Treathay Tablets Fexofenadine 120mg
Overview
1. Name of the
medicinal product
TREATHAY 120 mg film-coated tablets
2. Qualitative and
quantitative composition
Each film-coated tablet contains 120 mg of
fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical
form
Film-coated tablet.
Peach coloured, oblong, biconvex, film coated
tablets.
4. Clinical
particulars
4.1 Therapeutic
indications
TREATHAY 120 mg tablet is indicated in adults and
children 12 years and older for the relief of symptoms associated with seasonal
allergic rhinitis.
4.2 Posology and
method of 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
Adolescents aged 12 years and over
The recommended dose of fexofenadine hydrochloride
for adolescents 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.
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.
Method of administration
TREATHAY 120 mg tablet is for oral use.
4.3 Contraindications
Hypersensitivity to the active substance or to any
of the excipients listed in section 6.1.
4.4 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.
TREATHAY 120 mg tablets should only 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 TREATHAY 120 mg tablets only on
the advice of their doctor.
TREATHAY 120 mg tablets 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.
Excipient
This medicine contains less than 1 mmol sodium (23
mg) per tablet, that is to say essentially 'sodium-free.'
4.5 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.
4.6 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). TREATHAY
120 mg tablets should not be used during pregnancy unless on the advice of a
doctor.
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 TREATHAY 120 mg tablets is not recommended for mothers
breast-feeding their babies. Breast-feeding women should only use TREATHAY 120
mg tablets 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 treatment (see section 5.3).
4.7 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, fexofenadine 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.
4.8 Undesirable
effects
The following frequency rating has been used, when
applicable
Very common ≥1/10;
Common ≥1/100 to <1/10;
Uncommon ≥1/1,000 to <1/100;
Rare ≥1/10,000 to <1/1,000;
Very rare <1/10,000;
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 (can not 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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store
4.9 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.
5. Pharmacological
properties
5.1 Pharmacodynamic
properties
Pharmacotherapeutic group: Antihistamines for
systemic use, ATC code: R06A X26.
Mechanism of action
Fexofenadine hydrochloride is a non-sedating H1 antihistamine.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
Clinical efficacy and safety
Human histamine wheal and flare studies following
single and twice daily doses of fexofenadine hydrochloride demonstrate that the
medicinal products exhibits an antihistaminic effect beginning within one hour,
achieving maximum at 6 hours and lasting 24 hours. There is no evidence of
tolerance to these effects after 28 days of dosing. A positive dose-response
relationship between doses of 10 mg to 130 mg taken orally was found to exist.
In this model of antihistaminic activity, it was found that doses of at least
130 mg were required to achieve a consistent effect that was maintained over a
24 hour period. Maximum inhibition in skin wheal and flare areas was greater
than 80%. Clinical studies conducted in seasonal allergic rhinitis have shown
that a dose of 120 mg is sufficient for 24 hour efficacy.
No significant differences in QTc, intervals were
observed in seasonal allergic rhinitis patients given fexofenadine
hydrochloride up to 240 mg twice daily for 2 weeks when compared to placebo.
Also, no significant change in QTc intervals was observed in healthy
subjects given fexofenadine hydrochloride up to 60 mg twice daily for 6 months.
400 mg twice daily for 6.5 days and 240 mg once daily for 1 year, when compared
to placebo. Fexofenadine at concentrations 32 times greater than the
therapeutic concentration in man had no effect on the delayed rectifier K+ channel cloned
from human heart.
Fexofenadine hydrochloride (5-10 mg/kg per orally)
inhibited antigen induced bronchospasm in sensitised guinea pigs and inhibited
histamine release at supra-therapeutic concentrations (10- 100 µM) from
peritoneal mast cells.
5.2 Pharmacokinetic
properties
Absorption
Fexofenadine hydrochloride is rapidly absorbed into
the body following oral administration, with Tmax occurring at
approximately 1-3 hours post dose. The mean Cmax 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.
5.3 Preclinical
safety data
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 in vivo 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.
6. Pharmaceutical
particulars
6.1 List of
excipients
Tablet core
Microcrystalline cellulose,
Maize starch,
Magnesium stearate,
Croscarmellose sodium,
Povidone.
Film-coating
Hypromellose (E464),
Macrogol (PEG 400),
Macrogol (PEG 4000),
Titanium dioxide (E171),
Iron oxide yellow (El72),
Iron oxide red (E172).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special
precautions for storage
Store the tablets in the original package. This
medicinal product does not require any special temperature storage conditions.
6.5 Nature and
contents of container
PVC/PVDC/Alu blister packs of 7, 10, 14, 15, 20,
21, 28 or 30 tablets.
Not all pack sizes may be marketed.
6.6 Special
precautions for disposal and other handling
No special requirements for disposal.
7. Marketing
authorisation holder
CIPLA (EU) Limited
Dixcart House, Addlestone Road,
Bourne Business Park,
Addlestone, Surrey,
KT15 2LE, United Kingdom
8. Marketing
authorisation number(s)
PLGB 36390 / 0343
9. Date of first
authorisation/renewal of the authorisation
19/09/2011
10. Date of
revision of the text
04/02/2022
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Delivery
UK Standard Delivery:
Within 3 working days (excluding public holidays).
Cost is £3.75.
Completed by a Royal Mail or a Courier.