Neoclarityn 5 mg film-coated tablets

• 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.

1. What Neoclarityn is and what it is used for
2. What you need to know before you take Neoclarityn
3. How to take Neoclarityn
4. Possible side effects
5. How to store Neoclarityn
6. 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.

Neoclarityn may be taken with or without a meal.

Use caution when taking Neoclarityn with alcohol.

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.

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.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 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 in Great Britain:

Marketing Authorisation Holder in UK (Northern Ireland):

Manufacturer:

For any information about this medicine, please contact:

Great Britain

United Kingdom (Northern Ireland)