Olmesartan, amlodipine, and hydrochlorothiazide (Oral)

Olmesartan, amlodipine, and hydrochlorothiazide is a combination of medicines that can be used on its own or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the workload on 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 help reduce the risk of strokes and heart attacks.

Olmesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. Olmesartan relaxes the blood vessels and lowers blood pressure. Lower blood pressure will increase the amount of blood and oxygen that reaches the heart.

Amlodipine is a calcium channel blocker (CCB). It affects how calcium moves into the cells of the heart and blood vessels. Amlodipine relaxes the blood vessels and lowers blood pressure.

Hydrochlorothiazide is a thiazide diuretic (water pill). It decreases the amount of water in the body by increasing urine flow. This helps 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 properly. You may need blood and urine tests 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 pregnancy. If you think you may be pregnant while using this medicine, tell your doctor immediately. You may need to stop using this medicine.

This medicine may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from lying down or sitting. Make sure you know how you react to this medicine before you drive, operate machines, or do anything else that could be dangerous if you feel dizzy. 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 sick while taking this medicine, particularly if you have severe nausea, vomiting, or diarrhea that does not stop. 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 during exercise or in hot weather.

This medicine may cause angina (chest pain) or a heart attack in some patients with severe heart or blood vessel disease. Contact your doctor immediately if you are experiencing chest pain or discomfort, a fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.

Contact your doctor right away if you have bloody urine, a decrease in the frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney problem.

Contact your doctor right away if you experience blurred vision, difficulty with reading, eye pain, or any other change in vision during or after treatment. This could indicate a serious eye problem. Your doctor may want you to see an eye doctor.

This medicine may affect blood sugar levels. Diabetic patients may notice a change in the results of blood or urine glucose tests. Talk to your doctor if you have any questions.

Severe, chronic diarrhea with weight loss may develop months to years after taking this medicine. Tell your doctor immediately if you experience these symptoms.

This medicine may increase your risk of developing skin cancer (e.g., non-melanoma skin cancer). Avoid sun exposure and use sunscreen when you are outdoors. Talk to your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as well as herbal or vitamin supplements.

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. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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 done on how olmesartan, amlodipine, and hydrochlorothiazide combination affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of olmesartan, amlodipine, and hydrochlorothiazide combination in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together at all, in other situations, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential importance and are not necessarily all-inclusive.

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

• Aliskiren
• Dofetilide

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 how often you take one or both of the medicines.

• Abametapir
• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Atazanavir
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Celecoxib
• Ceritinib
• Chlorpropamide
• Choline Salicylate
• Clarithromycin
• Clonixin
• Clopidogrel
• Codeine
• Conivaptan
• Cyclosporine
• Dantrolene
• Dapagliflozin
• Darunavir
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Domperidone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Epirubicin
• Erythromycin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosnetupitant
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Itraconazole
• Ketanserin
• Ketoprofen
• Ketorolac
• Lacosamide
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Omaveloxolone
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piperaquine
• Piroxicam
• Porfimer
• Pramlintide
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Repaglinide
• Rifampin
• Ritonavir
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Simvastatin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sulindac
• Tacrolimus
• Tapentadol
• Tegafur
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trimethoprim
• Valdecoxib
• Vildagliptin

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

• Aminolevulinic Acid
• Amprenavir
• Aprepitant
• Bepridil
• Boceprevir
• Carbamazepine
• Cholestyramine
• Cimetidine
• Ciprofloxacin
• Clofazimine
• Cobicistat
• Colesevelam
• Crizotinib
• Diltiazem
• Dronedarone
• Duvelisib
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Ginkgo
• Gossypol
• Idelalisib
• Indinavir
• Ketoconazole
• Letermovir
• Licorice
• Lonafarnib
• Mifepristone
• Nefazodone
• Nelfinavir
• Nilotinib
• Posaconazole
• Ribociclib
• Rifapentine
• Saquinavir
• Schisandra sphenanthera
• Telithromycin
• Troleandomycin
• Tucatinib
• Verapamil
• Voriconazole
• Voxelotor

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Angina (severe chest pain), history of or
• Diabetes or
• Glaucoma, secondary angle-closure or
• Gout or
• Heart attack, history of or
• Hypercalcemia (high calcium in the blood) or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hyperuricemia (high uric acid in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Myopia (changes in the eyeball causing vision problems), acute or
• Systemic lupus erythematosus (immune system disease)—Use with caution. May worsen these conditions.

• Anuria (not able to create urine) or
• Diabetes patients who are also taking aliskiren (Tekturna®) or
• Severe kidney disease or
• History of sulfa drug allergy—Should not be used in patients with these conditions.

• Severe aortic stenosis (heart valve problem) or
• History of asthma or
• Severe dehydration or
• History of severe heart disease or
• Hyponatremia (low sodium in the blood)—Use with caution. May make side effects worse.

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

• Liver disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Rapid weight gain
• Tingling of the hands or feet
• Unusual weight gain or loss

Less common

• Bladder pain
• Bloody or cloudy urine
• Body aches or pain
• Cough
• Difficult, burning, or painful urination
• Difficulty with breathing
• Fainting
• Frequent urge to urinate
• Headache
• Loss of voice
• Lower back or side pain
• Swelling of the joints
• Unusual tiredness or weakness

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. Your health care professional may also 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:

Less common

• Diarrhea
• Muscle aches or spasms
• Nausea

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.

• Tribenzor

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Amlodipine

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

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.

In addition to using 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.

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 might 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, strokes, or kidney disease.

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

If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Tribenzor®.

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 adjust the dose as needed. However, the dose is usually not more than olmesartan 40 milligrams (mg), amlodipine 10 mg, and hydrochlorothiazide 25 mg per day. 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.