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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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FENADEX contains Fexofenadine Hydrochloride, which is an antihistamine.
FENADEX 60 and 120:
FENADEX 60 and 120 are used in adults and adolescents of 12 years and older to
relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as
sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.
FENADEX 180:
FENADEX 180 are used in adults and adolescents of 12 years and older to relieve
the symptoms that occur with long term allergic skin reactions (chronic idiopathic
urticaria) such as itching, swelling and rashes.
Do not take FENADEX:
If you are allergic to Fexofenadine or any of the other ingredients of FENADEX (see
section 6).
Take special care with FENADEX:
Talk to your doctor or pharmacist before taking FENADEX if:
□ You have problems with your liver or kidneys.
□ You have or ever had heart disease, since this kind of medicine may lead to a fast
or irregular heartbeats.
□ You are elderly.
If any of these apply to you, or if you are not sure, tell your doctor before taking
FENADEX.
Taking other medicines with FENADEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
□ Indigestion remedies containing aluminum and magnesium may affect the action of
FENADEX, by lowering the amount of medicinal product absorbed.
□ It is recommended that you leave about 2 hours between the time that you take
FENADEX and your indigestion remedy.
Pregnancy and breastfeeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take FENADEX if you are pregnant, unless necessary.
FENADEX is not recommended during breast-feeding.
Driving and using machines:
FENADEX is unlikely to affect your ability to drive to operate machinery. However, you
should check that these tablets do not make you feel sleepy or dizzy before driving or
operating machinery.
Always take FENADEX exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
For adults and children aged 12 years and over:
FENADEX 60:
The recommended dose is two tablets daily.
FENADEX 120 and 180:
The recommended dose is one tablet daily.
Take your tablet with water before a meal.
FENADEX starts to relieve your symptomps within 1 hour and lasts for 24 hours.
If you take more FENADEX than you should:
□ If you take too many tablets, contact your doctor or nearest hospital emergency
department immediately.
□ Symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry
mouth.
If you forget to take FENADEX:
□ Do not take a double dose to make up for a forgotten dose.
□ Take the next dose at the usual time as prescribed by your doctor.
If you stop taking FENADEX:
□ Tell your doctor if you want to stop taking FENADEX before you have finished your
course of treatment.
□ If you stop taking FENADEX earlier than planned, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or
pharmacist
Like all medicines, FENADEX can cause side effects, although not everybody gets
them.
Tell your doctor immediately and stop taking FENADEX if you experience:
□ Swelling of the face, lip, tongue or throat and difficulty in breathing as these may be
signs of serious allergic reaction.
Common side effect (may affect up to 1 in 10 people):
□ Headache
□ Drowsiness
□ Feeling sick (nausea)
□ Dizziness
Uncommon side effect (may affect up to 1 in 100 people):
□ Tiredness
□ Sleepiness
Additional side effects (frequency not known: cannot be estimated from the
available data) which may occur are:
□ Difficulty sleeping (insomnia)
□ Sleeping disorders
□ Bad dreams
□ Nervousness
□ Fast or irregular heart beat
□ Diarrhea
□ Skin rash and itching
□ Hives
□ Serious allergic reactions which can cause swelling of the face, lips,tongue or
throat,flushing,chest tightness and difficulty breathing.
□ Appetite increase
□ Agitation
□ Paroniria
□ Keep out of the reach and sight of children.
□ Do not store above 30°C, protected from humidity.
□ Do not use FENADEX after the expiry date which is stated on the carton and on the
blister, after (EXP).Date.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.
□ The active substance is Fexofenadine Hydrochloride. Each tablet contains 60, 120
and 180 mg of Fexofenadine Hydrochloride, respectively.
□ The other ingredients are: Lactose, Maize Starch, Croscarmellose Sodium,
Magnesium Stearate, Opadry 33G24737 Pink.
The Jordanian pharmaceutical manufacturing co.(P.L.C.|)
یحتوي فینادكس على ھھیدروكلوراید فیكسوفینادین، وھو مضاد للھستامی
: فینادكس ٦۰ و ۱۲۰
یستخدم فینادكس ٦۰ و ۱۲۰ للبالغین و المراھقین الذین تتراوح أعمارھم ما بین ۱۲ سنة فما فوق لتخفیف
الأعراض التي تحدث مع حمى الكلأ (التھاب الأنف التحسسي الموسمي) مثل العطس، الحكة، سیلان أو انسداد
الأنف وحكة، احمرار و إدماع العیون.
: فینادكس ۱۸۰
یستخدم فینادكس ۱۸۰ للبالغین و المراھقین الذین تتراوح أعمارھم ما بین ۱۲ سنة فما فوق لتخفیف الأعراض
التي تحدث مع التفاعل التحسسي للجلد طویل المدى (شرى مزمن مجھول السبب) مثل الحكة، التورم والطفح
الجلدي
موانع استعمال فینادكس:
.( إذا كنت تعاني من حساسیة لفیكسوفینادین، أو لأي من مكونات فینادكس الأخرى (انظر القسم ٦
الاحتیاطات عند استعمال فینادكس:
تحدث إلى طبیبك أو الصیدلي قبل اخذ فینادكس إذا:
كنت تعاني من مشاكل في الكبد أو الكلى. □
كنت تعاني أو عانیت سابقاً من أمراض القلب، حیث أن ھذا النوع من الأدویة قد یؤدي إلى تسارع أو عدم □
انتظام دقات القلب.
كنت من كبار السن. □
إذا كان أي من المذكور أعلاه ینطبق علیك أو إذا لم تكن متأكداً، فإن علیك إخبار طبیبك قبل تناولك فینادكس.
تناول أدویة أخرى مع فینادكس:
أخبر الطبیب أو الصیدلي إذا كنت تأخذ أو أخذت مؤخراً أو قد تأخذ أي أدویة أخرى.
علاجات عسر الھضم التي تحتوي على الألمنیوم والمغنیزیوم و التي قد تؤثر على عمل فینادكس عن طریق □
تقلیل نسبة امتصاصھ.
یوصى بترك حوالي ساعتین بین الوقت الذي تأخذ بھ فینادكس والوقت الذي تأخذ بھ علاجات عسر الھضم . □
الحمل والإرضاع:
إذا كنت حاملاً أو مرضعة، أو تعتقدي بأنك حامل أو تخططین للإنجاب، اسألي طبیبك أو الصیدلاني للحصول
على المشورة قبل تناول ھذا الدواء
لا ینصح باستخدام فینادكس أثناء عملیة الإرضاع.
قیادة السیارات واستعمال الآلات :
من غیر المحتمل أن یؤثر فینادكس في قدرتك على القیادة أو على تشغیل الآلات. بالرغم من ذلك، یجب
علیك التأكد من أن ھذه الاقراص لا تجعلك تشعر بالنعاس أو بالدوار قبل أن تقوم بقیادة السیارة أو تشغیل
الآلات.
یجب علیك الالتزام بتعلیمات الطبیب في كیفیة أخذ الدواء.
علیك مراجعة الطبیب أو الصیدلاني إذا لم تكن متأكداً.
البالغین والأطفال الذین تتراوح أعمارھم ما بین ۱۲ سنة فما فوق:
: فینادكس ٦۰
الجرعة التي ینصح بھا ھي قرصین یومیاً.
: فینادكس ۱۲۰ و ۱۸۰
الجرعة التي ینصح بھا عي قرص واحد یومیاً.
تناول قرصك مع الماء قبل الوجبة.
یبدأ فینادكس بتخفیف الاعراض خلال ساعة واحدة و یستمر لمدة ۲٤ ساعة.
إذا تناولت فینادكس أكثر مما یجب:
اذا تناولت الكثیر من أقراص فینادكس علیك التحدث إلى طبیبك أوالذھاب إلى أقرب مستشفى فوراً. □
أعراض فرط الجرعة لدى المرضى البالغین ھي دوخة و نعاس و تعب و جفاف في الفم. □
إذا نسیت تناول فینادكس:
لا تحاول مضاعفة الجرعة لتعویض الجرعة التي نسیتھا. □
انتظر حتى الجرعة التالیة الواجبة وتناولھا في نفس الوقت المقرر من قبل طبیبك. □
إذا توقفت عن تناول فینادكس:
أخبر طبیبك إذا كنت ترغب في التوقف عن تناول فینادكس قبل أن تنتھي فترة علاجك. □
إذا توقفت عن تناول فینادكس قبل الموعد المقرر، فقد تعود لك الأعراض التي كنت تعاني منھا. □
إذا كان لدیك أي أسئلة أخرى حول استخدام ھذا الدواء، اسأل طبیبك أو الصیدلي
كغیره من الأدویة، فقد یسبب فینادكس آثاراً جانبیةً، بالرغم من أنھا لا تحدث للجمیع
أخبر طبیبك فوراً وتوقف عن تناول فینادكس إذا واجھت:
تورم في الوجھ أواللسان أو الشفاه أو الحلق مع صعوبة في التنفس لأن ھذه الأعراض قد تكون علامات □
لتفاعلات حساسیة خطیرة.
الآثار الجانبیة الشائعة (قد تؤثر على شخص واحد من ۱۰ أشخاص):
الصداع □
النعاس □
الشعور بالغثیان □
الدوخة □
الآثار الجانبیة غیر شائعة (قد تؤثر على شخص واحد من ۱۰۰ شخص):
التعب □
النعاس □
آثار جانبیة أخرى ( تكرار حدوثھا غیر معروف: لا یمكن تقدیرھا من البیانات المتوفرة):
الصعوبة في النوم (الأرق) □
اضطرابات النوم □
الأحلام المزعجة □
العصبیة □
ضربات القلب السریعة أو غیر المنتظمة
الإسھال □
طفح جلدي وحكة □
الشرى □
تفاعلات حساسیة خطیرة و التي یمكن أن تسبب تورم في الوجھ أو الشفاه أو اللسان أو الحلق، توھج، □
ضیق الصدر وصعوبة في التنفس
ھیجان □
زیادة في الشھیة □
حلم مرضي(اضطراب في النوم) □
حفظ بعیداً عن متناول الأطفال. □
لا یحفظ بدرجة حرارة أعلى من ۳۰ °م، یحفظ بعیداً عن الرطوبة. □
لا ینبغي استعمال فینادكس بعد تاریخ انتھاء الصلاحیة الموجود على العلبة وعلى شریط الدواء. □
لا ینبغي التخلص من الأدویة من خلال میاه الصرف الصحي أو المنزلي. اسأل الصیدلاني عن كیفیة التخلص
من الأدویة التي لم تعد مطلوبة. سوف تساعد ھذه الإجراءات على حمایة البیئة.
المادة الفعالة ھي فیكسوفینادین ھیدروكلوراید. كل قرص یحتوي على ٦۰ و ۱۲۰ و ۱۸۰ ملغم من □
فیكسوفینادین ھیدروكلوراید على التوالي.
المكونات الأخرى ھي : لاكتوز، نشا ذرة، صودیوم كروسكارمیلوز، مغنیزیوم ستیاریت، أوبادراي □
۳۳ وردیة. G۲٤۷۳۷
ماھو
أقراص فینادكس ٦۰ ملغم ھي أقراص مغلفة وردیة اللون مسطحة ثنائیة التحدب بیضاویة منقوش علیھا □
من جھة واحدة و جلیة (غیر منقوشة) من الجھة الأخرى. " FX 60"
أقراص فینادكس ۱۲۰ ملغم ھي أقراص مغلفة وردیة اللون محززة مسطحة ثنائیة التحدب بیضاویة منقوش □
من جھة واحدة و جلیة (غیر منقوشة) من الجھة الأخرى. " FX علیھا " 120
أقراص فینادكس ۱۸۰ ملغم ھي أقراص مغلفة وردیة اللون مسطحة ثنائیة التحدب بیضاویة منقوش علیھا □
من جھة واحدة و جلیة (غیر منقوشة) من الجھة الأخرى. "FX 180"
علب تحتوي على ۳۰ قرص فینادكس ٦۰ محفوظة في أشرطة. □
علب تحتوي على ۱٥ قرص فینادكس ۱۲۰ محفوظة في أشرطة. □
علب تحتوي على ۱٥ قرص فینادكس ۱۸۰ محفوظة في أشرطة. □
المملكة العربیة السعودیة: للإبلاغ عن الأعراض الجانبیة: المركزالوطني للتیقظ والسلامة الدوائیة: ھاتف:
۰۰۹٦٦۱۱۲۰۳۸۲۲۲ ، فاكس: ۰۰۹٦٦۱۱۲۰٥۷٦٦۲ ، الخط الساخن: ۱۹۹۹۹ ، البرید الإلكتروني:
.www.sfda.gov.sa/npc : الموقع الإلكتروني ،npc.drug@sfda.gov.s
الشركة الاردنية لانتاج الادوية المساهمة العامة
Relief of symptoms associated with seasonal allergic rhinitis.
Route of administration: Oral
Paediatric population
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
q Children aged 12 years and over
The recommended dose of Fexofenadine Hydrochloride for children aged 12 years and over is 120 mg one daily taken before a meal.
Children under 12 years of age
The efficacy and safety of Fexofenadine Hydrochloride 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.
q As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine Hydrochloride should be administered with care in these special groups.
q 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).
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 Hhydrochloride and omeprazole was observed. However, the administration of 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
1-1-1 Use during 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.
1-1-2 Use during lactation
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.
1-1-3 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).
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
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).
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
Saudi Arabia: To report any side effect(s): National Pharmacovigilance
and Drug Safety Center (NPC):
Call NPC at +966-11-2038222, Exts: 2317- 2356- 2340,
Fax: +966-11-205-7662, E-mail: npc.drug@sfda.gov.sa, Reporting hotline:
19999, Website:www.sfda.gov.sa/npc
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
1-1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for systemic use
ATC Code: R06A X26
Fexofenadine hydrochloride is a non-sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.
Human histamine wheal and flare studies following single and twice daily doses of Fexofenadine Hydrochloride demonstrate that the medicinal product exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours. There was 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 were 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 po) inhibited antigen induced bronchospasm in sensitised guinea pigs and inhibited histamine release at supratherapeutic concentrations (10-100 μM) from peritoneal mast cells
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.
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.
q Lactose
q Maize starch
q Croscarmellose Sodium
q Magnesium stearate
Opadry II 33G24737 Pink
Not applicable
FENADEX 120 Tablets should not be stored at a temperature above 30ºC,protected from humidity.
FENADEX 120 Tablets are packed in boxes of 15 Tablets blistered in aluminium foil
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
