Allerway Meltaway 5mg Tablets

ALLERWAY MELTAWAY 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.

Special populations

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

Adults with renal impairment: The dosing interval must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. The CLcr (mL/min) may be estimated from serum creatinine (u03bcmol/l) determination using the following formula:

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

Dosing adjustments for patients with impaired renal function:

u2013 Patients undergoing dialysis

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 Patients with renal impairment above).

Method of administration

ALLERWAY MELTAWAY 5 tablet should be placed on the tongue and should be sucked, not chewed, until complete disintegration. The resulting suspension has to be swallowed with saliva. ALLERWAY MELTAWAY 5 can be taken with or without water and may be taken with or without food.

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

ALLERWAY MELTAWAY 5 is contraindicated:

• in hypersensitivity to levocetirizine, to any piperazine derivative or to any of the excipients of ALLERWAY MELTAWAY 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)
• In children under the age of 6 years

Alcohol: Precaution is recommended with intake of alcohol (see section 4.5). ALLERWAY MELTAWAY 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 MELTAWAY 5 may increase the risk of urinary retention.

Epilepsy: Caution should be taken in patients with epilepsy and patients at risk of convulsion as ALLERWAY MELTAWAY 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. Pruritus may occur when ALLERWAY MELTAWAY 5 is stopped even if those symptoms were not present before treatment initiation. 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: ALLERWAY MELTAWAY 5 contains lactose. Patients with the rare hereditary conditions of galactose intolerance total lactase deficiency or glucose-galactose malabsorption should not take ALLERWAY MELTAWAY 5. Lactose may have an effect on the glycaemic control of patients with diabetes mellitus.

Sorbitol: ALLERWAY MELTAWAY 5 contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take ALLERWAY MELTAWAY 5. This medicine contains 5 mg aspartame in each orodispersible tablet. which is equivalent to 5 mg weight. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

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

Theophylline: A small 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 slightly altered (-11 %) further to concomitant cetirizine administration.

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

Alcohol: In sensitive patients, the simultaneous administration of ALLERWAY MELTAWAY 5 and alcohol or other central nervous system (CNS) depressants may cause additional reductions in alertness and impairment of performance. It is advisable to avoid excessive alcohol consumption.

Pregnancy: ALLERWAY MELTAWAY 5 is contraindicated in pregnancy, as safety has not been demonstrated.

Lactation: ALLERWAY MELTAWAY 5 is contraindicated in women who are breastfeeding their babies, since levocetirizine dihydrochloride is excreted in breast milk.

Fertility: For levocetirizine no clinical data are available.

Some patients could experience somnolence, fatigue and asthenia during therapy with ALLERWAY MELTAWAY 5. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to ALLERWAY MELTAWAY 5 into account.

The following side effects have been reported:

Immune system disorders

Frequency not known: Hypersensitivity including anaphylaxis, angioedema

Metabolism and nutrition disorders

Frequency not known: Increased appetite

Psychiatric disorders

Frequent: Sleep disorders

Frequency not known: Aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare

Nervous system disorders

Frequent: Headache, somnolence

Frequency not known: Convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia

Eye disorders

Frequency not known: Visual disturbances, blurred vision, oculogyration.

Ear and labyrinth disorders

Frequency not known: Vertigo

Cardiac disorders

Frequency not known: Palpitations, tachycardia

Respiratory, thoracic and mediastinal disorders

Frequency not known: Dyspnoea

Gastrointestinal disorders

Frequent: Dry mouth, diarrhoea, constipation

Less frequent: Nausea and gastro-intestinal discomfort, abdominal pain, vomiting

Hepato-biliary disorders

Frequency not known: Hepatitis

Skin and subcutaneous tissue disorders

Frequency not known: In some individuals, hypersensitivity reactions including skin reactions, urticaria and pruritus may develop. Angioedema, fixed drug eruption, rash

Musculoskeletal, connective tissue and bone disorders

Frequency not known: Myalgia, 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

Investigations

Frequency not known: Increased weight, abnormal liver function tests

Description of selected adverse reactions

After levocetirizine discontinuation, pruritus has been reported.

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 and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to levocetirizine. Should overdose occur, symptomatic and supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.