Summary of Product Characteristics (SmPC) - Piriteze Hayfever & Allergy 10 mg film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Piriteze Hayfever & Allergy 10mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg of cetirizine hydrochloride
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets (tablets).
White to off white capsule-shaped tablet with a deep break line on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
In adults and paediatric patients 6 years and above:
- 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 urticaria.
4.2 Posology and method of administration
Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily).
Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet 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.
Method of administration
The tablets need to be swallowed with a glass of liquid.
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
Dosing Adjustments for Adult Patients with Impaired Renal Function
| Group | GFR(ml/min) | Dosage and frequency |
| Normal renal function | ≥90 | 10 mg once daily |
| Mildly decreased renal function | 60– < 90 | 10 mg once daily |
| Moderately decreased renal function | 30 – < 60 | 5 mg once daily |
| Severely decreased renal function | 15 - < 30 not requiring dialysis treatment | 5 mg once every 2 days |
| End-stage renal disease | <15 requiring dialysis treatment | Contra-indicated |
Paediatric population
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 end-stage renal disease with GFR (Glomerular Filtration Rate) below 15 ml/min.
4.4. Special warning 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 (see Section Adverse Reactions)
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 (see Section Adverse Reactions). 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 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.
Alcohol and other CNS depressants
In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance, although cetirizine does not potentiate the effect of alcohol (see Section Warnings and Precautions).
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/newborn 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.
Breastfeeding
Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. 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 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 trials
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) |
| General disorders and administration site conditions Fatigue | 1.63% | 0.95% |
Nervous system disorders Dizziness Headache | 1.10% 7.42% | 0.98% 8.07% |
Gastro-intestinal system disorders Abdominal pain | 0.98% 2.09% | 1.08% 0.82% |
| Dry mouth Nausea | 1.07% | 1.14% |
Psychiatric disorders Somnolence | 9.63% | 5.00% |
Respiratory thoracic and mediastinal disorders Pharyngitis | 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) | Cetirizine 10 mg (n=1656) | Placebo (n=1294) |
| Gastro-intestinal system disorders Diarrhoea | 1.0% | 0.6% |
| Psychiatric disorders Somnolence | 1.8% | 1.4% |
Respiratory thoracic and mediastinal disorders Rhinitis | 1.4% | 1.1% |
| General disorders and administration site conditions Fatigue | 1.0% | 0.3% |
Post-marketing experience
The adverse effects listed below are classified by system organ class and frequency according to the following convention: 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) or very rare (<1/10,000).
| MEDRA SOC | Adverse reaction | Frequency |
| Blood and lymphatic disorders | Thrombocytopenia | Very rare |
| Metabolism and | Increased appetite | Not known |
| nutrition disorders: | ||
| Psychiatric disorders: | Agitation | Uncommon: |
Aggression, confusion, depression, hallucinations, insomnia | Rare | |
| Tic | Very rare: | |
| Suicidal ideation, nightmare | Not known: | |
| Nervous system disorders: | Paraesthesia | Uncommon |
Convulsions, movement disorders | Rare | |
| Dysgeusia, syncope, tremor, dystonia, dyskinesia | Very rare | |
| Amnesia, memory impairment | Unknown | |
| Eye disorders | Accommodation disorder, blurred vision, oculogyric crisis | Very rare |
| Ear and labyrinth disorders | Vertigo | Not known |
| Cardiac disorders | Tachycardia | Rare |
| Gastro-intestinal disorders | Diarrhoea | Uncommon |
| Hepatobiliary disorders: | Hepatic function abnormal (increased transaminases, alkaline phosphates, γ-GT and bilirubin) | Rare |
| Hepatitis | Unknown | |
Skin and subcutaneous tissue disorders | Pruritus, rash | Uncommon |
| Urticaria | Rare | |
| Angioneurotic oedema, fixed drug eruption | Very rare | |
| Acute generalized exanthematous pustulosis (AGEP) | Unknown | |
| Musculoskeletal and connective tissue disorder | Arthralgia, myalgia | Not known |
| Renal and urinary disorders | Dysuria, enuresis | Very rare |
| Urinary retention (see | Not known |
| section Warnings and Precautions) | ||
| General disorders and administration site conditions | Asthenia, malaise | Uncommon: |
| Oedema | Rare | |
| Investigations | Weight increased | Rare |
| Immune system disorders | Hypersensitivity | Rare |
| Anaphylactic shock | Very rare |
Skin reactions occurring after discontinuation of cetirizine
After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported (see Section Warnings and Precautions).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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, 28 or 30 film-coated tablets.
6.6 Special precautions for disposal and other handling
Not applicable
7 MARKETING AUTHORISATION HOLDER
Haleon UK Trading Limited
The Heights
Weybridge
Surrey
KT13 0NY
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
13/08/2026