Active ingredients: Fexofenadine (Fexofenadine hydrochloride)
Fexofenadine Mylan Generics 120 mg film-coated tablets
Fexofenadine Mylan Generics 180 mg film-coated tablets
Why is Fexofenadine used - Generic Drug? What is it for?
Fexofenadine Mylan Generics contains fexofenadine hydrochloride which is an antihistamine.
Fexofenadine Mylan Generics 120 mg tablets are used in adults and adolescents over 12 years of age to relieve symptoms of hay fever (seasonal allergic rhinitis) such as sneezing, itching, runny or stuffy nose and itchy red eyes. and weeping.
Fexofenadine Mylan Generics 180 mg tablets are used in adults and adolescents over 12 years of age to relieve symptoms resulting from long-term allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling and rashes.
Contraindications When Fexofenadine - Generic Drug should not be used
Do not take Fexofenadine Mylan Generics:
- If you are allergic to fexofenadine or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Fexofenadine - Generic Drug
Talk to your doctor or pharmacist before taking Fexofenadine Mylan Generics if:
- have liver or kidney problems
- have or have ever had heart disease, as this type of medicine can lead to a fast or irregular heartbeat
- is an elderly person
If any of these apply to you, tell your doctor before taking Fexofenadine Mylan Generics.
Interactions Which drugs or foods can modify the effect of Fexofenadine - Generic Drug
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Indigestion medicines containing aluminum or magnesium can interfere with the action of Fexofenadine Mylan Generics by decreasing the amount of the medicine absorbed. It is recommended to allow 2 hours between taking Fexofenadine Mylan Generics and this drug.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after concomitant administration of erythromycin or ketoconazole appears to be due to an increase in gastrointestinal absorption and a decrease in biliary excretion or gastrointestinal secretion, respectively.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Fexofenadine Mylan Generics if you are pregnant unless clearly necessary. Fexofenadine Mylan Generics is not recommended while breastfeeding.
Driving and using machines
Fexofenadine Mylan Generics is unlikely to affect the ability to drive or use machines. However, you must check that the tablets do not make you drowsy or dizzy before driving or using machines.
Dosage and method of use How to use Fexofenadine - Generic Drug: Posology
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
For adults and adolescents over 12 years of age:
Fexofenadine Mylan Generics 120 mg tablets: The recommended dose is one tablet (120 mg) per day. Take your tablet with water before a meal.
Fexofenadine Mylan Generics 180 mg tablets: The recommended dose is one tablet (180 mg) per day. Take your tablet with water before a meal.
If you forget to take Fexofenadine Mylan Generics
Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time, as prescribed by your doctor.
If you stop taking Fexofenadine Mylan Generics
Tell your doctor if you want to stop taking Fexofenadine before finishing treatment. If you stop taking Fexofenadine sooner than expected, your symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken an overdose of Fexofenadine - Generic Drug
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Symptoms of an overdose in adults are dizziness, sleepiness, tiredness and dry mouth.
Side Effects What are the side effects of Fexofenadine - Generic Drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Fexofenadine Mylan Generics if you experience:
- swelling of the face, lips, tongue or throat and difficulty in breathing as these may be signs of a severe allergic reaction.
Common side effects (may affect up to 1 in 10 people):
- headache
- drowsiness
- malaise (nausea)
- dizziness
Uncommon side effects (may affect up to 1 in 100 people):
- tiredness.
Other side effects (frequency not known: cannot be estimated from the available data) that may occur are:
- difficulty sleeping (insomnia)
- sleep disorders
- nightmares
- nervousness
- fast and irregular heartbeat
- diarrhea
- rash and itching
- urticaria
- severe allergic reaction which can cause swelling of the face, lips, tongue or throat, redness, tightness in the chest and difficulty in breathing.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "www.agenziafarmaco.it/it/responsabili". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Fexofenadine Mylan Generics contains
The active ingredient is fexofenadine hydrochloride.
Each Fexofenadine Mylan Generics 120 mg tablet contains 120 mg of fexofenadine hydrochloride.
The excipients are:
- Tablet core: microcrystalline cellulose, croscarmellose sodium, corn starch, povidone, magnesium stearate.
- Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, macrogol 4000, yellow iron oxide (E 172) and red iron oxide (E 172).
Each Fexofenadine Mylan Generics 180 mg tablet contains 180 mg of fexofenadine hydrochloride.
The excipients are:
- Microcrystalline cellulose, croscarmellose sodium, corn starch, povidone, magnesium stearate.
- The coating contains hypromellose (E 464), titanium dioxide (E 171), macrogol 400, macrogol 4000, and yellow iron oxide (E 172).
What Fexofenadine Mylan Generics looks like and contents of the pack
Fexofenadine Mylan Generics 120 mg tablets: biconvex, oblong, peach-colored, film-coated tablets without scoring on the sides.
Fexofenadine Mylan Generics 180 mg Tablets: Yellow, oblong, biconvex film-coated tablets with central score line on one side.
Fexofenadine Mylan Generics is available in packs of 2, 7, 10, 15, 20, 30, 50, 100 or 200 tablets. Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FEXOFENADINA MYLAN GENERICS 120 MG, TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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.
03.0 PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated, biconvex, oblong, peach-colored, unmarked tablets on the sides.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Fexofenadine Mylan Generics 120 mg is indicated in adults and children over 12 years for the relief of symptoms associated with seasonal allergic rhinitis.
04.2 Posology and method of administration
Dosage
Adults
The recommended dose for adults is 120 mg once a day, taken before meals.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
Pediatric population
Children over 12 years of age
The recommended dose of fexofenadine hydrochloride for children over the age of 12 is 120 mg once daily, taken before meals.
Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 120 mg have not been studied in children below 12 years of age.
In children 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablets is the appropriate formulation for administration and dosage in this population.
Special populations
Studies performed in groups of patients at risk (elderly, patients with renal or hepatic impairment) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1)
04.4 Special warnings and appropriate precautions for use
As with most new medicines, data in elderly subjects and in patients with impaired renal or hepatic function are limited. Fexofenadine hydrochloride should be administered with caution to such groups of subjects.
Patients with a history of ongoing cardiovascular disease should be advised that antihistamines belong to a category of drugs that have been associated with adverse reactions such as tachycardia and palpitations (see section 4.8).
04.5 Interactions with other medicinal products and other forms of interaction
Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products at the level of hepatic mechanisms.
Co-administration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to increase the plasma levels of fexofenadine by 2-3 fold.
These changes were not accompanied by any effect on the QT interval and were not associated with any increase in adverse reactions when compared with the medicinal products administered individually.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after concomitant treatment with erythromycin or ketoconazole appears to be due to an increase in gastrointestinal absorption and a decrease in bile secretion or gastrointestinal secretion, respectively.
No interaction was observed between fexofenadine and omeprazole. However, administration of an antacid containing aluminum and magnesium hydroxide gels 15 minutes before fexofenadine hydrochloride, causing a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to wait 2 hours between administration of fexofenadine hydrochloride and antacids containing aluminum and magnesium hydroxide.
04.6 Pregnancy and breastfeeding
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 pregnancy, embryonal / fetal development, parturition or postnatal development (see section 5.3).
Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
Feeding time
There are no data on the concentration in breast milk after administration of fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers, fexofenadine was found to pass into breast milk. Therefore fexofenadine hydrochloride is not recommended in mothers who breastfeed their infants.
04.7 Effects on ability to drive and use machines
Based on the pharmacodynamic profile and reported adverse reactions, fexofenadine hydrochloride tablets are unlikely to affect the ability to drive or use machines. In objective tests, Fexofenadine Mylan Generics was shown to have no significant effect on central nervous system function. This means that patients can drive or perform tasks that require concentration.
However, in order to identify sensitive people who may have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complex tasks.
04.8 Undesirable effects
The following frequency class was used when applicable:
Very common ≥ 1/10; Common ≥ 1/100 e
Within each frequency group, undesirable effects are presented in order of decreasing severity.
In adults, the following undesirable effects were reported in clinical trials, with an "incidence similar to that seen with placebo:
Nervous system disorders
common: headache, somnolence, 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 monitoring. How often they occur is not known (cannot be estimated from the available data):
Disorders of the immune system
Hypersensitivity reactions with manifestations of angioedema, chest tightness, dispnea, redness and systemic anaphylaxis.
Psychiatric disorders
THEsleeplessness, nervousness, sleep disturbances or altered nightmares / dreams (paronyria)
Cardiac pathologies
Tachycardia, palpitations
Gastrointestinal disorders
Diarrhea
Skin and subcutaneous tissue disorders
Skin rashes, hives, itching.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Dizziness, somnolence, fatigue and dry mouth have been reported following overdose with 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 causing clinically significant adverse reactions when compared with the placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established.
Standard measures for the removal of the unabsorbed medicinal product should be considered.
Supportive and symptomatic treatment is recommended. Hemodialysis does not effectively remove fexofenadine hydrochloride from the blood.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines for systemic use.
ATC code: R 06 AX 26.
Mechanism of action: fexofenadine hydrochloride is a non-sedating anti-H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.
Clinical efficacy and safety
In men, studies of skin exacerbation with histamine (wheal and erythema) following single or twice daily administration of fexofenadine hydrochloride have shown that the antihistamine effect of the drug occurs within one "hour, reaching the maximum level. at the sixth hour and lasting for 24 hours. There was no evidence of tolerance to these effects after 28 days of treatment. A positive dose-response relationship was detected with oral doses ranging from 10 mg to 130 mg. In this activity model antihistamine, doses of at least 130 mg were found to be required to achieve a consistent effect that was maintained for more than 24 hours. The maximum inhibition of the wheal and erythema area 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 patients with seasonal allergic rhinitis treated with fexofenadine hydrochloride at doses up to 240 mg twice daily for 2 weeks compared to those treated with placebo. In addition, no significant changes in QTC intervals were detected in healthy subjects administered fexofenadine hydrochloride at doses 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, compared to those given placebo.
Fexofenadine at concentrations 32 times higher than the therapeutic concentration in humans had no effect on the delayed rectification K + channel cloned from human heart.
Fexofenadine hydrochloride (5-10 mg / kg orally) inhibited antigen-induced bronchospasm in sensitized guinea pigs, as well as histamine release from peritoneal mast cells at concentrations above therapeutic (10-100 μM).
05.2 Pharmacokinetic properties
Absorption
Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with a Tmax occurring approximately 1-3 hours after administration. The mean Cmax value was approximately 427 ng / mL following administration of 120 mg once daily.
Distribution
Fexofenadine is 60-70% bound to plasma proteins.
Biotransformation and elimination
Metabolization (hepatic and non-hepatic) is negligible since it was the only relevant compound identified in the urine and faeces of both animals and humans. The plasma concentration profile of fexofenadine follows a bi-exponential decline with a final elimination half-life after repeated administration ranging from 11-15 hours. Both single and repeated dose pharmacokinetics are linear up to doses of 120 mg twice daily. A dose of 240 mg, twice daily, produced a slightly higher than non-proportional (8.8%) increase in the area under the steady-state curve indicating that the pharmacokinetics of fexofenadine are practically linear at doses between 40 and 240 mg taken daily.The major route of elimination is believed to be biliary secretion, while up to 10% of the dose taken is eliminated unchanged in the urine.
05.3 Preclinical safety data
The dog tolerated 450 mg / kg administered twice daily for 6 and showed no manifestation of toxicity except sporadic emesis. In addition, in the single dose studies in dogs and rodents, no treatment-related gross findings were observed after necropsy.
Tissue distribution studies in rats treated with labeled fexofenadine hydrochloride indicated that fexofenadine does not cross the blood-brain barrier.
Various mutagenicity tests in vitro and in vivo have documented that fexofenadine hydrochloride does not exhibit mutagenic properties.
The carcinogenic potential of fexofenadine hydrochloride was assessed using studies with terfenadine with the help of supportive pharmacokinetic studies, which documented exposure to fexofenadine hydrochloride (by means of plasma AUC values). No signs of carcinogenesis were detected in rats and mice treated with terfenadine (up to 150 mg / kg / day)
In a reproductive toxicity study in mice, fexofenadine hydrochloride did not impair fertility, did not demonstrate teratogenic action, and did not alter pre- or postnatal development.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Core of the tablet
Microcrystalline cellulose
Croscarmellose sodium
Cornstarch
Povidone
Magnesium stearate
Coating film
Hypromellose (E 464)
Titanium dioxide (E 171)
Macrogol 400
Macrogol 4000
Iron oxide, yellow (E 172)
Iron oxide, red (E 172)
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
PVC / PVDC / Al blisters in cardboard box.
2, 7, 10, 15, 20, 30, 50, 100 or 200 (10 x 20) tablets per pack.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milan, Italy
08.0 MARKETING AUTHORIZATION NUMBER
120 mg film-coated tablets 7 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223018 / M
120 mg film-coated tablets 10 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223020 / M
120 mg film-coated tablets 15 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223032 / M
120 mg film-coated tablets 20 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223044 / M
120 mg film-coated tablets 30 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223057 / M
120 mg film-coated tablets 50 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223069 / M
120 mg film-coated tablets 100 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223071 / M
120 mg film-coated tablets 200 tablets in PVC / PVDC / AL blister - A.I.C. n. 038223083 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
November 2008
