Galidor tablets 100mg, No. 50

Vascular diseases

Peripheral vascular disease:

• Raynaud's disease

• other diseases with acrocyanosis and vasospasm, as well as chronic obliterating arterial diseases.

Cerebrovascular diseases:

• in the complex therapy of acute and chronic cerebral ischemia.

Elimination of spasm of internal organs

Gastrointestinal diseases:

• gastroenteritis of various etiologies (especially infectious),

• infectious and inflammatory colitis,

• functional diseases of the large intestine,

• tenesmus,

• postoperative flatulence,

• cholecystitis,

• cholelithiasis,

• condition after cholecystectomy,

• motility disorders with dyskinesia of the sphincter of Oddi,

• stomach or duodenal ulcer - in combination with other drugs.

Urological syndromes:

• spasms and tenesmus of the bladder,

• concomitant therapy of urolithiasis (in combination with analgesics for renal colic).

Vascular diseases
1 tablet 3 times a day for 2-3 months. The maximum daily dose is 400 mg. The interval between courses of treatment should be 2-3 months.

Elimination of spasm of internal organs
1-2 tablets once, no more than 4 tablets per day. For maintenance therapy: 1 tablet 3 times a day for 3-4 weeks, then 1 tablet 2 times a day. The duration of treatment is determined individually according to the disappearance of the symptoms of the disease and, as a rule, should not exceed 1-2 months.

active substance: bencyclane fumarate - 100mg

excipients: potato starch, polyvinyl acetate, magnesium stearate, carbomer 934 P, sodium carboxymethyl starch (type A), colloidal anhydrous silicon dioxide, talc.

• Hypersensitivity to the active or any other component of the drug.

• Severe respiratory, renal, or hepatic impairment.

• Decompensated heart failure

• acute myocardial infarction,

• atrioventricular block.

• Paroxysmal supraventricular or ventricular tachycardia.

• Epilepsy or other forms of spasmophilia.

• Recently suffered hemorrhagic stroke.

• Traumatic brain injury (within the last 12 months).

• Pregnancy and breastfeeding (see section 'Pregnancy and breastfeeding').

• Children under 18 years of age (due to lack of clinical data).

Trade name of the drug:

GalidorЃ

International non-proprietary name:

bencyclan

Dosage form:

pills

Composition:

active substance: bencyclane fumarate - 100mg

excipients: potato starch, polyvinyl acetate, magnesium stearate, carbomer 934 P, sodium carboxymethyl starch (type A), colloidal anhydrous silicon dioxide, talc.

Description :

White or grayish-white, flat, round beveled tablets, engraved with 'HALIDOR' on one side, with a slight characteristic odor.

Pharmacotherapeutic group:

antispasmodic

ATX code : —04ј XII

Pharmacological properties

Pharmacodynamics :

Bencyclan is a myotropic antispasmodic with a pronounced vasodilating effect. The vasodilating effect of bencyclane is mainly associated with its ability to block calcium channels, antiserotonin action, and to a lesser extent - with the blockade of sympathetic ganglia. In addition, bencyclan has an antispasmodic effect on the visceral muscles (gastrointestinal tract, urogenital organs, respiratory organs). The drug causes a slight increase in heart rate. Its weak tranquilizing effect is also known. Bencyclan can cause dose-dependent suppression of Na / K-dependent ATPase and aggregation of platelets and erythrocytes, as well as an increase in the elasticity of red blood cells. These effects are observed mainly in peripheral vessels, coronary arteries and cerebral vessels.

Pharmacokinetics :

Bencyclan is well absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is reached 2-8 hours (usually 3 hours) after ingestion. Due to the metabolism of the first pass through the liver, the bioavailability of the drug after oral administration is 25-35%. Approximately 30-40% of the amount of bencyclane in circulating blood is associated with plasma proteins, 30% with erythrocytes. 10% with platelets: the free fraction is 20%. Metabolism is carried out in the liver, mainly in two ways: dealkylation gives a demethylated derivative, and the cleavage of the ester bond gives benzoic acid, which is further converted into hippuric acid. The main part of the administered dose is excreted in the urine, mainly in the form of metabolites, but also unchanged (2-3%).
The vast majority of metabolites (90%) are excreted in unconjugated form, and a small part is excreted in conjugated form (approximately 50% as a conjugate with glucuronic acid).
The half-life is 6-10 hours; this parameter does not change in elderly patients, as well as with impaired renal and liver function. The total clearance is 40 l / h, the renal clearance is less than 1 l / h.

Indications

Vascular diseases

Peripheral vascular disease:

• Raynaud's disease

• other diseases with acrocyanosis and vasospasm, as well as chronic obliterating arterial diseases.

Cerebrovascular diseases:

• in the complex therapy of acute and chronic cerebral ischemia.

Elimination of spasm of internal organs

Gastrointestinal diseases:

• gastroenteritis of various etiologies (especially infectious),

• infectious and inflammatory colitis,

• functional diseases of the large intestine,

• tenesmus,

• postoperative flatulence,

• cholecystitis,

• cholelithiasis,

• condition after cholecystectomy,

• motility disorders with dyskinesia of the sphincter of Oddi,

• stomach or duodenal ulcer - in combination with other drugs.

Urological syndromes:

• spasms and tenesmus of the bladder,

• concomitant therapy of urolithiasis (in combination with analgesics for renal colic).

Contraindications

• Hypersensitivity to the active or any other component of the drug.

• Severe respiratory, renal, or hepatic impairment.

• Decompensated heart failure

• acute myocardial infarction,

• atrioventricular block.

• Paroxysmal supraventricular or ventricular tachycardia.

• Epilepsy or other forms of spasmophilia.

• Recently suffered hemorrhagic stroke.

• Traumatic brain injury (within the last 12 months).

• Pregnancy and breastfeeding (see section 'Pregnancy and breastfeeding').

• Children under 18 years of age (due to lack of clinical data).

Pregnancy and breastfeeding

Preclinical data did not reveal any embryotoxic or teratogenic effects. However, there have been no sufficient reliable studies on the use of the drug during pregnancy and lactation in humans. Therefore, the administration of the drug to patients in the first trimester of pregnancy is not recommended. During lactation, you should refrain from prescribing the drug, or decide on the termination of breastfeeding during treatment.

Method of administration and dosage

Vascular diseases
1 tablet 3 times a day for 2-3 months. The maximum daily dose is 400 mg. The interval between courses of treatment should be 2-3 months.

Elimination of spasm of internal organs
1-2 tablets once, no more than 4 tablets per day. For maintenance therapy: 1 tablet 3 times a day for 3-4 weeks, then 1 tablet 2 times a day. The duration of treatment is determined individually according to the disappearance of the symptoms of the disease and, as a rule, should not exceed 1-2 months.

Side effect

Gastrointestinal: dry mouth, abdominal pain, satiety, decreased appetite, nausea, vomiting, diarrhea.
Central nervous system: anxiety, headache, dizziness, gait disturbance, tremor, sleep disturbance, memory loss, sometimes transient confusion, hallucinations, asthenia, very rarely - symptoms of focal lesions of the central nervous system (CNS), epileptiform seizures.
Cardiovascular system: sometimes atrial or ventricular tachyarrhythmia may occur (especially when co-administered with other proarrhythmogenic drugs).
Laboratory indicators: transient increase in the activity of aspartate aminotransferase and alamine aminotransferase, leukopenia.
Others: general malaise, weight gain, allergic reactions.

Overdose:

Symptoms: increased heart rate, decreased blood pressure, collapse, urinary incontinence, drowsiness, anxiety, and in severe cases, epileptiform seizures. A significant overdose can cause tonic-clonic seizures.
Treatment: No specific antidote known. In case of an overdose, the stomach should be flushed and symptomatic treatment should be prescribed. There is no data on the possible elimination of bencyclane by dialysis.

Interaction with other medicinal products

Care should be taken when combined with the following agents:
- anesthetics and sedatives - their effects may be enhanced;
- drugs for general anesthesia - to enhance their action;
- sympathomimetics - due to the risk of atrial and ventricular tachyarrhythmias;
- drugs that reduce the level of potassium in the blood and quinidine - due to the possible summation of proarrhythmogenic effects;
- digitalis drugs - the risk of arrhythmia increases in case of digitalis overdose;
- beta-blockers - due to the opposite chronotropic effects (negative for beta-blockers and positive for bencyclane), it may be necessary to select the dosage of a beta-blocker;
- calcium channel blockers and other antihypertensive drugs - due to the possibility of enhancing their effect;
- drugs that cause side effects in the form of spasmophilia - due to the possibility of the summation of these effects;
- acetylsalicylic acid - due to increased inhibition of platelet aggregation.

special instructions

With prolonged therapy with Benznclan, regular monitoring of the real properties of the blood is recommended (approximately once every 2 months).
With simultaneous use with drugs that cause hypokalemia, cardiac glycosides, drugs that have a depressing effect on the myocardium, the daily dose of Halidor should not exceed 150-200 mg.

Impact on the ability to drive vehicles and control mechanisms

At the beginning of the course of treatment, driving vehicles and performing work with an increased risk of accidents requires special care.

Release form

Tablets 100 mg. 50 tablets in a dark glass vial with a PE cap with a first opening control with an accordion shock absorber. 1 bottle with instructions for use in a cardboard box.

Shelf life

5 years. Do not use after the expiration date stated on the package.

Storage conditions

At a temperature of 15-25 ? C. Keep out of the reach of children.

Conditions of dispensing from pharmacies

Prescribed by a doctor.