Allecet 10 mg Tablets

ALLECET is indicated for the treatment of allergic conditions, which respond to histamine H 1 - receptor antagonists:

• Respiratory: Allergic rhinitis (it effectively relieves sneezing, rhinorrhoea, nasal and ocular pruritis, and tearing), hay fever.
• Cutaneous: Allergic skin conditions associated with pruritus e.g. urticaria.

Posology

Adults, and children 12 years and older: 10 mg (one tablet) daily.

Children 6 to 12 years old: 10 mg (one tablet) once daily, or, alternatively, 5 mg (half a tablet) twice daily, depending on symptom severity.

Special populations

Elderly: Currently there is no data available to suggest that dose reduction is required in this population.

Renal impairment: The dosage should be reduced to half the usual recommended dose in patients where the creatinine clearance is less than 40 mL/min. Where the creatinine clearance is less than 30 mL/min, ALLECET is contraindicated (see section 4.3).

Hepatic impairment: In moderate to severe hepatic impairment, half the recommended daily dose should be used.

Paediatric population

ALLECET 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 is contraindicated in:

• Known hypersensitivity to cetirizine, or any of the other components in the formulation, to hydroxyzine, or any piperazine derivatives (see section 6.1).
• Severe renal impairment with creatinine clearance of less than 30 mL/min.
• ALLECET is contraindicated in lactating woman, as cetirizine has been shown to be excreted in breast milk (see section 4.6).
• Pregnancy, as safety has not been established (see section 4.6).
• In children younger than 2 years of age.

ALLECET lacks significant sedative effects, however a small number of patients may experience sedation. The simultaneous intake of alcohol or other central nervous system depressants may exacerbate this effect.

Although ALLECET is relatively free of anticholinergic activity, being a selective antagonist of peripheral H 1 -receptors, caution is advised in patients with urinary retention, prostatic hyperplasia, closed-angle glaucoma and pyloroduodenal obstruction. There have been reports of micturition difficulty, eye accommodation disorders and dry mouth (see section 4.8).

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).

Caution in epileptic patients and patients at risk of convulsions is recommended. ALLECET should be stopped several days (at least 3 days is recommended) before skin allergy tests as it may suppress positive skin test results. ALLECET is not indicated for the treatment of asthma.

Elderly patients have been shown to be more susceptible to many adverse effects of antihistamines, especially when inappropriately used for postural dizziness or vertigo (see section 4.8).

Pruritus and/or urticaria may occur when ALLECET 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.

There is no information to indicate that abuse or dependency occurs with cetirizine.

Paediatric population

The use of ALLECET in tablet form is not recommended in children younger than 6 years of age as the suitable dose adjustments to be made are not possible.

Lactose

ALLECET contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, total lactase deficiency, glucose-galactose malabsorption should not take ALLECET. Lactose may have an effect on the glycaemic control of patients with diabetes mellitus.

ALLECET may enhance the sedative effects of central nervous system depressants including anxiolytics, neuroleptics, opioid analgesics, hypnotics, barbiturates and alcohol. Other antimuscarinic medicines, such as atropine and tricyclic antidepressants and MAOIu2019s may enhance the antimuscarinic effects of ALLECET if used concomitantly.

Studies with diazepam, cimetidine, glipizide, pseudoephedrine ketoconazole, azithromycin and erythromycin have shown no evidence of pharmacokinetic interactions with ALLECET.

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

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

Pregnancy

Some antihistamines have been associated with foetal abnormalities when taken during pregnancy, but a number of large studies have failed to demonstrate any strong associations. Since the safety of cetirizine dihydrochloride in pregnancy has not been established, ALLECET is contraindicated in pregnancy (see section 4.3).

Breastfeeding

ALLECET is contraindicated in lactating women 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 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.

a. Summary of the safety profile

Clinical studies have shown that at recommended doses cetirizine has minor CNS undesirable effects such as somnolence, fatigue, dizziness and headache. Paradoxical CNS stimulation have been reported in some cases. There have been reports of isolated cases of micturition difficulty and eye accommodation disorders. Cases of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Cessation of the treatment with cetirizine dihydrochloride, mostly resolves this.

b. Tabulated summary of adverse reactions

MedDRA system organ class Frequency Side effects

Psychiatric disorders Frequent Somnolence.

Nervous system disorders Frequent Dizziness, headache.

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

Gastrointestinal disorders Frequent Dry mouth, nausea. Less frequent Abdominal pain.

General disorders and administration site conditions Frequent Fatigue.

Vascular disorders Less frequent Hypotension.

Ear and labyrinth Disorders Less frequent Tinnitus, vertigo.

Gastrointestinal disorders Less frequent Gastrointestinal discomfort, diarrhoea, constipation.

Skin and subcutaneous tissue disorders Less frequent Photosensitivity, hair loss, sweating.

Blood and lymphatic system disorders Less frequent Leucopoenia, haemolytic anaemia, agranulocytosis.

Nervous system Disorders Less frequent Drowsiness, fatigue.

Frequency unknown Anxiety, nervousness.

Hepatobiliary Disorders Less frequent Jaundice.

c. Description of selected adverse reactions

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

d. Paediatric population

Children 6 to 12 years of age

MedDRA system organ class Frequency Side effects

Psychiatric disorders Frequent Somnolence.

Respiratory, thoracic and mediastinal disorders Frequent Rhinitis.

Gastrointestinal disorders Frequent Diarrhoea.

General disorders and administration site conditions Frequent Fatigue.

Post marketing

MedDRA system organ class Frequency Side effects

Blood and lymphatic disorders Frequency unknown Thrombocytopenia.

Immune system disorders Frequency unknown Hypersensitivity, anaphylactic shock.

Psychiatric disorders Frequency unknown Agitation, aggression, confusion, depression, hallucination, insomnia, tics, suicidal ideation, nightmare.

Metabolism and nutrition disorders Frequency unknown Increased appetite.

Nervous system disorders Frequency unknown Paraesthesia, convulsions, dysgeusia, dyskinesia, dystonia, syncope, tremor.

Amnesia, memory impairment.

Eye disorders Frequency unknown Accommodation disorder, blurred vision, oculogyration.

Ear and labyrinth disorders Frequency unknown Vertigo.

Cardiac disorders Frequency unknown Tachycardia.

Gastrointestinal disorders Frequency unknown Diarrhoea.

Hepatobiliary disorders Frequency unknown Hepatic function abnormal (increased transaminases, alkaline phosphatase, u03b3GT and bilirubin), hepatitis.

Frequency unknown Hepatitis.

Skin and subcutaneous tissue disorders Frequency unknown Pruritus, rash, urticaria, angioneurotic oedema, fixed drug eruption, acute generalised exanthematous pustulosis.

Musculoskeletal and connective tissue disorders Frequency unknown Arthralgia, myalgia.

Renal and urinary disorders Frequency unknown Dysuria, enuresis, urinary retention.

General disorders and administration site conditions Frequency unknown Asthenia, malaise, oedema.

Investigations Frequency unknown Weight increase.

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 u201cAdverse drug reaction and quality problem reporting formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problem-reporting-form/ or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free).

Symptoms

Overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention have been reported as adverse effects after intake of at least 5 times the recommended daily dose.

Management

Treatment is symptomatic and supportive, should overdose occur. There is no known specific antidote to cetirizine. Haemodialysis doesnu2019t effectively remove cetirizine.