Claritinetablet is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic

urticaria.

Posology

Adults

Onetabletoncedaily.

Paediatric population

Children 6 years of age and older with a body weight greater than 30 kg: one tablet once daily. For

appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, there are

other formulations more suitable.

Children under 2 years of age:

The safety and efficacy ofClaritinehave not been established. No data are available .

Patients with hepaticimpairment

Patients with severe liver impairment should be administered a lower initialdose because they may

have reduced clearance of loratadine. An initial dose of10 mgevery other day is recommended for

adults and children weighing more than 30kg.

Patients with renal impairment

No dosage adjustments are required in patients with renal insufficiency.

Elderly

No dosage adjustments are required in the elderly.

Method of administration

Oral use.Thetabletmaybetakenwithoutregardtomealtime.

Claritineshould be administered with caution in patients with severe liver impairment(seesection 4.2).

This medicinal product contains lactose; thus patients with rare hereditary problems of

galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should

not take this medicine.

The administration of Claritine should be discontinued at least 48hours before skin tests

since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity

index.

When administered concomitantly with alcohol,Claritine has no potentiating effects as measured

by psychomotor performance studies.

Potential interaction may occur with all known inhibitorsof CYP3A4 or CYP2D6 resulting in

elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.

Increase in plasma concentrations of loratadine has been reported after concomitant use with

ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically

significant changes (includingelectrocardiographic).

Paediatric population

Interaction studies have only been performed in adults.

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no

malformative nor feto/ neonatal toxicity of loratadine.Animal studies do not indicate direct or

indirect harmful effects with respect to reproductivetoxicity (see section 5.3).As a precautionary

measure, it is preferable to avoid the use of Claritineduring pregnancy.

Breastfeeding

Loratadine is excreted in breast milk. Therefore, the use of Claritineis not recommended in

breast-feeding women.

Fertility

There are no dataavailable on male and female fertility

In clinical studies that assessed driving ability, no impairment was observed in patients receiving

loratadine. Claritine has no or negligible influence on the ability to drive and use machines.However,

patients should be informed that very rarely some people experiencedrowsiness, which may affect

their ability to drive or use machines.

Summary of the safety profile

In clinical trials involving adults and adolescents in a range of indications includingallergic rhinitis

(AR)andchronicidiopathic urticaria(CIU), at the recommended dose of 10 mg daily, adverse reactions

with loratadine were reported in 2 % of patients in excess of those treated with placebo. The most

frequent adverse reactions reported in excess of placebo were somnolence (1.2%),headache (0.6%),

increased appetite (0.5%) and insomnia (0.1%).

Tabulated listof adverse reactions

The followingadverse reactions reportedduringthepost-marketing period are listed in the following

table bySystemOrganClass. Frequencies are definedasvery common(≥1/10), common(≥1/100 to<

1/10),uncommon(≥1/1,000to< 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).Within each frequency grouping, adverse

reactions arepresented in order of decreasing seriousness.

Paediatric population

In clinical trials in a paediatric population, children aged 2through 12 years,commonadverse reactions

reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Toreportanysideeffect(s):

National Pharmacovigilance and Drug Safety Center (NPC)

Fax: + 966 – 11 – 205 – 7662

ToContacttheexecutivemanagementofthevigilanceandcrisismanagement

Telephone: + 966 – 11 – 2038222

Extension: 2353 – 2356 – 2317 – 2354 – 2334 – 2340

Toll free: 8002490000

Email : npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence,

tachycardia, and headache have been reported with overdoses.

Inthe event of overdose, general symptomatic and supportive measures are to be instituted and

maintained for as long as necessary. Administration of activated charcoal as a slurry with water may

be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is

not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be

continued after emergency treatment.

Pharmacotherapeutic group: antihistamines – H1antagonist,ATCcode:R06AX13.

Mechanismofaction

Loratadine, the active ingredient inClaritine, is a tricyclic antihistamine with selective, peripheral H1-

receptor activity.

Pharmacodynamiceffects

Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the

population and when used at the recommended dosage.

During long-term treatment there were no clinically significant changes in vital signs, laboratory test

values, physical examinations or electrocardiograms.

Loratadine has no significant H2-receptoractivity. It does not inhibit norepinephrine uptake and has

practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.

Human histamines in wheal studies following a single 10mg dose has shown that the antihistamine

effects are seen within 1-3hours reaching a peak at 8-12hours and lasting in excess of 24 hours. There

was no evidence of tolerance to this effect after 28 days of dosing with loratadine .

Clinicalefficacyandsafety

Over 10,000 subjects(12years and older)have been treated with loratadine10mgtablets in controlled

clinical trials. Loratadine 10 mgtablets once daily was superior to placebo and similar to clemastine in

improving the effects on nasal and non-nasalsymptoms ofAR. In these studies somnolence occurred

less frequently with loratadine than with clemastine and about the same frequency as terfenadine and

placebo.

Among these subjects (12years and older),1000subjectswith CIU were enrolled in placebo controlled

studies. A once daily 10 mg dose of loratadine was superior to placebo in the managementof CIU as

demonstrated by the reduction of associated itching, erythema and hives. In these studies the

incidence of somnolence with loratadine was similar to placebo.

Paediatric population

Approximately 200 paediatricsubjects (6 to 12yearsofage)with seasonal allergic rhinitis received

doses ofloratadine syrup up to 10 mgonce daily in controlled clinical trials.Inanotherstudy,

60paediatric subjects (2 to 5 years of age) received 5 mg of loratadine syrup once daily. No

unexpectedadverse events were observed.

The paediatric efficacy was similar to the efficacy observed in adults.

Absorption

Loratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the

absorption of loratadine but with out influencing the clinical effect. The bioavailability parameters of

loratadine and of the active metabolite are dose proportional.

Distribution

Loratadine is highly bound(97%to99%) and its active major metabolite desloratadine(DL) moderately

bound (73%to76%) to plasmaproteins.

Inhealthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately

1 and 2hours, respectively.

Biotransformation

After oral administration, loratadine is rapidly and well absorbed and under goes an extensive first pass

metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite - desloratadine(DL) - is

pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL

achieve maximum plasma concentrations(Tmax) between 1–1.5 hours and 1.5–3.7 hours after

administration, respectively.

Elimination

Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period

and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the

urine during the first 24hours. Less than 1% of the active substance is excreted unchanged inactive

form, as loratadine or D L.

The mean elimination half-lives in healthy adult subjects were 8.4hours (range=3to20hours) for

loratadine and 28hours (range=8.8to92hours) for the major active metabolite.

Renal impairment

Inpatients with chronicrenal impairment, both the AUC and peak plasma levels(Cmax) increased for

loratadine and its active metabolite as compared to the AUCs and peak plasma levels (Cmax) of

patients with normal renal function. The mean elimination half-lives of loratadine and its active

metabolite were not significantly different from that observed in normal subjects. Haemodialys is does

not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with

chronicrenal impairment.

Hepatic impairment

In patients with chronic alcoholic liver disease, the AUC and peak plasma levels(Cmax) of loratadine

were double while the pharmacokinetic profile of the active metabolite was not significantly changed

from that inpatients with normal liver function. The elimination half-lives for loratadine and its active

metabolite were 24hours and 37hours, respectively, and increased with increasing severity of liver

disease.

Elderly

The pharmacokinetic profile of loratadine and its active metabolite is comparable in healthy adult

volunteers and in healthy geriatric volunteers.

Non-clinical data reveal no special hazardforhumansbased on conventional studies of

safety,pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 

In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged

parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10times

higher than those achieved with clinical doses.

Lactose monohydrate

Maize starch

Magnesium stearate

Not applicable.

Store below 30°C. Protect from excessive moisture.

Blister strip consisting of a 20 μmaluminiumfoil with vinyl heat coating and a 250μmclear, transparent

polyvinylchloride(PVC)filmor a 250 μm clear, transparent polyvinyl chloride (PVC) film with

polyvinylidene chloride (PVdC) coating.

Pack sizes of 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, 60or 100 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.