Trinicet 10 10,0 mg CAPSULE

Allergic processes responding to a histamine H 1 -receptor antagonist. Respiratory: Allergic rhinitis, hay fever. Cutaneous: Allergic skin conditions associated with pruritus e.g. urticaria.

Posology
Adults or children 12 years of age or older: One 10 mg soft capsule daily.
Paediatric population
Children 6 to 12 years old: One 10 mg soft capsule daily.
The use of TRINICET is not recommended in children less than 6 years since this formulation does not allow for appropriate dose adaptation.

• Hypersensitivity to cetirizine, hydroxyzine, any piperazine or to any of the excipients of TRINICET (see section 6.1).
• Patients with severe renal impairment at less than 30 ml/min creatinine clearance.
• Pregnancy and lactation since safety has not been established during pregnancy and cetirizine is excreted in breastmilk. (see section 4.6).
• In children under 2 years of age.
• The use of TRINICET is not recommended in children less than 6 years since this formulation does not allow for appropriate dose adaptation.

Avoid alcohol consumption. Caution in epileptic patients and patients at risk of convulsions is recommended.
General
Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with cetirizine-containing products. This acute pustular eruption may exhibit an early or delayed onset with numerous small, mostly non-follicular pustules arising on a widespread edematous erythema mainly localised on the skin folds, trunk, and upper extremities, which may be accompanied by fever. Patients should be carefully monitored. If symptoms persist or worsen, or if new symptoms occur, the patient should discontinue use and consult a doctor.
Studies have shown no effect of cetirizine hydrochloride on cognitive function, motor performance or sleep latency in healthy volunteers. However, in clinical trials the appearance of some CNS effects, particularly somnolence, have been observed. If drowsiness occurs, patients should be advised not to drive or operate machinery and to avoid concurrent use of TRINICET with sedating substances because additional reductions in alertness and additional impairment of CNS performance may occur (see section 4.8).
Caution should be taken in patients with predisposition factors of urinary retention (e.g., spinal cord lesion, prostatic hyperplasia) as cetirizine as in TRINICET may increase the risk of urinary retention.
Pruritus and/or urticaria may occur when cetirizine as in TRINICET is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
Occasional instances of liver function test (transaminase) elevations have occurred during TRINICET therapy. This incidence was 1,6 % in the short-term trials and 4,4 % in the 6-month trials. These liver enzyme elevations, mainly ALT, were generally reversible. There was no evidence of jaundice or hepatitis, and the clinical significance is presently unknown. Consequently, TRINICET should be used with caution in patients with pre-existing liver disease.
Special populations:
Pregnant Women: TRINICET should not be used during pregnancy (see section 4.6).
Use in asthmatics: TRINICET has been safely administered to patients with mild to moderate asthma. TRINICET did not cause exacerbation of asthma symptoms.
Paediatric population: TRINICET should not be administered to children below 2 years of age (see section 4.2).
Elderly: TRINICET was well tolerated by patients aged 65 and over. Clearance of TRINICET is reduced in proportion to creatinine clearance.

To date there are no known interactions between cetirizine with other medicines. Studies with diazepam, glipizide, pseudoephedrine, antipyrine, ketoconazole, azithromycin, erythromycin and cimetidine have revealed no evidence of pharmacokinetic interactions. No clinically significant interactions have been found with theophylline and cimetidine. Epidemiologic data suggests that there also would not be interaction with other macrolide antibiotics or imidazole antifungals. In clinical trials, cetirizine hydrochloride has been safely administered with beta-agonists, non-steroidal anti-inflammatory drugs, oral contraceptives, narcotic analgesics, corticosteroids, H 2 -antagonists, cephalosporins, penicillins, thyroid hormones and thiazide diuretics. Allergy skin tests are inhibited by antihistamines such as TRINICET and a wash-out period of 3 days is recommended before performing them.

TRINICET is contra-indicated in pregnancy and lactation (see section 4.3).

Patients should be warned that some individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressant. If drowsiness occurs, patients should be advised not to drive or operate machinery and to avoid concurrent use of TRINICET with sedating substances because additional reductions in alertness and additional impairment of CNS performance may occur (see section 4.4).

a. Summary of the safety profile
TRINICET has potential adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulations has been reported. TRINICET is a selective antagonist of peripheral H 3 ,-receptors and is relatively free of anticholinergic activity. 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.
b. Tabulated summary of adverse reactions
MedDRA system organ class Frequency Adverse reactions Blood and lymphatic disorders Frequency unknown Thrombocytopenia Immune system disorders Frequency unknown Hypersensitivity, anaphylactic shock Metabolism and nutrition disorders Frequency unknown Increased appetite Psychiatric disorders Frequent Somnolence Frequency unknown Agitation, aggression, confusion, depression, hallucination, insomnia, tics, suicidal ideation, nightmare Nervous system disorders Frequent Headache, dizziness Frequency unknown Paraesthesia, convulsions, dysgeusia, dyskinesia, dystonia, syncope, tremor, amnesia, memory impairment Eye disorders Frequency unknown Accommodation disorder, blurred vision, oculogyration Ear and labyrinth disorder Frequency Vertigo MedDRA system organ class Frequency Adverse reactions unknown Cardiac disorders Frequency unknown Tachycardia Respiratory, thoracic and mediastinal disorders Frequent Pharyngitis, rhinitis Gastrointestinal disorders Frequent Dry mouth, nausea, diarrhoea Less frequent Abdominal pain Hepatobiliary disorders Frequency unknown Hepatic function abnormal (increased transaminases, alkaline phosphatase, y-GT and bilirubin) Skin and subcutaneous tissue disorders Frequency unknown Pruritus, rash, urticaria, angioneurotic oedema, fixed drug eruption Musculoskeletal and connective tissue disorders Frequency unknown Arthralgia Renal and urinary disorders Frequency unknown Dysuria, enuresis, urinary retention General disorders and administration site conditions Frequent Fatigue Frequency unknown Asthenia, malaise, oedema Investigations Frequency unknown Weight Increased.
c. Description of selected adverse reactions
After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.

Symptoms: Symptoms observed after an overdose of TRINICET are mainly associated with CNS effects or with effects that suggest an anticholinergic effect. Adverse events reported after an intake of at least 5 times the recommended daily dose is: 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 TRINICET. Should overdose occur, symptomatic or supportive treatment is recommended. Cetirizine is not effectively removed by dialysis.