Neorin is indicated in adults and adolescents aged 12 years and older for the relief of symptoms
associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)

Posology
Adults and adolescents (12 years of age and over): The recommended dose of Neorin is one
tablet once a day.
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.
Paediatric population
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).

The safety and efficacy of Neorin 5 mg film-coated tablets in children below the age of 12 years
have not been established. No data are available.
Method of administration
Oral use.
The dose can be taken with or without food.

In the case of severe renal insufficiency, Neorin should be used with caution (see section 5.2).
Desloratadine should be administered with caution in patients with medical or familial history of
seizures, and mainly young children, being more susceptible to develop new seizures under
desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in
patients who experience a seizure while on treatment.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine.

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in
which erythromycin or ketoconazole were co-administered (see section 5.1).
Paediatric population
Interaction studies have only been performed in adults.
In a clinical pharmacology trial, Neorin tablets taken concomitantly with alcohol did not
potentiate the performance impairing effects of alcohol (see section 5.1). However, cases of
alcohol intolerance and intoxication have been reported during post-marketing use. Therefore,
caution is recommended if alcohol is taken concomitantly.

Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no
malformative nor foeto/ neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a
precautionary measure, it is preferable to avoid the use of Neorin during pregnancy.
Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of
desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue
breast-feeding or to discontinue/abstain from Neorin therapy taking into account the benefit of
breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data available on male and female fertility.

Neorin has no or negligible influence on the ability to drive and use machines based on clinical
trials. Patients should be informed that most people do not experience drowsiness. Nevertheless,
as there is individual variation in response to all medicinal products, it is recommended that
patients are advised not to engage in activities requiring mental alertness, such as driving a car or
using machines, until they have established their own response to the medicinal product.

Summary of the safety profile
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 Neorin were reported
in 3 % of patients in excess of those treated with placebo. The most frequent of adverse reactions
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.
Paediatric population
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.
Tabulated list of adverse reactions
The frequency of the clinical trial adverse reactions reported in excess of placebo and
other undesirable effects reported during the post-marketing period are listed in the

following table. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to
< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<
1/10,000) and not known (cannot be estimated from the available data).

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an
unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour,
and aggression.

Reporting of suspected adverse reactions

The adverse event profile associated with overdosage, as seen during post-marketing use, is
similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
Symptoms
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.
Paediatric population
The adverse event profile associated with overdosage, as seen during post-marketing use, is
similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27
Mechanism of action
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 Pselectin
on endothelial cells. The clinical relevance of these observations remains to be
confirmed.
Clinical efficacy and safety
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 multipledose
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. Neorin 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 alcoholinduced
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, Neorin was effective in relieving symptoms such as sneezing,
nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Neorin effectively controlled symptoms for 24 hours. The efficacy of Neorin tablets has not been
clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Paediatric population
The efficacy of Neorin 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.

Neorin 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, Neorin 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 non-responsive 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 Neorin also significantly reduced interference
with sleep and daytime function, as measured by a four-point scale used to assess these variables.

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.
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.
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 Pglycoprotein.
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, grapefruit juice had
no effect on the disposition of desloratadine.
Renally impaired patients
The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was
compared with that of healthy subjects in one single-dose study and one multiple dose study. In
the single-dose study, the exposure to desloratadine was approximately 2 and 2.5-fold greater in
subjects with mild to moderate and severe CRI, respectively, than in healthy subjects. In the
multiple-dose study, steady state was reached after Day 11, and compared to healthy subjects the
exposure to desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-
fold greater in subjects with severe CRI. In both studies, changes in exposure (AUC and Cmax)
of desloratadine and 3-hydroxydesloratadine were not clinically relevant.

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 reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to
reproduction and development. The lack of carcinogenic potential was demonstrated in studies
conducted with desloratadine and loratadine.

The other ingredients of the tablet are Maize Starch, Starch 1500, Avicel pH 101, Meglumine,
Avicel pH 112, Colloidal Silicon Dioxide, Sodium Stearyl Fumarate, Opadry II Blue 32B10817,
and Purified Water.

Not applicable.

Store below 30°C.
Store in the original package.

Transparent Thermoformed PVC/PE/PVDC reel with hard tempered aluminum foil lid.
Each pack contains 10 tablets

No special requirements.