Allesoothe 10mg Tablets

ALLESOOTHE is indicated for the management of allergic processes which respond to histamine H1 receptor antagonists, including:

• hay fever,
• allergic rhinitis and
• allergic skin conditions that are associated with pruritus, e.g. urticaria.

Posology

Adults and children 12 years of age or older: Take 1 (one) tablet daily.

Children 6 to 12 years of age: Take 1 (one) tablet 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. In children with renal impairment, the dosing adjustment is to be done on an individual basis taking into account the renal clearance of the patient, their age and body weight (see section 5.2).

Dosage in hepatic impairment: Half of the recommended daily dose should be used in patients with moderate to severe hepatic impairment. For patients with renal insufficiency and moderate to severe hepatic impairment, an alternative dosage form is to be utilised, as ALLESOOTHE cannot be halved.

Method of administration: Oral administration.

• Hypersensitivity to cetirizine hydrochloride, hydroxyzine, any piperazine derivatives or any of the other ingredients in ALLESOOTHE (see section 6.1).
• Patients with severe renal impairment where the creatinine clearance is less than 30 mL/min.
• Asthma, as it may cause airway obstruction in patients who have previously experienced adverse reactions to antihistamines.
• ALLESOOTHE is contraindicated in lactating women as the active ingredient is excreted in breast milk (see section 4.6).
• ALLESOOTHE is contraindicated in pregnancy; safety has not been established (see section 4.6).

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as ALLESOOTHE may increase the risk of urinary retention.

ALLESOOTHE lacks significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation.

The daily dose should be reduced in patients with renal insufficiency and patients with moderate to severe hepatic impairment (see section 4.2).

Life-threatening hepatitis may develop in long-term use of ALLESOOTHE. For patients with renal insufficiency and moderate to severe hepatic impairment, an alternative dosage form is to be utilised as this film coated tablet cannot be halved.

It is recommended to take caution in epileptic patients and patients at risk of convulsions.

Allergy skin tests are inhibited by antihistamines and a wash-out period (of three days) is required before performing the tests.

At therapeutic doses, there are no clinically significant interactions 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).

Elderly patients are more susceptible to many of the adverse effects of ALLESOOTHE.

Pruritus and/or urticaria may occur when ALLESOOTHE 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.

Excipient warning: ALLESOOTHE contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take ALLESOOTHE.

Raised international normalised ratio (INR) and severe epistaxis have been reported in a patient after the addition of ALLESOOTHE to long-term anticoagulant therapy.

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with ALLESOOTHE.

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.

Alcohol and other Central Nervous System (CNS) depressants: In sensitive patients, the concurrent use of alcohol or other central nervous system (CNS) depressants may cause additional reductions in alertness and impairment of performance, although cetirizine, as in ALLESOOTHE, does not potentiate the effect of alcohol (see section 4.4).

Alcohol, consumed in excess, should be avoided while taking ALLESOOTHE.

Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing (see section 4.4).

Pregnancy

ALLESOOTHE is contraindicated in pregnancy; safety has not been established (see section 4.3).

Breastfeeding

ALLESOOTHE is contraindicated in lactating women as the active ingredient 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.

ALLESOOTHE does not produce significant sedative effects. However, patients should be warned that a small number of individuals may experience sedation. It is advisable to determine an individualu2019s response before driving a vehicle or using machines. Sedation may be enhanced by the simultaneous intake of alcohol or other central nervous system depressants, which may cause additional decrease in alertness and impaired performance in patients who are sensitive to the sedative effect of ALLESOOTHE.

Although ALLESOOTHE is relatively free of anticholinergic activity, cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported. Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with ALLESOOTHE.

System Organ Class Frequency Side effects

Blood and lymphatic system disorders Less frequent Agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia.

Immune system disorders Less frequent Anaphylactic shock, angioedema and hypersensitivity (including angioedema and bronchospasm).

Metabolism and nutrition disorders Frequent unknown Increased appetite.

Psychiatric disorders Frequent Less frequent Frequency unknown Somnolence Agitation, aggression, confusion, depression, hallucinations, insomnia and tic. Suicidal ideation, nightmare.

Nervous system disorders Frequent Less frequent Frequency unknown Dizziness and headache. Convulsions, dysgeusia, dyskinesia, dystonia, movement disorders, paraesthesia, syncope, tremor, drowsiness, tics. Amnesia, memory impairment, anxiety, nervousness.

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

Ear and labyrinth disorders Less frequent Tinnitus, vertigo.

Cardiac disorders Less frequent Dysrhythmias, palpitations and tachycardia.

Vascular disorders Less frequent Hypotension.

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

Gastrointestinal disorders Frequent Less frequent Abdominal pain, dry mouth and nausea. Diarrhoea (may be frequent in children aged 6 to 12 years), gastrointestinal discomfort, constipation.

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

Skin and subcutaneous tissue disorders Less frequent Frequency unknown Fixed drug eruption pruritus, hair loss, rash, sweating, urticaria, pruritis Acute generalised exanthematous pustulosis.

Musculoskeletal, connective tissue and bone disorders Less frequent Frequency unknown Extrapyramidal effects and myalgia. Arthralgia.

Renal and urinary disorders Less frequent Dysuria, enuresis, urinary retention.

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

Investigations Less frequent Weight increased.

Description of selected adverse reactions After discontinuation of ALLESOOTHE, 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.

Signs and symptoms: Symptoms observed after an overdose of cetirizine, as in ALLESOOTHE, 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 of overdose: There is no specific antidote. Cetirizine is not effectively removed by dialysis. Further treatment is symptomatic and supportive.