DESLORATADINE RATIOPHARM 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine ratiopharm 5mg film-coated tablets EFG

desloratadine

For adults

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the package leaflet

1. What is Desloratadine ratiopharm and what is it used for
2. What you need to know before taking Desloratadine ratiopharm
3. How to take Desloratadine ratiopharm
4. Possible side effects
5. Storage of Desloratadine ratiopharm
6. Package contents and additional information

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

What is Desloratadine ratiopharm

Desloratadine ratiopharm contains desloratadine, which is an antihistamine.

How Desloratadine ratiopharm works

Desloratadine ratiopharm is a non-drowsy anti-allergic medication that helps control allergic reactions and their symptoms.

When to use Desloratadine ratiopharm

Desloratadine ratiopharm relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, e.g., hay fever or house dust mite allergy) in adults. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

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

Relief from these symptoms lasts a full day and helps you continue your daily activities and normal sleep periods.

You should consult a doctor if your 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.

2. What you need to know before taking Desloratadine ratiopharm

Do not takeDesloratadine ratiopharm

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

Warnings and precautions

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

• if you have impaired renal function or 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 Desloratadine ratiopharm.

Children and adolescents

Do not give this medication to adolescents and children under 18 years of age.

Other medications andDesloratadine ratiopharm

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

There are no known interactions between Desloratadine ratiopharm and other medications.

TakingDesloratadine ratiopharmwith food, drinks, and alcohol

Desloratadine ratiopharm can be taken with or without food.

Be cautious when taking Desloratadine ratiopharm with alcohol.

Pregnancy, breastfeeding, and fertility

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

It is not recommended to take Desloratadine ratiopharm if you are pregnant.

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

There are no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medication 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 medication.

Desloratadine ratiopharmcontains lactose and sodium

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

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

3. How to take Desloratadine ratiopharm

Follow the administration instructions for this medication contained in this package 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 the symptoms. You should consult a doctor if your 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 the symptoms have disappeared. You can start using this medication again when the symptoms reappear.

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

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

If you take moreDesloratadine ratiopharmthan you should

An accidental overdose is not expected to cause serious problems. However, if you take more Desloratadine ratiopharm than you should, tell your doctor or pharmacist immediately.

If you forget to takeDesloratadine ratiopharm

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

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

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

Other side effectsthat may occur are:

Frequent (may affect up to 1 in 10 people)

• fatigue
• dry mouth
• headache

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

• 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, changes in liver function tests

Frequency not known(cannot be estimated from the 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, e.g., from a sunlamp
• slow heartbeat, changes in the heartbeat
• abnormal behavior, aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Reporting side effects

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

5. Storage of Desloratadine ratiopharm

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

Do not use this medication after the expiration date stated on the package and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofDesloratadine ratiopharm

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

Tablet core: poloxamer 188, citric acid monohydrate, microcrystalline cellulose, cornstarch, lactose monohydrate (see section 2 "Desloratadine ratiopharm contains lactose and sodium"), talc.

Coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), macrogol/PEG 3350, talc, and aluminum lake with indigo carmine (E132).

Appearance of the product and package contents

Round, biconvex, blue film-coated tablets.

Desloratadine ratiopharm 5 mg film-coated tablets are available in PVC/PVdC/aluminum blister packs of 7, 10, 14, 15, 20, and 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

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

You can obtain further information on this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this package leaflet:

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