Dasselta

Main information

  • Trade name:
  • Dasselta 5 mg film-coated tablets
  • Available from:
  • Krka, d.d., Novo mesto
  • Medicine type:
  • Human

Documents

Localization

  • Available in:
  • Dasselta 5 mg film-coated tablets
    European Union
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Antihistamines for systemic use
  • Therapeutic area:
  • Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

Other information

Status

  • Source:
  • EMA - European Medicines Agency - Europe
  • Authorization date:
  • 28-11-2011
  • EMEA code:
  • EMEA/H/C/002310
  • Last update:
  • 23-04-2015

Patient Information leaflet


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.

- 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. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

In this leaflet:

1. What Dasselta is and what it is used for

2. Before you take Dasselta

3. How to take Dasselta

4. Possible side effects

5. How to store Dasselta

6. Further information

1. WHAT DASSELTA IS AND WHAT IT IS USED FOR

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). 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.

Dasselta is indicated for adults and adolescents (12 years of age and older).

2. BEFORE YOU TAKE DASSELTA

Do not take Dasselta

- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Dasselta

or to loratadine.

Take special care with Dasselta

- if you have poor kidney function.

If this applies to you, or if you are not sure, please check with your doctor before taking Dasselta.

Children

Dasselta should not be used in children under 12 years old.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

There are no known interactions of Dasselta with other medicines.

Taking Dasselta with food and drink

Dasselta may be taken with or without a meal.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and

breastfeeding.

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

Driving and using machines

At the recommended dose, Dasselta is not expected to cause you to be drowsy or less alert. However,

very rarely some people experience drowsiness, which may affect their ability to drive or use

machines.

Important information about some of the ingredients of Dasselta

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

Adults and adolescents (12 years of age and older): take one tablet once a day.

Swallow the tablet whole with water, with or without food.

Regarding the duration of treatment, your doctor will determine the type of allergic disease 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 problems are expected with accidental

overdose. However, if you take more Dasselta than you were told to, contact your doctor or

pharmacist.

If you forget to take Dasselta

If you forget to take your dose on time, take it as soon as possible, 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, Dasselta 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 (in less than 1 user in 10,000).

Seek immediate medical care if this occurs.

In adults, side effects were about the same as with a dummy tablet. However, tiredness, dry mouth and

headache were reported more often than with a dummy tablet. In adolescents, headache was the most

commonly reported side effect.

Very rare side effects reported during the marketing:

- rash,

- palpitations,

- rapid heartbeat,

- stomach pain,

- nausea (feeling sick),

- vomiting,

- upset stomach,

- diarrhoea,

- dizziness,

- drowsiness,

- inability to sleep,

- muscle pain,

- hallucinations,

- seizures,

- restlessness with increased body movement,

- liver inflammation,

- abnormal liver function tests.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

5. HOW TO STORE DASSELTA

Keep out of the reach and sight of children.

Do not use Dasselta 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.

After first opening of the tablet container, the product should be used within 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. FURTHER 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

and talc (E553b).

- The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose

monohydrate, 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.

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

in plastic 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

KRKA, d.d., Novo mesto

Tél/Tel: + 32 (0)3 321 63 52

Luxembourg/Luxemburg

KRKA, d.d., Novo mesto

Tél/Tel: + 32 (0)3 321 63 52

България

Представителство на KRKA в България

Teл.: + 359 (02) 962 34 50

Magyarország

KRKA Magyarország Kereskedelmi Kft.

Tel.: + 361 (0) 355 8490

Česká republika

KRKA ČR, s.r.o.

Tel: + 420 (0) 221 115 150

Malta

KRKA Pharma Dublin, Ltd.

Tel: + 46 8 643 67 66

Danmark

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Nederland

KRKA, d.d., Novo mesto

Tel: + 32 3 321 63 52 (BE)

Deutschland

TAD Pharma GmbH

Tel: + 49 (0) 4721 6060

Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Eesti

KRKA, d.d., Novo mesto Eesti filiaal

Tel: + 372 (0)6 671 658

Österreich

KRKA Pharma GmbH, Wien

Tel: + 43 (0)1 66 24 300

Ελλάδα

QUALIA PHARMA S.A.

Τηλ: +30 (0)210 2832941

Polska

KRKA-POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500

España

KRKA, d.d., Novo mesto

Tel: + 34 (0)61 5089 809

Portugal

KRKA Farmacêutica, Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

France

KRKA, d.d., Novo mesto

Tél: + 32 3 321 63 52 (BE)

România

KRKA Romania S.R.L., Bucharest

Tel: + 402 (0)1 310 66 05

Ireland

KRKA Pharma Dublin, Ltd.

Tel: + 46 8 643 67 66

Slovenija

KRKA, d.d., Novo mesto

Tel: + 386 (0) 1 47 51 100

Ísland

KRKA Sverige AB Slovenská republika

KRKA Slovensko, s.r.o.,

Sími: + 46 (0)8 643 67 66 (SE)

Tel: + 421 (0) 2 571 04 501

Italia

KRKA, d.d., Novo mesto

Tel: + 39 069448827 Suomi/Finland

KRKA Sverige AB

Puh/Tel: + 46 (0)8 643 67 66 (SE)

Κύπρος

Kipa Pharmacal Ltd.

Τηλ: + 357 24 651 882

Sverige

KRKA Sverige AB

Tel: + 46 (0)8 643 67 66 (SE)

Latvija

KRKA, d.d., Novo mesto

Tel: + 371 6 733 86 10

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 44 (0)2089562310

Lietuva

UAB KRKA Lietuva

Tel: + 370 5 236 27 40

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

Summary of Product characteristics


1. NAME OF THE MEDICINAL PRODUCT

Dasselta 5 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg desloratadine.

Excipient:

- lactose: 16.15 mg/tablet

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet.

Light blue, round, film-coated tablets with beveled edges.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Dasselta is indicated for the relief of symptoms associated with:

- allergic rhinitis (see section 5.1),

- urticaria (see section 5.1).

4.2 Posology and method of administration

Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for

the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic

rhinitis) and urticaria (see section 5.1).

There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12

through 17 years of age (see sections 4.8 and 5.1).

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4

weeks) should be managed in accordance with the evaluation of patient’s disease history and the

treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4

weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients or to loratadine.

4.4 Special warnings and precautions for use

Efficacy and safety of Dasselta tablets in children under 12 years of age have not been established.

In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2).

Dasselta contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp

lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which

erythromycin or ketoconazole were co-administered (see section 5.1).

In a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the

performance impairing effects of alcohol (see section 5.1).

4.6 Pregnancy and lactation

Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during

pregnancy has not been established. The use of desloratadine during pregnancy is therefore not

recommended.

Desloratadine is excreted into breast milk, therefore the use of desloratadine is not recommended in

breastfeeding women.

4.7 Effects on ability to drive and use machines

In clinical trials that assessed the driving ability, no impairment occurred in patients receiving

desloratadine. However, patients should be informed that very rarely some people experience

drowsiness, which may affect their ability to drive or use machines.

4.8 Undesirable effects

In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at

the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3 % of

patients in excess of those treated with placebo. The most frequent of adverse events reported in

excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial

with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was

headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving

placebo.

Other undesirable effects reported very rarely during the post-marketing period are listed in the

following table.

Psychiatric disorders Hallucinations

Nervous system disorders Dizziness, somnolence, insomnia, psychomotor

hyperactivity, seizures

Cardiac disorders Tachycardia, palpitations

Gastrointestinal disorders Abdominal pain, nausea, vomiting, dyspepsia,

diarrhoea

Hepatobiliary disorders Elevations of liver enzymes, increased

bilirubin, hepatitis

Musculoskeletal and connective tissue disorders Myalgia

General disorders Hypersensitivity reactions (such as

anaphylaxis, angioedema, dyspnoea, pruritus,

rash, and urticaria)

4.9 Overdose

In the event of overdose, consider standard measures to remove unabsorbed active substance.

Symptomatic and supportive treatment is recommended.

Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine

times the clinical dose), no clinically relevant effects were observed.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal

dialysis.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other antihistamines for systemic use, ATC code: R06AX27

Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H

1 -receptor

antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H

1 -

receptors because the substance is excluded from entry to the central nervous system.

Desloratadine has demonstrated antiallergic properties from in vitro studies. These include inhibiting

the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast

cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on

endothelial cells. The clinical relevance of these observations remains to be confirmed.

In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14

days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical

pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the

clinical dose) for ten days, no prolongation of QTc interval was seen.

No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose

ketoconazole and erythromycin interaction trials.

Desloratadine does not readily penetrate the central nervous system. In controlled clinical trials, at the

recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to

placebo. Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance

in clinical trials. In a single dose study performed in adults, desloratadine 5 mg did not affect standard

measures of flight performance including exacerbation of subjective sleepiness or tasks related to

flying.

In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced

impairment in performance or increase in sleepiness. No significant differences were found in the

psychomotor test results between desloratadine and placebo groups, whether administered alone or

with alcohol.

In patients with allergic rhinitis, desloratadine was effective in relieving symptoms such as sneezing,

nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.

Desloratadine effectively controlled symptoms for 24 hours. The efficacy of desloratadine tablets has

not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.

In addition to the established classifications of seasonal and perennial, allergic rhinitis can

alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to

the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less

than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the presence of

symptoms for 4 days or more per week and for more than 4 weeks.

Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total

score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen in the

domains of practical problems and daily activities limited by symptoms.

Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the

underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be

more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,

desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions,

in addition to chronic idiopathic urticaria, as advised in clinical guidelines.

In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, desloratadine

was effective in relieving pruritus and decreasing the size and number of hives by the end of the first

dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with other

antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as

nonresponsive to antihistamines was excluded. An improvement in pruritus of more than 50 % was

observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated with

placebo. Treatment with desloratadine also significantly reduced interference with sleep and daytime

function, as measured by a four-point scale used to assess these variables.

5.2 Pharmacokinetic properties

Desloratadine plasma concentrations can be detected within 30 minutes of administration.

Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the

terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was

consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The

bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.

In a pharmacokinetic trial in which patient demographics were comparable to those of the general

seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of

desloratadine. This percentage may vary according to ethnic background. Maximum desloratadine

concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of

approximately 89 hours. The safety profile of these subjects was not different from that of the general

population.

Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of

clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to

20 mg) for 14 days.

The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore,

some interactions with other medicinal products can not be fully excluded. Desloratadine does not

inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit

CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.

In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high

caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect

on the disposition of desloratadine.

5.3 Preclinical safety data

Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with

desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in

the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine.

Non-clinical data with desloratadine reveal no special hazard for humans based on conventional

studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The

lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and

loratadine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Microcrystalline cellulose (E460)

Hypromellose (E464)

Hydrochloric acid (E507)

Sodium hydroxide (E524)

Maize starch

Lactose monohydrate

Talc (E553b)

Film-coating

Hypromellose (E464)

Macrogol

Lactose monohydrate

Titanium dioxide (E171)

Indigo carmine (E132)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

After first opening of the tablet container, the medicinal product should be used within 3 months.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Blister (OPA/Al/PVC//Al): 7, 10, 20, 30, 50, 90 and 100 film-coated tablets, in a box.

Tablet container (HDPE), PP closure with desiccant: 250 film-coated tablets, in a box.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

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

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines

Agency http://www.ema.europa.eu/

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