Eprosartan and hydrochlorothiazide (Oral)

Eprosartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the strain on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can lower the risk of strokes and heart attacks.

Eprosartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that makes the blood vessels tighten. This helps to relax the blood vessels, which lowers blood pressure and boosts 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 to lower blood pressure.

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

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you may be pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when getting up from lying down or sitting, or if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, stop using this medicine and call your doctor immediately.

Check with your doctor right away if you become ill while taking this medicine, especially with severe or ongoing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt, which may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Contact your doctor immediately if you experience blurred vision, difficulty reading, eye pain, or any other changes in vision during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, consult your doctor.

Ask your doctor before using any medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

Do not take other medicines unless you have discussed them with your doctor. This is especially important for nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as they may increase your blood pressure.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been conducted on the relationship of age to the effects of eprosartan and hydrochlorothiazide combination in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any age-related problems that would limit the effectiveness of eprosartan and hydrochlorothiazide combination in older adults.

Breast Feeding

There are no sufficient studies in women to assess infant risk when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. When taking this medicine, it is important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of your other medications.

• Aliskiren
• Dofetilide
• Sparsentan

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• 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
• Cilazapril
• 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
• 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
• Spirapril
• Sulindac
• Tacrolimus
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Zofenopril

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• 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 medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Anuria (not able to pass urine) or
• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Sulfa drug allergy (e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, Septra®)—Should not be used in these patients.

• Asthma, history of—May increase the chance of an allergic reaction.

• Severe congestive heart failure—Use may lead to kidney problems.

• Diabetes or
• Electrolyte imbalances (e.g., high or low potassium, magnesium, or sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Glaucoma, secondary angle closure or
• Gout or
• Hypercalcemia (high calcium in the blood) or
• Kidney problems or
• Liver disease or
• Acute myopia (changes in the eyeball causing vision problems) or
• Systemic

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:

Rare

• Abdominal or stomach pain
• ankle, knee, or great toe joint pain
• arm, back, or jaw pain
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• convulsions
• decreased urine output
• difficulty breathing
• difficult, burning, or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• flushed or dry skin
• frequent urination
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased volume of pale, dilute urine
• itching of the skin
• joint stiffness or swelling
• loss of appetite
• loss of bladder control
• loss of consciousness
• lower back or side pain
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness and tingling of the face, fingers, or toes
• pale, bluish-colored, or cold hands or feet
• pinpoint red or purple spots on the skin
• rapid weight gain
• sudden decrease in the amount of urine
• sudden sweating
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs

Incidence not known

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• chills
• constipation
• cough or hoarseness
• coughing up blood
• darkened urine
• decreased frequency or amount of urine
• diarrhea
• difficulty with swallowing
• drowsiness
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• hives
• indigestion
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nosebleeds
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen or painful glands
• thickening of bronchial secretions
• unusual weight loss
• vision changes
• weak pulse
• weight gain
• yellow eyes or skin

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:

Rare

• Acid or sour stomach
• belching
• body aches or pain
• bone pain
• burning feeling in the chest or stomach
• burning or stinging of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• change in hearing
• cold or flu-like symptoms
• congestion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough producing mucus
• depression
• difficulty moving
• ear drainage
• earache
• excess air or gas in the stomach or intestines
• fear or nervousness
• feeling of constant movement of self or surroundings
• feeling unusually cold
• full feeling
• headache, severe and throbbing
• hearing loss
• heartburn
• increased sweating
• irritation in the mouth
• itching ears
• lack or loss of strength
• loose teeth
• loss of voice
• multiple swollen and inflamed skin lesions
• muscle stiffness
• pain, inflammation, or swelling in the calves, shoulders, or hands
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• passing gas
• persistent breath odor or bad taste in your mouth
• rash with flat lesions or small raised lesions on the skin
• redness and swelling of the gums
• redness or swelling of the ears
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny or stuffy nose
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• shivering
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• sneezing
• tender, swollen glands in the neck
• tenderness in the stomach area
• toothache
• trembling or shaking of the hands or feet
• trouble sleeping
• voice changes
• weight loss

Incidence not known

• Decreased interest in sexual intercourse
• hair loss or thinning of the hair
• hives or welts
• inability to have or keep an erection
• increased sensitivity of the skin to sunlight
• loss in sexual ability, desire, drive, or performance
• muscle spasm
• redness of the skin
• redness or other discoloration of the skin
• severe sunburn
• tenderness of the salivary glands

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.

• Teveten HCT

Pharmacologic Class: Eprosartan

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 are 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. 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.

You may take this medicine with or without food.

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—One tablet once a day. Your doctor may increase your dose as 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

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

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.