISARTAN; HYDROCHLOROTHIAZIDE80 MG; 12.5 MGTABLETORAL
02419122ACH-TELMISARTAN HCTZTELMISARTAN; HYDROCHLOROTHIAZIDE80 MG; 25 MGTABLETORAL
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Summary Reports

Summary Safety Review - Hydrochlorothiazide - Assessing the potential risk of non-melanoma skin cancer

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

ACH-TELMISARTAN HCTZ is a combination of 2 drugs. It is used when 2 drugs are required to treat your high blood pressure.

What it does

ACH-TELMISARTAN HCTZ contains a combination of 2 drugs, telmisartan and hydrochlorothiazide:

  • Telmisartan 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.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking ACH-TELMISARTAN HCTZ regularly even if you feel fine.

When it should not be used

Do not take ACH-TELMISARTAN HCTZ if you:

  • Are allergic to telmisartan, hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
  • Are allergic to any sulfonamide-derived drugs (sulfa drugs), most of them have a medicinal ingredient that ends in “-MIDE”. This includes other diuretics (“water pills”).
  • 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 telmisartan tablets). 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 ACH-TELMISARTAN HCTZ during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. ACH-TELMISARTAN HCTZ pass into breast milk.
  • Are allergic to some sugars (fructose, lactose and/or mannitol).
  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
  • Have one of the following rare hereditary diseases:
    • Galactose intolerance;
    • Lapp lactase deficiency;
    • Glucose-galactose malabsorption. Because lactose is a non-medicinal ingredient in ACH-TELMISARTAN HCTZ.
What the medicinal ingredient is

Telmisartan and hydrochlorothiazide

What the non-medicinal ingredients are

Iron oxide red (for the 80 mg/12.5 mg tablet only), iron oxide yellow (for the 80 mg/25 mg tablet only), lactose monohydrate, magnesium stearate, maize starch, mannitol, meglumine, microcrystalline cellulose, povidone, and sodium hydroxide

What dosage form it comes in

Tablets 80 mg/12.5 mg and 80 mg/25 mg.

Warnings and precautions

Serious Warnings and Precautions – Pregnancy

ACH-TELMISARTAN HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking ACH-TELMISARTAN HCTZ, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.

Before you use ACH-TELMISARTAN HCTZ, 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 narrowing of an artery or a heart valve.
  • Have heart failure.
  • Have diabetes, liver or kidney disease.
  • Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with ACH-TELMISARTAN HCTZ is not recommended.
  • Are taking an angiotensin-converting-enzyme inhibitor (ACEI).
  • Have lupus or gout.
  • Are on dialysis.
  • Are dehydrated or if you 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 less than 18 years old.
  • Are having surgery and general anesthesia, (even at the dentist's office), tell the doctor or dentist that you are taking ACH-TELMISARTAN HCTZ as there may be a sudden fall in blood pressure associated with general anesthesia.
  • Have been told by your doctor that you have an intolerance to some sugars.
  • 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

  • ACH-TELMISARTAN 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 ACH-TELMISARTAN HCTZ for many years (more than 3) or at a high dose.
  • While taking ACH-TELMISARTAN 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 ACH-TELMISARTAN 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 ACH-TELMISARTAN HCTZ.

You may become sensitive to the sun while taking ACH-TELMISARTAN HCTZ. Exposure to sunlight should be minimized until you know how you respond.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ACH-TELMISARTAN 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 ACH-TELMISARTAN 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, such as Cholestyramine and Colestipol Resins.
  • Other blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin-convertingenzyme inhibitors (ACEI). When taken in combination with ACH-TELMISARTAN HCTZ, they may cause excessively low blood pressure.
  • 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, 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.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
  • Pressor Amines (e.g. norepinephrine)
  • Warfarin.
Proper use of this medication

Take ACH-TELMISARTAN HCTZ exactly as prescribed. It is recommended to take your dose at about the same time everyday preferably in the morning.

ACH-TELMISARTAN HCTZ can be taken with or without food, but it should be taken the same way each day. If ACH-TELMISARTAN HCTZ causes upset stomach, take it with food or milk.

Usual Adult Dose

The recommended dose of ACH-TELMISARTAN HCTZ is one tablet daily.

Overdose

If you think you have taken too much ACH-TELMISARTAN 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.

Side effects and what to do about them

Side effects may include:

  • Back or leg pain, muscle cramps, joint pain, muscle spasms, pain, weakness, restlessness
  • Headache, anxiety, dizziness, pins and needles in your fingers
  • Diarrhea, constipation, nausea, vomiting, upset stomach, abdominal pain, flatulence , decreased appetite, enlargement of the glands in your mouth
  • Dry mouth
  • Rash, eczema, skin eruptions, bleeding under the skin, red patches on the skin
  • Drowsiness, insomnia, fatigue
  • Visual disturbances
  • Upper respiratory infection
  • Reduced libido
  • Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding);
  • Low blood magnesium level;
  • High blood calcium level;
  • Increased pH (disturbed acid-base balance) due to low blood chloride level.

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

ACH-TELMISARTAN HCTZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
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. 		✔    
Anemia:
fatigue, loss of energy, weakness, shortness of breath 		  ✔  
Electrolyte Imbalance:
weakness, drowsiness, muscle pain or cramps, irregular heartbeat 		  ✔  
Chest Pain   ✔  
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
Kidney Disorder:
change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue 		  ✔  
Decreased White Blood Cells:
infections, fatigue, fever, aches, pains, and flu-like symptoms 		  ✔  
Increased blood sugar:
frequent urination, thirst, and hunger 		✔    
Urinary tract infection (Cystitis):
frequent or painful urination, feeling unwell 		  ✔  
Rare
Depression:
Low mood, loss of interest in activities, change in appetite and sleep patterns 		✔    
Decreased or increased levels of potassium in the blood:
irregular heartbeats, muscle weakness and generally feeling unwell 		  ✔  
Liver disorder:
yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite 		  ✔  
Eye disorders:
  • Myopia:
    sudden near sightedness or blurred vision
  • Glaucoma:
    increased pressure in your eyes, eye pain
     ✔
Low blood sugar:
shaky, irregular heartbeat, sweating, hunger, dizziness 		  ✔  
Decreased Platelets:
bruising, bleeding, fatigue and weakness 		  ✔  
Unknown
Allergic Reaction:
rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing 		    ✔
Rhabdomyolysis:
muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine 		    ✔
Heart Rhythm or Heart Rate disturbances:
heart racing or skipping a beat 		  ✔  
Sepsis (blood poisoning):
chills, confusion, fever or low body temperature, shakiness, irregular heartbeat (including fatal outcome) 		  ✔  
Toxic Epidermal Necrolysis:
severe skin peeling, especially in mouth and eyes 		    ✔
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 ACH-TELMISARTAN HCTZ, contact your doctor or pharmacist.

How to store

Store ACH-TELMISARTAN HCTZ at room temperature (15 to 30 °C) in the package provided by your doctor or pharmacist and protect from excessive moisture. Do not remove tablets from bottles until immediately prior to administration.

Keep ACH-TELMISARTAN HCTZ and all medicines out of the reach and sight of children.

Reporting side effects

REPORTING SIDE EFFECTS

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

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 ACH-TELMISARTAN 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/dpd-bdpp/index-eng.jsp); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.

Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada

Last revised: January 22, 2021

Date modified: