Histafree Tablets- Fexofenadine

Histafree Tablets is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis. Each tablet of Histfree contains 120 mg of fexofenadine hydrochloride.

Posology And Method Of Administration

  • 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 one daily taken before a meal.
  • Children Under 12 Years Of Age: The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12.
  • In Children From 6 To 11 Years Of Age: fexofenadine hydrochloride 30 mg tablet is the appropriate formulation for administration and dosing in this population.
  • 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.

Contraindications

Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1 of the Histafree patient information leaflet from the link here).

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 with care in these special groups.
  • 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 of the Histafree patient information leaflet from the link here).
  • Patients with rare glucose-galactose malabsorption should not take this medicine.this product contains lactose as inactive ingredient.

Interaction With Other Medicinal Products And Other Forms Of Interaction

  • Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms.
  • 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. Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.
  • 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.

Fertility Pregnancy And Lactation

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 of the Histafree patient information leaflet from the link here). Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.

Breast-feeding: 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 fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies.

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 treatment (see section 5.3 of the Histafree patient information leaflet from the link here).

Effects On Ability To Drive And Use Machines

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, Histafree 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.

Undesirable Effects

The following frequency rating has been used, when applicable:
Very common ≥1/10, Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. in adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:

  • Nervous system disorders: Common: headache, drowsiness, dizziness.
  • Gastrointestinal disorders: Common: nausea.
  • General disorders: Uncommon: fatigue.

In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from available data):

  • Immune system disorders: hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis.
  • Psychiatric disorders: insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria).
  • Cardiac disorders: tachycardia, palpitations.
  • Gastrointestinal disorders: diarrhoea.
  • Skin and subcutaneous tissue disorders: rash, urticaria, pruritus.

Overdose

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo.

The maximum tolerated dose of fexofenadine hydrochloride has not been established. Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.

Histafree – Patient Information Leaflet

Histafree tablets Produced by Hi Pharm for Manufacturing Pharmaceuticals and chemicals. Al Obour City – Egypt.

Histafree – more information

هيستافري أقراص فمويه مضادة للتحسس

HISTAFREE 120 mg tablets: Uses, Dosage, FAQ

هيستافري 120 مجم أقراص: الاستخدامات ، الجرعات ، الأسئلة الشائعة

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