Sibelium Janssen medicine for migraine treatment (5 blisters x 20 tablets)

Dosage form Box of 5 blisters x 20 tablets
Specifications Flunarizine

Ingredient

Composition information	Content
Flunarizine	5mg

Uses

indications

Sibelium 5mg is indicated in the following cases:

Preventive treatment of migraine in case other treatments is not effective or less tolerant. Flunarizin is a selective calcium antagonist. Its effect in maintaining migraine is based on the selective opposition of calcium ions into the cell.

flunarizin does not act on the ability to contract and myocardial transmission.

Pharmacokinetics

absorption

Flunarizin absorbs well at the digestive tract (> 80%), reaching the peak in plasma within 2 to 4 hours after drinking. Under decreasing stomach acid (higher gastric pH level), the bioavailability of flunarizin may be lower than moderate.

Distribution

Flunarizin cohesion plasma protein> 99%. Large distribution volume, about 78L/kg in healthy people and about 207l/kg in epilepsy patients proves high distribution capacity in blood vessels. The drug quickly passed through the brain blood barrier, the concentration of the brain is about 10 times higher than the plasma concentration.

Metabolism

flunarizin is converted in the liver into at least 15 metabolites. The main metabolic line is CYP2D6.

Elimination

flunarizin excreted mainly through biliary feces in the form of original drugs and metabolites. Within 24 - 48 hours after drinking, about 3% to 5% of the dose is eliminated in the form of stool in the form of original drugs and metabolic substances, and The half -life of the drug varies from 5 to 15 hours in most patients after single dose. In some people, the plasma concentration of flunarizin can be measured (> 0.5 ng/ml) for a long time (up to 30 days), which may be due to the re -distribution of drugs from other tissues.

Multi -dose: Flunarizin's plasma concentration achieves a stable state after about 8 weeks of dosage once a day, and is higher than the plasma concentration of flunarizin after taking a single dose of about 3 times. Flunarizin concentration is in a stable state corresponding to the dose ranging from 5mg - 30mg.

Before taking Sibelium Janssen medicine for migraine treatment (5 blisters x 20 tablets)

How to use

Sibelium 5mg Used orally. Should take medicine in the evening, before going to bed because of the risk of sleepy and sleeping.

Dosage

Adults to 65 years old

dose 5mg/day, drink in the evening, in 4 to 8 weeks.

During treatment, if the symptoms of depression, foreign tower or other serious adverse events appear, it is necessary to stop taking the drug (see warning and caution).

If after 8 weeks of treatment there is no improvement, the patient is considered not responded to treatment and should stop taking the drug.

If not fully clinically respected, the dose may be increased to 10mg/day but need to consider in the ability to tolerate drugs.

Treatment time does not exceed 6 months.

Elderly people over 65 years old

dose 5mg/day, drink in the evening, in 4 to 8 weeks.

If during the treatment period, if the symptoms of depression, foreign tower or other serious adverse events appear, it is necessary to stop taking the drug (see warning and caution).

If after 8 weeks of treatment there is no improvement, the patient is considered not responded to treatment and should stop taking the drug.

Children

Treatment time does not exceed 6 months.

Children aged 12 years and older: For exceptions, when migraines are in a decrease tend to: 5mg/day, drink in the evening. Treatment period must not exceed 6 months. It is not recommended to use flunarizin for children under 12 years old.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

The main symptom is observed: drowsiness, excitement and tachycardia.

Treatment includes activated carbon oral treatment.

No specific antidote.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Sibelium 5mg, you may experience unwanted effects (ADR).

Sibelium's safety is evaluated on 247 patients participating in two placebo tests, a trial in the treatment of migraine, an experiment in dizziness and over 476 patients treated with Flunarizin participating in two controlled tests with an active comparative substance used in dizziness and/or migraine (only in the dizziness and hemorrhoids. ).

Based on the safety data from clinical trials, the adverse adverse reaction of the drug is the most common report (≥ 4 event) is: weight gain (11%), drowsiness (9%), depression (5%, increase appetite (4%), and rhinitis (4%).

The table below presents all unwanted effects reported when using Sibelium in clinical trials (including adverse events on the above part) and during the circulation of drugs on the market. The following frequency is conventional:

Very common> 1/10.

System

Agency

The adverse reactions of the drug

Common (1/100 to

rarely (1/1 000 to

Unknown

Psalmology

Insomnia

Depression syndrome (see warning and caution); Sleep disorders; Nonchalant; Worry

Abnormal coordination of movement; loss of orientation; sleep; Perseptic; restless restlessness; slow; languid; tinnitus; Crooked neck

Standing restlessness; slow movement; Mechanical and stiffness of the tooth gear; movement disorders; Raw rule; Periodic disorders (see warning and caution); Parkinson's syndrome; asleep; Run

heart disorders Stomach discomfort; Nausea

intestinal obstruction; dry mouth; Stomach, intestinal disorders

Rashes

Mechanical spasm; Mechanical jerk

Mechanical hard

Breast pain

Menstrual period; Menstrual disorders; Sales; mammary hypertrophy; Reduce sexual ability

Increasing lactation

tired

Systemic edema; peripheral edema; weakness

weight gain

Reporting suspicious adverse reactions after the drug is circulated is very important. This allows to continue controlling the balance of the benefits and risks of the drug. The doctor is required to report any adverse reactions to the National Center and the regional center on drug information and monitor the adverse reaction of the drug.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Sibelium 5mg contraindications in the following cases:

Hypersensitivity to flunarizin or one of the excipients of the drug.

Symptoms of Parkinson's disease before treatment (see warning and caution and unwanted effects).

Pre -history with foreign symptoms (see warning and caution and unwanted effects).

depression or a history of depression (see warning and caution and unwanted effects).

Caution when using

due to flunarizin can increase the symptoms of extrapagans and depression and the development of Parkinson's syndrome, especially in the elderly. Therefore, caution should be used in these patients.

Do not use the recommended overdose. Patients should be regularly examined, especially during the maintenance treatment period to be able to detect the symptoms of foreign or depression and stop treatment promptly.

Symptoms of pagoda may appear late (about 1 year). Most cases are not severe, but may last for months after stopping treatment (the average retreat time is about 3 months). Improvement may not be completely and may need a treatment with anti -Parkinson. In some cases, this symptom can exist despite being treated.

Cases of depression syndrome have been reported, appearing after 5 to 8 months from the beginning of treatment. These cases are usually not severe, but in some cases, prescription antidepressants must be prescribed or treated in the hospital if necessary.

Patients may gain weight when treated with flunarizin. In rare cases of fatigue may increase during treatment with flunarizin: If this condition occurs, it is necessary to stop treatment.

This drug contains lactose. Patients are advised not to take drugs in case of intolerance with galactose, lactose-deficient lactose (lactase) or suffer from glucose-galactose absorption syndrome (rare genetic disease).

The ability to drive and operate machinery

Sleeping chicken can occur on drivers or operating machinery, especially in patients who are new to treatment or combination of treatment with this drug.

Pregnancy

There is no data on the use of flunarizin in pregnant women. Animal studies do not prove the direct or indirect effects on reproductive, embryo development, fetal or pregnancy process, or postpartum development and postpartum development.

When there is no monster effect on animals, there may be no deformity on humans. In fact, up to now, the active ingredients that cause human defects have shown the monster effects on animals throughout the legal studies conducted on both species.

Therefore, to be cautious, better than flunarizin should not be used during pregnancy.

Nursing period

It is not known whether flunarizin will excrete in milk. Animal research shows that there is a secretion of flunarizin into milk. The decision to stop breastfeeding or continue/stop treatment with flunarizin must be considered based on the benefit factor of breastfeeding with the benefit of treatment for the mother.

Drug interaction

The combination should be noted

Atropinic drugs:

Consider when using active ingredients atropinic can increase the unwanted effects of these drugs and increase the risk of urinary retention, acute glaucoma, constipation, dry mouth, etc. Atropinic, disopyramid, phenotiazinic and clozapin neuron.

Sedatives:

Consider when using drugs or active ingredients can increase their sedative effects on the central nervous system and contribute to vigilance. Ví dụ như các dẫn xuất morphin (điều trị giảm đau, chữa ho và điều trị thay thế), thuốc an thần kinh, các thuốc nhóm barbituric, các thuốc nhóm benzodiazepin, các thuốc giải lo âu khác không thuộc nhóm benzodiazepin (ví dụ Meprobamat), thuốc ngủ, thuốc chống trầm cảm có tác dụng an thần (Amitriptylin, Doxepin, Mianserin, Mirtazapin, Trimipramine), H1 antihistamines have sedative effects, drugs for hypertension effect on central nervous system, baclofen and thalidomid.

Unreasonable combinations

alcohol/alcohol:

Alcohol/also increases sedative effects. The degree of impairment of consciousness can be dangerous when driving and using machinery. Avoid using alcohol/alcoholic drinks and alcohol/alcoholic drugs.

Other combinations

Topiramat:

Flunarizin's

pharmacokinetics are not affected by Topiramat. During the simultaneous use of flunarizin and Topiramat 50mg every 12 hours, the level of flunarizin in the body increased by 16% in migraine patients compared to 14% in patients only treated with flunarizin. In constant concentration, pharmacokinetics of Topiramat are not affected by flunarizin.

Storage

Store at a temperature not exceeding 25 ° C.

Other drugs

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