HISTEK ALLERGY 10 MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-05-2024
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Active ingredient:
CETIRIZINE DIHYDROCHLORIDE
Available from:
Helsinn Birex Therapeutics Ltd
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2006-05-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Histek Allergy 10 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetirizine dihydrochloride 10 mg
Excipients include: Lactose monohydrate 117mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Film-coated, white or almost white convex, oval shaped, tablets.
Scored on one side. The tablets are marked “C” on one side, “J” and “E” on either side of a central division line on the
reverse.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of perennial rhinitis, seasonal allergic rhinitis (hay fever) and chronic idiopathic urticaria in adults
and children aged 12 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
Adults, the elderly and children aged 12 years and over: One 10mg tablet daily.
In patients with renal impairment (creatinine clearance 11 –31 ml/min), on haemodialysis (creatinine clearance < 7
ml/min) and in hepatically impaired patients, the dose should be reduced to 5mg daily.
4.3 CONTRAINDICATIONS
Cetirizine is contra-indicated in patients who are hypersensitive to cetirizine, hydroxyzine or any constituent of the
tablets.
Cetirizine has been reported to be excreted in human breast milk. Cetirizine is contra-indicated in lactating women, due
to lack of evidence of safety _(see section 4.6 Pregnancy and Lactation_).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/04/2012_
_CRN 2112748_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dosage adjustment is necessary in patients with moderate or severe renal impairment and in liver impairment _(s
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