Allerway 5mg Tablets

ALLERWAY 5 is indicated for the relief of symptoms associated with the following allergic conditions:

• seasonal allergic rhinitis
• perennial allergic rhinitis
• chronic idiopathic urticaria.

Posology

Adults and adolescents 12 years of age and older: The daily recommended dose is one 5 mg tablet.

Children aged 6 u2013 12 years: The daily recommended dose is one 5 mg tablet.

Children 2 u2013 6 years: ALLERWAY 5 film-coated tablets should not be used in children aged 2 u2013 6 years, as no adjusted dosage is possible with the film-coated tablet formulation (see section 4.4).

Children aged less than 2 years: ALLERWAY 5 film-coated tablets is contraindicated in children aged less than 2 years (see sections 4.3 and 4.4).

Special populations

Elderly: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Adults with renal impairment below).

Adults with renal impairment: The dosing intervals must be individualised according to renal function. Use the table below to adjust the dosage intervals as indicated. The patient's creatinine clearance (CLcr) can be estimated from the serum creatinine determination using the modified formula of Cockroft and Gault:

(140 u2013 age in years) x weight in kg
CLcr (ml/min) = __________________________ (x 0,85 for women)
serum creatinine (u03bcmol/l)

Dosage in patients with renal impairment:

Renal status
Creatinine clearance (CLcr)
Dose
Normal
u2265 80 ml/min
5 mg once daily
Mild impairment
50 - 79 ml/min
5 mg once daily
Moderate impairment
30 - 49 ml/min
5 mg once every second day
Severe impairment
< 30 ml/min
5 mg once every third day
End-stage renal disease/ receiving dialysis
< 10 ml/min
Contraindicated

In paediatric 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 and his/her body weight. There are no specific data for children with renal impairment.

Patients with hepatic impairment: No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Adults with renal impairment above).

Duration of use: Intermittent allergic rhinitis (symptoms 4 days/week or for more than 4 weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens.

Missed dose: Patients who forget to take ALLERWAY 5 should be advised to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

Method of administration

ALLERWAY 5 must be taken orally, swallowed with liquid. It may be taken with or without food. It is recommended to take the daily dose in one single intake.

ALLERWAY 5 is contraindicated:

• in hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine, to any piperazine derivative or to any of the excipients of ALLERWAY 5 listed in section 6.1
• in pregnancy and lactation (see section 4.6)
• in patients with end-stage renal disease (creatinine clearance < 10 ml/min) and in patients undergoing dialysis
• in infants and children under 2 years as safety and efficacy have not been demonstrated (see sections 4.2 and 4.4).

Alcohol: Precaution is recommended with concurrent intake of alcohol (see section 4.5). ALLERWAY 5 lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.5).

Risk of urinary retention: Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as ALLERWAY 5 may increase the risk of urinary retention.

Risk of seizure aggravation: Caution should be taken in patients with epilepsy and patients at risk of convulsion as ALLERWAY 5 may cause seizure aggravation.

Allergy skin tests: Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Withdrawal syndrome: Pruritus may occur when ALLERWAY 5 is stopped even if those symptoms were not present before treatment initiation (see section 4.8). The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

Lactose intolerance: ALLERWAY 5 tablets contain lactose. Patients who are lactose intolerant or have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take ALLERWAY 5.

Paediatric population: Children aged less than 6 years: ALLERWAY 5 film-coated tablets are not indicated in patients under 6 years of age as this formulation does not allow for appropriate dose adaptation (see sections 4.2 and 4.3).

No interaction studies have been performed with ALLERWAY 5 (including no studies with CYP3A4 inducers). Studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with ketoconazole, erythromycin, azithromycin, cimetidine, antipyrine, pseudoephedrine, glipizide and diazepam).

Theophylline: A decrease in the clearance of cetirizine (16 %) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.

Ritonavir: In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40 % while the disposition of ritonavir was decreased (-11 %).

Food: The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased.

Alcohol: In sensitive patients, the concurrent administration of ALLERWAY 5 and alcohol or other central nervous system (CNS) depressants may cause additional reductions in alertness and impairment of performance.

Pregnancy: ALLERWAY 5 is contra-indicated in pregnancy, as safety has not been demonstrated.

Breast-feeding: ALLERWAY 5 is contra-indicated in lactating women since levocetirizine dihydrochloride is excreted in breast milk.

Fertility: No clinical data are available.

Some patients could experience somnolence, fatigue and asthenia during therapy with ALLERWAY 5. Patients experiencing these should avoid driving, engaging in potentially hazardous activities or use of machines.

a) Tabulated summary of adverse reactions

System Organ Class
Frequency
Side effects
Immune system disorders
Frequency not known
Hypersensitivity including anaphylaxis, angioedema
Metabolism and nutrition disorders
Frequency not known
Increased weight, increased appetite
Psychiatric disorders
Frequent
Sleep disorders
Less frequent
Aggression, agitation, insomnia, suicidal ideation
Frequency not known
Hallucination, depression, nightmares
Neurological disorders
Frequent
Headache, somnolence, paraesthesia, dizziness, syncope, tremor, dysgeusia
Less frequent
Convulsions
Eye disorders
Less frequent
Visual disturbances
Frequency not known
Blurred vision, oculogyration
Ear and labyrinth disorders:
Frequency not known
Vertigo
Cardiac disorders
Less frequent
Palpitations
Frequency not known
Tachycardia
Respiratory, thoracic and mediastinal disorders
Frequent
Pharyngitis, nasopharyngitis, dyspnoea
Gastrointestinal disorders
Frequent
Dry mouth, constipation
Less frequent
Nausea, vomiting, abdominal pain, diarrhoea and gastrointestinal discomfort
Hepato-biliary disorders
Less frequent
Hepatitis, abnormal liver function tests
Skin and subcutaneous tissue disorders
Less frequent
Hypersensitivity reactions including skin reactions, rashes, fixed drug eruptions, urticaria, pruritus
Frequency not known
Angioedema
Musculoskeletal and connective tissue disorders
Less frequent
Myalgia
Frequency not known
Arthralgia
Renal and urinary disorders
Frequency not known
Dysuria, urinary retention
General disorders and administration site conditions
Frequent
Fatigue
Less frequent
Asthenia, malaise
Frequency not known
Oedema

b. Description of selected adverse reactions

Skin reactions occurring after discontinuation of ALLERWAY 5: After discontinuation of ALLERWAY 5, pruritus has 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 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/

Symptoms of overdose may include drowsiness in adults. In children, agitation and restlessness may occur, followed by drowsiness. There is no known specific antidote to levocetirizine. Should overdose occur, symptomatic and supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.