Reinal-5 Davipharm medicine for preventive treatment migraine (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Flunarizine

Ingredient

Composition information	Content
Flunarizine	5mg

Uses

indications

Reinal 5mg medicine is indicated in the following cases:

Preventive treatment migraine In case other treatments are ineffective or less tolerant. The drug prevents calcium overload in the cell, by reducing overflow overflow through the cell membrane. Flunarizin does not affect the heart muscle contraction, does not inhibit the atrial or atrial node, does not increase the heart frequency, does not have anti -hypertension effect.

Pharmacokinetics

absorption

Flunarizin is well absorbed through the gastrointestinal tract> 80%, reaching a plasma peak concentration within 2 to 4 hours after drinking and achieving a stable state at the 5th - 6th week. In the conditions of gastric juice decreasing (high gastric pH), the bioavailability of Flunarizin may be lower.

Distribution

Flunarizin is attached to plasma protein> 99%. The volume of the father is large: 78L/kg in healthy people and 207l/kg in patients with epilepsy, with a high level of distribution outside the circuit. The drug quickly passed through the brain barrier; The concentration of the brain is about 10 times higher than the plasma concentration.

Metabolism

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

Elimination

flunarizin is excreted mainly through biliary feces for the original drug and metabolic substances. After taking 24 to 48 hours, about 3-5% of the dose is eliminated in the form of stool in the form of original drugs and metabolic substances, and 0.5ng/ml) for a long period (up to 30 days), which may be due to the removal of drugs from other tissues.

Dosage is repeated

Flunarizin's plasma concentrations achieve a stable state after about 8 weeks of reminding the dose, once a day and about 3 times higher than the single dose. Flunarizin concentration reaches the corresponding stability in the change range of 5 - 30mg.

The drug is only influenced by the central nervous system when the dose is significantly higher than the maximum dose.

Before taking Reinal-5 Davipharm medicine for preventive treatment migraine (6 blisters x 10 tablets)

How to use

Reinal 5mg medicine is taken orally.

Dosage

Adults ≤ 65 years old and elderly (> 65 years)

dose of 5mg/day, drink in the evening, maintain for 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 the parts of caution when using the drug).

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

Treatment time does not exceed 6 months.

Recommendation is only for patients ≤ 65 years old: If the patient's clinical manifestation shows that the response is incomplete, may increase the dose up to 10mg/day but need to consider in the patient's tolerance ability.

Children

12 -year -old children, especially in the case of unexplained migraine: 5mg/day, drink in the evening. Treatment period must not exceed 6 months.

Children

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?

Symptoms

Based on the pharmacological properties of the drug, drowsiness and weakness may occur. A few cases of acute overdose (up to 600mg tall 1 time) have been reported, symptoms observed as drowsiness, tachycardia, agitation.

Land of Tri

There is no specific antidote. Within 1 hour after overdose, the stomach should be lavely. Can use activated carbon if appropriate.

What to do when you forget 1 dose? Using the next dose as usual.

Side Effects

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

Very common, 1/10 ≤ ADR

Testing: weight gain.

Common, 1/100 ≤ ADR

Infection and infection: rhinitis.

Metabolism and nutrition: Increasing appetite.

Mental: depression , insomnia. Neurological: Drowsy.

digestive: constipation, epigastric pain, nausea.

Muscle and connective tissue: muscle pain.

Genital and mammary glands: abnormal menstrual periods, breast pain.

all body: tired.

Uncommon, 1/1,000

Immune: Hypersensitivity.

Mental: depression syndrome, sleep disorders, indifference, anxiety. nerve: abnormal coordination, disorientation, coma, abnormal, impatient, slow, tinnitus, crooked neck.

heart: Brush the chest drum.

blood vessels: Hypotension, hot burning. digestive: indigestion, intestinal obstruction, dry mouth, digestive disorders, vomiting.

Skin and subcutaneous tissue: urticaria, skin rash, increased sweat.

Muscle and connective tissue: muscle spasm, muscle contraction.

Genital and mammary glands: bleeding, menstrual disorders, irregular menstruation, mammary gland hypertrophy, reduced libido.

Systemic body: Systemic edema, peripheral edema, weakness.

Unknown frequency

Neurological: Sitting restless, slow exercise, signs of serrated wheels, dysplasia, tremor, pagoda syndrome, Parkinson, sedation.

liver: Increased liver transaminase.

Skin and subcutaneous tissue: Evana, itching, pink.

muscle and connective tissue: Muscle hard.

Genital system and mammary glands: Unusual lactation.

Instructions on how to handle ADR

The drug can cause other unwanted effects, advising patients to notify unwanted effects when taking the drug.

Warnings

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

Contraindicated

Reinal 5mg drug contraindicated in the following cases:

Feeling with flunarizin or any ingredients of the drug.

symptoms of Parkinson's disease from before treatment.

History of foreign symptoms.

depression or a history of recurrent depression syndrome.

Be cautious when using

flunarizin can have pagoda symptoms, depression and the development of Parkinson's syndrome, especially in patients with risks like the elderly. Therefore, caution should be used in these patients.

Do not use the recommended overdose. It is necessary to monitor patients regularly, periodically, especially during the maintenance treatment period to early detect expressions of foreign tapes, depression and stop treatment promptly.

The time of output of foreign symptoms may be long (about 1 year). Symptoms are generally not severe but may persist many months after stopping treatment (time for symptoms on average 3 months). Improvement may not be completely and need to use Parkinson's treatment. In some cases, symptoms may persist despite being treated.

Depression syndrome has been reported regularly. These cases appear in 5 - 8 months after the beginning of the treatment, generally not serious, but in some cases, it may be necessary to use antidepressants and/ or hospitalized.

There may be weight gain when treated with flunarizin.

Some fatigue cases with increasing severity have been recorded when using flunarizin.

If this situation occurs, it is necessary to stop treating with flunarizin.

To be out of reach of children.

The ability to drive and operate machinery

Sleep sleep can occur, especially at the beginning of treatment. Should be cautious in activities such as driving or operating machinery.

Pregnancy

There is no information about using flunarizin for pregnant women. Animal research does not show any direct or indirect harmful effects on pregnant women, the development of embryos/fetuses, the development of babies at birth and after birth.

Due to not causing teratogenicity in animals, flunarizin is expected to not cause teratogenicity in humans. However, to prevent, it is best to avoid using flunarizin during pregnancy.

The period of breastfeeding

It is unclear whether Flunarizin will be secreted through breast milk or not. Animal research shows flunarizin secretion of milk.

Should decide to stop breastfeeding or stop using flunarizin based on the benefit of breastfeeding and the benefit of the drug with the mother.

Interactive drug

Interactive should avoid

Alcohol: Alcohol increases the sedative effects of the drug. The change of alertness can be dangerous if driving or operating machinery.

Avoid using alcoholic beverages and alcoholic preparations when taking the drug.

Interactive attention

Atropinic (Atropinic)

Used with Atropinic substances can make unwanted effects such as urinary retention, acute glaucoma, constipation, dry mouth ... more likely.

There are many Atropinic drugs such as imipramine antidepressants, most H1 antihistamine drugs, Parkinson's treatments, cholinergic drugs, Atropinic anti -spasms, disopyramids, phenothiazine sedatives as well as clozapin.

sedative

Should be mentioned because the common use can increase the central neurological inhibitor and reduce alertness. These drugs include Morphin's derivatives (analgesic, cough reduction and replacement treatment), sedative drugs, barbiturat, benzodiazepin, other anxiety antiders not Benzodiazepin (eg Meprobamat), sleeping pills, antidepressants with sedative effects (amitripylin, doxepin, mianserin, mirtazapin, trimipin), trimiPramin) H1 has sedative effects, anti -hypertension drugs for central effects, Baclofen and thalidomid.

pharmacokinetic interaction

Long -term use of flunarizin does not affect the plasma concentrations of phenytoin, carbamazepin, valproat or phenobarbital. Flunarizin's plasma concentrations are often lower than that of epilepsy patients who are using epilepsy drugs compared to healthy people using similar doses. Carbamazepine, Valproat and Phenytoin's plasma is not affected by simultaneous use of flunarizin.

Topiramat

Flunarizin pharmacokinetics are not changed by Topiramat. After using flunarizin along with 50mg of Topirqmat every 12 hours, an increase of 16% of flunarizin concentration has been recorded in patients with migraine pain compared to 14% increase in patients only using flunarizin. Pharmacokinetics in the stable state of Topiramat are not affected by flunarizin.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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