Desloratadine

What it is used for

Desloratadine Tablets are a prescription medicine that contains the medicine desloratadine (an antihistamine).

Desloratadine Tablets are used to help control the symptoms of:

• seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 12 years of age and older.
• perennial allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 12 years of age and older.
• chronic idiopathic urticaria (long-term itching) and to reduce the number and size of hives in people 12 years of age and older.

Desloratadine Tablets, 5 mg is not for children younger than 12 years of age.

How to take it

• Take Desloratadine Tablets exactly as your doctor tells you to take it.
• Do not change your dose of Desloratadine Tablets or take more often than prescribed.
• Desloratadine Tablets can be taken with or without food.
• If you take too many Desloratadine Tablets, call your doctor or get medical attention right away.

Side effects, and when to stop

Desloratadine Tablets may cause serious side effects, including:

• Allergic reactions. Stop taking Desloratadine Tablets and call your doctor right away or get emergency help if you have any of these symptoms:
• o rash
• o itching
• o hives
• o swelling of your lips, tongue, face, and throat
• o shortness of breath or trouble breathing

The most common side effects of Desloratadine Tablets in adults and children 12 years of age and older with allergic rhinitis include:

• sore throat
• dry mouth
• muscle pain
• tiredness
• sleepiness
• menstrual pain

Increased sleepiness or tiredness can happen if you take more Desloratadine Tablets than your doctor prescribed to you.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Desloratadine Tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Who should not take it

Do not take Desloratadine Tablets if you:

• are allergic to desloratadine or any of the ingredients in Desloratadine Tablets. See the end of this leaflet for a complete list of ingredients.
• are allergic to loratadine (Alavert, Claritin).

Talk to your doctor before taking this medicine if you have any questions about whether or not to take this medicine.

What to say before you start

Before you take Desloratadine Tablets, tell your doctor if you:

• have liver or kidney problems.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Desloratadine will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed. Desloratadine can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take Desloratadine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Desloratadine may affect the way other medicines work, and other medicines may affect how Desloratadine works. Especially tell your doctor if you take:

• ketoconazole (Nizoral)
• erythromycin (Ery-tab, Eryc, PCE)
• azithromycin (Zithromax, Zmax)
• antihistamines
• fluoxetine (Prozac)
• cimetidine (Tagamet)

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Storing it

• Store Desloratadine Tablets between 59°F to 86°F (15°C to 30°C).
• Desloratadine Tablets are sensitive to heat. Do not store above 86°F (30°C).
• Protect Desloratadine Tablets from moisture.

Keep Desloratadine Tablets, and all medicines out of the reach of children.

General information about Desloratadine Tablets

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Desloratadine Tablets for a condition for which it was not prescribed. Do not give Desloratadine Tablets to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Desloratadine Tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Desloratadine Tablets that is written for health professionals.