Patient Information Leaflet

Desloratadina ratiopharm 5mg Film-Coated Tablets

desloratadina

For adults

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Ifyou need advice or more information, consult your pharmacist.
• Ifyou experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet.See section4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

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

2.What you need to know before taking Desloratadina ratiopharm

3.How to take Desloratadina ratiopharm

4.Possible side effects

5.Storage of Desloratadina ratiopharm

6.Contents of the pack and additional information

What is Desloratadina ratiopharm

Desloratadina ratiopharm contains desloratadine, which is an antihistamine.

How Desloratadina ratiopharm works

Desloratadina ratiopharm is an antiallergic medication that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When to use Desloratadina ratiopharm

Desloratadina ratiopharm 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. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina ratiopharm is also used to relieve symptoms associated with chronic idiopathic urticaria (skin disease of unknown cause), diagnosed initially by your doctor. These symptoms include itching and skin hives.

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

You should consult a doctor if it worsens or does not improve after 7 days. If you notice difficulty breathing or swelling of the lips, tongue, or throat, you should consult a doctor immediately.

Do not takeDesloratadina ratiopharm

-if you are allergic to desloratadina, loratadinaor any of the other ingredients of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina ratiopharm:

• if you have impaired renal functionor a severe liver disease.
• if you have a personal or family history of seizures.

If you have chronic idiopathic urticaria, it must be diagnosed by your doctor before starting to take Desloratadina ratiopharm.

Children and adolescents

Do not administer this medication toadolescents andchildren under 18years of age.

Other medications andDesloratadina ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

No known interactions have been reported betweenDesloratadina ratiopharmand other medications.

TakingDesloratadina ratiopharmwith food, drinks and alcohol

Desloratadina ratiopharmcan be taken regardless of meals.

Be careful when taking Desloratadina ratiopharm 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 takeDesloratadina ratiopharmif you are pregnant.

Your doctor will decide whether to interrupt breastfeeding or interrupt treatment with Desloratadina ratiopharm.

No data is available on male and female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machinery. 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 operating machinery, until you have determined your own response to the medication.

Desloratadina ratiopharmcontains lactose and sodium

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

This medication contains less than 1mmol of sodium (23mg) per tablet; this is essentially “sodium-free”.

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

The recommended dose is one tablet once a day with water.

The tablet can be taken with or without food. Swallow the tablet whole.

The duration of treatment depends on the type, duration, and evolution of symptoms. You should consult a doctor if symptoms worsen or do not improve after 7 days. If you notice difficulty breathing or swelling of the lips, tongue, or throat, you should consult a doctor immediately.

If your allergic rhinitis symptoms used to last less than 4 days a week or less than 4 weeks, use this medication until symptoms have disappeared. You can start using this medication again when symptoms reappear.

If your allergic symptoms used to last longer (4 or more days a week and for more than 4 weeks), continuous treatment during the exposure period to the allergen may be necessary.

For chronic idiopathic urticaria, treatment may be necessary for more than 6 weeks, depending on your symptoms. If symptoms reappear after interrupting treatment, you can take this medication again.

If you take more Desloratadina ratiopharm than you should

No serious problems are expected from an accidental overdose. However, if you take more Desloratadina ratiopharm than you should, tell your doctor or pharmacist immediately.

If you forgot to take Desloratadina ratiopharm

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects are very rare, but you must stop taking this medication and seek urgent medical attention immediately if you notice them:

• Severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling).

Other Adverse Effectsthat may occur are:

Frequent (may affect up to 1 in 10people)

• Fatigue
• Dry mouth
• Headache

Very Rare(may affect up to 1 in 10,000people)

• Skin rash
• Strong or irregular heartbeat, rapid heartbeat
• Stomach pain, nausea, vomiting, upset stomach, diarrhea
• Dizziness, drowsiness, difficulty sleeping, seizures, agitation with increased body movement
• Muscle pain
• Hallucinations
• Liver inflammation, alteration in liver function tests

Unknown Frequency(cannot be estimated from available data)

• Unusual weakness
• Yellowing of the skin and/or eyes
• Increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to ultraviolet light from a tanning bed
• Slow heartbeat, changes in the way the heart beats
• Abnormal behavior, aggression
• Weight gain, increased appetite
• Depressed mood
• Dry eyes

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about 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 EXP.The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

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 medications that you no longer need. In this way, you will help protect the environment.

Composition ofDesloratadina ratiopharm

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

Core tablet: poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, cornstarch, lactose monohydrate (see section2 “Desloratadina ratiopharm contains lactose and sodium”, talc.

Covering: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc, andaluminum lacquer with indigo carmine blue (E132).

Appearance of the product and contents of the package

Round, biconvex, blue film-coated tablets.

Desloratadina ratiopharm5mg film-coated tablets are available in blister packs of PVC/PVdC/aluminum of7, 10, 14, 15, 20, and 30 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

or

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,

4042 Debrecen,

Hungary

or

Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
Netherlands

or

Teva Czech Industries s.r.o
Ostravska 29, c.p. 305, 74770
Opava-Komarov
Czech Republic

or

Teva Operations Poland Sp. Z o.o.

ul. Mogilska 80. 31-546
Krakow
Poland

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

Last review date of this leaflet:

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