Benicar (Olmesartan Medoxomil)

(all mi sar' tan)

Tell your doctor if you are pregnant or plan to become pregnant. Do not take olmesartan if you are pregnant. If you become pregnant while you are taking olmesartan, stop taking olmesartan and call your doctor immediately. Olmesartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

Olmesartan is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. Olmesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Olmesartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take olmesartan, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olmesartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If your child can not swallow a tablet, talk to your doctor or pharmacist. The pharmacist can prepare a liquid form of this medication for your child. Your doctor will probably start you on a low dose of olmesartan and may increase your dose after 2 weeks. Olmesartan controls high blood pressure but does not cure it. Your blood pressure may decrease during the first week of your treatment, but it may take up to 2 weeks before you notice the full benefit of olmesartan. Continue to take olmesartan even if you feel well. Do not stop taking olmesartan without talking to your doctor.

Before taking olmesartan,
• tell your doctor and pharmacist if you are allergic to olmesartan, any other medications, or any of the ingredients in olmesartan tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you have diabetes (high blood sugar) and are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT, Valturna). Your doctor will probably tell you not to take olmesartan if you have diabetes and are also taking aliskiren.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: an angiotensin-converting enzyme (ACE) inhibitor such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec), fosinopril, lisinopril (in Prinzide), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), trandolapril (Mavik, in Tarka); colesevelam (Welchol); diuretics ('water pills'); gemfibrozil (Lopid); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); and potassium supplements. Your doctor may need to change the doses of your medication or monitor you carefully for side effects.
• tell your doctor if you have or have ever had heart failure, or kidney or liver disease.
• tell your doctor if you are breast-feeding.
• you should know that olmesartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking olmesartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Olmesartan may cause side effects. Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• severe diarrhea
• weight loss
• difficulty breathing or swallowing
• hoarseness

Olmesartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to olmesartan. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.