How does this medication work? What will it do for me?

This is a combination product that contains two medications used to lower hypertension (high blood pressure): telmisartan and hydrochlorothiazide. It is used to treat high blood pressure for people who require treatment with both telmisartan and hydrochlorothiazide.

Telmisartan belongs to a class of medications called angiotensin II blockers, which help to lower blood pressure by relaxing blood vessels. Hydrochlorothiazide is a diuretic (water pill) that helps control blood pressure by getting rid of excess salt and water.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

80 mg/12.5 mg
Each white and pink, oblong-shaped tablet debossed with "TH 81" on the white layer and nothing on the pink side contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, silicified microcrystalline cellulose and sodium hydroxide. 80 mg/12.5 mg tablets contain also iron oxide red.

80 mg/25 mg
Each white and yellow, oblong-shaped tablet debossed with "TH 82" on the white layer and nothing on the yellow side contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, silicified microcrystalline cellulose and sodium hydroxide. 80 mg/25 mg tablets contain also iron oxide yellow.

How should I use this medication?

The recommended dose is 1 tablet once daily. This medication is intended to be used by people who have not had their blood pressure well-controlled with just telmisartan, or by people who have had doses of telmisartan and hydrochlorothiazide already established.

The medication can be taken with or without food, but it should be taken consistently with respect to food intake.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. It should be left in the protective blisters until immediately before it is to be taken.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take telmisartan - hydrochlorothiazide if you:

  • are allergic to telmisartan, hydrochlorothiazide, or any ingredients of the medication
  • are allergic to sulfa (sulfonamide) medications (e.g., sulfamethoxazole)
  • are pregnant or breast-feeding
  • have anuria (is able to pass little or no urine)
  • have diabetes or kidney disease and are taking aliskiren
  • have fructose intolerance (a rare hereditary condition)
  • have galactose intolerance (a rare hereditary condition)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • anxiety
  • back or leg pain
  • constipation
  • decreased appetite
  • diarrhea
  • dizziness
  • dry mouth
  • flu-like symptoms
  • headache
  • increased sweating
  • nausea
  • pins and needles sensation
  • sexual difficulties
  • tiredness
  • vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • pounding, rapid heartbeat
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of gout (e.g., joint pain, swelling and warmth of joints)
  • signs of infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
  • signs of liver damage (yellowing of skin or whites of eyes, abdominal pain, loss of appetite, brown urine, light-coloured stools, tiredness, or weakness)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • swelling legs, ankles, or hands
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • unexplained muscle tenderness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • chest pain
  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • signs of a serious allergic reaction (swelling of face or throat, hives, difficulty breathing)
  • symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of telmisartan. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergic reaction: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially to sulfonamide antibiotics or diabetes medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.

Cholesterol: Cholesterol and triglyceride levels may increase when taking hydrochlorothiazide. If you have increased cholesterol or triglyceride levels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: Hydrochlorothiazide may make it more difficult for people with diabetes to control their blood sugar levels. High blood sugar may occur, glucose tolerance may change, and diabetes may worsen. A dose adjustment of diabetes medications, including insulin, may be required. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Electrolytes: The use of hydrochlorothiazide can reduce the levels of electrolytes such as potassium, sodium, magnesium, and chloride and increase the levels of calcium. Your doctor will periodically check to see if these levels are in balance, and a potassium supplement may be recommended. Warning signs or symptoms of fluid and electrolyte imbalance include:

  • confusion
  • drowsiness
  • dryness of mouth
  • lethargy
  • low blood pressure
  • muscle pains or cramps
  • muscular fatigue
  • nausea and vomiting
  • racing heartbeat
  • restlessness
  • seizures
  • thirst
  • weakness

Hereditary fructose or galactose intolerance: Due to the sorbitol and lactose content in the medication, this medication is not suitable for people with hereditary fructose or galactose intolerance.

Gout: An acute gout attack may occur in some patients taking telmisartan - hydrochlorothiazide as a result of high levels of uric acid in the blood. Symptoms of an acute gout attack include sudden pain, swelling, and stiffness in the affected joint, often the big toe. You may also experience a fever. If this is your first attack, seek medical attention as soon as possible. If you have had gout attacks before, follow your doctor's instructions for dealing with the attack.

Kidney function: Use of this medication may affect the function of the kidneys, especially for those who already have kidney problems. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should not be taken by people with severely impaired kidney function.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with severe liver impairment.

This medication may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: Occasionally, a greater-than-expected drop in blood pressure occurs after taking this medication. It is more likely to occur if you are taking additional diuretics (water pills), have reduced salt intake, are on dialysis, or are experiencing diarrhea or vomiting. Blood pressure should be monitored more often in these situations. To reduce the risk of dizziness, those with low blood pressure or those just starting to take this medication should stand or sit up slowly when getting up from a lying down or sitting position.

If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Excessive sweating and lack of fluid intake may lead to an excessive fall in blood pressure because of reduced fluid in your blood vessels. Vomiting or diarrhea may also lead to a fall in blood pressure. Consult your doctor if you feel your blood pressure is too low.

Lupus: There have been reports of a worsening or activation of lupus in people taking hydrochlorothiazide. People with lupus or a history of lupus should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Telmisartan can cause injury or death to the developing fetus if taken by a woman who is pregnant. This medication should not be taken by pregnant women. If you become pregnant while taking telmisartan - hydrochlorothiazide, consult your doctor immediately as the medication should be stopped as soon as possible.

Breast-feeding: It is not known if telmisartan passes into breast milk. Hydrochlorothiazide does pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established and is not recommended for children.

Seniors: Seniors may be more sensitive to the effects of this medication.

What other drugs could interact with this medication?

There may be an interaction between telmisartan - hydrochlorothiazide and any of the following:

  • ACTH (adrenocorticotropic hormone)
  • alcohol
  • aliskiren
  • allopurinol
  • alpha-adrenergic blocking agents (e.g., clonidine, doxazosin, prazosin, terazosin)
  • amifostine
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • anticholinergics (e.g., benztropine, disopyramide, ipratropium, oxybutynin)
  • barbiturates (e.g., butalbital, pentobarbital phenobarbital)
  • beta-blockers (e.g., atenolol, carvedilol, propranolol)
  • beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)
  • brimonidine
  • calcium carbonate, calcium citrate
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • cholestyramine
  • colestipol resins
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • dalteparin
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • diazoxide
  • digoxin
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • enoxaparin
  • ginger
  • ginseng
  • heparin
  • hydralazine
  • lithium
  • licorice
  • medications that increase blood levels of potassium (e.g., potassium chloride, salt substitutes containing potassium)
  • methylphenidate
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • multivitamins/minerals with ADE
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine)
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen)
  • oxcarbazepine
  • pentoxifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • porfimer
  • rituximab
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • sodium phosphates
  • tolvaptan
  • topiramate
  • trimethoprim
  • vitamin D
  • warfarin
  • yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.