Clara syrup relieves symptoms associated with allergic rhinitis (for example, hayfever), such
as sneezing, runny or itchy nose and burning or itchy eyes.
The syrup may also be used to help relieve symptoms of urticaria (itching and redness), which
is often known as hives or nettle rash.

Adults and children over 12 years of age :
10ml (10mg) of the syrup once daily.
Paediatric population
Children 2 to 12 years of age are dosed by weight:
Body weight more than 30kg : 10ml (10mg) of the syrup once daily.
Body weight 30kg or less: 5ml (5mg) of the syrup once daily.
The safety and efficacy of Clara Syrup in children under 2 years of age has not been
established. No data are available.

Patients with hepatic impairment
Patients with severe liver impairment should be administered a lower initial dose because they
may have reduced clearance of loratadine. An initial dose of 10mg every other day is
recommended for adults and children weighing more than 30kg and for children weighing
30kg or less, 5ml (5mg) every other day is recommended.
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. The syrup may be taken without regard to meal time.

Clara Syrup should be administered with caution in patients with severe liver impairment.
This medicinal product contains sucrose; thus patients with rare hereditary problems of
fructose intolerance, glucose-galactose malabsorption or sucrose isomaltase insufficiency
should not take this medicine.
The administration of Clara Syrup 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, Clara Syrup has 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 , 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 feto/ neonatal toxicity of loratadine 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 of Clara Syrup during pregnancy.
Breast-feeding
Loratadine is excreted in breast milk. Therefore, the use of Clara Syrup is not recommended
in breast-feeding women.
Fertility
There are no data available on male and female fertility.

In clinical trials that assessed driving ability, no impairment was observed in patients
receiving loratadine. Clara Syrup has no or negligible influence on the ability to drive and use
machines. However, patients should be informed that very rarely some people experience
drowsiness, 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 including allergic
rhinitis (AR) and chronic idiopathic urticarial (CIU), at the recommended dose of 10mg 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.

Paediatric population
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%).

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 Clara Syrup, 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 metabolite 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 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 halflives
for loratadine and its active 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.

Sodium Benzoate
Citric acid Monohydrate
Edetate Disodium (EDTA)
Sucrose
Propylene Glycol
Glycerol (Glycerin)
Strawberry Flavor Liquid
Purified Water

Not applicable

Do not store above 30°C.
Keep out of reach and sight of children.

Amber colored glass bottles.

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