Clarinex Reditabs

Desloratadine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Desloratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

Desloratadine may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• fever, flu symptoms;

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dry mouth, sore throat, cough;

• muscle pain;

• drowsiness, tired feeling;

• nausea, diarrhea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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:

• Anaphylaxis, such as, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of eyelids or around the eyes or face or lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness, wheezing
• dyspnea, such as, shortness of breath, difficult or labored breathing, tightness in chest, wheezing
• edema, such as, swelling
• pruritus, such as, itching skin
• rash
• tachycardia, such as, fast, pounding, or irregular heartbeat or pulse
• urticaria, such as, hives or welts, itching, redness of skin, skin rash.

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:

• Headache

• Dizziness
• dry mouth
• dysmenorrhea, such as, difficult or painful menstruation
• dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, stomach discomfort , upset or pain,
• fatigue, such as, unusual tiredness or weakness
• myalgia, such as, joint pain, swollen joints, muscle aching or cramping, muscle pains or stiffness, difficulty in moving
• pharyngitis, such as, body aches or pain, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, tender swollen glands in neck, trouble in swallowing, voice changes.
• somnolence, such as, sleepiness or unusual drowsiness
• nausea

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. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to desloratadine, loratadine, or any other part of this medicine (Clarinex Reditabs).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling very tired or weak.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

Applies to desloratadine: oral syrup, oral tablet, oral tablet disintegrating

Along with its needed effects, desloratadine (the active ingredient contained in Clarinex Reditabs) 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 while taking desloratadine:

• Anaphylaxis, such as, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of eyelids or around the eyes or face or lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness, wheezing
• dyspnea, such as, shortness of breath, difficult or labored breathing, tightness in chest, wheezing
• edema, such as, swelling
• pruritus, such as, itching skin
• rash
• tachycardia, such as, fast, pounding, or irregular heartbeat or pulse
• urticaria, such as, hives or welts, itching, redness of skin, skin rash.

Some side effects of desloratadine 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:

• Headache

• Dizziness
• dry mouth
• dysmenorrhea, such as, difficult or painful menstruation
• dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, stomach discomfort , upset or pain,
• fatigue, such as, unusual tiredness or weakness
• myalgia, such as, joint pain, swollen joints, muscle aching or cramping, muscle pains or stiffness, difficulty in moving
• pharyngitis, such as, body aches or pain, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, tender swollen glands in neck, trouble in swallowing, voice changes.
• somnolence, such as, sleepiness or unusual drowsiness
• nausea

Applies to desloratadine: oral solution, oral tablet, oral tablet disintegrating

Cardiovascular

Cardiovascular side effects of spontaneous nature reported during the marketing of desloratadine (the active ingredient contained in Clarinex Reditabs) have included tachycardia and palpitations.[Ref]

Hypersensitivity

Hypersensitivity side effects of spontaneous nature reported during the marketing of desloratadine (the active ingredient contained in Clarinex Reditabs) have included rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis.[Ref]

Hepatic

Hepatic side effects have included elevated liver enzymes and bilirubin. Very rarely, hepatitis has been observed in clinical practice.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth, dry throat, nausea, and pharyngitis.[Ref]

Nervous system

Nervous system side effects have included somnolence and dizziness. Psychomotor hyperactivity and seizures have been observed in clinical practice.[Ref]

An increase in the incidence of somnolence has been reported in clinical trials (n=1838) at doses of 10 mg/day and 20 mg/day (5.2% and 7.6%, respectively), compared to placebo (2.3%).[Ref]

General

General side effects have included myalgia and influenza-like symptoms.[Ref]

Some side effects of Clarinex Reditabs may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial dose: 5 mg orally once a day.
Maintenance dose: 5 mg orally once a day.