Nifediac CC

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

You should not use this medicine if you are also taking certain other medications such as carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), or St. John's Wort. Using these medicines together can cause serious problems. Make sure your doctor knows all of the medications you are taking.

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

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 loss.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests. This medicine may affect the results of certain medical tests.

Grapefruits and grapefruit juice may increase the effects of nifedipine by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking this medicine.

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.

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:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• cough
• difficult or labored breathing
• dizziness or lightheadedness
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• headache
• muscle cramps
• rapid weight gain
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss
• weakness
• wheezing

• Blue lips and fingernails
• chest congestion
• chest pain
• chills
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, or noisy breathing, sometimes with wheezing
• dilated neck veins
• extreme fatigue
• fever
• increased sweating
• irregular breathing
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• severe unusual tiredness or weakness
• sweating
• troubled breathing
• vomiting

• Black, tarry stools
• bleeding gums
• blood in the eyes
• blood in the urine or stools
• bloody stools
• bluish color
• blurred vision
• body aches or pain
• changes in skin color
• cold sweats
• dark urine
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• dryness or soreness of throat
• ear congestion or pain
• extra heartbeats
• eye pain
• feeling unusually cold
• general tiredness and weakness
• headache, severe and throbbing
• hoarseness
• increased urge to urinate during the night
• irritation in the mouth
• itching
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• nasal congestion
• neck pain
• nervousness
• no blood pressure or pulse
• noisy breathing
• pain
• pain in the groin or genitals
• pain or burning while urinating
• painful or difficult urination
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness and swelling of the gums
• redness in the whites of the eyes
• runny nose
• shakiness and unsteady walk
• sharp back pain just below ribs
• shivering
• skin rash
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stopping of heart
• swelling around the eyes
• swollen glands
• tenderness
• tender, swollen glands in the neck
• troubled breathing with exertion
• unconsciousness
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• vision changes
• voice changes
• vomiting of blood or material that looks like coffee grounds
• waking to urinate at night
• yellow eyes and skin

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:

• Belching
• feeling of indigestion
• mood changes
• pain in the chest below the breastbone
• redness of the face, neck, arms, and occasionally, upper chest

• Abnormal ejaculation
• bloody nose
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• decreased interest in sexual intercourse
• decreased sexual performance or desire
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines
• feeling of constant movement of self or surroundings
• full feeling
• general feeling of discomfort or illness
• inability to have or keep an erection
• increased need to urinate
• joint stiffness
• leg cramps or pain
• loss in sexual ability, desire, drive, or performance
• nervousness
• passing gas
• passing urine more often
• sneezing
• stuffy nose
• trouble sleeping

• Acid or sour stomach
• ankle, knee, or great toe joint pain
• cracks in the skin
• difficulty with moving
• discouragement
• excessive muscle tone
• fear or nervousness
• feeling sad or empty
• hair loss or thinning of the hair
• heartburn
• increased sensitivity of the skin to sunlight
• irritability
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• lack of appetite
• lack or loss of strength
• loss of heat from the body
• loss of interest or pleasure
• loss of strength or energy
• loss in sexual ability, desire, drive, or performance
• lower back or side pain
• muscle pain or weakness
• muscle stiffness
• muscle tension or tightness
• pain or burning in the throat
• red, swollen skin
• redness or other discoloration of the skin
• scaly skin
• severe sunburn
• sleepiness or unusual drowsiness
• sleeplessness
• stomach discomfort, upset, or pain
• swelling of the breasts or breast soreness in both females and males
• tiredness
• trouble concentrating
• 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.

Rx only

For Oral use LB0010-04 Rev. 09/08

Nifediac® CC extended-release tablets are an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester.

The molecular formula is C17H18N2O6 and has the structural formula:

Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifediac® CC extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration.

In addition, each tablet contains the following inactive ingredients: anhydrous lactose, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide, and yellow 10 ferric oxide.

Nifedipine Extended-Release Tablets meet USP Dissolution Test 4.

Nifediac® CC extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Known hypersensitivity to nifedipine.

Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).

Nifedipine may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may need to take an extended-release tablet on an empty stomach. Follow the directions on your medicine label about taking this medication with or without food.

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

Your blood pressure will need to be checked often and you may need other blood tests at your doctor's office.

Some tablet forms of nifedipine are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of nifedipine and will not make the medication less effective.

If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine at least 36 hours before surgery.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you are also taking a beta-blocker (atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others) you should not stop using the beta-blocker suddenly or you could have serious heart problems that will not be prevented by nifedipine. Follow your doctor's instructions about tapering your beta-blocker dose.

You should not stop using nifedipine suddenly. Stopping suddenly may make your condition worse.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Grapefruit and grapefruit juice may interact with nifedipine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Other drugs may interact with nifedipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.