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Desloratadine ratiopharm (desloratadine) – Package leaflet - R06AX27

Updated on site: 06-Oct-2017

Medication nameDesloratadine ratiopharm
ATC CodeR06AX27
Substancedesloratadine
Manufacturerratiopharm GmbH

Package leaflet: Information for the patient

Desloratadine ratiopharm 5 mg film-coated tablets 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.

What is in this leaflet

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

2.What you need to know before you take 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 antiallergy medicine that does not make you drowsy. It helps control your 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 allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

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

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

2.What you need to know before you take Desloratadine ratiopharm

Do not take Desloratadine ratiopharm

-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

Talk to your doctor, pharmacist or nurse before taking Desloratadine ratiopharm:

if you have poor kidney function.

if you have medical or familial history of seizures.

Use in children and adolescents

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

Other medicines and Desloratadine ratiopharm

There are no known interactions of Desloratadine ratiopharm with other medicines.

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

Desloratadine ratiopharm with food, drink and alcohol

Desloratadine ratiopharm may be taken with or without a meal.

Use caution 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Desloratadine ratiopharm is not recommended if you are pregnant or nursing a baby.

Fertility

There is no data available on male/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 requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.

Desloratadine ratiopharm contains lactose

Desloratadine ratiopharm tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.How to take Desloratadine ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day 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 are suffering from and will determine for how long you should take Desloratadine ratiopharm.

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

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

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your doctor.

If you take more Desloratadine ratiopharm than you should

Take Desloratadine ratiopharm only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine ratiopharm than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Desloratadine ratiopharm

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Desloratadine ratiopharm

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

4.Possible side effects

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

During the marketing of Desloratadine ratiopharm, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

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

Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

Adults

During the marketing of Desloratadine ratiopharm, the following side effects were reported as:

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

 

 

● severe allergic reactions

● rash

 

● pounding or irregular heartbeat

● fast heartbeat

 

● stomach ache

 

● feeling sick (nausea)

● vomiting

 

● upset stomach

 

● diarrhoea

● dizziness

 

● drowsiness

● inability to sleep

● muscle pain

 

● hallucinations

 

● seizures

● restlessness with increased

 

● liver inflammation

● abnormal liver function tests

body movement

 

 

 

 

Not known: frequency 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 in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

Children

Not known: frequency cannot be estimated from the available data

● slow heartbeat

● change in the way the heart beats

● abnormal behaviour

● aggression

Reporting of side effects

If you get 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.How to store Desloratadine ratiopharm

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 that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Desloratadine ratiopharm contains

-The active substance is desloratadine 5 mg.

-The other ingredients are:

Tablet core: poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, lactose monohydrate (see section 2 “Desloratadine ratiopharm contains lactose”), talc,

Film-coating: polyvinyl alcohol (part. hydrolysed), titanium dioxide (E171), macrogol/PEG 3350, talc and indigo carmine aluminium lake (E132).

What Desloratadine ratiopharm looks like and contents of the pack

Round, biconvex, blue film-coated tablets.

Desloratadine ratiopharm 5 mg film-coated tablets are supplied in PVC/PVdC/aluminium blister packs of 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 and 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3

89079 Ulm

Germany info@ratiopharm.de

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Pharmaceutical Works Private Limited Company Pallagi út 13

4042 Debrecen Hungary

Teva UK Limited

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

Teva Operations Poland Sp. z o.o. ul. Mogilska 80

31-546 Kraków Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB "Sicor Biotech"

Tél/Tel: +32 3 820 73 73

Tel: +370 5 266 0203

 

 

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

ratiopharm GmbH, Allemagne/Deutschland

Teл: +359 2 489 95 82

Tél/Tel: +49 731 402 02

 

 

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel: +36 1 288 64 00

 

 

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland, L-Irlanda

Tlf.: +45 44 98 55 11

Tel: +353 51 321 740

 

 

Deutschland

Nederland

ratiopharm GmbH

Teva Nederland B.V.

Tel: +49 731 402 02

Tel.: +31 (0) 800 0228400

 

 

Eesti

Norge

UAB „Sicor Biotech“ Eesti filiaal

Teva Norway AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

 

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 007

 

 

España

Polska

ratiopharm España, S.A.

Teva Pharmaceuticals Polska Sp.z.o.o

Tel: +34 91 567 29 70

Tel: +48 22 345 93 00

 

 

France

Portugal

Teva Santé

ratiopharm, Comércio e Indústria de Produtos

Tél: +33 01 55 91 78 00

farmacêuticos Lda

 

Tel: +351 21 476 75 50

 

 

Hrvatska

România

Pliva Hrvatska d.o.o.

Teva Pharmaceuticals S.R.L

Tel: +385 1 37 20 000

Tel: +4021 230 65 24

 

 

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 51 321 740

Tel: +386 1 58 90 390

 

 

Ísland

Slovenská republika

ratiopharm Oy, Finnland

TEVA Pharmaceuticals Slovakia s.r.o.

Sími: +358 20 180 5900

Tel: +421 2 5726 7911

 

 

Italia

Suomi/Finland

Teva Italia s.r.l.

ratiopharm Oy

Tel: +39 02 8917981

Puh/Tel: +358 20 180 5900

 

 

Κύπρος

Sverige

Teva Ελλάς Α.Ε., Ελλάδα

Teva Sweden AB

Τηλ: +30 210 72 79 099

Tel: +46 42 12 11 00

 

 

Latvija

United Kingdom

UAB "Sicor Biotech" filiāle Latvijā

Teva UK Limited

Tel: +371 673 23 666

Tel: +44 1977 628500

 

 

This leaflet was last revised in

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

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine, the scientific conclusions of CHMP are as follows:

Two literature reports identified a possible relationship between aggressive reaction/abnormal behaviour and desloratadine use with supportive temporal relationships, positive dechallenges and some with positive rechallenges. Similar cases were reported in Eudravigilance for the reference period. Considering the potential seriousness of these events in children, and the number of reported cases with positive dechallenge and rechallenge, the ‘abnormal behaviour’ and ‘aggression’ should be added to the list of adverse drug reactions (ADRs) of desloratadine.

A literature article published during the reference period describes 4 cases of epilepsy in children with a family history of epilepsy or relevant medical history. The causality was assessed as possible for each case, based on temporal association and positive dechallenge. Based on these new data, it could be concluded that desloratadine may aggravate pre-existing seizures in patients (and mainly in children) with medical history of seizures, and that caution should be recommended in treating epileptic patients or those susceptible to convulsions with desloratadine.

Based on 4 new publications regarding a possible association between desloratadine and QT prolongation were reported in the literature and the fact that ‘QT prolongation’ is already listed as an ADR of desloratadine-containing products, this adverse reaction should be listed as an ADR of any desloratadine-containing product.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for desloratadine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing desloratadine is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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