Dasselta (desloratadine) – Package leaflet - R06AX27

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.

What is in this leaflet

1.What Dasselta is and what it is used for

2.What you need to know before you take Dasselta

3.How to take Dasselta

4.Possible side effects

5.How to store Dasselta

6.Contents of the pack and other information

1.What Dasselta is and what it is used for

What Dasselta is

Dasselta contains desloratadine which is an antihistamine.

How Dasselta works

Dasselta is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Dasselta should be used

Dasselta 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.

Dasselta 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.

2. What you need to know before you take Dasselta

Do not take Dasselta

-if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dasselta:

-if you have poor kidney function.

-if you have medical or familial history of seizures.

Children and adolescents

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

Other medicines and Dasselta

There are no known interactions of Dasselta with other medicines.

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

Dasselta with food, drink and alcohol

Dasselta may be taken with or without a meal.

Use caution when taking Dasselta 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.

If you are pregnant or nursing a baby, taking Dasselta is not recommended.

Fertility

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 medicinal product.

Dasselta contains lactose

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

3.How to take Dasselta

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

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 doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Dasselta.

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

If you take more Dasselta than you should

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

If you forget to take Dasselta

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 tablet.

If you have any further questions on 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, 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 desloratadine, the following side effects were reported as:

Common (the following may affect up to 1 in 10 people):

-fatigue,

-dry mouth,

-headache.

Adults

During the marketing of desloratadine-containing products, 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.

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

If you get any side effects, talk to your doctor or pharmacist. 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.How to store 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 packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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

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.

6. Contents of the pack and other information

What Dasselta contains

-The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.

-The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate (see section 2 under »Dasselta contains lactose«.) and talc (E553b).

-The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under »Dasselta contains lactose«.), titanium dioxide (E171) and indigo carmine (E132).

What Dasselta looks like and contents of the pack

Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3–3.5 mm).

Dasselta is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in tablet 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

Manufacturers

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

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

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

België/Belgique/Belgien	Lietuva
KRKA Belgium, SA.	UAB KRKA Lietuva
Tél/Tel: + 32 (0) 489 304 091	Tel: + 370 5 236 27 40
България	Luxembourg/Luxemburg
КРКА България ЕООД	KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50	Tél/Tel: + 32 (0) 489 304 091 (BE)
Česká republika	Magyarország
KRKA ČR, s.r.o.	KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150	Tel.: + 361 (0) 355 8490
Danmark	Malta
KRKA Sverige AB	E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE)	Tel: + 356 21 445 885
Deutschland	Nederland
TAD Pharma GmbH	KRKA Belgium, SA.
	Tél/Tel: + 32 (0) 489 304 091 (BE)
Eesti	Norge
KRKA, d.d., Novo mesto Eesti filiaal	KRKA Sverige AB
Tel: + 372 (0)6 671 658	Tlf: + 46 (0)8 643 67 66 (SE)
Ελλάδα	Österreich
QUALIA PHARMA S.A.	KRKA Pharma GmbH, Wien
Τηλ: +30 (0)210 2832941	Tel: + 43 (0)1 66 24 300
España	Polska
KRKA Farmacéutica, S.L.	KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 81	Tel.: + 48 (0)22 573 7500
France	Portugal
KRKA France Eurl	KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25	Tel: + 351 (0)21 46 43 650
Hrvatska	România
KRKA - FARMA d.o.o.	KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 100	Tel: + 4 021 310 66 05
Ireland	Slovenija
KRKA Pharma Dublin, Ltd.	KRKA, d.d., Novo mesto
Tel: + 353 1 293 91 80	Tel: + 386 (0) 1 47 51 100
Ísland	Slovenská republika
KRKA Sverige AB	KRKA Slovensko, s.r.o.
Sími: + 46 (0)8 643 67 66 (SE)	Tel: + 421 (0) 2 571 04 501
Italia	Suomi/Finland
KRKA Farmaceutici Milano S.r.l.	KRKA Finland Oy
Tel: + 39 02 3300 8841	Puh/Tel: +358 20 754 5330
Κύπρος	Sverige
Kipa Pharmacal Ltd.	KRKA Sverige AB

Τηλ: + 357 24 651 882	Tel: + 46 (0)8 643 67 66 (SE)
Latvija	United Kingdom
KRKA Latvija SIA	Krka UK Ltd.
Tel: + 371 6 733 86 10	Tel: +44 (0)207 400 3352
This leaflet was last revised in

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

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine, the scientific conclusions of CHMP are as follows:

Two literature reports identified a possible relationship between aggressive reaction/abnormal behaviour and desloratadine use with supportive temporal relationships, positive dechallenges and some with positive rechallenges. Similar cases were reported in Eudravigilance for the reference period. Considering the potential seriousness of these events in children, and the number of reported cases with positive dechallenge and rechallenge, the ‘abnormal behaviour’ and ‘aggression’ should be added to the list of adverse drug reactions (ADRs) of desloratadine.

A literature article published during the reference period describes 4 cases of epilepsy in children with a family history of epilepsy or relevant medical history. The causality was assessed as possible for each case, based on temporal association and positive dechallenge. Based on these new data, it could be concluded that desloratadine may aggravate pre-existing seizures in patients (and mainly in children) with medical history of seizures, and that caution should be recommended in treating epileptic patients or those susceptible to convulsions with desloratadine.

Based on 4 new publications regarding a possible association between desloratadine and QT prolongation were reported in the literature and the fact that ‘QT prolongation’ is already listed as an ADR of desloratadine-containing products, this adverse reaction should be listed as an ADR of any desloratadine-containing product.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the Marketing Authorisation(s)

On the basis of the scientific conclusions for desloratadine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing desloratadine is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.