- Approval Id
- 5304305901b3a169
- Drug Approval Emc Name
- Telfast 30mg Film-coated Tablets
- Drug Name
- Telfast 30mg Film-coated Tablets
- Company Name
- Opella Healthcare UK Limited
- Company Address
- 410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
- Company Telephone
- +44 (0)118 354 3000
- Company Medical Info Direct Line
- +44 (0)800 035 2525
- Company Medical Info Email
- uk-medicalinformation@sanofi.com
- Atc Code
- R06AX26
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Opella Healthcare UK Limited, trading as Sanofi
410 Thames Valley Park Drive,
Reading,
Berkshire,
RG6 1PT,
United Kingdom.
- Authorisation Number
- PL 53886/0064
- Authorisation Date
- 08/12/2014
- Instruction Authorisation Holder
- Opella Healthcare UK Limited, trading as Sanofi
410 Thames Valley Park Drive,
Reading,
Berkshire,
RG6 1PT,
United Kingdom.
- Instruction Authorisation Number
- PL 53886/0064
- Instruction Authorisation Date
- 08/12/2014
- Instruction Composition
- Each tablet contains 30 mg of fexofenadine hydrochloride, which is equivalent to 28 mg of fexofenadine.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Film-coated tablet.
Peach round film-coated tablet debossed with “03” on one side and a scripted “e” on the other side.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Telfast 30 mg is indicated in children aged 6 to 11 years for the relief of symptoms associated with seasonal allergic rhinitis.4.2 Posology and method of administration
\*\*Posology\*\*
\*Paediatric population\*
\*\*•\*\* \*Children 6 to 11 years of age\*
The recommended dose of Fexofenadine hydrochloride in children aged 6 to 11 years is 30 mg twice daily.
\*\*•\*\* \*Children under 6 years of age\*
The efficacy of Fexofenadine hydrochloride has not been established in children under 6 years of age.
\*Special population\*
The safety and efficacy of Fexofenadine hydrochloride in renally or hepatically impaired children have not been established (see section 4.4). Studies conducted in adults in special risk groups (renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Fexofenadine hydrochloride in adults.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
The safety and efficacy of fexofenadine hydrochloride in renally or hepatically impaired children have not been established (see section 4.2). Fexofenadine hydrochloride should be administered with caution in these patients.
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class have been associated with the adverse events, tachycardia and palpitations (see section 4.8).
\*\*Telfast contains sodium\*\*
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
Interaction studies have only been performed in adults.
Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms.
Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine.
Co administration of fexofenadine hydrochloride with P-gp inhibitors, 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.
A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.
No interaction between Fexofenadine hydrochloride 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). 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).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, Telfast 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 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 controlled clinical trials in children aged 6 to 11 years, the most commonly reported adverse reaction considered at least possibly related to fexofenadine hydrochloride by the investigator was headache. The incidence of headache in pooled data from clinical trials was 1.0% for patients taking fexofenadine hydrochloride 30 mg (673 children) and for patients taking placebo (700 children). There are no clinical safety data in children treated with fexofenadine hydrochloride for periods longer than two weeks
In controlled clinical trials in 845 children aged 6 months to 5 years with allergic rhinitis, 415 children were administered 15 mg or 30 mg of fexofenadine hydrochloride (capsule content sprinkled onto dosing vehicle) and 430 children were administered placebo. There were no unexpected adverse events in the children treated with fexofenadine and the adverse event profile was similar to that of older children and adults (see section 4.2).
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
\*Eye disorders\*
Not known: Vision blurred
\*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, 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. Doses up to 60 mg twice daily for two weeks have been administered to children, and 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 adult 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.
- Instruction Pharmacology
- 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\*\*
In children aged 6 to 11 years, the suppressive effects of Fexofenadine hydrochloride on histamine – induced wheal and flare were comparable to that in adults at similar exposure. Inhibition of histamine-induced wheal and flare was observed at one hour post dose following single doses of 30 and 60 mg Fexofenadine hydrochloride. Peak inhibitory effects of Fexofenadine generally occurred at 3-6 hours post dose.
In a pooled analysis of three placebo-controlled double-blind phase III studies, involving 1369 children with seasonal allergic rhinitis aged 6 to 11 years, Fexofenadine hydrochloride at 30 mg twice daily was significantly better than placebo in reducing total symptom score (p=0.0001). All individual component symptoms including rhinorrhea (p=0.0058), sneezing (p=0.0001), itchy/ watery/red eyes (p=0.0001), itchy nose/ palate and throat (p=0.0001), and nasal congestion (p=0.0334) were significantly improved by fexofenadine hydrochloride.
In children aged 6 to 11 years, no significant differences in QTc were observed following up to 60 mg Fexofenadine hydrochloride twice daily for two weeks compared with placebo. No significant differences in QTc intervals were observed in adult and adolescent patients with seasonal allergic rhinitis, when given Fexofenadine hydrochloride up to 240 mg twice daily for 2 weeks when compared with placebo. Also, no significant change in QTc intervals was observed in healthy adult 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 with 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.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. In children, the mean Cmax value was approximately 128 ng/ml following a single dose oral administration of 30 mg Fexofenadine hydrochloride.
A dose of 30 mg BID was determined to provide plasma levels (AUC) in paediatric patients which are comparable to those achieved in adults with the approved adult regimen of 120 mg once daily.
\*\*Distribution\*\*
After oral administration in adults, 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.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
\*\*Tablet core:\*\*
Microcrystalline Cellulose
Pregelatinised Starch
Croscarmellose Sodium
Magnesium Stearate
\*\*Film coat:\*\*
Hypromellose
Povidone
Titanium Dioxide (E171)
Colloidal Anhydrous Silica
Macrogol
Pink Iron oxide (E172) blend
Yellow Iron oxide (E172) blend6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
This medicinal product does not require any special storage condition6.5 Nature and contents of container
PVC/PE/PVDC/Al blisters packaged into cardboard boxes. 1, 2, 4, 8, 10 or 15 (sample only); 20, 30, 40, 50, 60 and 100 tablets per package.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements
- Instruction Content
- ## Composition
Each tablet contains 30 mg of fexofenadine hydrochloride, which is equivalent to 28 mg of fexofenadine.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Film-coated tablet.
Peach round film-coated tablet debossed with “03” on one side and a scripted “e” on the other side.
## Clinical Particulars
4.1 Therapeutic indications
Telfast 30 mg is indicated in children aged 6 to 11 years for the relief of symptoms associated with seasonal allergic rhinitis.4.2 Posology and method of administration
\*\*Posology\*\*
\*Paediatric population\*
\*\*•\*\* \*Children 6 to 11 years of age\*
The recommended dose of Fexofenadine hydrochloride in children aged 6 to 11 years is 30 mg twice daily.
\*\*•\*\* \*Children under 6 years of age\*
The efficacy of Fexofenadine hydrochloride has not been established in children under 6 years of age.
\*Special population\*
The safety and efficacy of Fexofenadine hydrochloride in renally or hepatically impaired children have not been established (see section 4.4). Studies conducted in adults in special risk groups (renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Fexofenadine hydrochloride in adults.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
The safety and efficacy of fexofenadine hydrochloride in renally or hepatically impaired children have not been established (see section 4.2). Fexofenadine hydrochloride should be administered with caution in these patients.
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class have been associated with the adverse events, tachycardia and palpitations (see section 4.8).
\*\*Telfast contains sodium\*\*
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
Interaction studies have only been performed in adults.
Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms.
Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine.
Co administration of fexofenadine hydrochloride with P-gp inhibitors, 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.
A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.
No interaction between Fexofenadine hydrochloride 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). 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).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, Telfast 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 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 controlled clinical trials in children aged 6 to 11 years, the most commonly reported adverse reaction considered at least possibly related to fexofenadine hydrochloride by the investigator was headache. The incidence of headache in pooled data from clinical trials was 1.0% for patients taking fexofenadine hydrochloride 30 mg (673 children) and for patients taking placebo (700 children). There are no clinical safety data in children treated with fexofenadine hydrochloride for periods longer than two weeks
In controlled clinical trials in 845 children aged 6 months to 5 years with allergic rhinitis, 415 children were administered 15 mg or 30 mg of fexofenadine hydrochloride (capsule content sprinkled onto dosing vehicle) and 430 children were administered placebo. There were no unexpected adverse events in the children treated with fexofenadine and the adverse event profile was similar to that of older children and adults (see section 4.2).
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
\*Eye disorders\*
Not known: Vision blurred
\*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, 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. Doses up to 60 mg twice daily for two weeks have been administered to children, and 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 adult 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.
## 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\*\*
In children aged 6 to 11 years, the suppressive effects of Fexofenadine hydrochloride on histamine – induced wheal and flare were comparable to that in adults at similar exposure. Inhibition of histamine-induced wheal and flare was observed at one hour post dose following single doses of 30 and 60 mg Fexofenadine hydrochloride. Peak inhibitory effects of Fexofenadine generally occurred at 3-6 hours post dose.
In a pooled analysis of three placebo-controlled double-blind phase III studies, involving 1369 children with seasonal allergic rhinitis aged 6 to 11 years, Fexofenadine hydrochloride at 30 mg twice daily was significantly better than placebo in reducing total symptom score (p=0.0001). All individual component symptoms including rhinorrhea (p=0.0058), sneezing (p=0.0001), itchy/ watery/red eyes (p=0.0001), itchy nose/ palate and throat (p=0.0001), and nasal congestion (p=0.0334) were significantly improved by fexofenadine hydrochloride.
In children aged 6 to 11 years, no significant differences in QTc were observed following up to 60 mg Fexofenadine hydrochloride twice daily for two weeks compared with placebo. No significant differences in QTc intervals were observed in adult and adolescent patients with seasonal allergic rhinitis, when given Fexofenadine hydrochloride up to 240 mg twice daily for 2 weeks when compared with placebo. Also, no significant change in QTc intervals was observed in healthy adult 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 with 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.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. In children, the mean Cmax value was approximately 128 ng/ml following a single dose oral administration of 30 mg Fexofenadine hydrochloride.
A dose of 30 mg BID was determined to provide plasma levels (AUC) in paediatric patients which are comparable to those achieved in adults with the approved adult regimen of 120 mg once daily.
\*\*Distribution\*\*
After oral administration in adults, 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.
## Pharmaceutical Particulars
6.1 List of excipients
\*\*Tablet core:\*\*
Microcrystalline Cellulose
Pregelatinised Starch
Croscarmellose Sodium
Magnesium Stearate
\*\*Film coat:\*\*
Hypromellose
Povidone
Titanium Dioxide (E171)
Colloidal Anhydrous Silica
Macrogol
Pink Iron oxide (E172) blend
Yellow Iron oxide (E172) blend6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
This medicinal product does not require any special storage condition6.5 Nature and contents of container
PVC/PE/PVDC/Al blisters packaged into cardboard boxes. 1, 2, 4, 8, 10 or 15 (sample only); 20, 30, 40, 50, 60 and 100 tablets per package.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements
