Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Descriptions Fexofenadine is an antihistamine. It is used to relieve the symptoms of hay fever (seasonal allergic rhinitis) and hives of the skin (chronic idiopathic urticaria) . Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some people histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some people to have hives, with severe itching of the skin . This medicine is available only with your doctor’s prescription . Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects . This product is available in the following dosage forms: • Tablet • Tablet, Disintegrating • Capsule • Suspension In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of fexofenadine in children below 6 months of age. Safety and efficacy have not been established . Do not give any cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects. Geriatric Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fexofenadine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving fexofenadine . Pregnancy Information about this fexofenadine-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Lomitapide • Nilotinib • Simeprevir • Tocophersolan Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Aluminum Carbonate, Basic • Aluminum Hydroxide • Aluminum Phosphate • Dihydroxyaluminum Aminoacetate • Dihydroxyaluminum Sodium Carbonate • Magaldrate • Magnesium Carbonate • Magnesium Hydroxide • Magnesium Oxide • Magnesium Trisilicate • St John’s Wort Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. • Apple Juice • Grapefruit Juice • Orange Juice Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body . • Phenylketonuria—Use with caution. The oral disintegrating tablets contain phenylalanine . You should always take this medicine with water. Do not take it with juice such as grapefruit, orange, or apple juice . You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist . For patients using the oral disintegrating tablet form of this medicine: • Make sure your hands are dry. • Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet. • Immediately place the tablet on top of the tongue. Do not chew or break the tablet. • The tablet will dissolve in seconds, and you may swallow it with your saliva. You may drink a glass of water after the tablet has dissolved. • Always take this tablet on an empty stomach . Shake the oral liquid well before using it. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup . Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. • For symptoms of hay fever: For oral dosage form (capsules, tablets): Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day. Children 6 to 11 years of age—30 mg two times a day. Children 4 to 6 years of age—Use and dose must be determined by your doctor . Children and infants up to 4 years of age—Use is not recommended . For oral dosage form (disintegrating tablets): Children 6 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach. Children 4 to 6 years of age—Use and dose must be determined by your doctor . Children and infants up to 4 years of age—Use is not recommended . For oral dosage form (suspension): Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day. Children younger than 4 years of age—Use and dose must be determined by your doctor . • For symptoms of chronic hives: For oral dosage form (capsules, tablets): Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day. Children 4 to 11 years of age—30 mg two times a day. Children younger than 4 years of age—Use and dose must be determined by your doctor . For oral dosage form (disintegrating tablets): Children 4 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach. Children younger than 4 years of age—Use and dose must be determined by your doctor . For oral dosage form (suspension): Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day. Children 6 months to 4 years of age—15 mg or 2.5 mL two times a day. Children younger than 6 months of age—Use and dose must be determined by your doctor . Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help reduce any side effects . Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Rare • Chest tightness • feeling of warmth, redness of the face, neck, arms and occasionally, upper chest • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs • shortness of breath, difficult or labored breathing Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common • Vomiting Less common • Back pain • body aches or pain • chills • coughing • diarrhea • difficulty with moving • dizziness • ear congestion • earache • fever • headache • joint pain • loss of voice • muscle aching or cramping • muscle pains or stiffness • nasal congestion • nausea • pain in arms or legs • pain or tenderness around eyes or cheekbones • painful menstrual bleeding • redness or swelling in ear • ringing or buzzing in ears • runny or stuffy nose • sleepiness or unusual drowsiness • sneezing • sore throat • stomach upset • swollen joints • unusual feeling of tiredness or weakness • viral infection (such as cold and flu) Rare • Nervousness • rash • sleeplessness • terrifying dreams • trouble sleeping Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.