Clara Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic
urticaria in adults and children over the age of 6 years with a body weight more than 30 kg.

Posology
Adults and children over 12 years of age:
10 mg once daily. The tablet may be taken without regard to mealtime.
Children 2 to 12 years of age with:
Body weight more than 30 kg: 10 mg once daily.
Body weight 30 kg or less: These tablets are not suitable in children with a body weight less than 30 kg.
Efficacy and safety of Loratadine Tablets in children under 2 years of age has not been established.
Patients with severe liver impairment should be administered a lower initial dose because they may have
reduced clearance of Loratadine. An initial dose of 10 mg every other day is recommended for adults
and children weighing more than 30 kg, and for children weighing 30 kg or less, 5 ml (5 mg) every other
day is recommended.
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
Method of administration
For oral administration.
 

Loratadine Tablets should be administered with caution in patients with severe liver impairment (see
4.2).
The administration of Loratadine Tablets should be discontinued at least 48 hours before skin tests since
antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

When administered concomitantly with alcohol, Loratadine Tablets have no potentiating effects as
measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of 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 (including electrocardiographic).
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 foeto/ neonatal toxicity of loratadine. 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 loratadine during pregnancy.
Breast-feeding
Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breastfeeding
women.
Fertility
There is no data available on male and female fertility.

In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine.
Loratadine tablets has no or negligible influence on the ability to drive and use machines. However,
patients should be informed that very rarely some people experienced drowsiness, which may affect
their ability to drive or use machines.

In clinical trials in a paediatric population children aged 2 through 12 years, common adverse reactions
reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
In clinical trials involving adults and adolescents in a range of indications including AR and 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 list of adverse reactions
The following adverse reactions reported during the post-marketing period are listed in the following
table by System Organ Class. 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.
In the 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 – H1 antagonist, ATC code: R06A X13.
Mechanism of action
Loratadine, the active ingredient in Loratadine Tablets, is a tricyclic antihistamine with selective,
peripheral H1-receptor activity.
Pharmacodynamic effects
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-receptor activity. It does not inhibit norepinephrine uptake and has
practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.
Human histamine skin wheal studies following a single 10 mg dose has shown that the antihistamine
effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in excess of 24 hours. There
was no evidence of tolerance to this effect after 28 days of dosing with loratadine.
Clinical efficacy and safety
Over 10,000 subjects (12 years and older) have been treated with loratadine 10 mg tablets in controlled
clinical trials.
Loratadine 10 mg tablets once daily was superior to placebo and similar to clemastine in improving the
effects on nasal and non-nasal symptoms of AR. In these studies somnolence occurred less frequently
with loratadine than with clemastine and about the same frequency as terfenadine and placebo. Among
these subjects (12 years and older), 1000 subjects with CIU were enrolled in placebo controlled studies.
A once daily 10 mg dose of loratadine was superior to placebo in the management of 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 paediatric subjects (6 to 12 years of age) with seasonal allergic rhinitis received
doses of loratadine syrup up to 10 mg once daily in controlled clinical trials. In another study, 60
paediatric subjects (2 to 5 years of age) received 5 mg of loratadine syrup once daily. No unexpected
adverse 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 without influencing the clinical effect. The bioavailability parameters of loratadine and
of the active metabolite are dose proportional.
Distribution
Loratadine is highly bound (97% to 99%) and its active major metabolite desloratadine (DL) moderately
bound (73% to 76%) to plasma proteins.
In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are
approximately 1 and 2 hours respectively.
Biotransformation
After oral administration, loratadine is rapidly and well absorbed and undergoes 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 24 hours.

Less than 1% of the active substance is excreted unchanged in the active form, as loratadine or DL.
The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for
loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.
Renal impairment
In patients with chronic renal 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. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its
active metabolite in subjects with chronic renal 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 in patients with normal liver function. The elimination half-lives for loratadine and its
metabolite were 24 hours and 37 hours, 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 hazard for humans based 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) 10 times higher than
those achieved with clinical doses.

Ludipress
Microcrystalline Cellulose
Crospovidone
Colloidal Silicon Dioxide
Magnesium Stearate

Not applicable.

Do not store above 30°C

Immediate Container:
PVC/PVDC Film, Clear & transparent
Al-Foil Printed, 258mm

No special requirements.