Wednesday, September 28, 2016

Adalat XL Plus Extended-Release Tablets


Pronunciation: nye-FED-i-peen/AS-pir-in
Generic Name: Nifedipine
Brand Name: Adalat XL Plus

Rarely, certain patients have had increased angina (chest pain) symptoms or heart attack when they start nifedipine or increase their dose. The risk is greater in patients with severe heart blood vessel problems.


Very low blood pressure and decreased heart function have been reported with the use of nifedipine in patients with severe heart failure. Use Adalat XL Plus Extended-Release Tablets with caution in patients with severe heart failure. Rarely, patients taking a beta-blocker (eg, propranolol) who also started nifedipine have developed heart failure.


Contact your doctor immediately if you experience chest pain, severe dizziness, fainting, numbness of an arm or leg, sudden vomiting or vision changes, trouble breathing, or swelling of the hands, ankles, or feet.





Adalat XL Plus Extended-Release Tablets are used for:

Treating high blood pressure. It is also used to help reduce the risk of nonfatal heart attack in certain patients, or to prevent a second heart attack or stroke. It may also be used for other conditions as determined by your doctor.


Adalat XL Plus Extended-Release Tablets are a calcium channel blocking agent and salicylate combination. The calcium channel blocker works to decrease blood pressure and chest pain by dilating (widening) blood vessels in the heart and other blood vessels. The salicylate works by decreasing the ability of the blood to clot.


Do NOT use Adalat XL Plus Extended-Release Tablets if:


  • you are allergic to any ingredient in Adalat XL Plus Extended-Release Tablets

  • you have had asthma symptoms (eg, shortness of breath, wheezing), nasal swelling, or growths in the nose caused by aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen)

  • you are pregnant, may become pregnant, or are breast-feeding

  • you have very low blood pressure or shock due to heart problems

  • you have a stomach ulcer or a bleeding tendency (eg, hemophilia)

  • you are taking a barbiturate (eg, phenobarbital), carbamazepine, dabigatran, a hydantoin (eg, phenytoin), a rifamycin (eg, rifampin, rifampicin), St. John's wort, or certain doses of methotrexate

  • the patient is a child

Contact your doctor or health care provider right away if any of these apply to you.



Before using Adalat XL Plus Extended-Release Tablets:


Some medical conditions may interact with Adalat XL Plus Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have had an allergic reaction (eg, rash, hives, difficulty breathing, swelling, dizziness) to a salicylate (eg, diflunisal) or an NSAID (eg, ibuprofen)

  • if you have asthma, other lung or breathing problems, hay fever, or growths in the nose

  • if you have a history of angina or heart blood vessel problems; brain blood vessel problems (eg, stroke); heart problems (eg, congestive heart failure, heart attack); fast, slow, or irregular heartbeat; low blood pressure; liver problems (eg, cirrhosis); kidney problems; swelling of the arms or legs; or fluid in your lungs

  • if you take other medicines to lower your blood pressure

  • if you have a history of diabetes, gout, stomach or bowel problems (eg, narrowing, inflammation, ulcers, bleeding), or if you have had a certain type of bowel surgery (ileostomy)

  • if you have anemia, low blood thrombin or platelet levels, a history of bleeding or blood clotting problems, or if you drink 3 or more alcohol-containing drinks per day

  • if you have recently had or will be having surgery, or have recently stopped taking a beta-blocker (eg, propranolol)

Some MEDICINES MAY INTERACT with Adalat XL Plus Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Barbiturates (eg, phenobarbital), carbamazepine, rifamycins (eg, rifampin, rifampicin), hydantoins (eg, phenytoin), or St. John's wort because they may decrease Adalat XL Plus Extended-Release Tablets's effectiveness

  • Dabigatran because the risk of bleeding may be increased

  • Certain doses of methotrexate because the risk of its side effects may be increased by Adalat XL Plus Extended-Release Tablets.

  • Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, high cholesterol, seizures, blood thinning, anxiety, depression, organ rejection, asthma, acid reflux, HIV, diabetes, cancer, allergies, or irregular heartbeat), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Adalat XL Plus Extended-Release Tablets, increasing the risk of side effects.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Adalat XL Plus Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Adalat XL Plus Extended-Release Tablets:


Use Adalat XL Plus Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Adalat XL Plus Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.

  • Take Adalat XL Plus Extended-Release Tablets by mouth after a meal unless your doctor tells you otherwise. Take it with a full glass of liquid (8 oz/240 mL).

  • Swallow Adalat XL Plus Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.

  • Do not eat grapefruit or drink grapefruit juice while you use Adalat XL Plus Extended-Release Tablets.

  • Take Adalat XL Plus Extended-Release Tablets on a regular schedule to get the most benefit from it. Taking Adalat XL Plus Extended-Release Tablets at the same time each day will help you remember to take it.

  • Continue to take Adalat XL Plus Extended-Release Tablets even if you feel well. Do not miss any doses. Do not suddenly stop Adalat XL Plus Extended-Release Tablets without checking with your doctor.

  • If you miss a dose of Adalat XL Plus Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Adalat XL Plus Extended-Release Tablets.



Important safety information:


  • Adalat XL Plus Extended-Release Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Adalat XL Plus Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Adalat XL Plus Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Adalat XL Plus Extended-Release Tablets may cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Adalat XL Plus Extended-Release Tablets.

  • Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.

  • Adalat XL Plus Extended-Release Tablets has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Adalat XL Plus Extended-Release Tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Tell your doctor or dentist that you take Adalat XL Plus Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

  • Proper dental care is important while you are taking Adalat XL Plus Extended-Release Tablets. Brush and floss your teeth and visit the dentist regularly.

  • You may notice the tablet shell in your stool. This is normal and not a cause for concern.

  • Diabetes patients - Adalat XL Plus Extended-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Adalat XL Plus Extended-Release Tablets may interfere with certain lab tests, including thyroid function and barium contrast x-rays. Be sure your doctor and lab personnel know you are taking Adalat XL Plus Extended-Release Tablets.

  • Lab tests, including blood pressure, may be performed while you use Adalat XL Plus Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Adalat XL Plus Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

  • Adalat XL Plus Extended-Release Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not use Adalat XL Plus Extended-Release Tablets if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Adalat XL Plus Extended-Release Tablets are found in breast milk. Do not breast-feed while you are taking Adalat XL Plus Extended-Release Tablets.


Possible side effects of Adalat XL Plus Extended-Release Tablets:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; stomach upset; tiredness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or dark, tarry stools; chest pain or tightness; dark urine; decreased sexual desire or ability; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hearing loss; mood or mental changes (eg, anxiety, confusion, depression); numbness of an arm or leg; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent dizziness or headache; severe or persistent nausea or diarrhea; severe or persistent tiredness or weakness; shortness of breath; stomach cramps or pain; sudden vision changes; swelling of the face, feet or hands; tender, bleeding, or swollen gums; tremor; unusual bruising or bleeding; vomit that looks like coffee grounds; vomiting; wheezing; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Adalat XL Plus side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; hearing loss; loss of coordination; rapid breathing; ringing in the ears; seizures; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; sluggishness; stomach pain; unusual sweating.


Proper storage of Adalat XL Plus Extended-Release Tablets:

Store Adalat XL Plus Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Adalat XL Plus Extended-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Adalat XL Plus Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Adalat XL Plus Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Adalat XL Plus Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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