FLUXARTEN 5 mg hard capsules
FLUXARTEN 10 mg hard capsules
flunarizine
THERAPEUTIC PHARMACOLOGICAL 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 listed in the composition
active depressive illness or 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 may unmask parkinsonism, especially in elderly patients. Therefore, it should be used with caution in such patients.
Recommended doses must not be exceeded. Patients should be monitored regularly, particularly during maintenance therapy, so that extrapyramidal or depressive symptoms can be detected early and, if present, treatment discontinued.
Fatigue
In rare cases, fatigue may progressively increase during flunarizine therapy. In such cases, treatment should be discontinued (see Adverse Effects).
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Alcohol, hypnotics or tranquillisers
Concomitant use of flunarizine with alcohol, hypnotics or tranquillisers may cause excessive sedation.
Topiramate
The pharmacokinetics of flunarizine are not altered by topiramate. Following repeated doses administered to migraine patients, systemic exposure to flunarizine increased by 14%. When flunarizine is administered concomitantly with topiramate 50 mg every 12 hours, repeated dosing resulted in a 16% increase in systemic exposure to flunarizine. The steady-state pharmacokinetics of topiramate are not altered by flunarizine.
Other anti-epileptic drugs
Chronic administration of flunarizine does not alter the availability of phenytoin, carbamazepine, valproate or phenobarbital. Plasma concentrations of flunarizine have generally been lower in epileptic patients taking these anti-epileptic drugs compared to healthy subjects receiving similar doses. The protein binding of carbamazepine, valproate or phenytoin is not altered by concomitant administration of flunarizine.
SPECIAL WARNINGS
Fertility
No data available.
Pregnancy
Consult your doctor or pharmacist 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. Animal studies do not indicate direct or indirect harmful effects related to pregnancy, embryonic/fetal development, delivery or postnatal development.
Lactation
The decision whether to discontinue breastfeeding or to continue/stop treatment with flunarizine should be made taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
It is not known whether flunarizine is excreted in human milk. Animal studies have shown excretion of flunarizine in breast milk.
Effects on ability to drive and use machines
As somnolence may occur, especially at the beginning of treatment, caution should be exercised when driving vehicles or operating dangerous machinery.
Important information about certain excipients
Lactose
Flunarizine capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Carmoisine (azorubine)
The medicine contains carmoisine (azorubine) which may cause allergic reactions.
DOSAGE, ADMINISTRATION AND DURATION
Adults
Acute treatment
In patients under 65 years of age, treatment should be initiated at a dose of 10 mg daily (to be taken in the evening).
If depression, extrapyramidal signs or other unacceptable adverse events occur during treatment, therapy should be discontinued.
If no significant improvement is observed after two months, the patient should be considered non-responsive to therapy and drug administration should be stopped.
Maintenance therapy
If the patient responds satisfactorily and maintenance therapy is required, the same daily dose should be used, but administration should 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 may be restarted only in case of relapse.
Elderly
In patients over 65 years of age, treatment should be initiated at a dose of 5 mg daily (to be taken in the evening).
Flunarizine should be used with caution in elderly patients (see Precautions for Use).
Children
Use in children and neonates is not recommended.
Renal impairment
No data available.
Hepatic impairment
No data available.
OVERDOSE
In case of accidental ingestion of an excessive dose of FLUXARTEN, contact your doctor immediately or go to the nearest hospital.
Symptoms and signs
Cases of acute overdose (up to 600 mg in a single intake) have been reported, with observed symptoms including sedation, agitation and tachycardia.
Treatment
Treatment of acute overdose consists of administration of activated charcoal, induction of emesis or gastric lavage, and supportive measures. A specific antidote is not known.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF FLUXARTEN, CONSULT YOUR DOCTOR OR
PHARMACIST.
ADVERSE EFFECTS
Like all medicines, FLUXARTEN can cause adverse effects, although not everyone experiences them.
Clinical trial data and post-marketing data
The safety of flunarizine has been evaluated in 247 subjects treated with flunarizine who participated in two placebo-controlled clinical trials for the treatment of vertigo and migraine, respectively, and in 476 subjects treated with flunarizine who participated in two active comparator-controlled clinical trials for the treatment of vertigo and/or migraine. Based on the pooled safety data from these clinical trials, the most commonly reported adverse effects (incidence ≥4%) were (% incidence): weight gain (11%), somnolence (9%), depression (5%), increased appetite (4%), and rhinitis (4%).
The following adverse effects, including those mentioned above, have been reported with the use of flunarizine in both clinical trials and post-marketing experience.
Adverse effects are listed by frequency using the following convention:
Very common ≥1/10
Common from ≥1/100 to <1/10
Uncommon from ≥1/1000 to <1/100
Rare from ≥1/10,000 to <1/1000
Very rare <1/10,000
Not known (frequency cannot be estimated from the 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 disturbances, anxiety, apathy
Nervous system disorders
Common: somnolence
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 hypertrophy, decreased libido
Not known: galactorrhea
General disorders and administration site conditions
Common: fatigue (see Precautions for Use)
Uncommon: generalized edema, peripheral edema, asthenia
Investigations
Very common: weight gain
Following the instructions contained in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at the website . Reporting adverse effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see date on the packaging.
The expiry date indicated on the packaging refers to the product in its original, unopened packaging stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
Keep the medicine out of the sight and reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
COMPOSITION
FLUXARTEN 5 mg hard capsules
Each capsule contains:
Active substance:
flunarizine hydrochloride 5.9 mg (equivalent to 5 mg flunarizine base).
Excipients: lactose, maize starch, talc, magnesium stearate, colloidal silica, azorubine (E122), red iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), gelatin.
FLUXARTEN 10 mg hard capsules
Each capsule contains:
Active substance:
flunarizine hydrochloride 11.8 mg (equivalent to 10 mg flunarizine base).
Excipients: lactose, maize starch, talc, magnesium stearate, colloidal silica, azorubine (E122), indigo carmine (E132), red iron oxide (E172), black iron oxide (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)

Fluxarten