Sudafed PE

Sudafed PE 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.

Sudafed PE 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 Sudafed PE if:

• you are allergic to any ingredient in Sudafed PE
• you have had an unusual reaction (eg, dizziness, weakness, tremors, irregular heartbeat) to another sympathomimetic medicine (eg, pseudoephedrine)
• you are taking furazolidone or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days
• you have severe high blood pressure, severe heart blood vessel disease, fast heartbeat, or severe heart problems

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

Before using Sudafed PE :

Some medical conditions may interact with Sudafed PE . 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 glaucoma or increased pressure in the eye, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, overactive thyroid, seizures, or stroke

Some MEDICINES MAY INTERACT with Sudafed PE . 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, entacapone), furazolidone, indomethacin, methyldopa, or MAOIs (eg, phenelzine) because they may increase the risk of Sudafed PE 's side effects
• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Sudafed PE 's effectiveness
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of its side effects may be increased by Sudafed PE
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Sudafed PE

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sudafed PE 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 Sudafed PE :

Use Sudafed PE as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sudafed PE by mouth with or without food.
• If you miss a dose of Sudafed PE 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 Sudafed PE .

Important safety information:

• Sudafed PE may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sudafed PE with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• 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 7 days or if you develop a high fever, check with your doctor.
• Sudafed PE has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine or pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not take diet or appetite control medicines while you are taking Sudafed PE .
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Sudafed PE .
• Tell your doctor or dentist that you take Sudafed PE before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients - Sudafed PE may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Use Sudafed PE with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Sudafed PE in CHILDREN; they may be more sensitive to its effects.
• Different brands of Sudafed PE may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
• Sudafed PE should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sudafed PE while you are pregnant. Sudafed PE is found in breast milk. Do not breast-feed while taking Sudafed PE .

Possible side effects of Sudafed PE :

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:

Dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; hallucinations; seizures; tremor; trouble urinating.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room right away. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Store Sudafed PE 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 Sudafed PE out of the reach of children and away from pets.

General information:

• If you have any questions about Sudafed PE , please talk with your doctor, pharmacist, or other health care provider.
• Sudafed PE 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 Sudafed PE . 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.

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