Flugeral

Italy
Brand name Flugeral
Form capsules, hard gelatin
Active substance / Dosage
FLUNARIZINE DIHYDROCHLORIDE
Prescription type Prescription only
ATC code
N07CA03
Registration number 024414
Manufacturer ITALFARMACO S.P.A.

FLUGERAL 5 mg hard capsules 20 capsules
FLUGERAL 5 mg hard capsules 30 capsules
FLUGERAL 5 mg hard capsules 50 capsules
FLUGERAL 10 mg hard capsules 20 capsules
FLUGERAL 10 mg hard capsules 30 capsules
FLUGERAL 10 mg hard capsules 50 capsules
flunarizine
COMPOSITION
Each 5 mg hard capsule contains:
Active substance:
flunarizine dihydrochloride mg 5.9
(equivalent to flunarizine mg 5)
Excipients:
Lactose, talc
Capsule constituents:
gelatin, titanium dioxide (E 171), iron oxide (E 172)

Each 10 mg hard capsule contains:
Active substance:
flunarizine dihydrochloride mg 11.8
(equivalent to flunarizine mg 10)
Excipients:
Lactose, talc
Capsule constituents:
gelatin, titanium dioxide (E 171), iron oxide (E 172)

PHARMACEUTICAL FORM AND CONTENT
Hard capsules
Pack sizes of 20 – 30 – 50 hard capsules of 5 mg in blister
Pack sizes of 20 – 30 – 50 hard capsules of 10 mg in blister

THERAPEUTIC CATEGORY
Antivertigo preparation.

MARKETING AUTHORISATION HOLDER
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - Milan

MANUFACTURER AND FINAL CONTROLLER
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 adverse effects.

CONTRAINDICATIONS
Flunarizine is contraindicated in patients with:

  • active depressive illness or 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 in the formulation.

PRECAUTIONS FOR USE
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 regularly evaluated, especially during maintenance therapy, so that extrapyramidal or depressive symptoms can be detected early and, if present, treatment discontinued. This monitoring should be particularly careful in elderly patients.
In rare cases, asthenia may progressively increase during flunarizine therapy. In such cases, treatment should be discontinued.
Any loss of drug efficacy during the maintenance phase requires discontinuation of therapy (for duration of treatment, see section "Dosage, method and duration of administration").

Lactose
Flunarizine capsules contain monohydrate lactose. Patients with rare hereditary problems of 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. Animal studies do not indicate direct or indirect harmful effects related to pregnancy, embryonic/fetal development, childbirth or postnatal development. As a precautionary measure, it is preferable to avoid using flunarizine during pregnancy.

Breastfeeding
It is not known whether flunarizine is excreted in human milk. Animal studies have documented excretion of flunarizine in breast milk. 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 mother.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Concomitant intake of flunarizine with alcohol, hypnotics, tranquillisers or other psychotropic drugs may cause excessive sedation.
Consumption of alcoholic beverages during therapy is not recommended.
The pharmacokinetics of flunarizine is not altered by topiramate. After 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 pharmacokinetics of topiramate at steady state is not altered 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 receiving similar doses. The protein binding of carbamazepine, valproate and phenytoin is not modified by concomitant administration of flunarizine.

SPECIAL WARNINGS
Ask your doctor for advice before taking any medicine.
Effects on ability to drive and use machines.
As drowsiness may occur, especially at the beginning of treatment, caution should be exercised when driving vehicles or operating dangerous machinery.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Migraine prophylaxis
Acute phase treatment:
In patients under 65 years of age, treatment should begin at a dose of 10 mg daily taken at bedtime; in patients over 65 years of age, the dosage should be reduced to 5 mg.
If depression, extrapyramidal signs or other serious adverse effects occur during this phase of treatment, therapy must be discontinued.
If no significant improvement is observed after two months, patients should be considered refractory to treatment and drug administration should be stopped.

Maintenance therapy:
If the patient responds satisfactorily and maintenance therapy is considered necessary, the daily dose should be reduced and administered on alternate days or for five consecutive days with a two-day break each week. Even if prophylactic treatment proves effective and well tolerated, it should be discontinued after six months and may only be restarted in case of relapse.

OVERDOSE
In case of accidental ingestion/overdose of Fluferal, contact your doctor immediately or go to the nearest hospital.
Based on the pharmacological characteristics of the drug, overdose is likely to result in sedation and asthenia. Cases of acute overdose (up to 600 mg in a single intake) have been reported, with observed symptoms including sedation, agitation and tachycardia. Treatment of acute overdose consists of administration of activated charcoal, induction of vomiting or gastric lavage, and supportive measures. A specific antidote is not known.
If you have any doubts about the use of Flugeral, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Flugeral can cause adverse effects, although not everyone experiences them.
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 aggregated safety data from these clinical trials, the most commonly reported adverse effects (incidence ≥ 4%) were (% incidence): weight gain (11%), drowsiness (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 both in clinical trials and post-marketing. Adverse effects are listed by frequency using the following convention:
Very common ≥ 1/10
Common ≥ 1/100 to <1/10
Uncommon ≥ 1/1,000 to <1/100
Rare ≥ 1/10,000 to <1/1,000
Very rare <1/10,000
Not known (frequency cannot be estimated from available data)

Very common:

  • Weight gain

Common:

  • Rhinitis
  • Increased appetite
  • Depression, insomnia
  • Drowsiness
  • Constipation
  • Stomach discomfort
  • Nausea
  • Myalgia
  • Menstrual irregularities
  • Breast pain
  • Fatigue

Uncommon:

  • Depressive symptoms
  • Sleep disturbances
  • Apathy
  • Anxiety
  • Coordination abnormalities
  • 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 hypertrophy
  • Decreased libido
  • Generalized edema
  • Peripheral edema
  • Asthenia

Frequency not known:

  • Akathisia
  • Increased blood levels of liver transaminases
  • Bradykinesia
  • cogwheel rigidity
  • Dyskinesia
  • Essential tremor
  • Extrapyramidal disorders
  • Parkinsonism
  • Sedation
  • Tremor
  • Erythema
  • Muscle rigidity
  • Galactorrhea

Following the instructions in the package leaflet reduces the risk of adverse effects.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse effects, you can help provide more information on the safety of this medicine.

Expiry date and storage
Expiry date: see date on the packaging.
The shelf life applies to the product in intact packaging, correctly stored.
WARNING: Do not use the medicine after the expiry date stated on the packaging.
Keep the medicine out of the reach of children.