Galidor - instructions for use, dose, side effects, contraindications

Active substanceBenzyclanBenzyclan

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Galidor®

solution w / m in / in

EGIS ZAO Pharmaceutical Plant Hungary

Galidor®

pills inwards

EGIS ZAO Pharmaceutical Plant Hungary

Dosage form: & nbsppills

Composition:

100 mg of bacciclan fumarate active substance in 1 tablet; auxiliary substances: potato starch, polyvinyl acetate, magnesium stearate, carbomer 934 P, sodium carboxymethyl starch (type A), silicon dioxide colloidal anhydrous, talc.

Description:

White or grayish-white, flat round tablets with a bevel, with an engraving "HALIDOR"on one side, with a weak characteristic odor.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

C.04.A.X.11 Benzyclan

Pharmacodynamics:

Benzyclan - myotropic antispasmodic with a pronounced vasodilating effect. The vasodilator effect of benzyclane is mainly due to its ability to block calcium channels, antiserotonin action, and to a lesser extent - with blockade of sympathetic ganglia. Besides, benzyclan has an antispasmodic effect on visceral musculature (gastrointestinal tract, urogenital organs, respiratory organs). The drug causes a slight increase in the heart rate. It is also known for its weak tranquilizing effect.

Benzyclane may cause dose-dependent suppression Na/K -dependent ATPase and platelet and erythrocyte aggregation, as well as increased erythrocyte elasticity. These effects are observed mainly in peripheral vessels, coronary arteries and cerebral vessels.

Pharmacokinetics:

Benzyclan is well absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is achieved in 2-8 hours (usually after 3 hours) after ingestion. Because of the metabolism of the first passage through the liver, the bioavailability of the drug after ingestion is 25-35%. Approximately 30 - 40% of the amount of bicyclic in the circulating blood is associated with plasma proteins, 30% with red blood cells, 10% with platelets; the free fraction is 20%. Metabolism is carried out in the liver, mainly along two routes: dealkylation gives a demethylated derivative, and the rupture of the ester bond gives benzoic acid, which later turns into a hippuric acid. The bulk of the administered dose is excreted in the urine, mainly in the form of metabolites, but also in unchanged form (2-3 %).

A significant majority of metabolites (90%) are released in unconjugated form, and a small part is released in a 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 in the violation of kidney and liver. The total ground clearance is 40 l / h, the renal clearance is less than 1 l / h.

Indications:

Vascular diseases

Diseases of peripheral vessels: Raynaud's disease, other diseases with acrocyanosis and spasm of blood vessels, as well as chronic obliterating diseases of the arteries.

Diseases of cerebral vessels: in the complex therapy of acute and chronic cerebral ischemia.

Elimination of spasm of internal organs

Gastrointestinal diseases: gastroenteritis of various etiologies (especially infectious and inflammatory colitis, functional diseases of the colon, tenesmus, postoperative flatulence, cholecystitis, cholelithiasis, condition after cholecystectomy, motor disorders with dyskinesia of the sphincter of Oddi, ulcer of the stomach or duodenum - in combination with other medications.

Urological syndromes: spasms and tenesmus of the bladder, concomitant therapy of urolithiasis (in combination with analgesics in renal colic).

Contraindications:

Hypersensitivity to the active or any other component of the drug. Severe respiratory, renal or hepatic insufficiency.

Decompensated heart failure, acute myocardial infarction, atreevepticular blockade.

Paroxysmal supraventricular or ventricular tachycardia.

Epilepsy or other forms of spasmophilia.

Recently suffered hemorrhagic stroke.

Craniocerebral trauma (for the last 12 months).

Pregnancy and lactation (see "Pregnancy and lactation").

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

Pregnancy and lactation:

Pre-clinical data showed no embryotoxic or teratogenic effects. However, sufficient reliable studies on the use of the drug during pregnancy and feeding piles in humans have not been conducted. 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 whether to stop breastfeeding during treatment.

Dosing and Administration:

Vascular diseases

1 tablet 3 times a day for 2-3 months. The maximum daily dose is 400 mg. The interval between treatment courses 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: but 1 tablet 3 times a day for 3-4 weeks, then 1 tablet 2 times a day. Duration of treatment is determined individually for the disappearance of symptoms of the disease and, as a rule, should not exceed 1-2 months.

Side effects:

Gastrointestinal: dry mouth, abdominal pain, a feeling of 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 lesion of the central nervous system (CNS), epileptiform seizures.

The cardiovascular system: sometimes atrial or ventricular tachyarrhythmia can occur (especially when combined with other pro-arrhythmogenic drugs).

Laboratory indicators: transient increase in activity of aspartate aminotransferase and alamine aminotransferase, leukopenia.

Others: general malaise, weight gain, allergic reactions.

Overdose:

Symptoms: increased heart rate, lower blood pressure, collapse, urinary incontinence, drowsiness, anxiety, and in severe cases - epileptiform convulsive seizures. A significant overdose can cause tonic-clonic seizures.

Treatment: The specific antidote is not known. In case of an overdose, wash the stomach and prescribe symptomatic treatment. Data on the possible excretion of bcyclical by dialysis are not available.

Interaction:

Care should be taken when combining with the following:

- anesthetics and sedatives - their effects can be enhanced;

- medicines for general anesthesia - strengthening their action;

- sympathomimetics - because of the risk of atrial and ventricular tachyarrhythmias;

- drugs that reduce blood potassium and quinidine - because of the possible summation of pro-rhythmogenic effects;

- drugs foxglove - increases the risk of arrhythmias with an overdose of digitalis;

- beta-blockers - due to the opposite of chronotropic effects (negative in beta-blockers and positive in bcycliclane), it may be necessary to select a beta-blocker dosage;

- calcium channel blockers and other antihypertensive drugs - because of the possibility of enhancing their effect;

- drugs, causing side effects in the form of spasmophilia - because of the possibility of summation of these effects;

- acetylsalicylic acid - due to increased inhibition of platelet aggregation.

Special instructions:

With prolonged therapy with bcycliklan, regular monitoring of blood reagents 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 Galidor should not exceed 150-200 mg.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Tablets of 100 mg.

Packaging:

For 50 tablets in a vial of dark glass with PE cover with control of the first opening with an accordion-shock absorber. 1 bottle with instructions for use in a cardboard box.

Storage conditions:

Keep temperature 15-25 ° C. Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:П N014344 / 01

Date of registration:24.12.2008 / 20.10.2014

Expiration Date:Unlimited

The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Manufacturer: & nbsp

EGIS PHARMACEUTICALS, Plc Hungary

Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Information update date: & nbsp12.03.2017

Illustrated instructions

Instructions

Galidor® (Halidor®)