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PIRITEZE ALLERGY 1MG/ML SYRUP

Active substance(s): CETIRIZINE HYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE / CETIRIZINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Piriteze Allergy 1mg/ml Syrup

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 1mg of cetirizine hydrochloride.
Excipients:
Piriteze Allergy 1mg/ml Syrup contains 315mg sorbitol per ml.
For full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
1mg/ml oral solution.
Clear and colourless liquid with a slightly sweet taste and a banana flavour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
In adults and children 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 chronic idiopathic urticaria.

Posology and method of administration
Children aged from 6 to 12 years: 5mg twice daily (5 ml of oral solution twice
daily).
Adults and adolescents over 12 years of age: 10 mg once daily (10 ml of oral
solution once daily).

Elderly subjects: data do not suggest that the dose needs to be reduced in
elderly subjects provided that the renal function is normal.
Patients with moderate to severe renal impairment: 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)] x weight (kg) (x 0.85 for woman)
72 x serum creatinine (mg/dl)

Dosing Adjustments for Adult Patients with Impaired Renal Function

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.
Patients with hepatic impairment: no dose adjustment is needed in patients
with solely hepatic impairment.
Patients with hepatic impairment and renal impairment: 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 product is not recommended in children aged less than 6 years.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause
allergic reactions (possibly delayed).
This product contains Sorbitol. Patients with rare hereditary problems of
fructose intolerance, should not take cetirizine 1 mg/ml oral solution.
Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is
required before performing them.

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 performed, 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 (see
5.3). 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
Cetirizine may have minor or moderate influence on the patient’s ability to react. This
should be considered when extra alertness is required e.g. when driving. Cetirizine
may potentiate the effects of alcohol and CNS depressants.
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 H1-receptors and is
relatively free of anticholinergic 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.

Clinical trails
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)
Body as a whole - general
disorders
Fatigue
Central and peripheral
nervous system disorders
Dizziness
Headache
Gastro-intestinal system
disorders
Abdominal pain
Dry mouth

Cetirizine 10 mg
(n=3260)

Placebo
(n=3061)

1.63%

0.95%

1.10%
7.42%

0.98%
8.07%

0.98%
2.09%

1.08%
0.82%

Nausea
Psychiatric disorders
Somnolence
Respiratory system
disorders
Pharyngitis

1.07%

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-marketing experience
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 eye 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
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 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 glare 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
Cetirizine is absorbed with small inter-individual variations. Cetirizine has not been
given intravenously, therefore the bioavailability, clearance and volume of
distribution (Vd) are unknown. Maximum plasma concentration is achieved within 1
hour and the terminal half-life is about 10 hours in adults and 6 hours in children
between the age of 6-12 years. The grade of protein binding in plasma is about 93%.
Cetirizine is metabolised to a small extent with a known inactive main metabolite.
60% of a dose of cetirizine is eliminated in unchanged form via the kidneys within 96
hours. Repeated administration does not lead to any accumulation, nor is the
absorption or elimination affected. In cases of impaired kidney function, the
elimination is slower and the half-life is prolonged. Elimination will also be
decreased in cases of hepatic impairment.
There is no evidence that the pharmacokinetics of cetirizine is altered in elderly
patients unless renal or hepatic function is reduced.

5.3

Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of
safety pharmacology, repeated dose toxicity, toxicity to reproduction, genotoxicity or
carcinogenicity.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol
Propylene glycol
Liquid Sorbitol (non-crystallising) (E420)
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
Sodium acetate
Acetic acid
Saccharin sodium
Banana flavour

Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
No special precautions for storage.

6.5

Nature and contents of container
70ml fill bottle.
Amber glass bottle with child-resistant polypropylene screw cap incorporating a
tamper evident seal (yellow polyethylene)
Measuring device: 5 ml plastic PP measuring spoon graduated at 2.5 ml

6.6

Special precautions for disposal
No special requirements.

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 44673/0095

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/05/2007 / 05/03/2012

10

DATE OF REVISION OF THE TEXT
03/03/2016

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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