FLUXARTEN 10 mg Kapsułki Twarde
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Treść ulotki
FLUXARTEN 5 mg hard capsules, 10 mg hard capsules
flunarizine
PHARMACOTHERAPEUTIC CATEGORY
Anti-vertigo preparations
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 adverse effects.
CONTRAINDICATIONS
Flunarizine is contraindicated in patients with:
- known hypersensitivity to flunarizine or to any of the excipients contained in the formulation
- current depressive illness or a positive history of recurrent depression
- pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders
PRECAUTIONS FOR USE
Extrapyramidal and depressive symptoms, parkinsonism
Flunarizine may cause extrapyramidal and depressive symptoms and highlight parkinsonism, especially
in elderly patients. Therefore, it must be used with caution in such patients.
The recommended doses must not be exceeded. Patients should be observed at regular intervals,
especially during maintenance therapy, so that extrapyramidal or depressive symptoms can
be detected early and, if present, treatment can be discontinued.
Fatigue
In rare cases, fatigue may increase progressively during therapy with flunarizine. In these cases,
therapy should be discontinued (see Undesirable Effects).
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, even those without
a prescription.
Alcohol, hypnotics or tranquilizers
The concomitant use of flunarizine with alcohol, hypnotics or tranquilizers may cause excessive
sedation.
Topiramate
The pharmacokinetics of flunarizine are not modified by topiramate. Following repeated doses administered to
migraine patients, systemic exposure to flunarizine increased by 14%. When flunarizine is
administered in conjunction 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.
Other anti-epileptic drugs
Chronic administration of flunarizine does not modify the availability of phenytoin, carbamazepine,
valproate or phenobarbital. Plasma concentrations of flunarizine were generally lower in
patients with epilepsy taking these anti-epileptic drugs, compared to healthy subjects to whom similar doses were
administered. The plasma protein binding of carbamazepine, valproate or phenytoin is not modified by the concomitant administration of flunarizine.
SPECIAL WARNINGS
Fertility
No data are available.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
As a precautionary measure, it is preferable to avoid using flunarizine during pregnancy. There are
no data on the use of flunarizine in pregnant women. Studies in animals have not shown direct or indirect harmful effects related to pregnancy, embryonic/fetal development, delivery or postnatal development.
Breast-feeding
The decision to discontinue or continue/interrupt breast-feeding or therapy with flunarizine
must be made taking into consideration the benefit of breast-feeding for the child and the benefit of
therapy for the woman.
It is not known whether flunarizine is excreted in human milk. Studies in animals have shown the excretion of
flunarizine in breast milk.
Effects on 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.
Important information about some excipients
Lactose
Flunarizine capsules contain lactose. Patients with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this
medicine.
Carmine (azorubine)
The medicine contains carmine (azorubine) which may cause allergic reactions.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Adults
Acute treatment
In patients under 65 years of age, treatment should be started at a dose of 10 mg per day (to be taken
in the evening).
If depression, extrapyramidal signs or other unacceptable adverse events occur during treatment, the
treatment must be discontinued.
If no significant improvement is observed after two months, the patient should be considered refractory
to therapy and the drug should be discontinued.
Maintenance therapy
If the patient responds satisfactorily and maintenance therapy is necessary, the same daily dose should be
used, but in this case the administration must be interrupted for two
consecutive days per week (drug-free days), for example on Saturday and Sunday. Even if
prophylactic treatment proves effective and well tolerated, it should be discontinued after six months and can be
resumed only in case of relapse.
Elderly
In patients over 65 years of age, treatment should be started at a dose of 5 mg per day (to be taken in the
evening).
Flunarizine should be used with caution in elderly patients (see Precautions for Use).
Children
Use in children and infants is not recommended.
Renal impairment
No data are available.
Hepatic impairment
No data are available.
OVERDOSE
In case of accidental ingestion of an excessive dose of FLUXARTEN, immediately notify
your doctor or go to the nearest hospital.
Symptoms and signs
Cases of acute overdose (up to 600 mg in a single dose) have been reported and the observed symptoms
were sedation, agitation and tachycardia.
Treatment
Treatment of acute overdose consists of the administration of activated charcoal, induction of
vomiting or gastric lavage and supportive measures. There is no known specific antidote.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF FLUXARTEN, ASK YOUR DOCTOR OR
PHARMACIST.
UNDESIRABLE EFFECTS
Like all medicines, FLUXARTEN can cause side effects, although not everyone gets them.
Data from clinical studies and post-marketing data
The safety of flunarizine has been evaluated in 247 subjects treated with flunarizine who participated in
two placebo-controlled clinical studies in the treatment of vertigo and migraine, respectively, and in
476 subjects treated with flunarizine who participated in two clinical studies controlled with a comparator drug in the treatment of vertigo and/or migraine. Based on 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 <1/10000
Not known (frequency cannot be estimated based on available data)
Infections and infestations
Common: rhinitis
Metabolism and nutrition disorders
Common: increased appetite
Psychiatric disorders
Common: depression, insomnia
Uncommon: depressive symptoms (see Precautions for Use) sleep disorders, anxiety, apathy
Nervous system disorders
Common: drowsiness
Uncommon: coordination abnormalities, disorientation, lethargy, paresthesia, restlessness, lack of
energy, tinnitus, torticollis
Not known: akathisia, bradykinesia, cogwheel sign, dyskinesia, essential tremor, extrapyramidal disorders, parkinsonism, sedation, tremor (see Precautions for Use)
Cardiac disorders
Uncommon: palpitations
Vascular disorders
Uncommon:hypotension
Gastrointestinal disorders
Common: constipation, stomach discomfort, nausea
Uncommon: intestinal obstruction, dry mouth, gastrointestinal disorders
Hepatobiliary disorders
Not known:increased liver transaminases
Skin and subcutaneous tissue disorders
Uncommon: hyperhidrosis
Not known: erythema
Musculoskeletal and connective tissue disorders
Common: myalgia
Uncommon: muscle spasms, muscle contractions
Not known: muscle rigidity
Reproductive system and breast disorders
Common: menstrual irregularities, breast pain
Uncommon: menorrhagia, menstrual disorders, oligomenorrhea, breast enlargement, decreased
libido
Not known: galactorrhea
General disorders and conditions related to the site of administration
Common: fatigue (see Precautions for Use)
Uncommon: generalized edema, peripheral edema, asthenia
Laboratory tests
Very common: weight gain
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. Side effects can also be reported directly through the
national reporting system at . Reporting side effects helps to provide more information about the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: Do not use the medicine after the expiry date printed on the packaging
Keep the medicine out of the sight and reach of children.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
COMPOSITION
FLUXARTEN 5 mg hard capsules
Each capsule contains:
Active ingredient:
flunarizine hydrochloride 5.9 mg (equivalent to 5 mg of flunarizine base).
Excipients: lactose, corn starch, talc, magnesium stearate, colloidal silica, azorubine (E122), iron oxide
red (E172), iron oxide black (E172), titanium dioxide (E171), gelatin.
FLUXARTEN 10 mg hard capsules
Each capsule contains:
Active ingredient:
flunarizine hydrochloride 11.8 mg (equivalent to 10 mg of flunarizine base).
Excipients: lactose, corn starch, talc, magnesium stearate, colloidal silica, azorubine (E122), indigotine
(E132), iron oxide red (E172), iron oxide black (E172), titanium dioxide (E171), gelatin.
PHARMACEUTICAL FORM AND CONTENT
Hard capsules
Pack sizes:
50 hard capsules of 5 mg
50 hard capsules of 10 mg
MARKETING AUTHORISATION HOLDER
Fidia Farmaceutici S.p.A.
Via Ponte della fabbrica, 3/A, 35031 – ABANO TERME – PADOVA (PD)
MANUFACTURER
Famar Italia S.p.A.
Via Zambeletti, 25 - Baranzate di Bollate (MI)
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 10 MG
- Kod ATCN07CA03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FLUXARTENPostać farmaceutyczna: Hard capsule, 5 MGSubstancja czynna: flunarizineProducent: ITALFARMACO S.P.A.Wymaga receptyPostać farmaceutyczna: Hard capsule, 5 MGSubstancja czynna: flunarizineProducent: VISUFARMA S.P.A.Wymaga receptyPostać farmaceutyczna: Hard capsule, 5 MGSubstancja czynna: flunarizineProducent: POLIFARMA S.P.A.Wymaga recepty
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FLUXARTEN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w FLUXARTEN jest flunarizine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FLUXARTEN jest produkowany przez FIDIA FARMACEUTICI S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie FLUXARTEN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić FLUXARTEN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (flunarizine) to m.in. FLUJERAL, FLUNAJEN, GRADIENT POLIFARMA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
