Product Information

Fexofenadine Hydrochloride, Pseudoephedrine Hydrochloride Oral tablet, Extended Release

What is this medicine?

FEXOFENADINE; PSEUDOEPHEDRINE is an antihistamine and a decongestant. This medicine is used to treat or prevent symptoms of allergies.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• difficulty urinating
• disease of the blood vessels or heart
• glaucoma
• high blood pressure
• kidney disease
• prostate trouble
• untreated thyroid problems
• an unusual or allergic reaction to fexofenadine, pseudoephedrine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Swallow this medicine with a glass of water. Do not break, crush, or chew. Follow the directions on the prescription label. Take the tablet on an empty stomach, one hour before or two hours after a meal. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 60 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bromocriptine
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• procarbazine
• stimulant medicines for attention disorders, weight loss, or to stay awake

This medicine may also interact with the following medications:

• antacids
• erythromycin
• grapefruit, apple, or orange juice
• ketoconazole
• linezolid
• magnesium products
• medicines for blood pressure
• medicines for heart problems
• methyldopa
• some medicines for colds, allergies and breathing difficulties

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Tell your doctor or health care professional if your symptoms do not improve. If you have high blood pressure, check your blood pressure regularly. Ask your health care professional what your blood pressure should be, and when you should contact them.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue
• difficulty urinating
• dizzy or confused
• fast heartbeat or chest pain
• infection or fever
• nausea or vomiting
• nervousness or difficulty sleeping
• rise in blood pressure
• tremor or muscle contractions
• trouble breathing

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• back pain
• dry mouth
• headache
• loss of appetite

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 to 25 degrees C (68 and 77 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.