BENADRYL ONE A DAY RELIEF, BENADRYL ALLERGY ONE A DAY

Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet). The tablets need to be swallowed with a glass of liquid. 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 impairement. 2), in cases no alternative treatment can be used, the dosing intervals must be individualized 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: Dosing adjustments for adult patients with impaired renal function Group Creatinine clearance (ml/min) Dosage and frequency Normal ≥80 10 mg once daily Mild 50 – 79 10 mg once daily Moderate 30 – 49 5 mg once daily Severe < 30 5 mg once every 2 days End-stage renal disease - Patients undergoing dialysis < 10 Contra-indicated In pediatric 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, his age and his 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).

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. Clinical trials Double blind controlled clinical 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.

0 % or greater: Adverse event (WHO-ART) Cetirizine 10 mg (n = 3260) Placebo (n = 3061) Body as a whole – general disorders Fatigue 1,63 % 0,95 % Central and peripheral nervous system disorders Dizziness 1,10 % 0,98 % Headache 7,42 % 8,07 % Gastro-intestinal system disorders Abdominal pain Dry mouth Nausea 0,98 % 2,09 % 1,07 % 1,08 % 0,82 % 1,14 % Psychiatric disorders Somnolence 9,63 % 5,00 % Respiratory system 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 trials are: Adverse drug reactions (WHO-ART) Cetirizin 10 mg (n = 1656) Placebo (n = 1294) Gastro-intestinal system disorders Diarrhoea 1,0 % 0,6 % Psychiatric disorders Somnolence 1,8 % 1,4 % Respiratory system disorders Rhinitis 1,4 % 1,1 % Body as a whole – general disorders Fatigue 1,0 % 0,3 % Post-marketing experience In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have been reported in postmarketing experience.

Undesirable effects are described according to MEDdra System Order Class and by estimated frequency, based on post-marketing experience.

Frequencies are defined as follows:

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); not known (cannot be estimated from the available data). System organ class Common Uncommon Rare Very rare Not Known Blood and lymphatic disorders: Thrombocytopenia Immune system disorders: Hypersensitivity Anaphylactic shock System organ class Common Uncommon Rare Very rare Not Known Metabolism and nutrition disorders: Increased appetite Psychiatric disorders: Agitation Aggression, confusion, depression, hallucination, insomnia Tics Suicidal ideation Nervous system disorders: Paraesthesia Convulsions Dysgeusia, dystonia, dyskinesia, syncope, tremor Amnesia, memory impairment Eye disorders: Accommodation disorder, vision blurred, oculogyration Eye pain Ear and labyrinth disorders: Vertigo Cardiac disorders: Tachycardia Gastro-intestinal disorders: Diarrhoea Hepatobiliary disorders: Hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin) Hepatitis Skin and subcutaneous tissue disorders: Pruritus, rash Urticaria Angioneurotic oedema, fixed drug eruption Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders: Arthralgia Renal and urinary disorders: Dysuria, enuresis Urinary retention Reproductive system and breast disorders: Erectile dysfunction General disorders and administration site conditions: Asthenia, malaise Oedema Pruritus on withdrawal Investigations: 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5 g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly. Patients with kidney disease are instructed to consult a physician before use. 2). g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

0 )/(72 )()(140 −CLcr = Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported very rarely with cetirizine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.

Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued and appropriate measures taken if needed. Caution in epileptic patients and patients at risk of convulsions is recommended.

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Paediatric Population The use of the film-coated tablet formulation is not recommended in children aged less than 12 years.

1. Patients with severe renal impairment at less than 10 ml/min creatinine clearance.