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PIRITEZE ALLERGY TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Piriteze Allergy Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg of cetirizine hydrochloride
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Film coated tablets.
White to off white capsule-shaped tablet, debossed with C10 on one side and a
deep breakline on the other.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
In adults and paediatric patients 6 years and above:
-

4.2

Cetirizine is indicated for the relief of nasal and ocular symptoms of
seasonal and perennial allergic rhinitis.
Cetirizine is indicated for the relief of symptoms of chronic idiopathic
urticaria.

Posology and method of administration
Childrenagedfrom 6to12years: 5mg twice daily (a half tablet
twice daily).
Adultsandadolescentsover12 years of age: 10 mg once daily (1
tablet once daily).
Elderlysubjects: data do not suggest that the dose needs to be
reduced in elderly subjects provided that the renal function is
normal.
Patientswithmoderateto severerenalimpairment: there are no data to
document the efficacy/safety ratio in patients with renal
impairment. Since cetirizine is mainly excreted via renal route (see
section 5.2), in cases no alternative treatment can be used, the
dosing intervals must be individualised according to renal
function. Refer to the following table and adjust the dose as

indicated. To use this dosing table, an estimate of the patient’s
creatinine clearance (CLcr) in ml/min is needed. The CLcr ml/min
may be estimated from serum creatinine (mg/dl) determination
using the following formula:
CLcr

=

[140– age(years)]xweight (kg)
72 x serum creatinine (mg/dl)

(x 0.85 for woman)

DosingAdjustmentsforAdultPatientswithImpairedRenalFunction

Group
Normal
Mild
Moderate
Severe
End-stage renal disease Patients undergoing
dialysis

Creatinine clearance
(ml/min)
80
50-79
30-49
< 30
< 10

Dosage and frequency
10 mg once daily
10 mg once daily
5 mg once daily
5 mg once every 2 days
Contra-indicated

In paediatric patients suffering from renal impairment, the dose
will have to be adjusted on an individual basis taking into account
the renal clearance of the patient, their age and body weight.
Patientswithhepaticimpairment: no dose adjustment is needed
in patients with solely hepatic impairment.
Patientswithhepaticimpairmentandrenalimpairment: dose
adjustment is recommended ( see Patients with moderate to severe
renal impairment above).

4.3

Contraindications
Hypersensitivity to the active substance, to any of the excipients, to
hydroxyzine or to any piperazine derivatives.
Patients with severe renal impairment at less than 10 ml/min creatinine
clearance.

4.4

Special warnings and precautions for use
At therapeutic doses, no clinically significant interactions have
been demonstrated with alcohol (for a blood alcohol level of 0.5
g/l). Nevertheless, precaution is recommended if alcohol is taken
concomitantly.
Caution should be taken in patients with predisposition
factors of urinary retention (e.g. spinal cord lesion, prostatic

hyperplasia) as cetirizine may increase the risk of urinary
retention.
Caution in epileptic patients and patients at risk of
convulsions is recommended.
The use of the film-coated tablet formulation is not recommended
in children aged less than 6 years since this formulation does not
allow for appropriate dose adaptation.
Pruritus and/or urticaria may occur when cetirizine is stopped, even if those
symptoms were not present before treatment initiation. In some cases, the
symptoms may be intense and may require treatment to be restarted. The
symptoms should resolve when the treatment is restarted.
Allergy skin tests are inhibited by antihistamines and a wash-out
period (of 3 days) is required before performing them.
This product contains lactose. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase
deficiency of glucose-galactose malabsorption should not
take cetirizine film-coated tablets.

4.5

Interaction with other medicinal products and other forms of interaction
Due to pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine,
no interactions are expected with this antihistamine. Actually, neither
pharmacodynamic nor significant pharmacokinetic interaction was reported in
drug-drug interactions studies perfomed, notably with pseudoephedrine or
theophylline (400 mg/day).
The extent of absorption of cetirizine is not reduced with food, although the
rate of absorption is decreased.

4.6

Fertility, Pregnancy and lactation
Data on a limited number of exposed pregnancies indicate no adverse effects
of cetirizine on pregnancy or on health of foetus/new born child. To date no
other relevant epidemiological data are available.
Animal studies do not indicate direct or indirect harmful effects with respect to
pregnancy, embryonal/foetal development, parturition or post-natal
development (see5.3). Caution should be exercised when prescribing to
pregnant women.
Breast feeding.

Caution should be exercised when prescribing cetirizine to lactating women.
Cetirizine is excreted in human milk at concentrations representing 25% to
90% of those measured in plasma, depending on sampling time after
administration.
4.7

Effects on ability to drive and use machines
Studies in healthy volunteers at 20 and 25mg/day have not revealed adverse
effects on alertness or reaction time. However, patients are advised not to
exceed the recommended dose if driving or operating machinery even though
cetirizine has no or negligible influence on these parameters.
In sensitive patients, concurrent use with alcohol or other CNS depressants
may cause additional reductions in alertness and impairment of performance.

4.8

Undesirable effects
Clinical studies have shown that cetirizine at the recommended
dosage has minor undesirable effects on the CNS, including
somnolence, fatigue, dizziness and headache. In some cases,
paradoxical CNS stimulation has been reported.
Although cetirizine is a selective antagonist of peripheral H1receptors and is relatively free of antichloinergic activity, isolated
cases of micturition difficulty, eye accommodation disorders and
dry mouth have been reported.
Instances of abnormal hepatic function with elevated hepatic
enzymes accompanied by elevated bilirubin have been reported.
Mostly this resolves upon discontinuation of the treatment with
cetirizine hydrochloride.

Clinicaltrails
Double blind controlled clinical or pharmacoclinical trials
comparing cetirizine to placebo or other antihistamines at the
recommended dosage (10 mg daily for cetirizine), of which
quantified safety data are available, included more than
3200 subjects exposed
to cetirizine.
From this pooling, the following adverse events were reported for
cetirizine 10
mg in the placebo-controlled trials at rates of
1.0% or greater:
Adverse event
(WHO-ART)

Cetirizine 10 mg
(n=3260)

Placebo
(n=3061)

Body as a whole - general
disorders
Fatigue
Central and peripheral
nervous system disorders
Dizziness
Headache
Gastro-intestinal system

1.63%

0.95%

1.10%
7.42%

0.98%
8.07%

disorders
Abdominal pain
Dry mouth
Nausea
Psychiatric disorders
Somnolence
Respiratory system
disorders
Pharyngitis

0.98%
2.09%
1.07%

1.08%
0.82%
1.14%

9.63%

5.00%

1.29%

1.34%

Although statistically more common than under placebo, somnolence was mild
to moderate in the majority of cases. Objective tests as demonstrated by other
studies have demonstrated that usual daily activities are unaffected at the
recommended daily dose in healthy young volunteers.
Adverse drug reactions at rates of 1 % or greater in children aged from 6
months to 12 years, included in placebo-controlled clinical or
pharmacoclinical trials are:
Adverse event
(WHO-ART)
Gastro-intestinal system
disorders
Diarrhoea
Psychiatric disorders
Somnolence
Respiratory system
disorders
Rhinitis
Body as a whole - general
disorders
Fatigue

Cetirizine 10 mg
(n=1656)

Placebo
(n=1294)

1.0%

0.6%

1.8%

1.4%

1.4%

1.1%

1.0%

0.3%

Post-marketingexperience
In addition to the adverse effects reported during clinical studies and listed
above, isolated cases of the following adverse drug reactions have been
reported in post-marketing experience. For the less frequently reported
undesirable effects, the estimated frequencies (uncommon: 1/1,000 to 1/100,
rare: 1/10,000 to 1/1,000, very rare: 1/10,000) are made based on postmarketing experience.
Blood and lymphatic disorders:
Very rare: thrombocytopenia
Immune system disorders:
Rare: hypersensitivity
Very rare: anaphylactic shock
Metabolism and nutrition disorders:

Not known: increased appetite
Psychiatric disorders:
Uncommon: agitation
Rare: aggression, confusion, depression, hallucinations, insomnia
Very rare: tic
Not known: suicidal ideation
Nervous system disorders:
Uncommon: paraesthesia
Rare: convulsions, movement disorders
Very rare; dysgeusia, syncope, tremor, dystonia, dyskinesia
Unknown: amnesia, memory impairment
Eye disorders:
Very rare: accommodation disorder, blurred vision, oculogyration
Ear and labyrinth disorders:
Not known: vertigo
Cardiac disorders:
Rare: tachycardia
Gastro-intestinal disorders:
Uncommon: diarrhoea
Hepatobiliary disorders:
Rare: hepatic function abnormal (increased transaminases, alkaline
phosphataes, γ-GT and bilirubin)
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioneurotic oedema, fixed drug eruption
Renal and urinary disorders:
Very rare: dysuria, enuresis
Not known: urinary retention (see section Warnings and Precautions)
General disorders and administration site conditions:
Uncommon: asthenia, malaise
Rare: oedema
Investigations:
Rare: weight increased
Skin reactions occuring after discontinuation of cetirizine
After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have
been reported (see Section Warnings and Precautions).

Reporting ofsuspectedadversereactions
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
at:www.mhra.gov.uk/yellowcard.
4.9

Overdose
Toxicity: There is limited experience of overdosing. 20 mg to a 2 year old, 30
mg to a 3 year old and 40 mg to an 11 year old did not give any symptoms. 60
mg to a 4 year old gave mild intoxication, 400 mg to a 14 year old gave mild
symptoms while 400-500 mg to an adult gave no symptoms at all.
a) Symptoms
Symptoms observed after an overdose of cetirizine are mainly associated with
CNS effects or with effects that could suggest an anticholinergic effect.
Adverse events reported after an intake of at least 5 times the recommended
daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise,
mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia,
tremor, and urinary retention.
b) Management
There is no known specific antidote to cetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended.
Cetirizine is not effectively removed by dialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Piperazine derivatives, ATC code: R06A E07
Cetirizine, a human metabolite of hydroxyzine, is a potent and
selective antagonist of peripheral H1-receptors. In vitro receptor
binding studies have shown no measurable affinity for receptors
other than H1-receptors.
In addition to its anti-H1 effect, cetirizine was shown to display
anti-allergic activities: at a dose of 10 mg once or twice daily, it
inhibits the late phase recruitment of eosinophils, in the skin and
conjuctivia of atopic subjects submitted to allergen challenge.
Studies in healthy volunteers show that cetirizine, at doses of 5
and 10 mg strongly inhibits the wheal and flare reactions
induced by very high concentrations of histamine into the skin,
but the correlation with efficacy is not established.

In a 35-day study in children aged 5 to 12, no tolerance to the antihistamine
effect (suppression of wheal and flare) of cetirizine was found. When a
treatment with cetirizine is stopped after repeated administration, the skin
recovers its normal reactivity to histamine within 3 days.
In a six-week, placebo-controlled study of 186 patients with
allergic rhinitis and concomitant mild to moderate asthma,
cetirizine 10 mg once daily improved rhinitis symptoms and did
not alter pulmonary function. This study supports the safety of
administering cetirizine to allergic patients with mild to moderate
asthma.
In a placebo-controlled study, cetirizine give at the high daily dose
of 60 mg for seven days did not cause statistically significant
prolongation of QT interval.
At the recommended dosage, cetirizine has demonstrated that it
improves the quality of life of patients with perennial and
seasonal allergic rhinitis.
5.2

Pharmacokinetic properties
Peak blood levels in the order of 0.3μg/ml are reached within about one hour after the
oral administration of cetirizine. The terminal half-life is approximately ten hours in
adults and six hours in children aged 6 - 12 years.
This is consistent with the urinary excretion half-life of the drug. The cumulative
urinary excretion represents about two thirds of the dose given for both adults and
children.
Consequently, the apparent plasma clearance in children is higher than that measured
in adults. Plasma levels are linearly related to the dose given. A high proportion of
cetirizine is bound to human plasma proteins.

5.3

Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity,
carcinogenic potential, toxicity to reproduction.
Preclinical results were observed only at exposures considered sufficiently in
excess of the maximum human exposure indicating little relevance to clinical
use.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate

Coating:
Hypromellose (E464)
Macrogol 4000
Titanium dioxide (E171)
Polydextrose

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
No special precautions for storage

6.5

Nature and contents of container
Transparent or white opaque PVC/PVdC – aluminium blister packs containing
4, 7, 12, 14 or 30 film-coated tablets.

6.6

Special precautions for disposal and other handling
Not applicable

7

MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 44673/0097

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25 September 2003/13 March 2009

10

DATE OF REVISION OF THE TEXT
08/12/2017

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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