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Histallay 120mg Film-Coated Tablets

Histallay

Item no: HISTALLAY
 
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Histallay 120 mg Film-Coated Tablets

Each film-coated tablet contains 120 mg of fexofenadine hydrochloride; which is equivalent to 112 mg of fexofenadine.

Histallay 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.

Posology

Adults

The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine.

Paediatric population

? Children aged 12 years and over

The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 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.

Special populations

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.

As with most new medicinal products there is only limited data in the elderlyand renally or hepatically impaired patients. Histallay should be administered with care 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 Histallay 120 mg only on the advice of their doctor.

Histallay 120 mg should not be used in children under 12 years of age.

In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet (prescription only medicine) is the appropriate formulation for administration and dosing in this population.

Histallay 120 mg Film-Foated Tablets also contain Allura Red AC Lake, which may cause allergic reactions.

Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.

A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.

No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

Pregnancy

There are no adequate data from the use of fexofenadine hydrochloride in pregnant women.

Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Histallay 120 mg should not be used during pregnancy unless unless on the advice of a doctor.

Lactation

There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore Histallay is not recommended for mothers breastfeeding their babies. Breast-feeding women should only use Histallay 120 mg if advised to do so by a doctor.

Fertility

No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatments (see section 5.3).

On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines.

In objective tests, fexofenadine hydrochloride has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

 

Shipping charges mainland GB zone1

Value Weight Delivery Charge
Over £49.00 Any Weight FREE
Under £49.00 No weight limit £4.50
Under £49.00 Under 250 grams £3.49

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available at extra cost - these usually arrive in 24-48hrs from dispatch but delays are possible during busy periods.

Postcodes outside of Zone 1 (including some areas within mainland UK) may incur extra carriage charges due to surcharges imposed by the couriers. These will be calculated on the website at the checkout. 

NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.

Estimated "Usually shipped in" information is shown against most products

Overseas orders

We no longer send goods outside of the UK.

Prescription Items

Prescription items will be sent on receipt of a legally valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

  • Refrigerated lines Packaging Cost: Despatched with Woolcool Refrigerated Packaging for £7.50.
Wool cool keeps pharmaceutical products at fridge-like, ambient, or even freezing temperatures for up to 72 hours, and possibly longer depending on the contents and use of ice packs.
Important Delivery Information:
  • Receipt Required: Someone must be available to receive the delivery. Woolcool packaging is designed for temperature-controlled goods, so parcels cannot be left unattended.
  • Immediate Refrigeration: Upon receipt, refrigerate the contents immediately to ensure your food or medicine remains at the correct temperature.
  • Failed Delivery Attempts: We are not responsible for the cost of replacements if a delivery attempt fails due to the absence of someone to receive it.

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email sales@hyperdrug.co.uk to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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