Zero p 100 mg film tablet инструкция на русском

Топ 20 лекарств с такими-же компонентами:

Топ 20 лекарств с таким-же применением:

Внутрь. Таблетки необходимо рассасывать в полости рта до полного растворения. При рассасывании следует перемещать таблетку по всей полости рта во избежание повреждения слизистой оболочки в месте рассасывания.

Рекомендуется применять взрослым и детям старше 12 лет по 1 табл. по мере необходимости. Не следует употреблять более 5 табл. в течение 24 ч. Не следует принимать таблетки более 3 дней.

повышенная чувствительность к любому из компонентов препарата;

язвенная болезнь желудка (обострение);

бронхиальная астма и ринит на фоне приема ацетилсалициловой кислоты или других НПВС;

дефицит глюкозо-6-фосфатдегидрогеназы;

беременность;

период лактации;

детский возраст (до 12 лет).

С осторожностью: гипербилирубинемия (в т.ч. синдром Жильбера, Дубина-Джонсона и Ротора); хроническая недостаточность кровообращения; отеки; артериальная гипертензия; гемофилия; гипокоагуляция; язвенная болезнь желудка или двенадцатиперстной кишки (в стадии ремиссии, в анамнезе); печеночная и/или почечная недостаточность; снижении свертываемости крови; угнетении костномозгового кроветворения; снижении слуха; патологии вестибулярного аппарата. При назначении лицам пожилого возраста, применение препарата возможно только после консультации с лечащим врачом.

Побочные реакции, касающиеся применения препарата Стрепсилс^® Интенсив, связаны в основном с искажением вкусовых восприятий и элементами парестезии (жжение, покалывание или пощипывание). Возможно изъязвление слизистой ротовой полости. Нежелательные побочные эффекты, свойственные препаратам группы НПВС, могут наблюдаться при приеме препарата внутрь в дозе 50–100 мг 2–3 раза в сутки (12–30 табл. Стрепсилс^® Интенсив в день).

Со стороны ЖКТ: диспепсия (тошнота, рвота, изжога, диарея), НПВС — гастропатия, абдоминальные боли, нарушение функции печени; при длительном применении в больших дозах — изъязвление слизистой оболочки ЖКТ, кровотечение (желудочно-кишечное, десневое, геморроидальное).

Со стороны ССС: повышение АД, тахикардия, сердечная недостаточность.

Со стороны органов кроветворения: редко — анемия (железодефицитная, гемолитическая, апластическая), агранулоцитоз, лейкопения, тромбоцитопения.

Со стороны нервной системы: головная боль, головокружение, сонливость или бессонница, астения, депрессия, амнезия, тремор, возбуждение; редко — атаксия, парестезии, нарушение сознания.

Со стороны мочевыделительной системы: тубулоинтерстициальный нефрит, отечный синдром, нарушение функции почек.

Аллергические реакции: кожная сыпь, зуд, крапивница, бронхоспазм, фотосенсибилизация, отек Квинке, анафилактический шок.

Прочие: снижение слуха, шум в ушах, усиление потоотделения.

Симптомы: при приеме 1 г — сонливость; более 1,5 г — возбуждение; 2,5–4 г — тошнота, головная боль, головокружение, боли в эпигастрии, диплопия, миоз, гипотонус; более 4 г — угнетение сознания вплоть до комы. При передозировке прием препарата следует прекратить.

Лечение: симптоматическое.

Механизм действия флурбипрофена связан с ингибированием ферментов ЦОГ-1 и ЦОГ-2 с последующим угнетением синтеза ПГ — медиаторов боли. Оказывает противовоспалительное и анальгезирующее действие. Препарат не обладает противомикробным действием.

Действие препарата наступает через 30 мин после начала рассасывания таблетки в полости рта и продолжается в течение 2–3 ч.

• Нестероидный противовоспалительный препарат (НПВП) [НПВС — Производные пропионовой кислоты]

Источники:

• https://www.drugs.com/search.php?searchterm=zero-p
• https://pubmed.ncbi.nlm.nih.gov/?term=zero-p

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For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains.

Flurbiprofen is also indicated for its analgesic effect in the relief of mild to moderate pain in conditions such as dental pain, post-operative pain, dysmenorrhoea and migraine.

For oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults:

150 to 200 mg daily in two, three or four divided doses. In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg in divided doses.

For dysmenorrhoea, a dosage of 100 mg may be administered at the start of symptoms followed by 50 or 100 mg given at four- to six-hour intervals. The maximum total daily dosage should not exceed 300 mg.

Children:

Not recommended for use in children under 12 years.

Elderly:

The elderly are at increased risk of the serious consequences of adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be used with caution and dosage should be assessed individually.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Flurbiprofen is contraindicated in patients with hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the inactive ingredients.

Flurbiprofen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to flurbiprofen, aspirin or other NSAIDs.

Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Flurbiprofen should not be used in patients with active, or history of, ulcerative colitis, Crohn’s disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).

Flurbiprofen is contraindicated in patients with severe heart failure, hepatic failure and renal failure.

Flurbiprofen is contraindicated during the last trimester of pregnancy.

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactose deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medication.

The use of flurbiprofen with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential for additive effects.

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation has been reported with all NSAIDs at any time during treatment.).

Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.

Respiratory disorders

Caution is required if flurbiprofen is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, renal and hepatic impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.).

Flurbiprofen should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with flurbiprofen administration.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with flurbiprofen administration and NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke.).

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

Haematological effects

Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Flurbiprofen should be used with caution in patients with a potential for abnormal bleeding.

Impaired female fertility

The use of flurbiprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of flurbiprofen should be considered.

Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following flurbiprofen administration. Less frequently, gastritis, has been observed. Pancreatitis has been reported very rarely.

Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).

Cardiac disorders and Vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Respiratory, thoracic and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, dyspnoea).

Other adverse events reported less commonly and for which causality has not necessarily been established include:

Blood and lymphatic system disorders: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Psychiatric disorders: Depression, confusional state, hallucination

Nervous system disorders: Cerebrovascular accident, optic neuritis, headache, paraesthesia, dizziness, and somnolence.

Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation).

Eye disorders: Visual disturbance

Ear and labyrinth disorders: Tinnitus, vertigo

Hepatobiliary disorders: Abnormal liver function, hepatitis and jaundice.

Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritis, urticaria, purpura and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme) and photosensitivity reaction.

Renal and urinary disorders: Toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

General disorders and administration site conditions: Malaise, fatigue

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 directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Symptoms

Symptoms of overdosage may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.

Flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 90 minutes after ingestion. It is about 99% protein-bound and has an elimination half-life of about three to four hours.

The rate of urinary excretion of flurbiprofen and its two major metabolites ([2-(2-fluoro-4′-hydroxy-4-biphenylyl) propionic acid] and [2-(2-fluoro-3′-hydroxy-4′-methoxy-4-biphenylyl) propionic acid]) in both free and conjugated states is similar for both the oral and rectal routes of administration. Metabolic patterns are quantitatively similar for both routes of administration.

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Страна: Турция

Язык: турецкий

Источник: TİTCK (Türkİye İlaç Ve Tibbİ Cİhaz Kurumu)

Активный ингредиент:

flurbiprofen

Доступна с:

DEVA HOLDİNG A.Ş.

код АТС:

M01AE09

ИНН (Международная Имя):

flurbiprofen

Тип рецепта:

Normal

Терапевтические области:

Celebrex

Статус Авторизация:

Aktif

Дата Авторизация:

2009-10-16

тонкая брошюра

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KULLANMA TALİMATI
ZERO-P 100 MG FILM KAPLI TABLET
AĞIZDAN ALINIR.
_ETKIN MADDE:_ Her bir film kaplı tablet_ _100 mg flurbiprofen
içermektedir.
_YARDIMCI _
_MADDE(LER): _
Laktoz
monohidrat
(inek
sütünden
üretilir),
magnezyum
stearat,
mikrokristal
selüloz
pH
101,
mikrokristal
selüloz
pH
102,
koloidal
silikon
dioksit,
kroskarmeloz sodyum,
hidroksi propil metil selüloz, opadry
II mavi 32K20439 (laktoz
monohidrat (sığır sütünden üretilir), hidroksi propil metil
selüloz, titanyum dioksit, triasetin,
FD&C mavi #2 indigo karmin alüminyum lake, sarı demir oksit)
_ _
BU
ILACI
KULLANMAYA
BAŞLAMADAN
ÖNCE
BU
KULLANMA
TALİMATINI
DIKKATLICE
OKUYUNUZ, ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER IÇERMEKTEDIR.

• _Bu kullanma talimatını saklayınız. Daha sonra tekrar okumaya
ihtiyaç duyabilirsiniz. _

• _Eğer ilave sorularınız olursa, lütfen doktorunuza veya
eczacınıza danışınız. _

• _Bu ilaç kişisel olarak sizin için reçete edilmiştir,
başkalarına vermeyiniz. _

• _ Bu ilacın kullanımı sırasında, doktora veya hastaneye
gittiğinizde doktorunuza bu ilacı _
_kullandığınızı söyleyiniz. _

• _Bu talimatta yazılanlara aynen uyunuz. İlaç hakkında size
önerilen dozun dışında YÜKSEK _
_VEYA DÜŞÜK doz kullanmayınız. _
_ _
BU KULLANMA TALIMATINDA:
_1._
_ _
_ZERO-P NEDIR VE NE IÇIN KULLANILIR? _
_2._
_ _
_ZERO-P’YI KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER _
_3._
_ _
_ZERO-P NASIL KULLANILIR? _
_4._
_ _
_OLASI YAN ETKILER NELERDIR? _
_5._
_ _
_ZERO-P’NIN SAKLANMASI _
BAŞLIKLARI YER ALMAKTADIR.
1. ZERO-P NEDIR VE NE IÇIN KULLANILIR?
ZERO-P mavi renkli film kaplı tablettir. Her bir film kaplı tablet,
100 mg flurbiprofen içeren
15 ve 30 tabletlik blister ambalajlarda kullanıma sunulmuştur.
ZERO-P çeşitli ağrıları ortadan kaldırmak ya da hafifletmek
amacı ile kullanılan steroid
olmayan antiinflamatuvar ilaçlar (NSAİİ) olarak bilinen grupta yer
alır.
ZERO-P,

Eklemlerde ağrı, şişlik ve şekil bozukluğuna neden olan d
                                
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Характеристики продукта

                                1 / 17
KISA ÜRÜN BİLGİSİ
1. BEŞERİ TIBBİ ÜRÜNÜN ADI
ZERO-P 100 mg film kaplı tablet
2. KALİTATİF VE KANTİTATİF BİLEŞİMİ
Her bir tablet;
ETKEN MADDE:
Flurbiprofen
100 mg
YARDIMCI MADDELER:
Laktoz monohidrat (inek sütünden üretilir)
100 mg
Laktoz monohidrat (sığır sütünden üretilir)
4,8 mg
Yardımcı maddeler için, Bkz. 6.1
3. FARMASÖTİK FORM
Film kaplı tablet;
Mavi renkli, oblong tabletler.
4 . KLİNİK ÖZELLİKLERİ
4.1 TERAPÖTIK ENDIKASYONLAR
Romatoid artrit, osteoartrit ve ankilozan spondilit belirti ve
bulgularının tedavisi ile akut kas
iskelet sistemi ağrıları, akut gut artriti ve dismenore tedavisinde
endikedir.
4.2 POZOLOJI VE UYGULAMA ŞEKLI
POZOLOJI/UYGULAMA SIKLIĞI VE SÜRESI:
Diğer nonsteroid antiinflamatuvar ilaçlarda (NSAİİ) olduğu gibi,
istenmeyen etkileri en aza
indirebilmek için, her hastaya en düşük doz verilmeye
çalışılmalıdır. Bu nedenle, ZERO-P ile
yapılan başlangıç tedavisi gözlenerek doz ve sıklığı her bir
hastanın ihtiyaçlarına uyacak
şekilde ayarlanmalıdır.
Tavsiye edilen günlük doz, bölünmüş dozlar halinde 200
mg’dır.
Semptomların şiddetine göre günlük doz toplam 300 mg’a
çıkarılabilir.
Romatoid
artrit
veya
osteoartrit
belirti
ve
semptomlarının
giderilmesi
için
ZERO-P’nin
tavsiye edilen dozu, günde iki veya üç defaya bölünerek
uygulanmak üzere günde 200 ila 300
mg’dır.
Adet sancılarında, semptomların başlangıcında 100 mg, bunu
takiben 4-6 saatte bir 100
mg’dır. Maksimum günlük doz 300 mg’dır.
Çoklu doz uygulamalarında tavsiye edilen en yüksek tek doz 100
mg’dır.
Yemeklerden hemen sonra, yeterli miktarda sıvı (bir bardak su) ile
alınmalıdır.
Bu belge, güvenli elektronik imza ile imzalanmıştır.
Belge Doğrulama Kodu: 1ZW56M0FyZ1AxQ3NRS3k0M0FyZW56ak1U
Belge Takip Adresi:https://www.turkiye.gov.tr/saglik-titck-ebys
2 / 17
ÖZEL POPÜLASYONLARA ILIŞKIN EK BILGILER:
PEDIYATRIK POPÜLASYON:
Çocuklarda kullanımına dair veri mevcut değildir.
GERIYATRIK POPÜLASY
                                
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