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|Pseudoephedrine Sustained-Release Capsules

Pseudoephedrine Sustained-Release Capsules

Pseudoephedrine Sustained-Release Capsules is used for:

Relieving congestion due to colds, flu, hay fever, and other allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine Sustained-Release Capsules is a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Pseudoephedrine Sustained-Release Capsules if:

• you are allergic to any ingredient in Pseudoephedrine Sustained-Release Capsules
• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days
• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

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

Before using Pseudoephedrine Sustained-Release Capsules:

Some medical conditions may interact with Pseudoephedrine Sustained-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 history of heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

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

• Rauwolfia derivatives (eg, reserpine) because the effectiveness of Pseudoephedrine Sustained-Release Capsules may be decreased
• Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Pseudoephedrine Sustained-Release Capsules may be increased
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Pseudoephedrine Sustained-Release Capsules

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

Use Pseudoephedrine Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine Sustained-Release Capsules with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Pseudoephedrine Sustained-Release Capsules and are taking it regularly, 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 Pseudoephedrine Sustained-Release Capsules.

Important safety information:

• Pseudoephedrine Sustained-Release Capsules may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine Sustained-Release Capsules. Using Pseudoephedrine Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Pseudoephedrine Sustained-Release Capsules.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine Sustained-Release Capsules.
• Pseudoephedrine Sustained-Release Capsules contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Diabetes patients - Pseudoephedrine Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Pseudoephedrine Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Pseudoephedrine Sustained-Release Capsules with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pseudoephedrine Sustained-Release Capsules during pregnancy. It is unknown if Pseudoephedrine Sustained-Release Capsules is excreted in breast milk. If you are or will be breast-feeding while you are using Pseudoephedrine Sustained-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine Sustained-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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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 confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Store Pseudoephedrine Sustained-Release Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine Sustained-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 Pseudoephedrine Sustained-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.