DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Desloratadina Actavis 5 mg 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Desloratadina Actavis

Desloratadina Actavis contains desloratadine, which is an antihistamine.

How Desloratadina Actavis works

Desloratadina Actavis is a non-drowsy antiallergic medicine that helps control allergic reactions and their symptoms.

When to use Desloratadina Actavis

Desloratadina Actavis 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.

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

Relief from these symptoms lasts a full day and helps you to carry out your daily activities and have normal sleep periods.

2. What you need to know before you take Desloratadina Actavis

Do not take Desloratadina Actavis

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Desloratadina Actavis

• if you have kidney problems.
• 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 Desloratadina Actavis

There are no known interactions between Desloratadina Actavis and other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Desloratadina Actavis with food, drinks and alcohol

Desloratadina Actavis can be taken with or without food.

Be careful when taking Desloratadina Actavis 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 Desloratadina Actavis 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.

3. How to take Desloratadina Actavis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

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 Desloratadina Actavis.

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 therefore you should follow your doctor's instructions.

If you take more Desloratadina Actavis than you should

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

If you forget to take Desloratadina Actavis

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 Desloratadina Actavis

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria 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:

Frequent: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

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

Very rare: may affect up to 1 in 10,000 people

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

• increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, such as that from a sunlamp.
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Desloratadina Actavis

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, label and blister after EXP. The expiry date is the last day of the month stated.

Blister packs:

This medicine does not require any special storage conditions.

Bottles:

This medicine does not require any special storage temperature.

Keep the bottle tightly closed to protect from light.

If you notice any change in the appearance of the tablets, inform your pharmacist.

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 other information

Composition of Desloratadina Actavis

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other ingredients are:

Core of the tablet: Microcrystalline cellulose, pregelatinized starch, mannitol, talc, magnesium stearate. Coating of the tablet: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, carmine indigo (E132).

Appearance and packaging

Blue, round, 6 mm diameter, biconvex, film-coated tablets with "LT" engraved on one side.

Desloratadina Actavis 5 mg film-coated tablets EFG are available in:

Blister packs: 7, 10, 14, 21, 30, 50, 90 or 100 tablets.

Plastic bottles containing a desiccant and closed with a plastic cap: 30 or 100 tablets.

Do not swallow the desiccant.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

Manufacturers

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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