Fexotel® is indicated in adults, children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.

Oral administration.
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 120 mg has not been studied in children under 12.
In children from 6 to 11 years of age: 30 mg tablet is the appropriate formulation for administration and dosing in this population.

- In cases of hepatic and renal impairment: lower doses should be given.
- There is no adequate and well controlled study in pregnant and lactating women so recommended not to be used.

- 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.

- Plasma concentration of Fexofenadine increased after concomitant administrationof Erythromycin and Ketoconazole.
- Antacids containing Al and Mg hydroxides have reduced the absorption of Fexofenadine therefore it is advisable to leave 2 hours between taking Fexotel® and antacids.

- Pregnancy: As precautionary measure, this drug should preferably not be used during pregnancy.
- Animal studies have shown no evidence of teratogenic activity. In the absence of teratogenic activity in animals, fetal malformation in humans is not to be expected since so far, substances that cause fetal malformations in humans have proved to be teratogenic in well conducted animal studies in two species. There are no relevant clinical data by which to evaluate the potential of Fexofenadine to induce fetal malformation or toxicity when used during pregnancy.
- Fexofenadine has been assigned to pregnancy category C
Breastfeeding: The use of Fexofenadine by breastfeeding women is inadvisable. There is no data concerning excretion of Fexofenadine in human breast milk. However, Fexofenadine was detected in breast milk after administration of Terfenadine to breastfeeding woman.

Fexofenadine lacks sedative effect, but small numbers of individuals may experience sedation, therefore determine individual response before driving or operating machinery.

• 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 and administration site conditions
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, dyspnea, flushing and systemic
anaphylaxis
• Psychiatric disorders:
Appetite increase, insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)
• Cardiac disorders:
Tachycardia, palpitations
• Gastrointestinal disorders:
diarrhea
• Skin and subcutaneous tissue disorders:
Rash, urticaria, pruritus
To report any side effect(s):
National Pharmaco-vigilance and Drug Safety Centre info:
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222 Exts: 2317- 2356- 2353- 2354- 2334- 2340.
• Toll- free number: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

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.

Fexofenadine is the active carboxylic acid metabolite of Terfenadine. It is non-sedating selective histamine Hl receptor antagonist. Fexofenadine exhibits an antihistaminic effect beginning within one hour, reaching the maximum effect at 6 hours and lasting for 24 hours. It is rapidly absorbed from the GI-Tract into the body following oral administration with tmax occurring at approx- 1-3 hours after dose. Peak plasma concentration is achieved in about 2-6 hours, it is 60-70 % plasma protein bound. Its major route of elimination is via biliary excretion, while up to 10% of the ingested dose is excreted unchanged through the urine.

Absorption
Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with T-max occurring at approximately 1-3 hours post dose. The mean C-max value was approximately 427 ng/ml following the administration of a 120 mg dose once daily.
Distribution
Fexofenadine is 60-70% plasma protein bound.
Biotransformation and elimination
Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear for oral doses up to 120 mg BID. A dose of 240 mg BID produced slightly greater than proportional increase (8.8%) in steady state area under the curve, indicating that fexofenadine pharmacokinetics are practically linear at these doses between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine.

Dogs tolerated 450 mg/kg administered twice daily for 6 months and showed no toxicity other than occasional emesis. Also, in single dose dog and rodent studies, no treatment-related gross findings were observed following necropsy.
Radiolabelled fexofenadine hydrochloride in tissue distribution studies of the rat indicated that fexofenadine did not cross the blood brain barrier.
Fexofenadine hydrochloride was found to be non-mutagenic in various in vitro and invivo mutagenicity tests.
The carcinogenic potential of fexofenadine hydrochloride was assessed using terfenadine studies with supporting pharmacokinetic studies showing fexofenadine hydrochloride exposure (via plasma AUC values). No evidence of carcinogenicity was observed in rats and mice given terfenadine (up to 150 mg/kg/day).
In a reproductive toxicity study in mice, fexofenadine hydrochloride did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.

Microcrystalline Cellulose, Lactose anhydrous, Lactose monohydrate, Maize starch, Povidone, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Ethanol, Hydroxypropyl Methylcellulose, Titanium Dioxide, Carmoisine.

Not applicable.

Store at temperature not above 30ºC.

FEXOTEL® Tablets are present in a carton box containing a PVC / aluminum blister of 14 tablets along with a leaflet.

No special requirements.