NEOCLARITYN 5 mg FILM-COATED TABLETS

Introduction

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.

• 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.

Contents of the pack

1. What is Neoclarityn and what is it used for

1. What you need to know before you take Neoclarityn
2. How to take Neoclarityn
3. Possible side effects
4. Storage of Neoclarityn
5. Contents of the pack and other information

1. What is Neoclarityn and what is it used for

What is Neoclarityn

Neoclarityn contains desloratadine, which is an antihistamine.

How Neoclarityn works

Neoclarityn is an anti-allergic medicine that does not cause drowsiness. It helps to control the allergic reaction and its symptoms.

When to use Neoclarityn

Neoclarityn relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites) in adults and adolescents aged 12 years 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 disease caused by an allergy). These symptoms include itching and skin rash.

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

2. What you need to know before you take Neoclarityn

Do not take Neoclarityn

• 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

Consult your doctor, pharmacist, or nurse before taking Neoclarityn:

• if you have impaired kidney function.
• if you have a history of seizures.

Children and adolescents

Do not give this medicine to children under 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.

Taking Neoclarityn with food, drinks, and alcohol

Neoclarityn can be taken with or without food. Be careful when taking Neoclarityn with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Neoclarityn if you are pregnant or breastfeeding. There is no data available on male and female fertility.

Driving and using machines

At the recommended dose, it is not expected that this medicine will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Neoclarityn tablets contain lactose

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

3. How to take Neoclarityn

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

Use in adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily 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 have and how long you should take Neoclarityn.

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

If your allergic rhinitis is persistent (symptoms present for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from one patient to another, and you should follow your doctor's instructions.

If you take more Neoclarityn than you should

Take Neoclarityn only as your doctor has told you. It is not expected that an accidental overdose will cause serious problems. However, if you take more Neoclarityn than you should, tell your doctor, pharmacist, or nurse immediately.

If you forget to take Neoclarityn

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

If you stop taking Neoclarityn

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 Neoclarityn, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, rash, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.

In clinical trials in adults, the side effects were approximately the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In adolescents, headache was the most commonly reported adverse reaction.

In clinical trials with Neoclarityn, the following side effects were reported:

Frequent: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

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

• severe allergic reactions
• skin rash
• strong or irregular heartbeat
• fast heartbeat
• stomach pain
• nausea
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• liver inflammation
• abnormal liver function tests

Frequency not known: cannot be estimated from the 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, such as from a sunlamp
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite

Children

Frequency not known: cannot be estimated from the available data

• slow heartbeat
• changes in heart rhythm
• abnormal behavior
• 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. Storage of 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 is the last day of the month stated.

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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Neoclarityn

• The active substance is desloratadine 5 mg
• The other ingredients of the tablet are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. The tablet coating contains a film coating (containing lactose monohydrate (see section 2 "Neoclarityn tablets contain lactose"), hypromellose, titanium dioxide, macrogol 400, indigo carmine (E-132)), a clear coating (containing hypromellose, macrogol 400), carnauba wax, white wax.

Appearance and packaging of the product

Neoclarityn 5 mg film-coated tablets are light blue, round, and engraved with the letters "S" and "P" on one side and smooth on the other.

Neoclarityn 5 mg film-coated tablets are available 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

Netherlands

Manufacturer:

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

For further information on this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: MM/AAAA.

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