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AstraZeneca

Neoclarityn
desloratadine

Package leaflet: Information for the patient


Neoclarityn 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.

Children and adolescents

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


Other medicines and Neoclarityn

There are no known interactions of Neoclarityn with other medicines.

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


Neoclarityn with food, drink and alcohol Neoclarityn may be taken with or without a meal. Use caution when taking Neoclarityn 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 Neoclarityn is not recommended if you are pregnant or nursing a baby. 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 medicine.


Neoclarityn tablet contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


  1. How to take Neoclarityn


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


    Use in 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 physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Neoclarityn.

    If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician 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 physician 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 physician.


    If you take more Neoclarityn than you should

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

    If you forget to take Neoclarityn

    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 Neoclarityn

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


  2. Possible side effects


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


    During the marketing of Neoclarityn, 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 Neoclarityn, the following side effects were reported as: Common: the following may affect up to 1 in 10 people

    • fatigue

    • dry mouth

    • headache

      During the marketing of Neoclarityn, 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 body movement

    • liver inflammation

    • abnormal liver function tests


      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

    • weight increased, increased appetite

    • depressed mood

    • dry eyes


      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

      image

      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.


  3. How to store Neoclarityn


    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.


    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 protect the environment.


  4. Contents of the pack and other information What Neoclarityn contains

macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.


What Neoclarityn looks like and contents of the pack

Neoclarityn 5 mg film-coated tablet is light blue, round and embossed with elongated letters “S” and “P” on one side and plain on the other.

Neoclarityn 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21,

30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

N.V. Organon Kloosterstraat 6

5349 AB Oss

The Netherlands


Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.


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


België/Belgique/Belgien

Organon Belgium

Tél/Tel: 0080066550123 (+32 2 2418100)

dpoc.benelux@organon.com

Lietuva

Organon Pharma B.V. Lithuania atstovybė Tel.: +370 52041693

dpoc.lithuania@organon.com


България

Органон (И.А.) Б.В. - клон България Тел.: +359 2 806 3030

dpoc.bulgaria@organon.com

Luxembourg/Luxemburg

Organon Belgium

Tél/Tel: 0080066550123 (+32 2 2418100)

dpoc.benelux@organon.com


Česká republika

Organon Czech Republic s.r.o. Tel.: +420 233 010 300

dpoc.czech@organon.com

Magyarország

Organon Hungary Kft.

Tel.: +36 1 766 1963

dpoc.hungary@organon.com


Danmark

Organon Denmark ApS Tlf: +45 4484 6800

info.denmark@organon.com

Malta

Organon Pharma B.V., Cyprus branch Tel: +356 2277 8116

dpoc.cyprus@organon.com


Deutschland

Organon Healthcare GmbH

Tel: 0800 3384 726 (+49 (0) 89 2040022 10)

dpoc.germany@organon.com

Nederland

N.V. Organon

Tel.: 00800 66550123

(+32 2 2418100)

dpoc.benelux@organon.com


Eesti

Organon Pharma B.V. Estonian RO Tel: +372 66 61 300

dpoc.estonia@organon.com

Norge

Organon Norway AS Tlf: +47 24 14 56 60

info.norway@organon.com


Ελλάδα

N.V. Organon

Τηλ: +30-216 6008607

Österreich

Organon Austria GmbH Tel: +43 (0) 1 263 28 65

medizin-austria@organon.com


España

Organon Salud, S.L.

Tel: +34 91 591 12 79

organon_info@organon.com

Polska

Organon Polska Sp. z o.o. Tel.: +48 22 105 50 01

organonpolska@organon.com

France

Organon France

Tél: +33 (0) 1 57 77 32 00

Portugal

Organon Portugal, Sociedade Unipessoal Lda.

Tel: +351 218705500

geral_pt@organon.com


Hrvatska

Organon Pharma d.o.o. Tel: +385 1 638 4530

dpoc.croatia@organon.com

România

Organon Biosciences S.R.L. Tel: +40 21 527 29 90

info.romania@organon.com


Ireland

Organon Pharma (Ireland) Limited

Tel: +353 15828260

medinfo.ROI@organon.com

Slovenija

Organon Pharma B.V., Oss, podružnica Ljubljana

Tel: +386 1 300 10 80

info.slovenia@organon.com


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Organon Slovakia s. r. o. Tel: +421 2 44 88 98 88

dpoc.slovakia@organon.com


Italia

Organon Italia S.r.l.

Tel: +39 06 3336407

dpoc.italy@organon.com

Suomi/Finland

Organon Finland Oy

Puh/Tel: +358 (0) 29 170 3520

dpoc.finland@organon.com


Κύπρος

Organon Pharma B.V., Cyprus branch Τηλ: +357 22866730

dpoc.cyprus@organon.com

Sverige

Organon Sweden AB Tel: +46 8 502 597 00

dpoc.sweden@organon.com


Latvija

Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība

Tel: +371 66968876

dpoc.latvia@organon.com

United Kingdom (Northern Ireland) Organon Pharma (Ireland) Limited Tel: +353 15828260

medinfo.ROI@organon.com


This leaflet was last revised in <{MM/YYYY}><{month YYYY}>


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