Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
PROFESSIONAL INFORMATION FOR FEXOHET 120 & 180  
SCHEDULING STATUS  
S1  
1 NAME OF THE MEDICINE  
FEXOHET 120 film coated tablets  
FEXOHET 180 film coated tablets  
2 QUALITATIVE AND QUANTITATIVE COMPOSITION  
FEXOHET 120: Each film coated tablet contains 120 mg fexofenadine hydrochloride.  
FEXOHET 180: Each film coated tablet contains 180 mg fexofenadine hydrochloride.  
FEXOHET is sugar free.  
For full list of excipients, see section 6.1.  
3 PHARMACEUTICAL FORM  
FEXOHET 120: Pink, modified capsule shaped, biconvex, film coated tablets debossed with 'J' on one side  
and '67' on the other side.  
FEXOHET 180: Pink, modified capsule shaped, biconvex, film coated tablets debossed with 'J' on one side  
and '44' on the other side.  
4 CLINICAL PARTICULARS  
4.1 Therapeutic indications  
•
FEXOHET 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis  
(SAR).  
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01 April 2022  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
•
FEXOHET 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria  
(CIU).  
4.2 Posology and method of administration  
Posology  
Adults and children aged 12 years and over:  
Seasonal allergic rhinitis (SAR): Take one 120 mg tablet daily.  
Chronic idiopathic urticarial (CIU): Take one 180 mg tablet daily.  
Children under 12 years of age:  
The efficacy and safety of FEXOHET has not been studied in children under the age of 12.  
Special risk groups: (See sections 4.4 and 5.2)  
Method of administration  
FEXOHET is administered orally. FEXOHET may be taken before a meal.  
FEXOHET is a coated tablet, should not be chewed as it may make them to taste very unpleasant.  
FEXOHET should not be broken because the coating is intended to ensure a prolonged release.  
4.3 Contraindications  
•
Hypersensitivity to fexofenadine hydrochloride or any of the excipients of FEXOHET listed in  
section 6.1.  
•
There is no experience with FEXOHET in pregnant women. FEXOHET should not be taken  
during pregnancy or by mothers breastfeeding their babies.  
4.4 Special warnings and precautions for use  
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01 April 2022  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
The data available on the use of FEXOHET in the elderly and renally or hepatically impaired patients are  
limited. FEXOHET should be administered with care in these special risk 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).  
4.5 Interaction with other medicines and other forms of interaction  
FEXOHET does not undergo hepatic biotransformation.  
Co-administration of FEXOHET with erythromycin or ketoconazole has been found to result in 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 medicines  
given individually.  
It was reported that animal studies have shown that the increase in plasma levels of fexofenadine as in  
FEXOHET observed after co-administration with 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 as in FEXOHET and omeprazole was observed. However, the  
administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to  
fexofenadine as in FEXOHET, caused a reduction in bioavailability, most likely due to binding in the gastro-  
intestinal tract. It is advisable to leave 2 hours between administration of FEXOHET and aluminium and  
magnesium hydroxide containing antacids.  
Paediatric population  
The efficacy and safety of fexofenadine as in FEXOHET has not been studied in children under the age of 12  
years.  
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01 April 2022  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
4.6 Fertility, pregnancy and lactation  
Pregnancy  
There is no adequate experience with fexofenadine as in FEXOHET in pregnant women, therefore  
FEXOHET is contraindicated in pregnant women (see section 4.3).  
Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on  
pregnancy, embryonal/foetal development, parturition or postnatal development.  
Breastfeeding  
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 FEXOHET should not be taken by mothers breastfeeding their babies (see section 4.3).  
Fertility  
No human data on the effect of fexofenadine hydrochloride on fertility are available.  
4.7 Effects on ability to drive and use machines  
Fexofenadine lacks significant sedative effects. Patients should, however, be warned that a small number of  
individuals may experience sedation. It is therefore advisable to determine individual response before driving  
or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other  
central nervous system depressants.  
4.8 Undesirable effects  
Tabulated summary of adverse reactions  
Immune system disorders  
Less frequent: Hypersensitivity reactions with manifestations such as angioedema, chest tightness,  
dyspnoea, flushing and systemic anaphylaxis have been reported.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
Psychiatric disorders  
Less frequent: Nervousness and sleep disorders or paroniria  
Nervous system disorders  
Frequent: Headache, drowsiness, dizziness  
Less frequent: Insomnia  
Cardiac disorders  
Frequency unknown: Tachycardia, palpitations  
Gastrointestinal disorders  
Frequent: Nausea  
Frequency unknown: Diarrhoea  
Skin and subcutaneous tissue disorders  
Less frequent: Rash, urticaria, pruritus  
General disorders and administration site conditions  
Less frequent: Fatigue  
Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued  
monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any  
suspected adverse reactions via the “6.04 Adverse Drug Reactions Reporting Form”, found online under  
SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 and to the Holder of certificate of  
registration through the mail: pvg.cdma@heterogroups.com.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
4.9 Overdose  
Symptoms:  
Most reports of fexofenadine as in FEXOHET overdose contain limited information. However, dizziness,  
drowsiness and dry mouth have been reported.  
Treatment:  
Standard measures should be considered to remove any unabsorbed medicine. Fexofenadine is not  
effectively removed by haemodialysis from the blood.  
5
PHARMACOLOGICAL PROPERTIES  
Category and class: A 5.7.1 Antihistaminics  
Pharmacotherapeutic group: Antihistamines for systemic use, ATC code: R06A X26  
5.1 Pharmacodynamic properties  
Fexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating,  
histamine H1-receptor antagonist.  
Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving maximum effect at 6  
hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing.  
5.2 Pharmacokinetic properties:  
Absorption: Fexofenadine is 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 and 494 nm/ml  
following the administration of a 120 mg and 180 mg dose once daily, respectively.  
Distribution: Fexofenadine is 60 – 70 % plasma protein bound.  
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01 April 2022  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
Biotransformation: Fexofenadine undergoes negligible metabolism as it was the only major compound  
identified in urine and faeces of animals and man.  
Elimination: 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 major route of elimination  
is believed to be via biliary excretion while up to 10 % of ingested dose is excreted unchanged through the  
urine.  
Linearity/non-linearity: The single and multiple dose pharmacokinetics of fexofenadine are linear between  
40 mg and 240 mg, taken daily.  
Effect of age: It was reported that in older subjects (≥ 65 years old), peak plasma levels of fexofenadine  
were 99 % greater than those observed in normal volunteers (< 65 years old). Mean elimination half-lives  
were similar to those observed in normal volunteers.  
Renally impaired: It was reported that in patients with mild (creatinine clearance 41 – 80 mℓ/min) to severe  
(creatinine clearance 11 – 40 mℓ/min) renal impairment, peak plasma levels of fexofenadine were 87 % and  
111 % greater, respectively, and mean elimination half-lives were 59 % and 72 % longer, respectively, than  
observed in normal volunteers. Peak plasma levels in patients on dialysis (creatinine clearance ≤ 10 mℓ/min)  
were 82 % greater and half-life was 31 % longer than observed in normal volunteers.  
6 PHARMACEUTICAL PARTICULARS  
6.1 List of excipients  
•
•
•
•
Cellulose microcrystalline  
Colloidal silicon dioxide  
Magnesium stearate  
Silica colloidal anhydrous  
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01 April 2022  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
•
•
•
Sodium starch glycolate  
Starch pregelatinized  
Purified water  
Film coating  
•
FEXOHET 120: Opadry pink 13G140000 (HPMC 2910/hypromellose, titanium dioxide,  
macrogol/PEG 6000, talc, polysorbate 80, iron oxide red, iron oxide yellow)  
FEXOHET 180: Opadry pink 13G140000 (HPMC 2910/hypromellose, titanium dioxide,  
macrogol/PEG 6000, talc, polysorbate 80, iron oxide red, iron oxide yellow).  
•
6.2 Incompatibilities  
Not applicable  
6.3 Shelf life  
24 months  
6.4 Special precautions for storage  
•
•
•
•
Store at or below 25 °C. Keep well closed.  
Protect from light and moisture.  
This medicine does not require any special storage conditions.  
Keep the tablets in original container until required for use.  
6.5 Nature and contents of container  
Blister strips:  
FEXOHET 120 & 180  
Blister strips of PVC/Aluminium/OPA cold forming film and plain Aluminium lidding foil containing 10 film  
coated tablets per blister.  
Or  
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01 April 2022  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
FEXOHET 120  
Blister strips of clear triplex (PVC/PE/PVdC) forming film and plain Aluminium lidding foil containing 10 film  
coated tablets per blister.  
Pack size: 1 or 3 blisters packed in an outer carton box.  
FEXOHET 120 & 180  
HDPE bottles:  
Round white opaque HDPE (High density polyethylene) container, with a white opaque polypropylene,  
ribbed, child resistant plastic cap with pulp liner.  
Pack size: 30 or 100 film coated tablets per bottle.  
Or  
Round white opaque HDPE (High density polyethylene) container, with a white opaque polypropylene,  
ribbed, continuous thread (CT) plastic cap with pulp liner.  
Pack size: 500 film coated tablets per bottle.  
Not all pack sizes may be marketed.  
6.6 Special precautions for disposal and other handling  
No special requirements  
7 HOLDER OF CERTIFICATE OF REGISTRATION  
Hetero Drugs South Africa (Pty) Ltd  
Waterfall Corporate Campus  
Building No. 2, First floor  
74 Waterfall Drive  
Midrand  
2066  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: FEXOHET 120 & 180  
Dosage form and strength: Film coated tablet and 120 mg & 180 mg fexofenadine hydrochloride respectively  
8 REGISTRATION NUMBER(S)  
FEXOHET 120 - 52/5.7.1/0008  
FEXOHET 180 - 52/5.7.1/0009  
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
26th July 2022  
10 DATE OF REVISION OF THE TEXT  
01 April 2022  
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