Інструкція із застосування FLUJERAL
Зміст інструкції
FLUGERAL 5 mg hard capsules 20 capsules, 5 mg hard capsules 30 capsules, 5 mg hard capsules 50 capsules, 10 mg hard capsules 20 capsules, 10 mg hard capsules 30 capsules, 10 mg hard capsules 50 capsules
flunarizine
COMPOSITION
Each 5 mg hard capsule contains.
Active ingredient
flunarizine dihydrochloride 5.9 mg
(corresponding to flunarizine 5 mg)
Excipients
Lactose, talc
Capsule constituents:
gelatin, titanium dioxide (E 171), iron oxide (E 172)
Each 10 mg hard capsule contains.
Active ingredient
flunarizine dihydrochloride 11.8 mg
(corresponding to flunarizine 10 mg)
Excipients
Lactose, talc
Capsule constituents:
gelatin, titanium dioxide (E 171), iron oxide (E 172)
PHARMACEUTICAL FORM AND CONTENT
Hard capsules
Pack of 20 – 30 - 50 hard capsules of 5 mg in blisters
Pack of 20 – 30 - 50 hard capsules of 10 mg in blisters
PHARMACOTHERAPEUTIC CATEGORY
Anti-vertigo preparation.
MARKETING AUTHORISATION HOLDER
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - Milan
PRODUCER AND FINAL CHECKER
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - Milan
THERAPEUTIC INDICATIONS
Prophylactic treatment of migraine with frequent and severe attacks limited to
patients who have not responded to other therapies or in whom such therapies have caused
serious side effects.
CONTRAINDICATIONS
Flunarizine is contraindicated in patients with:
- current depressive illness or a positive history of recurrent depression (see “Precautions for use” and “Undesirable effects”)
- pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders (see “Precautions for use” and “Undesirable effects”)
- known hypersensitivity to flunarizine or to any of the excipients contained in the formulation.
PRECAUTIONS FOR USE
Flunarizine may cause extrapyramidal and depressive symptoms and highlight
parkinsonism, especially in elderly patients. Therefore, in such patients it must be
used with caution.
The recommended doses must not be exceeded. Patients should be evaluated
at regular intervals, especially during maintenance therapy, so that
extrapyramidal or depressive symptoms can be detected early and, if
present, treatment can be discontinued. This control must be particularly careful
in elderly patients.
In rare cases, asthenia may increase progressively during therapy with flunarizine.
In these cases, therapy should be discontinued.
Any loss of efficacy of the drug during the maintenance phase requires
suspension of therapy (for the duration of treatment see "Dosage, method and
time of administration").
Lactose
Flunarizine capsules contain lactose monohydrate. Patients with rare hereditary
galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use during pregnancy and breastfeeding
Pregnancy
There are no data on the use of flunarizine in pregnant women. Studies in animals
do not indicate any direct or indirect harmful effects related to pregnancy, embryonic/fetal development,
delivery or postnatal development. As a precaution, it is preferable
to avoid using flunarizine during pregnancy.
Breastfeeding
It is not known whether flunarizine is excreted in human milk. Studies in animals have
documented the excretion of flunarizine in breast milk. The decision to discontinue or
not discontinue breastfeeding or to continue/discontinue therapy with flunarizine should be
made considering the benefit of breastfeeding for the child and the benefit
of therapy for the woman.
INTERACTIONS
Tell your doctor or pharmacist if you have recently taken any other
medicines, even those without a prescription.
The concomitant use of flunarizine with alcohol, hypnotics, tranquillizers or other
psychotropic drugs may cause excessive sedation.
It is advisable not to drink alcoholic beverages during therapy.
The pharmacokinetics of flunarizine are not modified by topiramate. Following repeated
doses administered to migraine patients, systemic exposure to flunarizine is
increased by 14%. When flunarizine is administered in combination with topiramate
50 mg every 12 hours, repeated dosing resulted in a 16% increase in systemic exposure to flunarizine. The pharmacokinetics of topiramate at steady state are not modified by flunarizine.
Chronic administration of flunarizine does not modify the bioavailability of phenytoin,
carbamazepine, valproate or phenobarbital. Plasma concentrations of flunarizine
were generally lower in epileptic patients taking these
antiepileptic drugs, compared to healthy subjects who were administered similar doses.
The protein binding of carbamazepine, valproate and phenytoin is not
modified by the concomitant administration of flunarizine.
SPECIAL WARNINGS
Ask your doctor for advice before taking any medicine.
Effects on the ability to drive and operate machinery.
As drowsiness may occur, especially at the beginning of treatment, caution should be
exercised during activities such as driving vehicles or operating dangerous machinery.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
Migraine prophylaxis
Attack therapy:
In patients under 65 years of age, treatment should be started at a dose of 10 mg at
nighttime; in patients over 65 years of age this
dosage should be reduced to 5 mg.
If depression, extrapyramidal signs or other
serious side effects appear during this phase of treatment, treatment should be discontinued.
If no significant improvements are observed after two months, patients should be
considered refractory to therapy and the administration of the drug should be
interrupted.
Maintenance therapy:
If the patient responds satisfactorily, and if maintenance therapy is considered necessary, the dose
daily should be reduced and administered on alternate days
or for 5 consecutive days with a two-day break each week. Even if
prophylactic treatment is effective and well tolerated, it should be discontinued after
six months and can only be resumed in case of relapse.
OVERDOSE
In cases of accidental ingestion/intake of an excessive dose of Fluferal, immediately warn
the doctor or go to the nearest hospital.
Based on the pharmacological characteristics of the drug, in case of overdose it is
likely to occur sedation and asthenia. Cases of acute overdose have been reported
(up to 600 mg in a single intake) and the observed symptoms were sedation,
agitation and tachycardia. Treatment of acute overdose consists of
administration of activated charcoal, induction of vomiting or gastric lavage and
supportive measures. No specific antidote is known.
If you have any doubts about the use of Flugeral, contact your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Flugeral can cause side effects, although not everyone
will experience them.
The safety of flunarizine has been evaluated in 247 subjects treated with flunarizine who
participated in two clinical studies controlled with placebo in the treatment of vertigo
and migraine, respectively, and in 476 subjects treated with flunarizine who participated in
two clinical studies controlled with comparator drug in the treatment of
vertigo and/or migraine. Based on the aggregated safety data from these clinical studies, the
most commonly reported adverse effects (incidence ≥ 4%) are (% incidence):
weight gain (11%), drowsiness (9%), depression (5%), increased appetite (4%)
and rhinitis (4%).
The following adverse effects, including those listed above, have been reported with the use of
flunarizine both in clinical studies and after marketing. Adverse effects
are listed by frequency using the following convention:
Very common ≥ 1/10
Common ≥ 1/100 to <1/10
Uncommon ≥ 1/1000 to <1/100
Rare ≥ 1/10000 to <1/1000
Very rare <1/1000
Not known (frequency cannot be estimated on the basis of available data)
Very common:
- Weight gain.
Common:
- Rhinitis
- Increased appetite
- Depression, insomnia
- Drowsiness
- Constipation
- Stomach disorders
- Nausea
- Myalgia
- Menstrual irregularities
- Breast pain
- Fatigue.
Uncommon:
- Depressive symptoms
- Sleep disorders
- Apathy
- Anxiety
- Coordination anomalies
- Disorientation
- Lethargy
- Paresthesia
- Restlessness
- Lack of energy
- Tinnitus
- Torticollis
- Palpitations
- hypotension
- Intestinal obstruction
- Dry mouth
- Gastrointestinal disorders
- Hyperhidrosis
- Muscle spasms
- Muscle contractions
- Menorrhagia
- Menstrual disorders
- Oligomenorrhea
- Breast enlargement
- Decreased libido
- Generalized edema
- Peripheral edema
- Asthenia.
Not known frequency:
- Acatisia
- Increased liver transaminase levels
- Bradykinesia
- cogwheel rigidity
- Dyskinesia
- Essential tremor
- Extrapyramidal disorders
- Parkinsonism
- Sedation
- Tremor
- Erythema
- Muscle rigidity
- Galactorrhea.
undesirable.
.
Reporting of adverse reactions
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date reported on the packaging.
The period of validity refers to the product in intact packaging, correctly
stored.
ATTENTION:: do not use the medicine after the expiry date indicated on the
packaging.
Keep the medicine out of reach of children.

- Країна реєстрації
- Лікарська формаHard capsule, 5 MG
- Код АТХN07CA03
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до FLUJERALЛікарська форма: Hard capsule, 5 MGДіюча речовина: flunarizineВиробник: VISUFARMA S.P.A.Потрібен рецептЛікарська форма: Hard capsule, 10 MGДіюча речовина: flunarizineВиробник: FIDIA FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Hard capsule, 5 MGДіюча речовина: flunarizineВиробник: POLIFARMA S.P.A.Потрібен рецепт
Аналоги FLUJERAL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог FLUJERAL у Польща
Аналог FLUJERAL у Іспанія
Аналог FLUJERAL у Україна
Лікарі онлайн щодо FLUJERAL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на FLUJERAL онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
FLUJERAL потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FLUJERAL — flunarizine. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FLUJERAL виробляється компанією ITALFARMACO S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування FLUJERAL з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати FLUJERAL у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (flunarizine) включають FLUNAJEN, FLUXARTEN, GRADIENT POLIFARMA. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















