Texa Allergy 10 mg/1 mg/1 mL Film-Coated Tablets

TEXA ALLERGY is indicated for symptomatic relief of allergic conditions such as allergic rhinitis, hay fever and allergic skin conditions associated with pruritus, such as urticaria.

Tablets:
Adults or children 12 years of age or older: 10 mg (one tablet) once daily.
Children 6 to 12 years old: 5 mg (half a tablet) twice daily or 10 mg (one tablet) once daily.
Syrup:
Adults or children 12 years of age or older: 10 mg (10 mL) once daily.
Children 6 to 12 years old: 10 mg (10 mL) daily, either as a single dose or as divided doses of 5 mL in the morning and 5 mL in the evening.
Children age 2 to 6 years: 5 mg (5 mL) daily, as either a single dose or as divided doses of 2.5 mL in the morning and 2.5 mL in the evening.
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.
Dosage in hepatic impairment: In moderate to severe hepatic impairment, half the recommended daily dose should be used.
Method of administration: Oral administration.
Missed dose: Doctors should advise patients who forget to take TEXA ALLERGY 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.
Pediatric population: TEXA ALLERGY is contraindicated in children under the age of two years, as safety and efficacy have not been demonstrated (see section 4.3).

• hypersensitivity to cetirizine, hydroxyzine, any piperazine derivatives or to any of the ingredients of TEXA ALLERGY
• patients with severe renal impairment at less than 30 mL/min creatinine clearance
• asthma, as it may cause airway obstruction in patients who have previously experienced adverse reactions to antihistamines
• safety in pregnancy and lactation has not been established (see section 4.6)
• children under the age of two years, as safety and efficacy have not been demonstrated.

• TEXA ALLERGY lacks significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation.
• 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).
• Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia), as TEXA ALLERGY may increase the risk of urinary retention.
• Caution in epileptic patients and patients at risk of convulsions is recommended.
• The use of the film coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
• Allergy skin tests are inhibited by TEXA ALLERGY and a wash-out period (of 3 days) is required before performing them.
• Methyl parahydroxybenzoate and propyl parahydroxybenzoate, as contained in TEXA ALLERGY SYRUP, may cause allergic reactions (possibly delayed).
• Elderly patients are more susceptible to many of the adverse effects of TEXA ALLERGY.
• Pruritus and/or urticaria may occur when TEXA ALLERGY 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.

Information on excipients of TEXA ALLERGY TABLETS and SYRUP: TEXA ALLERGY TABLETS contains lactose. Patients with the rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. TEXA ALLERGY SYRUP contains sorbitol. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. TEXA ALLERGY SYRUP contains saccharin sodium.

Concomitant use of alcohol and other sedating medicines should be avoided. Due to pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day). 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 CNS depressants may cause additional reductions in alertness and impairment of performance, although cetirizine, as in TEXA ALLERGY, does not potentiate the effect of alcohol (see section 4.4).

Safety and efficacy in pregnancy and lactation have not been established (see section 4.3).
Breastfeeding: Caution should be exercised when prescribing TEXA ALLERGY to lactating women. Cetirizine is excreted in human breast milk at concentrations representing 25 % to 90 % of those measured in plasma, depending on sampling time after administration.
Fertility: Limited data is available on human fertility but no safety concern has been identified. Animal data show no safety concern for human reproduction.

TEXA ALLERGY can lead to drowsiness and patients should be aware of how they react to TEXA ALLERGY and exercise caution before driving, operating hazardous machinery or performing hazardous tasks.

b. Tabulated summary of adverse reactions
System Organ Class Frequency Side effects
Blood and lymphatic system disorders Less frequent Thrombocytopenia, leucopoenia, haemolytic anaemia, agranulocytosis
Immune system disorders Less frequent Urticaria, skin rash, pruritus, angioedema, hypersensitivity reactions, anaphylaxis
Metabolism and nutrition disorders Frequency unknown Increased appetite
Psychiatric disorders Less frequent Frequency unknown Somnolence, depression, confusion, agitation, aggression, hallucinations, insomnia, suicidal ideation, nightmares
Nervous system disorders Less frequent Frequency unknown Drowsiness, fatigue, malaise, asthenia, tics, headaches, dizziness, anxiety, nervousness, paraesthesia, convulsions, movement disorders, dysgeusia, syncope, tremor, dystonia, dyskinesia, amnesia, memory impairment
Eye disorders Less frequent Accommodation disorder, blurred vision, oculogyration
Ear and labyrinth disorders Less frequent Tinnitus, vertigo
Cardiac disorders Less frequent Palpitations, dysrhythmias, tachycardia
Vascular disorders Less frequent Hypotension
Respiratory, thoracic and mediastinal disorders Frequent Less frequent Pharyngitis, rhinitis, thickening of mucous, bronchospasm
Gastrointestinal disorders Less frequent Nausea, gastrointestinal discomfort, diarrhoea, constipation, dry mouth
Hepatobiliary disorders Less frequent Frequency unknown Hepatic function abnormal (increased transaminases, alkaline phosphatase, u03b3 -GT and bilirubin), jaundice, hepatitis
Skin and subcutaneous tissue disorders Less frequent Frequency unknown Pruritus, rash, urticaria, fixed drug eruption, photosensitivity, hair loss, sweating, acute generalised exanthematous pustulosis
Musculoskeletal, connective tissue and bone disorders Less frequent Frequency unknown Myalgia, arthralgia
Renal and urinary disorders Less frequent Dysuria, enuresis, urinary retention
General disorders and administration site conditions Less frequent Asthenia, malaise, oedema
Investigations Less frequent Weight increased
c. Description of selected adverse reactions
Skin reactions occurring after discontinuation of TEXA ALLERGY: After discontinuation of TEXA ALLERGY, 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 professionals are asked to report any suspected adverse reactions to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8 An email can be sent directly to the company, [email protected] to ensure safety of the product.

Signs and symptoms: Symptoms observed after an overdose of cetirizine, as in TEXA ALLERGY, 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.