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Histahive 180 mg Film-coated Tablets
Each film-coated tablet contains 180 mg of fexofenadine hydrochloride; which is equivalent to 168 mg of fexofenadine.
Excipient with known effect: Allura Red AC Lake (FD&C Red #40) (E129)
Histahive 180 mg Film-coated Tablets are pink coloured; oval, biconvex film coated embossed “ FXF” on one side and “ 180” on the other side.
Histahive is indicated in adults and children 12 years and older for the relief of symptoms associated with chronic idiopathic urticaria.
The recommended dose of fexofenadine hydrochloride for adults is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine.
- Adolescents aged 12 years and over The recommended dose of fexofenadine hydrochloride for adolescents aged 12 years and over is 180 mg once daily taken before a meal.
- Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12. Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients. Histahive is for oral use.
Special warnings and precautions for use
As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered in these special groups on the advice of a doctor.
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations (see section 4.8) and should use fexofenadine hydrochloride only on the advice of their doctor.
Histahive 180 mg Film-Coated Tablets contains Allura Red AC Lake, which may cause allergic reactions.
Pregnant and breast-feeding women should only use fexofenadine hydrochloride if advised to do so by a doctor.
It is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. However, it is advisable to check the individual response before driving or performing complicated tasks.
Common side effects: - headache, drowsiness, nausea, dizziness. Uncommon side effects: tiredness - sleepiness. Additional side effects which may occur are insomnia, sleeping disorders, bad dreams, nervousness, blurred vision, fast or irregular heart beat, diarrhoea, skin rash and itching, hives.
List of excipients: Tablet core: Powdered cellulose,
Mannitol, Maize starch, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate
Tablet coating: Opadry Pink 03B54504 film-coating mixture containing Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Allura Red AC Lake (FD&C Red #40) (E129), and Iron oxide, black (E172)
Shelf life:3 years. Pack-sizes of 10, 30 film-coated tablets.
Marketing authorisation holder: Dr. Reddy's Laboratories (UK) Ltd. 410 Cambridge Science Park Milton Road, Cambridge CB4 0PE UK. Marketing authorisation number: PL 08553/0756