Keep out of reach of children.
Read the directions carefully before use.
For prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Flunarizine ............................................... 5 mg
(as flunarizine dihydrochloride)
Excipients: q.s …………………………………. 1 capsule
Hard capsule.
Product description: A red/gray, hard capsule filled with white to off-white powder.
Box of 10 blisters x 10 hard capsules.
Pharmacotherapeutic group: antivertigo preparations, ATC code: N07C A03
Flunarizine is a selectively acting calcium entry blocker, so that contractility, conduction and stimulation of the heart are not influenced. The drug prevents cellular "calcium flooding" by reducing excessive calcium influx across the cell membrane.
Flunarizine is the prototype of class IV calcium antagonists (WHO classification)
Flunarizine is well resorbed from the intestinal canal. Maximum plasma concentrations are reached 2 to 4 hours after dosing. Steady-state plasma levels are reached after 5 to 6 weeks. Plasma protein binding (90%) and volume of distribution (43.2 L/kg) are appreciable. The final elimination half-life (t 1/2 β) is 18 days.
After metabolism in the liver, excretion is mainly via faeces (biliary excretion), while only a very small amount (< 0.1%) is excreted via urine.
Pregnancy
There are no data on the safety of the use of flunarizine during pregnancy for humans. Animal studies do not indicate direct or indirect harmful effects with respect to reproduction, embryonic or fetal development, the course of pregnancy and perinatal and postnatal development. Since the safety of flunarizine during pregnancy has not been established, the use of this medicine during pregnancy is not recommended.
Breastfeeding
Studies in lactating female dogs have shown that flunarizine is excreted in milk and the concentration in milk is higher than in plasma. There are no available human data on excretion in breast milk. The decision whether or not to discontinue breast-feeding or to continue/discontinue treatment with flunarizine should be taken taking into account the benefits of breast-feeding for the child and the benefits of treatment for the mother.
The safety of flunarizine was evaluated in 247 flunarizine-treated patients who participated in two placebo-controlled clinical trials for the treatment of vertigo and migraine, respectively, and in 476 flunarizine-treated patients who participated in two comparative clinical trials in the treatment of vertigo and/or migraine. Based on the pooled safety data from these clinical trials, the most frequently reported adverse reactions (AI) (incidence > 4%) are the following (incidence in %): increase in weight (11%), drowsiness (9%), depression (5%), increased appetite (4%) and rhinitis (4%).
Considering the above side effects, the following table shows the side effects that have been reported when taking flunarizine during clinical trials or after the drug has been placed on the market. The frequency categories in the table use the following convention: Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,1000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Infections and infestations
Common: Rhinitis.
Metabolic and nutrition disorders
Common: Increased appetite.
Psychiatric disorders
Common: Depression, sleeping troubles.
Uncommon: Depressive symptoms, sleeping troubles, apathy, anxiety.
Nervous system disorders
Common: Somnolence.
Uncommon: Abnormal coordination, disorientation, lethargy, paresthesia, restlessness, softness, tinnitus, torticollis
Not known: Akathisia; bradykinesia, cogwheel phenomenon, dyskinesia, essential tremor, extrapyramidal disorders; Parkinson's disease; sedation; tremors.
Cardiac disorders:
Uncommon: Palpitations.
Vascular disorders:
Uncommon: Hypotension.
Gastrointestinal disorders:
Common: Constipation, abdominal discomfort, nausea
Uncommon: Bowel obstruction, dry mouth, gastrointestinal disorders.
Skin and subcutanenous disorders:
Uncommon: Hyperhidrosis
Not known: Erythema.
Musculoskeletal and connective tissue disorders
Common: Myalgia.
Uncommon: Muscle spasms, muscle contractions.
Not known: muscle stiffness.
Reproductive system and breast disorders
Common: Irregular menstruation; breast pain.
Uncommon: Menstrual disorders, oligomenorrhea, breast hypertrophy, decreased libido.
General disorders and administration site conditions
Common: Fatigue.
Uncommon: Generalized edema; peripheral edema; asthenia.
Investigations
Very common: Weight increase.
Please inform your doctor of all undesirable effects upon drug administration.
In case of overdose, drowsiness or asthenia may occur. These disappear when treatment is stopped.
A few cases of acute overdose (more than 600 mg in one dose) have been reported. The symptoms observed were: sedation, agitation and tachycardia.
Treatment of an acute overdose consists of the administration of medicinal charcoal, inducing vomiting or gastric emptying, together with supportive measures. There is no specific antidote.
Store in dry places, not exceeding 30°C, protect from light.
Flunarizine may cause the onset of extrapyramidal and depressive symptoms and update Parkinson's disease, especially in the elderly. Therefore, flunarizine should be used with caution in these patients.
The recommended dose should not be exceeded. Patients should be examined regularly, particularly during maintenance therapy, so that extrapyramidal or depressive symptoms can be detected early and, if necessary, treatment can be discontinued.
In rare cases, fatigue may gradually increase during treatment with flunarizine. Treatment should then be discontinued.
If therapeutic efficacy declines during maintenance treatment, treatment should also be discontinued.
Caution should be exercised in patients with porphyria.
Flunarizine is not intended for the immediate cessation of a migraine attack or an attack of dizziness.
Excipients
Lactose monohydrate: Patients with problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.
Excessive sedation may occur if alcohol, hypnotics, or painkillers are taken concurrently. Flunarizine is not contraindicated during treatment with beta-blockers.
Substances which activate microsomal liver enzymes, such as carbamazepine, phenytoin, oral contraceptives and barbiturates, may accelerate the metabolism of flunarizine, which may lead to decreased efficacy. In some cases, an adjustment of the dose will then be necessary.
The pharmacokinetics of flunarizine were not affected by topiramate. Following repeated administration to patients with migraine, systemic exposure to flunarizine increased by 14%. When flunarizine was co-administered with 50 mg topiramate every 12 hours, repeated administrations resulted in a 16% increase in systemic exposure to flunarizine. The steady-state pharmacokinetics of topiramate were not affected by flunarizine.
Chronic administration of flunarizine did not affect the characteristics of phenytoin, carbamazepine, valproate and phenobarbital. Flunarizine plasma concentrations were generally lower in patients with epilepsy taking these antiepileptics (AEDs) than in healthy subjects given the same doses. Plasma protein binding of carbamazepine, valproate and phenytoin is not affected by concurrent administration of flunarizine.
Prophylaxis of migraine in patients with frequent and severe attacks who experience unbearable side effects with other treatments and/or who do not react sufficiently to them.
Symptomatic treatment of vestibular vertigo following the diagnosis of a functional disorder of the vestibular system.
Flunarizine is contraindicated in patients with current depressive illness or a history of recurrent depression.
Flunarizine is contraindicated in patients with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
Flunarizine is contraindicated in patients with known hypersensitivity to flunarizine or to any of the excipients in the formulation.
METHOD OF ADMINISTRATION: Oral use.
POSOLOGY
Migraine prophylaxis
Starting dose
Treatment starts with 10 mg per day (evening) in patients under 65 years old and with 5 mg per day in patients over 65 years old.
If depressive symptoms, extrapyramidal reactions or other intolerable side effects occur during treatment, treatment should be discontinued.
Since the elimination half-life is long, a single dose per day is sufficient.
If no significant improvement occurs two months after the start of treatment, it should be considered ineffective and should therefore be stopped.
Maintenance treatment
If the patient responds favorably to treatment and if maintenance treatment is desired, the daily dose should be reduced, or the drug should be taken every other day, or taken for 5 days each time directly followed by 2 days without treatment with week. After 6 months the maintenance treatment should be stopped.
If the patient relapses, a new treatment can be started.
Vertigo
The same dose should be used as for migraine, bearing in mind that treatment cannot be given longer than necessary to control symptoms. This usually lasts no longer than 2 months.
If no significant improvement occurs after 1 month of treatment for chronic vertigo and after 2 months of treatment for paroxysmal vertigo, the treatment should be considered ineffective and should be stopped.
Or as directed by the physician.
Register an account - receive thousands of information
You will be one of the first to receive information, news, recruitment news... from Hau Giang Pharmaceutical as soon as possible. Register today to enjoy thousands of incentives from Hau Giang Pharmaceutical.
