Dasselta
desloratadine
desloratadine
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 Dasselta is and what it is used for
What you need to know before you take Dasselta
How to take Dasselta
Possible side effects
How to store Dasselta
Contents of the pack and other information
Dasselta contains desloratadine which is an antihistamine.
Dasselta is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
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.
if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Talk to your doctor or pharmacist before taking Dasselta:
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 Dasselta 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.
If you are pregnant or nursing a baby, taking Dasselta is not recommended.
Fertility
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 medicinal product.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
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 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.
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 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.
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,
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 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.
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.
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) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment), maize starch, lactose monohydrate (see section 2 under »Dasselta contains lactose and sodium«.) and talc (E553b).
The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under »Dasselta contains lactose and sodium«.), titanium dioxide (E171) and indigo carmine (E132).
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.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
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:
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62
UAB KRKA Lietuva Tel: + 370 5 236 27 40
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
E. J. Busuttil Ltd.
Tel: + 356 21 445 885
TAD Pharma GmbH Tel: + 49 (0) 4721 606-0
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)
KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613
KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300
KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80
KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
KRKA - FARMA d.o.o. Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710
KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
LYFIS ehf.
Sími: + 354 534 3500
KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841
KRKA Finland Oy Puh/Tel: + 358 20 754 5330
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA Tel: + 371 6 733 86 10
KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710
Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine, the scientific conclusions of the CHMP are as follows:
In view of available data from the literature including in some cases a close temporal relationship, a positive de-challenge and/or re-challenge and in view of a plausible mechanism of action, the PRAC considers a causal relationship between desloratadine and depressed mood is at least a reasonable possibility. The PRAC concluded that the product information of products containing desloratadine should be amended accordingly.
As described in the literature and signal section of some MAHs, WHO identified a potential safety signal of dry eyes for desloratadine during the reporting period. Based on the anticholinergic properties of desloratadine and strengthened by the reports with a short time to onset and both de- and rechallenges described, the PRAC considers that “eye dryness” should be considered for inclusion in the product labels and patient leaflets.
The CHMP agrees with the scientific conclusions made by the PRAC.
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.