Neoclarityn
desloratadine
desloratadine
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 Neoclarityn is and what it is used for
What you need to know before you take Neoclarityn
How to take Neoclarityn
Possible side effects
How to store Neoclarityn
Contents of the pack and other information
Neoclarityn contains desloratadine which is an antihistamine.
Neoclarityn is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
Neoclarityn 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.
Neoclarityn 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.
if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Talk to your doctor, pharmacist or nurse before taking Neoclarityn:
if you have poor kidney function.
if you have medical or familial history of seizures.
Do not give this medicine to children less than 12 years of age.
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.
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.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.
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 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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
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.
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.
The active substance is desloratadine 5 mg
The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate (see section 2 “Neoclarityn tablet contains lactose”), hypromellose, titanium dioxide,
macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
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:
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:
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
Organon Pharma B.V. Lithuania atstovybė Tel.: +370 52041693
Органон (И.А.) Б.В. - клон България Тел.: +359 2 806 3030
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
Organon Czech Republic s.r.o. Tel.: +420 233 010 300
Organon Hungary Kft.
Tel.: +36 1 766 1963
Organon Denmark ApS Tlf: +45 4484 6800
Organon Pharma B.V., Cyprus branch Tel: +356 2277 8116
Organon Healthcare GmbH
Tel: 0800 3384 726 (+49 (0) 89 2040022 10)
N.V. Organon
Tel.: 00800 66550123
(+32 2 2418100)
Organon Pharma B.V. Estonian RO Tel: +372 66 61 300
Organon Norway AS Tlf: +47 24 14 56 60
N.V. Organon
Τηλ: +30-216 6008607
Organon Austria GmbH Tel: +43 (0) 1 263 28 65
Organon Salud, S.L.
Tel: +34 91 591 12 79
Organon Polska Sp. z o.o. Tel.: +48 22 105 50 01
Organon France
Tél: +33 (0) 1 57 77 32 00
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
Organon Pharma d.o.o. Tel: +385 1 638 4530
Organon Biosciences S.R.L. Tel: +40 21 527 29 90
Organon Pharma (Ireland) Limited
Tel: +353 15828260
Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +386 1 300 10 80
Vistor hf.
Sími: +354 535 7000
Organon Italia S.r.l.
Tel: +39 06 3336407
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
Organon Pharma B.V., Cyprus branch Τηλ: +357 22866730
Organon Sweden AB Tel: +46 8 502 597 00
Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība
Tel: +371 66968876