Dasselta

Package leaflet: Information for the user

Dasselta 5 mg film-coated tablets

desloratadine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Dasselta is and what it is used for
2. What you need to know before taking 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 antiallergic medicine that does not cause drowsiness. 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 allergy, such as hay fever or 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 symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improving your sleep.

2. What you need to know before taking Dasselta

Do not take Dasselta

• if you are allergic to desloratadine or 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 reduced 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.
Other medicines and Dasselta
No interactions between Dasselta and other medicines are known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Dasselta with food, drinks and alcohol
Dasselta can be taken with or without food.
Use caution when taking Dasselta with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Dasselta is not recommended if you are pregnant or breast-feeding.
Fertility
There are 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 vehicle or operating machinery, until you know how this medicine affects you.
Dasselta contains lactose and sodium
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Dasselta

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
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 (symptoms present for less than 4 days per week or for less than 4 weeks),
your doctor will prescribe a treatment regimen based on an assessment of your medical history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than 4 weeks),
your doctor may prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, therefore you must
follow your doctor's instructions.
If you take more Dasselta than you should
Take Dasselta only if it has been prescribed for you. No adverse effects are expected following
accidental intake of higher doses. However, if you take more Dasselta than prescribed, inform 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
your treatment as usual. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During post-marketing surveillance with desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious side effects, stop taking the medicine and contact a doctor immediately.

In clinical studies in adults, side effects were similar to those observed with an inactive tablet (placebo). However, fatigue, dry mouth, and headache occurred more frequently than with an inactive tablet (placebo). In adolescents, headache was the most commonly reported side effect.

In clinical studies with desloratadine, the following side effects have been reported as:

Common: these may affect up to 1 in 10 people:

• fatigue,
• dry mouth,
• headache.

Adults
During post-marketing experience with desloratadine, the following side effects have been reported as:

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

• serious allergic reactions,
• skin rash,
• pounding or irregular heartbeat,
• rapid heartbeat,
• stomach ache,
• feeling unwell (nausea),
• vomiting,
• stomach discomfort,
• diarrhoea,
• dizziness,
• drowsiness,
• difficulty sleeping (insomnia),
• muscle pain,
• hallucinations,
• seizures,
• restlessness with increased body movement,
• liver inflammation,
• changes in 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 sunlight, even on cloudy days, and to UV (ultraviolet) light, for example from sunbeds,
• changes in heart rhythm,
• abnormal behaviour,
• aggression,
• weight gain,
• increased appetite,
• depressed mood,
• dry eyes.

Children
Not known: frequency cannot be estimated from the available data:

• slowing of the heartbeat,
• changes in heart rhythm,
• abnormal behaviour,
• aggression.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex 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 stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
Period of validity after first opening of the container: 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dasselta contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other components of 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 “Dasselta contains lactose and sodium”), and talc (E553b).
• The excipients of the coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 “Dasselta contains lactose and sodium”), titanium dioxide (E171), and indigo carmine (E132).

Description of the appearance of Dasselta and package contents
Sky-blue, round, film-coated tablets with bevelled edges (diameter: 6.5 mm, thickness: 2.3–3.5 mm).
Dasselta tablets are available in cardboard boxes containing 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters, and in bottles of 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 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) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 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.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (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
KRKA ΕΛΛΑΣ ΕΠΕ KRKA Pharma GmbH, Wien
Τηλ: + 30 2100101613 Tel: + 43 (0)1 66 24 300

España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 80 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 1 413 3710 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 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
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

Latvija United Kingdom (Northern Ireland)
KRKA Latvija SIA KRKA Pharma Dublin, Ltd.
Tel: + 371 6 733 86 10 Tel: + 353 1 413 3710

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu