Dorius is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: -allergic rhinitis
-urticaria

Posology
Adults and adolescents (12 years of age and over)
The recommended dose of Dorius 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 adolenscents 12 through 17 years of age.
The safety and efficacy of Dorius 5mg film-coated tablets in children below the age of 12 years have not been established. Mode of administration Oral use. The dose can be taken with or without food.

In the case of severe renal insufficiency, Dorius should be used with caution.
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. Patient 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.
Paediatric population Interaction studies have only been performed in adults. In a clinical pharmacology trial, Dorius tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol. 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. As a precautionary measure, it is preferable to avoid the use Dorius 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 for the child and benefit of therapy for the woman. Fertility: There are no data available on male and female fertility.

Dorius 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 with Dorius 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%).Paediatric population
In 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. A retrospective observational safety study indicated an increased incidence of new-onset
seizure in patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background
rate of new onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate
of 36.4 per 100,000 PY. Reporting of suspected adverse reactions
• Saudi Arabia:
The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
• Other GCC States:
Please contact the relevant competent authority.

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:
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.

Adults
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.

Tablet core: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate. Tablet coating: opadry blue (containing Hypromellose, titanium dioxide, purified stearic acid, microcrystalline cellulose, FD&C blue #2/Indigo carmine aluminum lake).

Not applicable

Do not store above 30°C.
Store in the original package to protect from moisture

Dorius is supplied in blisters.
The materials of the blister consist of polyvinyl chloride, polyethylene and coated with
a 90g/m2 polyvinylidene chloride (PVDC) layer with an aluminium foil lidding coated with a thermosealable lacquer.

No special requirements.