Zyncet 10 mg FC tablets

ZYNCET is indicated for symptomatic relief of allergic conditions such as allergic rhinitis, hay fever and allergic skin conditions associated with pruritus, such as urticaria.

Tablets:
Adults or children 12 years of age or older: one 10 mg tablet once daily.
Children 6 to 12 years old: one 10 mg tablet once daily or 5 mg (half a tablet) twice daily.
Special populations:
Elderly: No dose adjustment is necessary in healthy elderly patients with normal renal function.
Dosage in renal impairment: In patients with renal impairment, where the creatinine clearance is less than 40 mL/min, the recommended daily dose of cetirizine should be halved.
Dosage in hepatic impairment: In moderate to severe hepatic impairment half the recommended daily dose should be used.
Method of administration: Oral administration.
Missed dose: Doctors should advice patients who forget to take ZYNCET to take a dose as soon as possible and then to continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

• Hypersensitivity to cetirizine hydrochloride, hydroxyzine, any piperazine derivatives or any of the other ingredients in ZYNCET (see section 6.1).
• Patients with severe renal impairment at less than 30 mL/min creatinine clearance.
• Asthma, as it may cause airway obstruction in patients who have previously experienced adverse reactions to antihistamines.
• Lactating women, since the active ingredient is excreted in breastmilk.
• Pregnancy, as safety has not been established.
• Children under the age of two years, as safety and efficacy have not been demonstrated.

ZYNCET lacks significant sedative effects. Patients should be warned however that a small number of individuals may experience sedation. 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. Caution is recommended in epileptic patients and patients at risk of convulsions. Response to allergy skin tests is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Pruritus and/or urticaria may occur when cetirizine, as in ZYNCET, 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. Porphyria: Use with caution. ZYNCET contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take ZYNCET. Paediatric Population: The use of ZYNCET is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric formulation of cetirizine.

Concomitant use of alcohol and other sedating medicines should be avoided. 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 (0,5 g/L blood levels) (see section 4.4). Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in medicine-interaction studies performed, notably with pseudoephedrine or theophylline (400 mg/day). There is no evidence of an interaction between cetirizine and cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizide, and pseudoephedrine. The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

Safety in pregnancy and lactation has not been established (see section 4.3).
Fertility: Limited data is available on human fertility, but no safety concern has been identified.

ZYNCET lacks significant sedative effects. However, patients should be warned that a small number of individuals may experience sedation, drowsiness or impaired concentration. The patientu2019s ability to perform hazardous activities requiring mental alertness or physical coordination such as driving or operating machinery may be impaired. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be aggravated by simultaneous intake of alcohol or other central nervous system depressants (see section 4.5).

System organ class Frequency Side effects
Blood and lymphatic system disorders Less frequent thrombocytopenia, leucopoenia, haemolytic anaemia, agranulocytosis
Immune system disorders Less frequent angioedema, hypersensitivty reactions, anaphylaxis
Metabolism and nutrition disorders Frequency unknown increased appetite
Psychiatric disorders Less frequent drowsiness, depression, confusion, agitation, aggression, hallucinations, insomnia
Frequency unknown suicidal ideation, nightmares
Nervous system disorders Less frequent tics
Frequency unknown headaches, dizziness, anxiety, nervousness, paraesthesia, convulsions, movement disorders, dysgeusia, syncope, tremor, dystonia, dyskinesia, amnesia, memory impairment
Eye disorders Less frequent accommodation disorder, blurred vision, oculogyration
Ear and labyrinth disorders Less frequent tinnitus, vertigo
Cardiac disorders Less frequent palpitations, dysrhythmias, tachycardia
Vascular disorders Less frequent hypotension
Respiratory, thoracic and mediastinal disorders Frequent pharyngitis, rhinitis
Less frequent thickening of mucous, bronchospasm
Gastrointestinal disorders Less frequent nausea, gastrointestinal discomfort, dry mouth, constipation, diarrhoea
Hepatobiliary disorders Less frequent abnormal hepatic function (increased transaminases, alkaline phosphatase, y-GT and bilirubin), jaundice
Frequency unknown hepatitis
Skin and subcutaneous tissue disorders Less frequent pruritus, rash, urticaria, fixed drug eruption, photosensitivity, hair loss, sweating
Frequency unknown acute generalised exanthematous pustulosis (AGEP)
Musculoskeletal, connective tissue and bone disorders Less frequent myalgia
Frequency unknown arthralgia
Renal and urinary disorders Less frequent dysuria, enuresis, urinary retention
General disorders and administration site conditions Less frequent fatigue, malaise, asthenia, oedema
Investigations Less frequent increased weight
Description of selected adverse reactions: Skin reactions occurring after discontinuation of ZYNCET: After discontinuation of ZYNCET, pruritus (intense itching) and/or urticaria have been reported (see section 4.4).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Symptoms: Symptoms observed after an overdose of cetirizine, as in ZYNCET, are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Drowsiness is an expected symptom of overdosage. Overdosage may produce agitation, confusion, diarrhoea, dizziness, headache, malaise, mydriasis, restlessness, sedation, somnolence, stupor, pruritus, rash, urinary retention, fatigue, tremor, and tachycardia.
Management: There is no specific antidote. Cetirizine is not effectively removed by dialysis. FURTHER TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.