1. health and fitness
2. drugs

CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PL 33410/0043 & PL 33410/0062
UKPAR
TABLE OF CONTENTS
Lay Summary
Page 2
Scientific discussion
Page 3
Steps taken for assessment
Page 11
Steps taken after authorisation – summary
Page 12
Summary of Product Characteristics
Page 13
Patient Information Leaflet
Page 18
Labelling
Page 20
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
PL 33410/0043
PL 33410/0062
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CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PL 33410/0043 & PL 33410/0062
LAY SUMMARY
The Medicines and Healthcare products Regulatory Agency (MHRA) granted APSLA
Limited Marketing Authorisations (licences) for the medicinal product Cetirizine
Dihydrochloride 10 mg Film-Coated Tablets (PL 33410/0043 and PL 33410/0062) on
9 June 2011.
The products are available in numerous pack sizes and presentations. Pack sizes of up to
and including 14 tablets are available on the General Sales List (GSL), and can be
purchased at pharmacies, supermarkets and other retail outlets without the supervision of a
pharmacist. Pack sizes of up to and including 60 tablets are P licensed medicines available
only from pharmacies, under the supervision of a pharmacist.
Cetirizine dihydrochloride is an antiallergic medication. In adults and children aged 6 years
and above cetrizine dihydrochloride is used to treat the symptoms of hayfever (allergic
rhinitis) and year round allergies such as dust or pet allergies (perennial allergic rhinitis), as
well as the relief of swelling, redness and itchiness of the skin.
No new or unexpected safety concerns arose from these applications and it was, therefore,
judged that the benefits of taking Cetirizine Dihydrochloride 10 mg Film-Coated Tablets
outweigh the risks; hence Marketing Authorisations have been granted.
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PL 33410/0043
PL 33410/0062
CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PL 33410/0043 & PL 33410/0062
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction
Page 4
Pharmaceutical assessment
Page 5
Preclinical assessment
Page 8
Clinical assessment
Page 9
Overall conclusions and risk benefit assessment
Page 10
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PL 33410/0043
PL 33410/0062
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INTRODUCTION
The UK granted Marketing Authorisations for the medicinal product Cetirizine
Dihydrochloride 10 mg Film-Coated Tablets (PL 33410/0043) and its duplicate licence
(PL 33410/0062) to APSLA Limited on 9 June 2011.
Cetirizine Dihydrochloride 10 mg Film-Coated Tablets (PL 33410/0043) is available as a
pharmacy only medicine under the supervision of a pharmacist. Cetirizine Dihydrochloride
10 mg Film-Coated Tablets (PL 33410/0062) is available as a GSL product and is sold
without the supervision of a pharmacist in pack sizes of no greater than 14 tablets.
Cetirizine Dihydrochloride 10mg Film-Coated Tablets are for the symptomatic relief of
perennial rhinitis, seasonal allergic rhinitis and idiopathic chronic urticaria in adults and
children aged 6 years and over.
These are generic applications for Cetirizine Dihydrochloride 10 mg Film-Coated Tablets,
submitted under Article 10(1) of Directive 2001/83/EC, as amended. The applications refer
to the UK reference (innovator) product, Zirtek 10mg, originally licensed to UCB S.A
(PL 05221/0001) on 16 August 1988. The reference licence has since undergone two
Change of Ownership (CoA) procedures; the first to UCB Waterford Limited on 23 March
2000 and subsequently to the current Marketing Authorisation Holder (MAH), UCB
Pharma Limited UK (PL 00039/0542) on 12 December 2005. The second change of
ownership resulted in separate licences being created for Pharmacy supply
(PL 00039/0542) and GSL (Zirtek Allergy Relief/Zirtek Allergy 10mg Tablets
(PL 00039/0561). The reference product has been authorised in the EEA for over 10 years.
The Marketing Authorisation Holder has provided adequate justification for not submitting
an Environmental Risk Assessment (ERA). Cetirizine Dihydrochloride is a wellestablished active substance that has had widespread clinical used for many years. These
were applications for generic products, which will not be administered at a higher dosage,
for a longer duration or for different indications that were previously authorised. There is
no reason to conclude that marketing of these products will change the overall use pattern
of the existing market.
The pharmacovigilance system, as described by the MAH, fulfils the requirements and
provides adequate evidence that the MAH has the services of a qualified person responsible
for pharmacovigilance and has the necessary means for the notification of any adverse
reaction suspected of occurring either in the Community or in a third country.
The MAH has provided adequate justification for not submitting a Risk Management Plan
(RMP). As the application is for a generic version of an already authorised reference
product, for which safety concerns requiring additional risk minimisation have not been
identified, a risk minimisation system is not considered necessary. The reference product
has been in use for many years and the safety profile of the active is well established.
No new pre-clinical or clinical studies were performed, which is acceptable given that the
proposed product is a generic medicinal product of the reference product that have been
licensed for over 10 years.
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No new or unexpected safety concerns arose during the review of information provided by
the MAH and it was, therefore, judged that the benefits of taking product Cetirizine
Dihydrochloride 10 mg Film-Coated Tablets outweigh the risks; hence Marketing
Authorisations have been granted.
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PL 33410/0043
PL 33410/0062
PHARMACEUTICAL ASSESSMENT
DRUG SUBSTANCE
Cetirizine dihydrochloride
INN:
Cetirizine dihydrochloride
Chemical name:
(RS)-2-[2-[(4-Chlorophenyl)phenylmethyl]piperazin-1yl]ethoxy]acetic acid dihydrochloride.
Structure:
Molecular formula: C21H25ClN2O3.2(HCl)
Molecular mass: 461.81
General Properties
Description:
A white or almost white powder, freely soluble in water, and practically
insoluble in acetone and in methylene chloride.
Cetirizine dihydrochloride is the subject of a European Pharmacopoeia monograph.
Manufacture
All aspects of the manufacture and control of the active substance cetirizine
dihydrochloride are covered by a European Directorate for the Quality of Medicines
(EDQM) Certificate of Suitability.
DRUG PRODUCT
Description and Composition
Cetirizine Dihydrochloride 10 mg Film-Coated tablets are presented as white coloured,
circular, biconvex film-coated tablets, marked with ‘A’ on one side and a breakline score
on the other. The tablets can be divided into equal halves. Each film-coated tablet contains
10 mg of cetirizine dihydrochloride.
Other ingredients consist of pharmaceutical excipients, namely microcrystalline cellulose
(Avicel PH 102), lactose monohydrate for DC (Tabletose 80), colloidal anhydrous silica
(Aerosil), maize starch, purified talc, magnesium stearate making up the tablet core;
Opadry White which makes up the film coating consists of hypromellose 15cP, lactose
monohydrate, titanium dioxide, macrogol and sodium citrate which are controlled by an inhouse specification and is satisfactory.
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Appropriate justification for the inclusion of each excipient has been provided. All
excipients used comply with their relevant European Pharmacopoeia (Ph. Eur)
monographs. Satisfactory Certificates of Analysis have been provided for all excipients.
With the exception of lactose monohydrate none of the excipients used contain material
derived from animal or human consumption. The applicant has provided a declaration that
milk used in the production of lactose is sourced from healthy animals under the same
conditions as that for human consumption. None of the excipients are sourced from
genetically modified organisms.
Pharmaceutical Development
Details of the pharmaceutical development of the medicinal product have been supplied
and are satisfactory. The objective was to develop robust, stable, generic formulation,
bioequivalent to the innovator product Zirtek Allergy 10 mg Tablets first licensed in the
UK on 16 August 1988 to UCB SA.
Comparative impurity and dissolution profiles were provided for the test and reference
products and were found to be similar.
Manufacture
A description and flow-chart of the manufacturing method has been provided.
In-process controls were considered appropriate considering the nature of the product and
the method of manufacture. Process validation studies have been conducted and are
accepted. The validation data demonstrated consistency of the manufacturing process.
Finished Product Specification
Finished product specifications are provided for both release and shelf-life, and are
satisfactory; they provide an assurance of the quality and consistency of the finished
product. Acceptance limits have been justified with respect to conventional pharmaceutical
requirements and, where appropriate, safety. Test methods have been described and
adequately validated, as appropriate. Satisfactory batch analysis data are provided and
accepted. The data demonstrate that the batches are compliant with the proposed
specifications. Certificates of Analysis have been provided for any reference standards
used.
Container Closure System
The finished product is presented in blisters composed of aluminium and clear polyvinyl
chloride (PVC) which are packed with the Patient Information Leaflet (PIL) into cardboard
outer cartons in pack sizes of either:
• 7, 14, 21, 28, 30 or 60 tablets for PL 33410/0043
Or
• 4,5,7 or 14 tablets for PL 33410/0062
The MA Holder (MAH) has stated that not all pack sizes may be marketed however, the
MAH has committed to submitting the proposed packaging/labelling for any pack size
before it is marketed.
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Satisfactory specifications and Certificates of Analysis for all packaging components used
have been provided. All primary product packaging complies with EU legislation,
Directive 2002/72/EC (as amended), and is suitable for contact with foodstuffs.
Stability
Finished product stability studies have been conducted in accordance with current
guidelines and results were within the proposed specification limits. Based on the results, a
shelf-life of 3 years has been set which is satisfactory. This medicinal product does not
require any special temperature storage conditions. Keep the blister in the outer carton in
order to protect from light.
Bioequivalence Study
A bioequivalence study was presented under fasting conditions comparing the test product,
Cetirizine 10mg Tablets to the reference product; Zirtek Allergy 10mg Tablets, UCB, UK
(PL 00039/0542).
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL),
Labels
The approved SmPCs, PILs and labelling are pharmaceutically acceptable. Mock-ups of the
package leaflet and labelling have been provided. The labelling fulfils the statutory
requirements for Braille.
The package leaflet has been evaluated via a user consultation study in accordance with the
requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for
the purpose of user testing the PIL was English. The results show that the package leaflet
meets the criteria for readability as set out in the Guideline on the readability of the label
and package leaflet of medicinal products for human use.
Expert Report
A satisfactory quality overview is provided, and has been prepared by an appropriately
qualified expert. The CV of the expert has been supplied.
Conclusion
It is recommended that Marketing Authorisations are granted for these applications.
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NON-CLINICAL ASSESSMENT
This application was submitted as an abridged, application, according to Article 10.1 of
Directive 2001/83/EC, as amended.
The pharmacodynamic, pharmacokinetic and toxicological properties of cetirizine
dihydrochloride are well-known. Therefore, no further studies are required and the
applicant has provided none.
The pre-clinical overview was written by a suitably qualified person and is satisfactory.
The curriculum vitae of the expert has been provided.
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CLINICAL ASSESSMENT
Pharmacokinetics
In support of this application, the marketing authorisation holder has submitted the
following bioequivalence study. The reference product used for the bioequivalence study is
Zirtek Allergy 10 mg Tablets (PL 00039/0542), UCB Pharma Limited UK.
This is a single dose, randomised, balanced, two-way crossover comparative oral
bioavailability study of Cetirizine Dihydrochloride 10 mg Film-Coated Tablets(test
product) and Zirtek Allergy 10 mg Tablets (UCB Pharma Limited, UK) in healthy adults
under fasting conditions.
The study was conducted in compliance with Good Clinical Practice (ICH-GCP) and Good
Laboratory Practice.
Study design
A single dose of the investigational products (1 tablet of 10mg) was administered orally to
each subject in each period with 240 ml of water after an overnight fast of at least 10 hours.
Serial blood sampling before dosing and up to 48hours after drug administration was
carried out.
A washout period of 7 days was maintained between the two dosing periods in each group
which is sufficient time for cetirizine dihydrochloride to be eliminated from the body.
A validated HPLC-MS/MS analytical methodology was used for quantification of
Cetirizine dihydrochloride from the human plasma samples. Primary variables analysed
were: Cmax, AUC0-t and AUC0-∞ and additional pharmacokinetic parameters were tmax, t1/2,
MRT and AUC% Extrap.
Results
All volunteers completed both treatment periods and their data were included in the
statistical analysis.
There were no protocol deviations.
Baseline plasma levels were zero at period 2, indicating that the washout period was
adequate.
The results are summarised in Tables 1 and 2.
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Table 1. Results for main pharmacokinetic parameters:
Bioequivalence results for log-transformed test/reference ratios with 90% Confidence
Intervals:
Table 2: Summary of pharmacokinetic data for Cetirizine
Conclusion
The 90% Confidence Intervals for the geometric ratios from ln-transformed data of Cmax,
AUC0-∞ and AUC0-t of Cetirizine dihydrochloride, were within the bioequivalence
acceptance range (80-125%). Based on these results, Cetirizine Dihydrochloride 10 mg
Film-Coated Tablets (Test) is bioequivalent with that of Zirtek Allergy 10 mg Tablets
(Reference) of UCB Pharma Limited, UK, under fasting conditions.
Pharmacodynamics
No new pharmacodynamic data have been submitted and none is required for this
application.
Clinical efficacy
No new efficacy data have been submitted and none is required for this applications.
Clinical safety
A total of 6 non-serious adverse events were reported during the study (3 related to the test
formulation and 3 related to the reference formulation). No serious or severe adverse event
was reported during the study and both formulations were well tolerated. No new safety
data have been submitted and none are required for this application.
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BENEFIT RISK ASSESSMENT
The benefit-risk ratio is considered favourable.
Expert Report
A satisfactory clinical overview is provided, and has been prepared by an appropriately
qualified physician. The curriculum vitae of the expert has been provided.
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL),
Labels
The SmPCs, labels and PILs are medically acceptable, and consistent with those for the
reference product. The labelling is medically acceptable and in-line with current
requirements.
Marketing Authorisation Application (MAA) form
The MAA forms are medically satisfactory.
Conclusion
There are no objections to approval of Cetirizine Dihydrochloride 10 mg Film-Coated
Tablets from a clinical point of view.
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OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT
QUALITY
The important quality characteristics of Cetirizine Dihydrochloride 10 mg Film-Coated
Tablets are well-defined and controlled. The specifications and batch analytical results
indicate consistency from batch to batch. There are no outstanding quality issues that
would have a negative impact on the benefit/risk balance.
PRECLINICAL
No new preclinical data were submitted and none are required for applications of this type.
EFFICACY
The applicant’s Cetirizine Dihydrochloride 10 mg Film-Coated Tablets has been
demonstrated to be generic version of the reference product, Zirtek Allergy 10 mg Tablets,
currently authorised to UCB Pharma Limited UK (PL 00039/0542) on 12 December 2005
and originally granted to UCB SA on 16 August 1988.
No new or unexpected safety concerns arise from these applications.
PRODUCT LITERATURE
The SmPCs and PILs are acceptable, and consistent with those for the reference product.
The labelling is acceptable and in-line with current requirements.
The package leaflet has been evaluated via a user consultation study in accordance with the
requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The results show that
the package leaflet meets the criteria for readability as set out in the Guideline on the
readability of the label and package leaflet of medicinal products for human use.
BENEFIT/RISK ASSESSMENT
The quality of the product is acceptable, and no new preclinical or clinical safety concerns
have been identified. The qualitative and quantitative assessment supports the claim that
the applicant’s Cetirizine Dihydrochloride 10 mg Film-Coated Tablets and the reference
product Zirtek Allergy 10 mg Tablets (UCB Pharma Limited, UK) are interchangeable.
Extensive clinical experience with Cetirizine dihydrochloride is considered to have
demonstrated the therapeutic value of the active substances. The benefit:risk is, therefore,
considered to be positive.
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PL 33410/0062
CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PL 33410/0043 & PL 33410/0062
STEPS TAKEN FOR ASSESMENT
1
The MHRA received the marketing authorisation application on 11 August
2009.
2
Following standard checks and communication with the applicant the MHRA
considered the application valid on 18 August 2009.
3
Following assessment of the applications the MHRA requested further
information relating to the quality dossier on 5 May 2010, 24 August 2010 and
10 December 2010
4
Following assessment of the applications the MHRA requested further
information relating to the clinical dossier on 25 September 2009.
5
The applicant responded to the MHRA’s requests, providing further information
on the quality dossier on 13 August 2010, 23 November 2010 and 2 March
2011.
6
The applicant responded to the MHRA’s requests, providing further information
on the clinical dossier on 22 March 2010
7
The application was determined on 9 June 2011.
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PL 33410/0062
CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PL 33410/0043 & PL 33410/0062
STEPS TAKEN AFTER AUTHORISATION - SUMMARY
Date
Application
submitted type
Scope
Outcome
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PL 33410/0043
PL 33410/0062
CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS
PL 33410/0043 & PL 33410/0062
SUMMARY OF PRODUCT CHARACTERISTICS
The UK Summary of Product Characteristics (SmPC) for Cetirizine Dihydrochloride 10 mg
Film-Coated Tablets (PL 33410/0043 and PL 33410/0062) is as follows: Differences
between the two SmPCs are highlighted in yellow.
1
NAME OF THE MEDICINAL PRODUCT
Cetirizine Dihydrochloride 10mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of Cetirizine Dihydrochloride
Excipients: one film-coated tablet contains 100.2 mg of lactose monohydrate (see section 4.4).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet. The diameter of each tablet is 8mm.
White coloured, circular, biconvex film coated tablets, marked with ‘A’ on one side and a breakline
score on the other.
The tablet can be divided into equal halves.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
Cetirizine is indicated for the symptomatic treatment of perennial rhinitis, seasonal allergic rhinitis
and chronic idiopathic urticaria.
4.2
Posology and method of administration
Children aged from 6 to 12 years: 10mg once daily (1 tablet).
Adults and children over 12 years of age: 10 mg once daily (1 tablet).
The tablets need to be swallowed with a glass of liquid.
Elderly subjects: At present there is no data to suggest that the dose needs to be reduced in elderly
subjects provided that the renal function is normal.
Patients with renal insufficiency: the dosage should be reduced to half the recommended daily dose
Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic
impairment.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose- galactose malabsorption should not take cetirizine film-coated tablet.
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4.4
Special warnings and precautions for use
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.
Do not exceed the stated dose. If symptoms persist consult your doctor.
4.5
Interaction with other medicinal products and other forms of interaction
To date there have been no known interactions with other drugs. Studies with diazepam and
cimetidine revealed no evidence of interactions. As with other antihistamines, it is advisable to avoid
excessive alcohol consumption.
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.
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is
decreased.
4.6
Pregnancy and lactation
No adverse effects have been reported from animal studies. There has been little or no clinical
experience of cetirizine in pregnancy. As with other drugs the use of cetirizine in pregnancy should
be avoided. Cetirizine is contraindicated in lactating women as it is excreted in breast milk.
4.7
Effects on ability to drive and use machines
Antihistamines can cause drowsiness in some patients. Although this has not been reported with
cetirizine at the recommended dose, please be cautious whilst driving or operating machinery.
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 dihydrochloride.
Post-marketing experience
The following adverse drug reactions have been reported from postmarketing experience.
Very common (≥1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare
(≥1/10,000 to ≤1,000); very rare (≤1/10,000), not known, cannot be estimated from available data.
Blood and lymphatic disorders:
Very rare: thrombocytopenia
Immune system disorders:
Rare: hypersensitivity
Very rare: anaphylactic shock
Psychiatric disorders:
Uncommon: agitation
Rare: aggression, confusion, depression, hallucination, insomnia
Very rare: tic
Nervous system disorders:
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Uncommon: paraesthesia
Rare: convulsions, movements disorders
Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Eye disorders:
Very rare: accommodation disorder, blurred vision, oculogyration
Cardiac disorders:
Rare: tachycardia
Gastro-intestinal disorders:
Uncommon: diarrhoea
Hepatobiliary disorders:
Rare: abnormal hepatic function (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioneurotic oedema, fixed drug eruption, erythema multiforme
Renal and urinary disorders:
Very rare: dysuria, enuresis, micturition difficulties
General disorders and administration site conditions:
Uncommon: asthenia, malaise
Rare: oedema
Investigations:
Rare: weight increased
4.9
Overdose
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.
Management
There is no known specific antidote to cetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended. The patient should be
kept under clinical observationfor at least 4 hours after ingestion, and his blood pressure, heart rate
and vital signs monitored until stable. In symptomatic cases ECG should be performed. The benefit
of gastric lavage is uncertain.oral activated charcoal (50g for an adult, 10-15g for a child) should be
considered if more than 2.5mg/kg cetirizine has been ingested within 1 hour. Cetirizine is not
effectively removed by dialysis.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Piperazine derivatives, ATC code: R06A E07
Cetirizine is a potent antihistamine with a low potential for drowsiness at normal therapeutic doses
which has additional anti-allergic properties. It is a selective H1 antagonist with negligible effects on
other receptors and so is virtually free from anti-cholinergic and anti-serotonin effects. Cetirizine
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inhibits the histamine-mediated early phase of the allergic-reaction and also reduces the migration of
certain inflammatory cells and the release of certain mediators associated with the late allergic
response.
5.2
Pharmacokinetic properties
Peak blood levels of the order of 0.3micrograms/ml are reached between 30 and 60 minutes after
oral administration of a 10mg dose of cetirizine. The terminal half-life is approximately ten hours in
adults, approximately six hours in children aged between 6 to12 years and approximately 5 hours in
children 2-6years.
This is consistent with the urinary excretion half life of the drug. The cumulative urinary excretion
represents about two thirds of the administered dose for both adults and children.
The apparent plasma clearance in children is higher than that measured in adults. A high proportion
of cetirizine is bound to human plasma proteins.
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, carcinogenic potential, toxicity to reproduction.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Microcrystalline Cellulose (Avicel PH 102)
Lactose monohydrate for DC (Tabletose 80)
Colloidal anhydrous silica (Aerosil)
Maize Starch
Purified Talc
Magnesium Stearate
Film Coating:
Opadry White 31F58914
- Hypromellose 15cP
- Lactose monohydrate
- Titanium dioxide
- Macrogol /
- Sodium citrate
6.2
Incompatibilities
Not applicable.
6.3
Shelf life
3 years
6.4
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep the blister
in the outer carton in order to protect from light.
6.5
Nature and contents of container
Aluminium/PVC clear blister strips,
PL 33410/0043: pack sizes containing 7, 14, 21, 28, 30 or 60 tablets.
PL 33410/0062:pack sizes containing 4, 5, 7 or 14 tablets
Not all pack sizes may be marketed.
6.6
Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
7
MARKETING AUTHORISATION HOLDER
APSLA Limited,
Bayview House,
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PL 33410/0062
49 North Strand Road,
Dublin 3, Ireland.
8
MARKETING AUTHORISATION NUMBER(S)
PL 33410/0043
PL 33410/0062
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
09/06/2011
10
DATE OF REVISION OF THE TEXT
09/06/2011
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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AUTHORISATION
PL 33410/0043
PL 33410/0062
PATIENT INFORMATION LEAFLET
PL 33410/0043
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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21 -
PL 33410/0043
PL 33410/0062
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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22 -
PL 33410/0043
PL 33410/0062
PL 33410/0062
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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23 -
PL 33410/0043
PL 33410/0062
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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24 -
PL 33410/0043
PL 33410/0062
LABELLING
PL 33410/0043
CARTON
BLISTER FOIL
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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25 -
PL 33410/0043
PL 33410/0062
LABELLING
PL 33410/0062
CARTON
BLISTER FOIL
MHRA-UKPAR – Cetirizine Dihydrochloride 10mg Film-Coated Tablets
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26 -
PL 33410/0043
PL 33410/0062