Felodipine (Oral Route)

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.

Felodipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels . Felodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart, which reduces the workload.

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

This product is available in the following dosage forms:

• Tablet, Extended Release

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 felodipine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of felodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require an adjustment of dose in patients receiving felodipine.

Pregnancy

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

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


• Cyclosporine


• Dantrolene


• Droperidol


• Fentanyl


• Mibefradil

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


• Amprenavir


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Dalfopristin


• Dilevalol


• Esmolol


• Fluconazole


• Indinavir


• Itraconazole


• Ketoconazole


• Labetalol


• Levobunolol


• Magnesium


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Nelfinavir


• Oxcarbazepine


• Oxprenolol


• Penbutolol


• Phenobarbital


• Pindolol


• Propranolol


• Quinupristin


• Rifapentine


• Saquinavir


• Sotalol


• St John`s Wort


• Talinolol


• Tertatolol


• Timolol

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.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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:

• Heart failurea€”Use with caution. May make this condition worse.

• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

In addition to the use of 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. 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.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

You may take this medicine without food or with a light meal .

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 (extended-release tablets):
  
  
  
  • For high blood pressure:
    
    
    
    • Adultsa€”At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    
    
    • Childrena€”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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.

This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet; tingling of the hands or feet; or unusual weight gain or weight loss .

Redness, swelling, or bleeding of the gums may occur while taking this medicine. Brushing and flossing your teeth carefully and regularly, and massaging your gums may help prevent this. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any redness, swelling, or bleeding of your gums.

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 face, arms, hands, lower legs, or feet


• Rapid weight gain


• Tingling of hands or feet


• Unusual weight gain or loss

Less common

• Body aches or pain


• Chills


• Cough


• Difficulty in breathing


• Ear congestion


• Fever


• Headache


• Loss of voice


• Nasal congestion


• Runny nose


• Sneezing


• Sore throat


• Unusual tiredness or weakness

Incidence not known

• Blurred vision


• Chest pain, tightness, or heaviness


• Confusion


• Congestion


• Cough producing mucus


• Diarrhea


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Fast, slow, or irregular heartbeat


• General feeling of discomfort or illness


• Hoarseness


• Joint pain


• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• Loss of appetite


• Muscle aches and pains


• Nausea


• Pain or discomfort in arms, jaw, back, or neck


• Pale skin


• Shivering


• Shortness of breath


• Sweating


• Swelling or puffiness of face


• Tender or swollen glands in neck


• Trouble in swallowing


• Trouble sleeping


• Troubled breathing with exertion


• Unusual bleeding or bruising


• Voice changes


• Wheezing

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

Symptoms of overdose

• Feeling of warmth


• Redness of the face, neck, arms and occasionally, upper chest

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


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Constipation


• Heartburn


• Indigestion


• Lack or loss of strength


• Skin rash


• Stomach discomfort, upset, or pain

Rare

• Bleeding gums


• Irritation in mouth


• Redness and swelling of gums

Incidence not known

• Bloated or full feeling


• Bloody nose


• Burning while urinating


• Decreased interest in sexual intercourse


• Difficult or painful urination


• Difficulty in moving


• Discouragement


• Disturbed color perception


• Double vision


• Dry mouth


• Excess air or gas in stomach or intestines


• Feeling sad or empty


• Fear or nervousness


• Frequent strong or increased urge to urinate


• Halos around lights


• Hives or welts


• Inability to have or keep an erection


• Increased need to urinate


• Increased volume of pale or dilute urine


• Irritability


• Itching


• Loss in sexual ability, desire, drive, or performance


• Loss of interest or pleasure


• Muscle cramps or stiffness


• Night blindness


• Overbright appearance of lights


• Pain or tenderness around eyes and cheekbones


• Passing gas


• Passing urine more often


• Redness of skin


• Sleepiness or unusual drowsiness


• Sleeplessness


• Sores, welting, or blisters


• Swelling of the breasts or breast soreness in both females and males


• Swollen joints


• Tiredness


• Trouble concentrating


• Tunnel vision


• Unable to sleep

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.