BENADRYL ALLERGY CHILDRENS

5 ml oral solution twice daily (a half spoon twice daily)). Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution bid (a full spoon twice daily)). Adults and adolescents over 12 years of age: 10 mg once daily (10 ml oral solution (2 full spoons)).

The solution can be swallowed as such. 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.

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.

85 for women 72 x serum creatinine (mg / dl) 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 - < 10 Contra- indicated Patients undergoing dialysis 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.

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.

8 % 1. 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. Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on post-marketing experience.

Frequencies are defined as follows:

Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).

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, hallucination, insomnia Very rare: tic Not known: suicidal ideation, nightmares Nervous system disorders: Uncommon: paraesthesia Rare: convulsions, movements disorders Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia Not known: amnesia, memory impairment Eye disorders: Very rare: accommodation disorder, blurred vision, eye swelling, oculogyration Not known: eye pain Ear and labyrinth disorders: Not known: vertigo Cardiac disorders: Rare: tachycardia Respiratory, thoracic and mediastinal disorders: Very rare: cough Gastro-intestinal disorders: Uncommon: diarrhoea Very rare: nausea Hepatobiliary disorders: Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ- GT and bilirubin) Not known: Hepatitisa a: Including Drug-induced liver injury (DILI) and other types of non-infectious hepatitis.

Skin and subcutaneous tissue disorders:

Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic oedema, fixed drug eruption Not known: acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders: Not known: arthralgia Renal and urinary disorders: Very rare: dysuria, enuresis Not known: urinary retention Reproductive system and breast disorders: Not known: erectile dysfunction General disorders and administration site conditions: Uncommon: asthenia, malaise Rare: oedema Very rare: feeling abnormal Not known: pruritus upon withdrawal 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. 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 liver or kidney disease should consult with a physician before use. The physician should determine if a different dose is needed. , 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 2 years. 9g sorbitol in each 5ml which is equivalent to 580mg/ml. Sorbitol is a source of fructose.

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. This medicine contains less than 1mmol sodium (23mg) per 5ml, that is to say essentially ‘sodium-free’.

54mg/ml. 865 mg/ml). Allergy skin tests are inhibited by antihistamines and a wash-out period of 3 days is recommended before performing them. If symptoms persist or worsen, stop use and consult a physician.

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