Patient Information Leaflet

Desloratadina Teva 5 mg Film-Coated Tablets

desloratadina

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Desloratadina Teva and what it is used for

2.What you need to know before taking Desloratadina Teva

3.How to take Desloratadina Teva

4.Possible side effects

5.Storage of Desloratadina Teva

6.Contents of the pack and additional information

What is Desloratadina Teva

Desloratadina Teva contains desloratadine, which is an antihistamine.

How Desloratadina Teva works

Desloratadina Teva is an antiallergic medication that does not cause drowsiness. It helps to control allergic reactions and their symptoms.

When to use Desloratadina Teva

Desloratadina Teva relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Teva is also used to relieve symptoms associated with urticaria (skin disease caused by an allergy). These symptoms include itching and skin hives.

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

Do not takeDesloratadina Teva

• if you are allergic (hypersensitive) to desloratadine or to any of the other ingredients of this medication (described in section 6) or to loratadine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Teva

• if you have impaired renal function.
• if you have a personal or family history of seizures.

Use in children and adolescents

Do not administer this medication tochildren under 12 years of age.

Other medications and Desloratadina

No known interactions of Desloratadina Teva with other medications.

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication, even those acquired without a prescription.

Taking Desloratadina Teva with food, drinks, and alcohol

Desloratadina Teva can be taken regardless of meals.

Be careful when taking Desloratadina Teva with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It is not recommended to take Desloratadina Teva if you are pregnant or breastfeeding.

Fertility

No data is available on male and female fertility.

Driving and operating machines

At the recommended dose, it is not expected that this medication will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of mental alertness, such as driving a car or using machines, until you have determined your own response to the medication.

Desloratadina Teva contains lactose

Desloratadina Teva contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and adolescents 12 years of age and older

The recommended dose is one tablet once a day with water, with or without food.

This medication is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and for how long you should take Desloratadina Teva.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment plan based on the evaluation of your disease history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient and you should follow your doctor's instructions.

If you take more Desloratadina Teva than you should

Take Desloratadina Teva only as your doctor has instructed. An accidental overdose is not expected to cause serious problems. However, if you take more Desloratadina Teva than you have been told, tell your doctor, pharmacist, or nurse immediately.

If you forgot to take Desloratadina Teva

If you forgot to take your dose at the usual time, take it as soon as possible and continue with your usual dosing schedule. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Desloratadina Teva

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Desloratadina Teva can cause side effects, although not everyone will experience them.

During the marketing of Desloratadina Teva, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these severe side effects, stop taking this medication and seek immediate medical attention.

In clinical trials in adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet.In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadina, the following side effects were reported:

Frequent: the following may affect up to 1 in 10 people

?fatigue

?dry mouth

?headache

Adults

During the marketing of Desloratadina Teva, the following side effects were reported:

Rare: the following may affect fewer than 1 in 10,000 patients

Unknown: the frequency cannot be estimated from the available data

Children

Unknown: the frequency cannot be estimated from the available data

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you observe any change in the appearance of the tablets.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofDesloratadina Teva

• The active ingredient is desloratadine5mg
• The other components are microcrystalline cellulose, pregelatinized cornstarch, talc, anhydrous colloidal silica, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

Appearance of the product and contents of the package

Round, biconvex, smooth on both sides, blue-coated tablets. Desloratadina Teva5mg coated tablets are available in packages of 7, 10, 14, 20,21,28, 30, 40,50,60, 90,100 and 105coated tablets and in a perforated unit dose blister pack of 50 x 1 coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Merckle GmbH

Ludwig-Merckle-Strasse 3

D-89143 Blaubeuren

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

This leaflet has been revised in

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.