Olmesartan

Olmesartan

Side Effects

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

  • Body aches or pain
  • Blood in the urine
  • Chills
  • Cough or cough producing mucus
  • Difficulty with breathing
  • Ear congestion
  • Fever
  • Headache
  • Loss of voice
  • Nasal congestion
  • Runny nose
  • Shortness of breath
  • Sneezing
  • Sore throat
  • Tightness in the chest
  • Unusual tiredness or weakness
  • Wheezing

Rare

  • Bladder pain
  • Bloody or cloudy urine
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • Chest pain
  • Difficult, burning, or painful urination
  • Fast, pounding, or irregular heartbeat or pulse
  • Frequent urge to urinate
  • Joint pain, stiffness, or swelling
  • Large amount of fat in the blood
  • Lower back, side, or stomach pain
  • Swelling of the feet or lower legs

Incidence not known

  • Dark-colored urine
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Muscle cramps or spasms
  • Muscle pain or stiffness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Blurred vision
  • Chest pain or discomfort
  • Confusion
  • Dizziness, faintness, or lightheadedness
  • Sweating

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:

Less common

  • Abdominal or stomach pain
  • Back pain
  • Diarrhea
  • Dizziness
  • Dry mouth
  • Flushed, dry skin
  • Fruit-like breath odor
  • General feeling of discomfort or illness
  • Increased hunger
  • Increased thirst
  • Increased urination
  • Loss of appetite
  • Muscle aches and pains
  • Nausea
  • Pain or tenderness around the eyes and cheekbones
  • Shivering
  • Tender, swollen glands in the neck
  • Trouble sleeping
  • Trouble with swallowing
  • Troubled breathing
  • Unexplained weight loss
  • Vomiting

Rare

  • Acid or sour stomach
  • Belching
  • Difficulty with moving
  • Feeling of constant movement of self or surroundings
  • Heartburn
  • Indigestion
  • Rash
  • Rapid weight gain
  • Sensation of spinning
  • Sleeplessness
  • Swelling or puffiness of the face
  • Tingling of the hands or feet
  • Unusual weight gain or loss

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.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness or lightheadedness may occur after the first dose of this medicine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

Check with your doctor right away if you or your child become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, which can lead to low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you or your child exercise or if the weather is hot. Heavy sweating may cause you to lose too much water or salt, which may cause low blood pressure. Use extra care during exercise or hot weather.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Proper Use

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

In addition to taking this medicine, treatment for your high blood pressure may include weight control and a change in the 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 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, stroke, or kidney disease.

This medicine may be taken 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—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg once a day.
      • Children 6 to 16 years of age weighing 35 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 40 milligrams once a day. If the child cannot swallow the tablets, an oral suspension is recommended.
      • Children 6 to 16 years of age weighing at least 20 kilograms (kg) and less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 20 milligrams once a day. If the child cannot swallow the tablets, an oral suspension is recommended.
      • Children younger than 6 years of age—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.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olmesartan in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olmesartan in the elderly.

Pregnancy

Pregnancy Category Explanation
1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

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

Drug Interactions

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 doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines 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 medicines may cause an increased 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 change the dose or how often you use one or both of the medicines.

  • Bromfenac
  • Celecoxib
  • Diclofenac
  • Diflunisal
  • Etodolac
  • Fenoprofen
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Magnesium Salicylate
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Oxaprozin
  • Piroxicam
  • Salsalate
  • Sulindac
  • Tolmetin

Other Interactions

Certain medicines 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 medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Congestive heart failure or
  • Dehydration or
  • Hyponatremia (low sodium in the blood)—Use with caution. May cause side effects to become worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of medicine from the body.

Description

Olmesartan is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

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

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

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