Telmisartan and Amlodipine

Telmisartan and Amlodipine

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:

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • Body aches or pain
  • Chills
  • Cough
  • Difficulty with breathing
  • Ear congestion
  • Fever
  • Headache
  • Loss of voice
  • Nasal congestion
  • Rapid weight gain
  • Runny nose
  • Sneezing
  • Sore throat
  • Tingling of the hands or feet
  • Unusual tiredness or weakness
  • Unusual weight gain or loss

Less common

  • Bladder pain
  • Bloody or cloudy urine
  • Blurred vision
  • Chest pain
  • Diarrhea
  • Difficult, burning, or painful urination
  • Dizziness
  • Frequent urge to urinate
  • General feeling of discomfort or illness
  • Joint pain
  • Loss of appetite
  • Lower back or side pain
  • Muscle aches and pains
  • Nausea
  • Nervousness
  • Pounding in the ears
  • Shivering
  • Slow or fast heartbeat
  • Sweating
  • Trouble with sleeping
  • Vomiting

Rare

  • Abdominal or stomach pain
  • Arm, back, or jaw pain
  • Black, tarry stools
  • Bleeding gums
  • Blistering, peeling, or loosening of the skin
  • Blood in the urine or stools
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Chest tightness or heaviness
  • Cold sweats
  • Confusion
  • Constipation
  • Cough or hoarseness
  • Dark urine
  • Difficult or labored breathing
  • Difficulty with swallowing
  • Dilated neck veins
  • Dry mouth
  • Extreme fatigue
  • Fast, irregular, pounding, or racing heartbeat or pulse
  • Feeling of warmth
  • Flushed, dry skin
  • Fruit-like breath odor
  • Hives
  • Increased hunger
  • Increased sweating
  • Increased thirst
  • Increased volume of pale, dilute urine
  • Indigestion
  • Irregular heartbeat
  • Irritation in the mouth
  • Joint or muscle pain
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Lightheadedness, dizziness, or fainting
  • Loss of consciousness
  • Muscle cramps or stiffness
  • Pale, bluish-colored, or cold hands or feet
  • Pinpoint red spots on the skin
  • Rash
  • Redness and swelling of the gums
  • Redness, soreness, or itching skin
  • Severe or sudden headache
  • Sudden loss of coordination
  • Sudden slurring of speech
  • Swollen glands
  • Tightness in the chest
  • Trembling or shaking of the hands or feet
  • Troubled breathing
  • Unexplained weight loss
  • Unsteadiness, trembling, or other problems with muscle control or coordination
  • Unusual bleeding or bruising
  • Vomiting of blood
  • Waking to urinate at night
  • Weakness in the arms, hands, legs, or feet
  • Weight gain
  • Yellow eyes or skin

Incidence not known

  • Decreased urine output
  • Nervousness
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Weakness or heaviness of the legs

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

  • Acid or sour stomach
  • Belching
  • Difficulty with moving
  • Heartburn
  • Indigestion
  • Pain or tenderness around the eyes and cheekbones
  • Sleepiness or unusual drowsiness

Rare

  • Abnormal dreams
  • Abnormal ejaculation
  • Ankle, knee, or great toe joint pain
  • Anxiety
  • Bad, unusual, or unpleasant (after) taste
  • Bleeding after defecation
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • Bloody nose
  • Burning feeling in the chest or stomach
  • Burning, dry, or itching eyes
  • Changes in vision
  • Cold and clammy skin
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • Cough producing mucus
  • Cracked, dry, or scaly skin
  • Decreased sexual performance or desire
  • Depression
  • Discharge or excessive tearing
  • Dry mouth
  • Dryness of the eyes
  • Dryness of the skin
  • Earache
  • Excess air or gas in the stomach or intestines
  • Feeling of constant movement of self or surroundings
  • Feeling of unreality
  • Feeling of warmth
  • Full feeling
  • Hair loss or thinning of the hair
  • Headache, severe and throbbing
  • Hearing loss
  • Hives or welts
  • Hyperventilation
  • Inability to have or keep an erection
  • Increased appetite
  • Irritability
  • Lack of feeling or emotion
  • Lack or loss of strength
  • Loose stools
  • Loss of memory
  • Pinpoint red or purple spots on the skin
  • Redness of the face, neck, arms, and occasionally, upper chest
  • Redness of the skin
  • Redness or swelling in the ear
  • Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • Restlessness
  • Tenderness in the stomach area
  • Toothache
  • Unable to sleep
  • Uncomfortable swelling around the anus

Incidence not known

  • Decreased interest in sexual intercourse
  • Swelling of the breasts or breast soreness in both females and males

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 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, lightheadedness, or fainting 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 not alert.

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 sodium or potassium in the body).

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 which may cause low blood pressure.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Proper Use

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 the use of this medicine, 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.

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, one tablet containing 40 milligrams (mg) or 80 mg of telmisartan and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg of telmisartan and 10 mg of amlodipine 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.

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 and amlodipine combination 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 and amlodipine combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require starting at a lower dose in these patients.

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.

  • Amiodarone
  • Atazanavir
  • Conivaptan
  • Dantrolene
  • Droperidol
  • Ramipril
  • Simvastatin
  • Telaprevir

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.

  • Acebutolol
  • Alprenolol
  • Atenolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bromfenac
  • Bucindolol
  • Carteolol
  • Carvedilol
  • Celecoxib
  • Celiprolol
  • Clopidogrel
  • Dalfopristin
  • Diclofenac
  • Diflunisal
  • Digoxin
  • Dilevalol
  • Diltiazem
  • Esmolol
  • Etodolac
  • Fenoprofen
  • Fluconazole
  • Flurbiprofen
  • Ibuprofen
  • Imatinib
  • Indinavir
  • Indomethacin
  • Itraconazole
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Labetalol
  • Levobunolol
  • Lithium
  • Magnesium Salicylate
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Nabumetone
  • Nadolol
  • Naproxen
  • Nebivolol
  • Nepafenac
  • Oxaprozin
  • Oxprenolol
  • Penbutolol
  • Pindolol
  • Piroxicam
  • Propranolol
  • Quinupristin
  • Rifapentine
  • Ritonavir
  • Salsalate
  • Sotalol
  • St John’s Wort
  • Sulindac
  • Talinolol
  • Tertatolol
  • Timolol
  • 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:

  • Kidney Problems or
  • Congestive heart failure—Use with caution. May make these conditions worse.
  • Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or
  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
  • Heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.
  • Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks.
  • Liver disease (including biliary obstructive disorders)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Description

Telmisartan and amlodipine is a combination of medicines that may be used alone or 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 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 blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

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

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