Desloratadine ratiopharm 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine ratiopharm 5 mg film-coated tablets EFG

desloratadine

For adults

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Leaflet contents

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

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

What Desloratadine ratiopharm is

Desloratadine ratiopharm contains desloratadine, which is an antihistamine.

How Desloratadine ratiopharm works

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

When Desloratadine ratiopharm should be used

Desloratadine 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 or itchy nose, itching of the palate, and eye itching, redness, or watering.

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

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

You should consult a doctor if your condition worsens or does not improve after 7 days. If you experience difficulty breathing or swelling of the lips, tongue, or throat, you must seek immediate medical attention.

2. What you need to know before taking Desloratadine ratiopharm

Do not take Desloratadine ratiopharm

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloratadine ratiopharm:

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

If you suffer from chronic idiopathic urticaria, it must be diagnosed by your doctor before starting treatment with Desloratadine ratiopharm.

Children and adolescents

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

Other medicines and Desloratadine ratiopharm

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

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

Taking Desloratadine ratiopharm with food, drinks and alcohol

Desloratadine ratiopharm can be taken regardless of meals.

Be cautious when taking Desloratadine ratiopharm with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Desloratadine ratiopharm is not recommended during pregnancy.

Your doctor will decide whether breastfeeding should be discontinued or treatment with Desloratadine ratiopharm should be discontinued.

There are 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 perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how you personally react to the medicine.

Desloratadine ratiopharm contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Desloratadine ratiopharm

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet once daily with water.

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

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

If your allergic rhinitis symptoms previously lasted less than 4 days per week or less than 4 weeks, use this medicine until symptoms have disappeared. You may start using this medicine again when symptoms reappear.

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

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

If you take more Desloratadine ratiopharm than you should

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

If you forget to take Desloratadine ratiopharm

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Other adverse effects that 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 heartbeats, rapid heartbeat
• stomach pain, nausea, vomiting, upset stomach, diarrhea
• dizziness, drowsiness, difficulty sleeping, seizures, restlessness with increased body movement
• muscle pain
• hallucinations
• liver inflammation, changes in liver function tests

Frequency not known (cannot be estimated from available data)

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example, ultraviolet light from a sunbed
• slow heartbeat, changes in heart rhythm
• abnormal behaviour, aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to 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 medicine if you notice any changes in the appearance of the tablets.

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

6. Contents of the pack and other information

Composition of Desloratadine ratiopharm

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

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

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

Appearance of the product and pack contents

Film-coated, round, biconvex blue tablets.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

Manufacturer responsible

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
The 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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