Fexofenadine hydrochloride 180 mg Fil m-Coat ed Tablets SMPC, Taj Phar maceuticals

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The recommended dose of fexofenadine

RX hydrochloride for children aged 12 years and
over is 180 mg once daily taken before a meal.
FEXOFINADINE ▪ Children under 12 years of age
FILM COATED The efficacy and safety of fexofenadine
hydrochloride 180 mg has not been studied in
TABLETS children under 12.
180MG Special populations
Studies in special risk groups (elderly, renally or
1.NAME OF THE MEDICINAL PRODUCT
hepatically impaired patients) indicate that it is
Fexofenadine hydrochloride 180 mg Film- not necessary to adjust the dose of fexofenadine
Coated Tablets hydrochloride in these patients.
2. QUALITATIVE AND QUANTITATIVE 4.3 Contraindications
COMPOSITION Hypersensitivity to the active substance or to
any of the excipients (listed in section 6.1).
Each film-coated tablet contains 180 mg of
fexofenadine hydrochloride; which is equivalent 4.4 Special Warnings and precautions for use
to 168 mg of fexofenadine.
As with most new medicinal products there is
For the full list of excipients, see section 6.1 only limited data in the elderly and renally or
hepatically impaired patients. Fexofenadine
3. PHARMACEUTICAL FORM hydrochloride should be administered with care
Film-coated tablet in these special groups.
Fexofenadine hydrochloride 180 mg Film- Patients with a history of or ongoing
Coated Tablets are pink coloured; oval, cardiovascular disease should be warned that,
biconvex film coated antihistamines as a medicine class, have been
associated with the adverse reactions,
4. CLINICAL PARTICULARS tachycardia and palpitations (see section 4.8).
4.1 Therapeutic indications Fexofenadine hydrochloride 180 mg Film-
Fexofenadine hydrochloride 180 mg is indicated Coated Tablets also contain Allura Red AC
in adults and children 12 years and older for the Lake, which may cause allergic reactions.
relief of symptoms associated with chronic
idiopathic urticaria. 4.5 Interaction with other medicinal products
and other forms of interaction
4.2 Posology and method of administration
Fexofenadine does not undergo hepatic
Posology biotransformation and therefore will not interact
Adults with other medicinal products through hepatic
mechanisms. Coadministration of fexofenadine
The recommended dose of fexofenadine hydrochloride with erythromycin or
hydrochloride for adults is 180 mg once daily ketoconazole has been found to result in a 2-3
taken before a meal. Fexofenadine is a times increase in the level of fexofenadine in
pharmacologically active metabolite of plasma. The changes were not accompanied by
terfenadine. any effects on the QT interval and were not
Paediatric population associated with any increase in adverse reactions
compared to the medicinal products given
▪ Children aged 12 years and over singly.
Fexofenadine hydrochloride 180 mg Fil m-Coat ed Tablets SMPC, Taj Phar maceuticals
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Animal studies have shown that the increase in fexofenadine hydrochloride tablets will produce
plasma levels of fexofenadine observed after an effect on the ability to drive or use machines.
coadministration of erythromycin or
ketoconazole, appears to be due to an increase in In objective tests, fexofenadine hydrochloride
gastrointestinal absorption and either a decrease has been shown to have no significant effects on
in biliary excretion or gastrointestinal secretion, central nervous system function. This means that
respectively. patients may drive or perform tasks that require
concentration. However, in order to identify
No interaction between fexofenadine and sensitive people who have an unusual reaction to
omeprazole was observed. However, the medicinal products, it is advisable to check the
administration of an antacid containing individual response before driving or performing
aluminium and magnesium hydroxide gels 15 complicated tasks.
minutes prior to fexofenadine hydrochloride
caused a reduction in bioavailability, most likely 4.8 Undesirable Effects
The following frequency rating has been used,
due to binding in the gastrointestinal tract. It is
when applicable:
advisable to leave 2 hours between
administration of fexofenadine hydrochloride Very common ≥1/10;
and aluminium and magnesium hydroxide
containing antacids. Common ≥1/100 and <1/10;

4.6 Fertility, Pregnancy and lactation Uncommon ≥1/1,000 and <1/100;

Pregnancy Rare ≥1/10,000 and <1/1,000;

There are no adequate data from the use of Very rare <1/10,000
fexofenadine hydrochloride in pregnant women. and not known (frequency cannot be estimated
Limited animal studies do not indicate direct or from the available data).
indirect harmful effects with respect to effects Within each frequency grouping, undesirable
on pregnancy, embryonal/foetal development, effects are presented in order of decreasing
parturition or postnatal development (see section seriousness.
5.3). Fexofenadine hydrochloride should not be
used during pregnancy unless clearly necessary. In adults, the following undesirable effects have
been reported in clinical trials, with an incidence
Breastfeeding similar to that observed with placebo:
There are no data on the content of human milk Nervous system disorders
after administering fexofenadine hydrochloride.
However, when terfenadine was administered to Common: headache, drowsiness, dizziness
nursing mothers fexofenadine was found to Gastrointestinal disorders
cross into human breast milk. Therefore
fexofenadine hydrochloride is not recommended Common: nausea
for mothers breastfeeding their babies.
General disorders and administration site
Fertility conditions
No human data on the effect of fexofenadine Uncommon: fatigue
hydrochloride on fertility are available. In mice,
In adults, the following undesirable effects have
there was no effect on fertility with fexofenadine
been reported in post-marketing surveillance.
hydrochloride treatments (see section 5.3).
The frequency with which they occur is not
4.7 Effects on ability to drive and use known (can not be estimated from available
machines data):
S On the basis of the pharmacodynamic profile
Immune system disorders
and reported adverse reactions it is unlikely that
Fexofenadine hydrochloride 180 mg Fil m-Coat ed Tablets SMPC, Taj Phar maceuticals
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hypersensitivity reactions with manifestations Fexofenadine hydrochloride is a non-sedating

such as angioedema, chest tightness, dyspnoea, H1 antihistamine. Fexofenadine is a
flushing and systemic anaphylaxis pharmacologically active metabolite of
terfenadine.
Psychiatric disorders
Clinical efficacy and safety
insomnia, nervousness, sleep disorders or
nightmares/excessive dreaming (paroniria) Human histamine wheal and flare studies
following single and twice daily doses of
Cardiac disorders:
fexofenadine hydrochloride demonstrate that the
tachycardia and, palpitations medicinal product exhibits an antihistaminic
effect beginning within one hour, achieving
Gastrointestinal disorders maximum at 6 hours and lasting 24 hours. There
diarrhoea was no evidence of tolerance to these effects
after 28 days of dosing. A positive dose-
Skin and subcutaneous tissue disorders response relationship between doses of 10 mg to
rash, urticaria, pruritus 130 mg taken orally was found to exist. In this
model of antihistaminic activity, it was found
Reporting of suspected adverse reactions that doses of at least 130 mg were required to
achieve a consistent effect that was maintained
Reporting suspected adverse reactions after
over a 24 hour period. Maximum inhibition in
authorisation of the medicinal product is
skin wheal and flare areas were greater than
important. It allows continued monitoring of the
80%.
benefit/risk balance of the medicinal product.
No significant differences in QTc intervals were
4.9 Overdose
observed in seasonal allergic rhinitis patients
Dizziness, drowsiness, fatigue and dry mouth given fexofenadine hydrochloride up to 240 mg
have been reported with overdose of twice daily for 2 weeks when compared to
fexofenadine hydrochloride. Single doses up to placebo. Also, no significant change in QTc
800 mg and doses up to 690 mg twice daily for 1 intervals was observed in healthy subjects given
month or 240 mg once daily for 1 year have fexofenadine hydrochloride up to 60 mg twice
been administered to healthy subjects without daily for 6 months, 400 mg twice daily for 6.5
the development of clinically significant adverse days and 240 mg once daily for 1 year, when
reactions as compared with placebo. The compared to placebo. Fexofenadine at
maximum tolerated dose of fexofenadine concentrations 32 times greater than the
hydrochloride has not been established. therapeutic concentration in man had no effect
on the delayed rectifier K+ channel cloned from
Standard measures should be considered to human heart.
remove any unabsorbed medicinal product.
Symptomatic and supportive treatment is Fexofenadine hydrochloride (5-10 mg/kg po)
recommended. Haemodialysis does not inhibited antigen induced bronchospasm in
effectively remove fexofenadine hydrochloride sensitised guinea pigs and inhibited histamine
from blood. release at supratherapeutic concentrations (10-
100 μM) from peritoneal mast cells.
5. PHARMACOLOGICAL PROPERTIES
5.2 Pharmacokinetic properties
5.1 Pharmacodynamic properties
Absorption
Pharmacotherapeutic group: Antihistamines for
Fexofenadine hydrochloride is rapidly absorbed
systemic use
into the body following oral administration, with
Mechanism of action Tmax occurring at approximately 1-3 hours post
dose. The mean Cmax value was approximately
Fexofenadine hydrochloride 180 mg Fil m-Coat ed Tablets SMPC, Taj Phar maceuticals
Fexofenadine hydrochloride Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Fexofenadine hydrochloride Dosage & Rx Info | Fexofenadine hydrochloride Uses, Side Effects -: Indications, Side Effects, Warnings, Fexofenadine hydrochloride - Drug Information - Taj Phar ma, F exofenadine hydrochloride dose Taj pharmaceuticals Fexofenadine hydrochloride interactions, Taj Pharmaceutical Fexofenadine hydrochloride contraindications, Fexofenadine hydrochloride price, Fexofenadine hydrochloride Taj Pharma Fexo fenadine hydrochloride 180 mg Fil m-Coate d Tablets SMPC- Taj Phar ma . Stay connected to all updated on Fexofenadine hydrochloride Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.

494 ng/ml following the administration of a 180 fertility, was not teratogenic and did not impair
mg dose once daily. pre- or postnatal development.
Distribution 6. PHARMACEUTICAL PARTICULARS
Fexofenadine is 60-70% plasma protein bound.
6.1 List of excipients
Biotransformation and elimination Tablet core:
Fexofenadine undergoes negligible metabolism Powdered Cellulose,
(hepatic or non-hepatic), as it was the only major Mannitol,
compound identified in urine and faeces of
animals and man. The plasma concentration Maize starch,
profiles of fexofenadine follow a bi-exponential
decline with a terminal elimination half-life Croscarmellose Sodium,
ranging from 11 to 15 hours after multiple Colloidal anhydrous Silica,
dosing. The single and multiple dose
pharmacokinetics of fexofenadine are linear for Magnesium Stearate,
oral doses up to 120 mg BID. A dose of 240 mg Tablet coating
BID produced slightly greater than proportional
increase (8.8%) in steady state area under the Opadry Pink 03B54504 film-coating mixture
curve, indicating that fexofenadine containing Hypromellose (E464), Titanium
pharmacokinetics are practically linear at these dioxide (E171), Macrogol 400, Allura Red AC
doses between 40 mg and 240 mg taken daily. Lake (FD&C Red #40) (E129), and Iron Oxide,
The major route of elimination is believed to be Black (E172)
via biliary excretion while up to 10% of ingested 6.2 Incompatibilities
dose is excreted unchanged through the urine. Not applicable.
5.3 Preclinical safety data 6.3 Shelf life
Dogs tolerated 450 mg/kg administered twice 3 years.
daily for 6 months and showed no toxicity other 6.4 Special precautions for storage
than occasional emesis. Also, in single dose dog This medicinal product does not require any
and rodent studies, no treatment-related gross special storage conditions.
findings were observed following necropsy.
6.5 Nature and contents of container
Radiolabelled fexofenadine hydrochloride in
tissue distribution studies of the rat indicated Aluminium/PVC-PE-PVdC blisters. Pack-sizes
that fexofenadine did not cross the blood brain of 20 or 30 film-coated tablets.
barrier.
Not all pack sizes may be marketed.
Fexofenadine hydrochloride was found to be
6.6 Special precautions for disposal and other
non-mutagenic in various in vitro and in
handling
vivo mutagenicity tests.
No special requirements.
The carcinogenic potential of fexofenadine
hydrochloride was assessed using terfenadine 7. MANUFACTURER:
studies with supporting pharmacokinetic studies
showing fexofenadine hydrochloride exposure
(via plasma AUC values). No evidence of
carcinogenicity was observed in rats and mice Manufactured in India by:
given terfenadine (up to 150 mg/kg/day).
TAJ PHARMACEUTICALS LTD.
In a reproductive toxicity study in mice, Mumbai, India
fexofenadine hydrochloride did not impair
Fexofenadine hydrochloride 180 mg Fil m-Coat ed Tablets SMPC, Taj Phar maceuticals
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At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad

438225, Gujarat, INDIA

This leaflet was last revised in October 2019