Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Oethmaan Biosims (Ply) Ltd, 14 Komatie Road, Emmarentia, Johannesburg, 2195
History of hypersensitivity to cetirizine dihydrochloride or any of the constituents of Sensahist.
Hypersensitivity to hydroxyzine or any piperazine derivative.
Sensahist is contraindicated in pregnancy and in lactating women (see Pregnancy and Lactation).
Sensahist is contraindicated in children less than 2 years old as the safety has not been established.
Patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Sensahist lacks significant sedative effects. However, it is advisable to avoid concomitant use with alcohol or other central nervous system depressants during treatment with Sensahist.
Sensahist contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Sensahist.
To date there are no known interactions of Sensahist with other medicines through interactions with medicines metabolised by liver enzymes. Studies with diazepam, glipizide, pseudoephedrine, ketoconazole, azithromycin, erythromycin and cimetidine have revealed no evidence of pharmacokinetic interactions. Concomitant intake of alcohol or other central nervous system depressants may enhance the sedative effects of Sensahist. Allergy skin tests are inhibited by antihistamines such as Sensahist. A washout period of 3 days is recommended before performing such tests.
Ritonavir increases the plasma concentration of racemic cetirizine about 42%, increases the half-life by 53% and decreases the clearance by 29%. The disposition of ritonavir is not altered by concomitant cetirizine administration.
Sensahist is contraindicated in pregnancy as safety has not been established (see Contraindications).
Sensahist is contraindicated in lactation since the active ingredient, cetirizine is excreted in breast milk (see Contraindications).
Patients should be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants.
Sensahist has the following side effects:
Less frequent: Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia, sweating.
Less frequent: Allergic reactions such as cutaneous reactions, angioedema and anaphylaxis.
Less frequent: Sleep disorders, depression, confusion.
Frequent: Tiredness and sleepiness.
Less frequent: Headache, dizziness, restlessness, convulsions, drowsiness, fatigue, nervousness, malaise, asthenia and paraethesias.
Less frequent: Tinnitus.
Less frequent: Palpitations, ventricular dysrhythmias.
Less frequent: Hypotension.
Less frequent: Thickening of mucous.
Frequent: Dry mouth, nausea, vomiting, diarrhoea, epigastric pain, increased appetite.
Less frequent: Gastric discomfort and gastrointestinal disorders.
Less frequent: Hypersensitivity reactions including urticaria, skin rash, pruritus.
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