Dasselta 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dasselta 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dasselta and what is it used for
2. What you need to know before you take Dasselta
3. How to take Dasselta
4. Possible side effects
5. Storage of Dasselta
6. Contents of the pack and other information

1. What is Dasselta and what is it used for

What is Dasselta

Dasselta contains desloratadine, which is an antihistamine.

How Dasselta works

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

When should Dasselta be used

Dasselta relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or house dust mite allergy) 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.

Dasselta is also used to relieve the symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.

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 Dasselta

Do not take Dasselta

• 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 or pharmacist before taking Dasselta:

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

Children and adolescents

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

Taking Dasselta with other medicines

There are no known interactions between Dasselta and other medicines.

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

Taking Dasselta with food, drinks and alcohol

Dasselta can be taken with or without food.

Be careful when taking Dasselta 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 Dasselta if you are pregnant or breastfeeding.

Fertility

There is no data available on male and 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 that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Dasselta contains lactose and sodium

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Dasselta

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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 Dasselta.

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

If your allergic rhinitis is persistent (presence of symptoms 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 patient to patient and therefore you should follow your doctor's instructions.

If you take more Dasselta than you should

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

If you forget to take Dasselta

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 have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

During the marketing of desloratadine, very rare cases of serious 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, side effects were approximately the same as with a tablet that does not contain active substance. However, fatigue, dry mouth and headache were reported more frequently than with a tablet that does not contain active substance. In adolescents, headache was the most frequently reported adverse reaction.

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

Frequent: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of desloratadine, the following side effects were reported:

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

• serious 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 the sun, even on cloudy days, and to ultraviolet light, for example, to the light of a sunbed
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

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 experience 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 Dasselta

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 after “EXP”. The expiry date refers to the last day of that month.

Store in the original package to protect from moisture.

Shelf life after first opening of the tablet container: 3 months.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Dasselta

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment), corn starch, lactose monohydrate (see section 2 “Dasselta contains lactose and sodium”) and talc (E553b).
• The other ingredients in the tablet coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 “Dasselta contains lactose and sodium”), titanium dioxide (E171) and carmine indigo (E132).

Appearance of the product and pack size

Film-coated tablets, light blue, round with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).

Dasselta is available in cartons of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in a container of 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

Date of last revision of this leaflet:

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