Telmisartan and hydrochlorothiazide (Oral)

Telmisartan and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure increases the workload of the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can damage the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can decrease the risk of strokes and heart attacks.

Telmisartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It decreases the amount of water in the body by increasing urine flow, which helps lower blood pressure.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to prevent getting pregnant. If you think you may be pregnant while using this medicine, tell your doctor immediately. You may need to stop using this medicine.

Dizziness, lightheadedness, or fainting may happen, especially when standing up from lying down or sitting. Make sure you know how this medicine affects you before you drive, operate machinery, or do anything else that could be dangerous if you feel dizzy or drowsy. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to help prevent the dizziness from returning.

Contact your doctor right away if you become ill while taking this medicine, especially if you have severe or ongoing nausea, vomiting, or diarrhea. These issues may cause you to lose too much water and lead to low blood pressure. You can also lose water by sweating, so drink plenty of water while exercising or in hot weather.

This medicine may affect your blood sugar levels. If you notice changes in your blood or urine sugar test results, or if you have any questions, talk to your doctor.

Contact your doctor immediately if you experience blurred vision, difficulty reading, eye pain, or any other changes in your vision during or after treatment. This may indicate a serious eye problem. Your doctor may want you to see an ophthalmologist (eye doctor).

Hyperkalemia (high potassium in the blood) may occur while using this medicine. Contact your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in your hands, feet, or lips, trouble breathing, or weakness or heaviness in your legs. Do not use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

This medicine may increase your risk of developing skin cancer (e.g., non-melanoma skin cancer). Avoid sun exposure. Use sunscreen when outdoors. Avoid sunlamps and tanning beds. Discuss any concerns about this risk with your doctor.

Alcohol, narcotic pain relievers, or sleeping pills may make you feel more lightheaded, dizzy, or faint when taken with this medicine. Inform your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless you have discussed them with your doctor. This especially includes nonprescription medicines, like aspirin, and medications for appetite control, asthma, colds, cough, hay fever, or sinus issues, as they may raise your blood pressure.

In deciding to use a drug, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of telmisartan and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of telmisartan and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are using this medicine, it is especially important that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is not advised. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Dofetilide
• Sparsentan

Using this medicine with any of the following drugs is normally not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the drugs.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Captopril
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalapril
• Enalaprilat
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosinopril
• Furosemide
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Moexipril
• Morniflumate
• Mycophenolate Mofetil
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium Citrate
• Potassium Phosphate
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sulindac
• Tacrolimus
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin

Using this medicine with any of the following medicines may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the medications.

• Aceclofenac
• Acemetacin
• Aminolevulinic Acid
• Amtolmetin Guacil
• Bepridil
• Bromfenac
• Bufexamac
• Carbamazepine
• Celecoxib
• Cholestyramine
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ginkgo
• Gossypol
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Licorice
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may additionally cause interactions to occur. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Anuria (not able to pass urine) or
• Diabetes patients or those with renal impairment who are additionally taking aliskiren (Tekturna®) or
• Sulfa drug allergy (eg, sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Asthma—May raise likelihood of having an allergic reaction.

• Congestive heart failure, serious—Use may lead to kidney problems.

• Diabetes or
• Electrolyte imbalances (eg, high calcium or low magnesium, potassium, or sodium in the blood) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Gallbladder disease or gallstones, history of or
• Glaucoma, secondary angle closure or
• Gout or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney issues or
• Liver disease (including cirrhosis) or
• Myopia, acute (changes in the eyeball causing vision issues) or
• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

• Sympathectomy—Blood pressure–lowering effects may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Confusion
• Decreased urine
• Difficult, burning, or painful urination
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• Dry mouth
• Fainting
• Fast, pounding, or irregular heartbeat or pulse
• Frequent urge to urinate
• Increased thirst
• Loss of appetite
• Lower back or side pain
• Muscle pain or cramps
• Nausea or vomiting
• Numbness or tingling in the hands, feet, or lips
• Seizures
• Sudden sweating
• Trouble breathing
• Unusual tiredness or weakness

Rare

• Chills
• Cold sweats

Rare

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Incidence not known

• Persistent non-healing sore
• Pink growth
• Reddish patch or irritated area
• Shiny bump
• White, yellow or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain
• Cough
• Difficulty breathing
• Dizziness
• Ear congestion
• Fever
• Headache
• Loss of voice
• Runny or stuffy nose
• Sneezing
• Sore throat

Less common

• Acid or sour stomach
• Back pain
• Belching
• Blistering, peeling, loosening of the skin
• Cough producing mucus
• Diarrhea
• Heartburn
• Hoarseness
• Indigestion
• Itching
• Joint pain
• Loss of appetite
• Muscle aches and pains
• Pain or tenderness around the eyes and cheekbones
• Rash
• Red irritated eyes
• Red skin lesions, often with a purple center
• Shivering
• Sores, ulcers, or white spots in the mouth or on the lips
• Stomach pain
• Sweating
• Tender, swollen glands in the neck
• Tightness in the chest
• Trouble sleeping
• Trouble swallowing
• Voice changes

Incidence not known

• Decreased interest in sexual intercourse
• Inability to have or keep an erection
• Loss in sexual ability, desire, drive, or performance

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Micardis HCT

Available Dosage Forms:

• Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Thiazide

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these is most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not break, crush, or chew it. You may take this medicine with or without food.

If you also use cholestyramine or colestipol, take these at least 4 to 6 hours before or 4 hours after you take this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For high blood pressure: Adults—At first, one tablet containing 40 milligrams (mg) of telmisartan and 12.5 mg of hydrochlorothiazide once a day. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the tablets in the blister pack and remove only the medicine you need when you are ready to take your dose.