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Telmisartan

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:

Rare

  • Changes in vision
  • Dizziness, lightheadedness, or fainting
  • Fast heartbeat
  • Large hives
  • Painful urination or changes in urinary frequency
  • Swelling in the hands, lower legs, and feet

Incidence not known

  • Blurred vision
  • Chest pain or discomfort
  • Confusion
  • Dark-colored urine
  • Decreased urine output
  • Difficult breathing
  • Dilated neck veins
  • Extreme fatigue
  • Fast or irregular heartbeat
  • Flushing
  • Hives or welts
  • Hoarseness
  • Irregular breathing
  • Irritation
  • Itching
  • Joint pain, stiffness, or swelling
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Muscle cramps or stiffness
  • Numbness or tingling in the hands, feet, or lips
  • Pain or discomfort in the arms, jaw, back, or neck
  • Pounding in the ears
  • Rash
  • Redness of the skin
  • Shortness of breath
  • Slow or fast heartbeat
  • Sweating
  • Swelling of the eyelids, face, or lips
  • Tightness in the chest
  • Troubled breathing or swallowing
  • Trouble with speaking or walking
  • Trouble with thinking
  • Unusual tiredness or weakness
  • Unusually warm skin
  • Weakness or heaviness of the legs
  • Weakness, numbness, or tingling in the arms or legs
  • Weight gain
  • Wheezing

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
  • Bloating or gas
  • Changes in appetite
  • Coughing
  • Diarrhea
  • Dry mouth
  • Ear pain or hearing problems
  • Fever
  • General tiredness or weakness
  • Headache
  • Heartburn
  • Increased sweating
  • Muscle pain or spasm
  • Nausea
  • Nervousness
  • Runny or stuffy nose
  • Sneezing
  • Sore throat

Incidence not known

  • Acid or sour stomach
  • Belching
  • Decreased interest in sexual intercourse
  • Difficulty with moving
  • Inability to have or keep an erection
  • Indigestion
  • Joint pain
  • Lack or loss of strength
  • Leg cramps
  • Loss in sexual ability, desire, drive, or performance
  • Muscle aching
  • Stomach discomfort, upset, or pain
  • Swelling
  • Weakness

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 your progress at regular visits to make sure 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. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. 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 or not alert.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position. Getting up slowly may help. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.

Check with your doctor right away if you 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 or salt and may lead to low blood pressure.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of potassium, magnesium, or sodium in the body).

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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

Proper Use

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and a change 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.

This medicine also works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same time each day.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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—At first, 40 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • To lower the risk of heart or blood vessel problems:
      • Adults 55 years of age and older—80 milligrams (mg) once a 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.

Protect the tablets from moisture and do not remove from the blister pack until you are ready to use them.

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 have not been performed on the relationship of age to the effects of telmisartan 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 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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ramipril

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
  • Digoxin
  • Etodolac
  • Fenoprofen
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lithium
  • 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 (fluid and electrolyte loss due to excessive perspiration, vomiting, diarrhea, prolonged diuretic therapy, dialysis, or dietary salt restriction) or
  • Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or
  • Heart disease or other heart problems (e.g., coronary artery disease)—Use with caution. The blood pressure–lowering effects of telmisartan may be increased.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Description

Telmisartan 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 may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Telmisartan is also used to lower the risk of heart attack or stroke in patients 55 years of age and older who have been diagnosed with diabetes or heart or blood vessel problems.

Telmisartan is an angiotensin II receptor blocker. 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.

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