Allecet Syrup

ALLECET SYRUP is indicated for the treatment of allergic conditions responding to histamine H1-receptor antagonist:

• Respiratory: Allergic rhinitis, hay fever.
• Cutaneous: Allergic skin conditions associated with pruritus, e.g. urticaria.

Posology

Adults and children 12 years or older: 10 mg (10 mL) daily (two medicine measures) once daily.

Children 6 to 12 years: 10 mg (10 mL) daily, either as a single 10 mL dose (two medicine measures), or as two divided doses of 5 mL (one medicine measure) each in the morning and in the evening, respectively.

Children 2 to 6 years: 5 mg (one 5 mL medicine measure) daily, either as a single dose (5 mL), or as two divided doses of 2.5 mL (half a medicine measure) each in the morning and in the evening, respectively.

Special populations

Elderly: At present there are no data to suggest that the dose needs to be reduced in elderly patients with normal renal function.

Renal impairment: The dosage should be reduced to half the usual recommended dose in patients with renal impairment (creatinine clearance less than 40 mL/min) (see section 4.3).

Hepatic impairment: The dosage should be reduced to half the recommended daily dose in patients with moderate to severe hepatic impairment.

Paediatric population: ALLECET SYRUP is contraindicated in children under the age of two years, as safety and efficacy have not been demonstrated (see section 4.3).

Method of administration

Oral administration

ALLECET SYRUP is contraindicated in:

• History of hypersensitivity to cetirizine or to any of the excipients of ALLECET SYRUP, to hydroxyzine or to any piperazine derivatives.
• Patients with severe renal impairment at less than 30 mL/min creatinine clearance (see section 5.2).
• Since cetirizine is excreted in breast milk, ALLECET SYRUP is contraindicated in breastfeeding women (see section 4.6).
• ALLECET SYRUP is contraindicated during pregnancy as its safety has not been established (see section 4.6).
• In children younger than 2 years of age.

ALLECET SYRUP lacks significant sedative effects, however a small number of individuals may experience sedation.

Antihistamines, including ALLECET SYRUP, should be used with care in patients with urinary retention, prostatic hyperplasia, closed-angle glaucoma and pyloroduodenal obstruction due to their antimuscarinic properties.

As cetirizine may increase the risk of urinary retention, caution is advised in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia).

ALLECET SYRUP should be used with caution in patients with epilepsy or at risk of convulsions and severe cardiovascular disorders based on its side effects (see section 4.8).

ALLECET SYRUP is not indicated for the treatment of asthma.

Elderly patients have been shown to be more susceptible to many adverse effects of ALLECET SYRUP, including sedation, antimuscarinic effects and hypotension (see section 4.8).

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 (see section 4.5).

Excessive alcohol consumption should be avoided when taking ALLECET SYRUP.

ALLECET SYRUP should be stopped several days (at least 3 days is recommended) before skin allergy tests as it may suppress positive skin test results.

Pruritus and/or urticaria may occur when ALLECET SYRUP is stopped, even if those symptoms were not present before treatment initiation. The symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

Special warnings about the excipients

ALLECET SYRUP contains sorbitol. Patients with the rare hereditary condition of sorbitol intolerance should not take ALLECET SYRUP.

The preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate included in ALLECET SYRUP may cause allergic reactions (possibly delayed).

ALLECET SYRUP may enhance the sedative effects of central nervous system depressants including anxiolytics, neuroleptics, opioid analgesics, hypnotics, barbiturates and alcohol.

ALLECET SYRUP has an additive antimuscarinic action when combined with other antimuscarinic medicines, such as atropine and tricyclic antidepressants.

MAOIs may enhance the antimuscarinic effects of ALLECET SYRUP.

It has been suggested that antihistamines, such as ALLECET SYRUP could possibly mask the warning signs of otic damage caused by ototoxic medicines such as aminoglycoside antibiotics.

There is no reduction in the extent of absorption of ALLECET SYRUP when it is taken with food although a decrease in the rate of absorption has been reported.

Pregnancy: Since the safety of cetirizine dihydrochloride in pregnancy has not been established ALLECET SYRUP is contraindicated in pregnancy (see section 4.3).

Breastfeeding: ALLECET SYRUP is contraindicated in women breastfeeding their infants, since cetirizine is excreted in breast milk (see section 4.3).

Fertility: Limited data is available on human fertility, but no safety concern has been identified. Animal data show no safety concern for human reproduction.

ALLECET SYRUP may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

b. Tabulated summary of adverse reactions

MedDRA system organ class Frequency Side effects

Blood and lymphatic system disorders Less frequent Haemolytic anaemia, agranulocytosis, leucopenia, thrombocytopenia.

Psychiatric disorders Frequent Somnolence (may vary from slight drowsiness to deep sleep). Frequency unknown Agitation.

Nervous system disorders Frequent Dizziness, headache. Frequency unknown In-coordination, nervousness, paraesthesias.

Ear and labyrinth disorders Frequency unknown Tinnitus.

Vascular disorders Frequency unknown Hypotension.

Respiratory, thoracic and mediastinal disorders Frequent Pharyngitis, rhinitis. Less frequent Thickening of mucous, bronchospasm.

Gastrointestinal disorders Frequent Dry mouth, nausea. Less frequent Epigastric pain. Frequency unknown Constipation, vomiting, increased appetite.

General disorders and administration site conditions Frequent Lassitude.

Skin and subcutaneous tissue disorders Less frequent Jaundice, hair loss, sweating, photosensitivity. Frequency unknown Skin reactions (rash), angioedema (with cross sensitivity to related medicines).

c. Description of selected adverse reactions

Skin reactions occurring after discontinuation of ALLECET SYRUP: After discontinuation of ALLECET syrup, pruritis (intense itching) and/or urticaria have been reported (see section 4.4).

d. Paediatric population

Children below 12 years of age MedDRA system organ class Frequency Side effects

Gastro - intestinal disorders Frequent Diarrhoea

Psychiatric disorders Frequent Somnolence. Less frequent Hallucinations, nightmares. Frequency unknown Insomnia, euphoria, nervousness, irritability.

Nervous system disorders Frequency unknown Tremors, convulsions.

Respiratory, thoracic and mediastinal disorders Frequent Rhinitis.

General disorders and administration site conditions Frequent Fatigue.

Post-marketing data The following post-marketing adverse effects, have been reported: MedDRA system organ class Frequency Side effects

Blood and lymphatic disorders Less frequent Thrombocytopenia.

Immune system disorders Less frequent Hypersensitivity, anaphylactic shock, angioedema.

Metabolism and nutrition disorders Frequency unknown Increased appetite.

Psychiatric disorders Less frequent Agitation, aggression, confusion, depression, hallucination, insomnia, tics. Frequency unknown Suicidal ideation, nightmare.

Nervous system disorders Less frequent Paraesthesia, convulsions, dysgeusia, dyskinesia, dystonia, syncope, tremor. Frequency unknown Amnesia, memory impairment.

Eye disorders Less frequent Accommodation disorder, blurred vision, oculogyration.

Ear and labyrinth disorders Frequency unknown Vertigo.

Cardiac disorders Less frequent Tachycardia.

Gastrointestinal disorders Less frequent Diarrhoea.

Hepatobiliary disorders Less frequent Abnormal hepatic function (increased transaminases, alkaline phosphatase, u03b3-GT and bilirubin). Frequency unknown Hepatitis.

Skin and subcutaneous tissue disorders Less frequent Pruritus, rash, urticaria, fixed drug eruption. Frequency unknown Acute generalized exanthematous pustulosis.

Musculoskeletal and connective tissue disorders Frequency unknown Myalgia, arthralgia.

Renal and urinary disorders Less frequent Dysuria, enuresis. Frequency unknown Urinary retention.

General disorders and administration site conditions Less frequent Asthenia, malaise, oedema.

Investigations Less frequent Weight increased.

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 asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free).

Symptoms

Symptoms observed after an overdose of cetirizine, as in ALLECET SYRUP, 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. Overdosage with ALLECET SYRUP may be fatal, especially in infants and children. In infants and children, central nervous system stimulation usually predominates over central nervous system depression, leading to tremors, excitement, ataxia, psychoses, hallucinations and convulsions. Hyperpyrexia may also occur. This may be followed by deepening coma and cardiorespiratory collapse. Alternatively in adults, central nervous system depression is more common presenting with drowsiness, convulsions and coma, which may progress to respiratory failure or possible cardiovascular collapse.

Management

Treatment is symptomatic and supportive. ALLECET SYRUP is not effectively removed by dialysis.