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CLARITYN ALLERGY 10MG TABLETS

Active substance(s): LORATADINE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Clarityn Allergy 10mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg loratadine.
Excipients with known effect. The quantity of lactose monohydrate in the
loratadine 10 mg tablet composition is 71.3 mg.
For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
White to off-white, oval tablets with flask and bowl, score and “10” on one
side, plain on the other side.
The score line of the tablet is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Clarityn Allergy Tablets are indicated for the symptomatic treatment of allergic
rhinitis and chronic idiopathic urticaria.

4.2

Posology and method of administration

4.2

Posology and method of administration
Posology
Adults
One tablet once daily.
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 of Clarityn Allergy Tablets have 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 10 mg every other day is recommended for adults and
children weighing more than 30 kg.
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 tablet may be taken without regard to mealtime.

4.3

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.

4.4

Special warnings and precautions for use
Clarityn Allergy Tablets should be administered with caution in patients with
severe liver impairment (see section 4.2).
This medicinal product contains lactose; thus patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
The administration of Clarityn Allergy Tablets should be discontinued at least
48 hours before skin tests since antihistamines may prevent or reduce
otherwise positive reactions to dermal reactivity index.

4.5

Interaction with other medicinal products and other forms of interaction
When administered concomitantly with alcohol, Clarityn Allergy 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.

4.6

Fertility, pregnancy and lactation

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 (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Clarityn Allergy Tablets
during pregnancy.
Breastfeeding
Loratadine is excreted in breast milk. Therefore, the use of Clarityn Allergy Tablets is not
recommended in breast-feeding women.
Fertility
There are no data available on male and female fertility.

4.7

Effects on ability to drive and use machines
In clinical studies that assessed driving ability, no impairment was observed in
patients receiving loratadine. Clarityn Allergy Tablets 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.

4.8

Undesirable effects
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.
System Organ Class
Immune System disorders

Frequency
Very rare

Nervous system disorders
Cardiac disorders
Gastrointestinal disorders
Hepatobiliary disorders
Skin and subcutaneous
tissue disorders
General disorders and
administration site
conditions
Investigations

Very rare
Very rare
Very rare
Very rare
Very rare

Adverse Experience Term
Hypersensitivity reactions
(including angioedema and
anaphylaxis)
Dizziness, convulsion
Tachycardia, palpitation
Nausea, dry mouth, gastritis
Abnormal hepatic function
Rash, alopecia

Very rare

Fatigue

Not known

Weight increase

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%).
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. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard.

4.9

Overdose
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A
X13.

Mechanism of action
Loratadine, the active ingredient in Clarityn Allergy 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 10mg 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
10mg tablets in controlled clinical trials. Loratadine 10mg 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 10mg 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 10mg once daily in
controlled clinical trials. In another study, 60 paediatric subjects (2 to 5 years
of age) received 5mg of loratadine syrup once daily. No unexpected adverse
events were observed.
The paediatric efficacy was similar to the efficacy observed in adults.

5.2

Pharmacokinetic properties
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 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 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 volunteers and in healthy geriatric volunteers.

5.3

Preclinical safety data
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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose Monohydrate
Maize Starch
Magnesium Stearate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container
Blister comprising 20µm aluminium foil with vinyl heat coating and a 250µm
clear, transparent polyvinylchloride (PVC) film, or a 250µm clear, transparent
polyvinyl chloride (PVC) film with polyvinylidene chloride (PVdC) coating.
Pack sizes of 2, 5, 7, 10, 14, 15, 20, 21, 28 and 30 tablets.
Not all pack sizes may be marketed.

6.6

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

7

MARKETING AUTHORISATION HOLDER
Bayer plc
400 South Oak Way
Reading

RG2 6AD

8

MARKETING AUTHORISATION NUMBER(S)
PL 00010/0657

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/06/1992

10

DATE OF REVISION OF THE TEXT
07/03/2018

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