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Aerius 5 Mg 20 Film Tablets

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1. NAME OF THE MEDICINAL PRODUCT

Aerius® 5 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg desloratadine.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablets

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Aerius® is indicated for the relief of symptoms associated with:

- allergic rhinitis (see section 5.1)

- urticaria

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).

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 Aerius® tablets in children under 12 years of age have not been established.

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

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 Aerius® 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 Aerius® during pregnancy is therefore not

recommended.

Desloratadine is excreted into breast milk, therefore the use of Aerius® 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 Aerius® 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 %). 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

Hepato-biliary 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: antihistamines – H1 antagonist, ATC code: R06A X27

Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-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.

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. Aerius® 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, Aerius® was effective in relieving symptoms such as sneezing, nasal

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

effectively controlled symptoms for 24 hours. Efficacy has not been clearly demonstrated in patients

12–17 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.

Aerius 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.

In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Aerius® 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 Aerius® 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 loratadine.

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch,

talc,carnauba wax, white wax.

Tablet coating: film coat (contains lactose monohydrate, hydroxypropyl methycellulose, titanium

dioxide, polyethylene glycol, indigotin (E132)), clear coat (contains, hydroxypropyl methycellulose,

polyethylene glycol)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 30°C.

Store in the original package.

6.5 Nature and contents of container

Aerius® is supplied in unit dose blisters comprised of laminant blister film with foil lidding.

The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC)

film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product

contact surface) which is heat sealed.

Packs of, 2, 5, 7, 10, 14, 15, 20, 30 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. Manufacturer:

Schering-Plough Labo N.V., Heist-op-den-berg, Belgium

8. License holder:

Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170.

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Aerius 5 Mg 20 Film Tablets

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