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|Novafed A Controlled-Release Capsules

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Novafed A Controlled-Release Capsules

Generic Name: Chlorpheniramine/Pseudoephedrine Controlled-Release Capsules (klor-fen-IHR-ah-meen/sue-do-eh-FED-rin)
Brand Name: Examples include Deconamine SR and Novafed A

Novafed A Controlled-Release Capsules is used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Novafed A Controlled-Release Capsules is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Novafed A Controlled-Release Capsules if:

you are allergic to any ingredient in Novafed A Controlled-Release Capsules
you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Novafed A Controlled-Release Capsules:

Some medical conditions may interact with Novafed A Controlled-Release Capsules. 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 a fast, slow, or irregular heartbeat
if you have a history of asthma, lung problems (eg, emphysema), adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your stomach or intestines, ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid

Some MEDICINES MAY INTERACT with Novafed A Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of this medicine"s side effects
Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Novafed A Controlled-Release Capsules
Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Novafed A Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Novafed A Controlled-Release Capsules 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 Novafed A Controlled-Release Capsules:

Use Novafed A Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Novafed A Controlled-Release Capsules by mouth with or without food.
Swallow Novafed A Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Novafed A Controlled-Release Capsules, 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 Novafed A Controlled-Release Capsules.

Important safety information:

Novafed A Controlled-Release Capsules may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Novafed A Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not take diet or appetite control medicines while you are taking Novafed A Controlled-Release Capsules without checking with you doctor.
Novafed A Controlled-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
Novafed A Controlled-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Novafed A Controlled-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Novafed A Controlled-Release Capsules may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Novafed A Controlled-Release Capsules for a few days before the tests.
Tell your doctor or dentist that you take Novafed A Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
Use Novafed A Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Caution is advised when using Novafed A Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Novafed A Controlled-Release Capsules while you are pregnant. It is not known if Novafed A Controlled-Release Capsules is found in breast milk. Do not breast-feed while taking Novafed A Controlled-Release Capsules.

Possible side effects of Novafed A Controlled-Release Capsules:

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; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Novafed A Controlled-Release Capsules:

Store Novafed A Controlled-Release Capsules 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 Novafed A Controlled-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Novafed A Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Novafed A Controlled-Release Capsules is 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.

This information is a summary only. It does not contain all information about Novafed A Controlled-Release Capsules. 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: November 1, 2006

Database Edition 06.4.1.002

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