DESLORATADINE TEVA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Teva 5mg film-coated tablets EFG

desloratadine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Desloratadine Teva and what is it used for
2. What you need to know before taking Desloratadine Teva
3. How to take Desloratadine Teva
4. Possible side effects
5. Storage of Desloratadine Teva
6. Contents of the pack and further information

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

What is Desloratadine Teva

Desloratadine Teva contains desloratadine, which is an antihistamine.

How Desloratadine Teva works

Desloratadine Teva is a non-sedating antiallergic medicine that helps to control allergic reactions and their symptoms.

When to use Desloratadine Teva

Desloratadine Teva relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Desloratadine Teva is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rash.

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

2. What you need to know before taking Desloratadine Teva

Do not takeDesloratadine Teva

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

Warnings and precautions

Consult your doctor or pharmacist before taking Desloratadine Teva

• if you have impaired kidney function.
• if you have a history of seizures.

Use in children and adolescents

Do not give this medicine to children under 12 years of age.

Other medicines and Desloratadine Teva

There are no known interactions between Desloratadine Teva and other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking Desloratadine Teva with food, drinks, and alcohol

Desloratadine Teva can be taken with or without food.

Be careful when taking Desloratadine Teva with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Fertility

There is no available data on male and female fertility.

Driving and using machines

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

Desloratadine Teva contains lactose

Desloratadine Teva contains lactose.If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Desloratadine Teva

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

Adults and adolescents aged 12 and over

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

This medicine 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 Desloratadine Teva.

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

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

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

If you take moreDesloratadine Tevathan you should

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

If you forget to takeDesloratadine Teva

If you forget to take your dose at the scheduled time, take it as soon as possible and then continue with your normal dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Desloratadine Teva

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

4. Possible side effects

Like all medicines, Desloratadine Teva can cause side effects, although not everybody gets them.

During the marketing of Desloratadine Teva, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, rash, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.

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

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

Common: may affect up to 1 in 10 people

? fatigue

? dry mouth

? headache

Adults

During the marketing of Desloratadine Teva, the following side effects have been reported:

Very rare: may affect less than 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Children

Frequency not known: frequency cannot be estimated from the available data

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Teva

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

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.

No special storage conditions are required.

Do not use this medicine if you notice any change in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition ofDesloratadine Teva

• The active substance is desloratadine 5 mg
• The other ingredients are microcrystalline cellulose, pre-gelatinized maize starch, talc, colloidal anhydrous silica, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

Appearance and packaging of the product

Round, biconvex, blue, film-coated tablets. Desloratadine Teva 5 mg film-coated tablets are available in packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100, and 105 film-coated tablets, and in unit dose blister packs of 50 x 1 film-coated tablet.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

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 further information on this medicine, contact the local representative of the marketing authorisation holder:

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.