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Pharmacodynamic properties  Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27 Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheralH1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-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.  Pharmacokinetic properties  Absorption 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. Distribution  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.  Biotransformation  The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot 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.  Elimination  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

The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.  The other ingredients are: lactose; microcrystalline cellulose; pregelatinised starch (maize) 1500 LM; heavy magnesium oxide; magnesium stearate; Opadry, blue [contains: hypromellose 6cP; titanium dioxide; macrogol 400; indigo carmine, aluminium lake]

Deslora-Denk 5 mg 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.  Deslora-Denk 5 mg 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

Do not take Deslora-Denk 5 mg if you are allergic to desloratadine, loratadine or any of the other ingredients of this medicine

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, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people • severe allergic reactions • fast heartbeat • vomiting • dizziness • muscle pain • restlessness with increased body movement • rash • stomach ache • upset stomach • drowsiness • hallucinations • liver inflammation • pounding or irregular heartbeat • feeling sick (nausea) • diarrhoea • inability to sleep • seizures • 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 • abnormal behavior • aggression • changes in the way the heart beats Children Not known: frequency cannot be estimated from the available data • slow heartbeat • abnormal behavior • aggression • changes in the way the heart beats • weight increased, increased appetite

There are no known interactions of DesloraDenk 5 mg with other medicines.  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Take Deslora-Denk 5 mg only as it is prescribed for you.  No serious problems are expected with accidental overdose.  However, if you take more Deslora-Denk 5 mg than you were told to, tell your doctor or pharmacist immediately.

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 physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Deslora-Denk 5 mg.  If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician 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 physician 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 physician.

Store below 30°C.  Store in the original package in order to protect from light.