Belladonna extract

Belladonna extract
Instructions for medical use-RU no. R N000580/01-2001

Last modified date: 15.06.2017

Dosage form

Rectal suppositories

Composition

1 suppository contains:

Active ingredient : belladonna extract thick (with the content of the sum of the alkaloids of belladonna in terms of hyoscyamine 1.5% - 0.225 mg) - 15 mg,

Excipients: phenol, water, a mixture of macrogols (macrogol 1500-98%, macrogol 400-2%).

Description of the dosage form

Suppositories from white with a yellowish tinge to light brown, torpedo-shaped. Marbling is allowed.

Pharmacological Group

Antispasmodic agent of plant origin

Pharmacodynamics

The pharmacological effect of the drug is due to the complex of alkaloids that are part of the belladonna extract (hyoscyamine, scopolamine, atropine). The drug has an antispasmodic, analgesic effect.

Pharmacokinetics

No data available.

Indications

Hemorrhoids, anal fissures.

Contraindications

Hypersensitivity to the components of the drug, angle-closure glaucoma, prostatic hypertrophy with impaired urinary outflow, obstructive diseases of the gastrointestinal tract, intestinal atony, active ulcerative colitis, chronic heart failure in the decompensation stage, tachycardia, myasthenia gravis, pregnancy, breastfeeding, children under 18 years of age.

With caution

Vegetative neuropathy, hyperthyroidism, coronary heart disease, chronic heart failure, mitral stenosis, kidney disease, hiatal hernia, reflux esophagitis, increased body temperature (the likelihood of fever and heat stroke due to suppression of the activity of the sweat glands).

Use during pregnancy and lactation

The use of the drug during pregnancy and during breastfeeding is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Method of administration and dosage

Rectally, after a cleansing enema or self-emptying of the intestine. 1 suppository 2-3 times a day, the maximum daily dose is 10 suppositories. Usually, the duration of the course of treatment is 7-10 days.

Before use, the suppository should be removed from the contour cell packaging.

Side effects

Possible allergic reactions, dry mouth, thirst, constipation, tachycardia, mydriasis, paresis of accommodation, dizziness, photophobia, urinary retention.

Overdose

Symptoms: dryness of the oral and nasal mucosa, thirst, constipation, tachycardia, mydriasis, paresis of accommodation, dizziness, photophobia, decreased sweating, urinary retention, in more severe cases - psychomotor agitation, convulsions, acute urinary retention. In case of overdose, the use of the drug should be discontinued and consult a doctor.

Treatment: symptomatic and supportive therapy.

Interaction

When used simultaneously with tricyclic antidepressants, it is possible to increase the m-holinoblocking effects of the drug (dry mouth, impaired accommodation, tachycardia, constipation, etc.).d.). When used with drugs that increase the heart rate (including procainamide) - pronounced tachycardia is possible. MAO inhibitors increase the risk of side effects and enhance the positive chrono - and bathmotropic effect, when used together with cardiac glycosides-an increase in the positive bathmotropic effect. With the simultaneous intake of ethanol (alcohol) with preparations of belladonna (belladonna), it is possible to increase the inhibitory effect on the central nervous system (CNS)

Special instructions

It is necessary to take into account the possible penetration of belladonna alkaloids through the blood-brain barrier and possible interaction with drugs that affect the central nervous system.

In therapeutic doses, the alkaloids of belladonna have a moderate stimulating effect on the central nervous system, in large doses - an excitatory effect, in toxic doses-agitation, hallucinations, followed by inhibition and a comatose state.

Simultaneous administration of suppositories with belladonna extract and other drugs with anticholinergic activity should be avoided, since the likelihood of side effects increases.

Belladonna extract helps to reduce the rate of absorption of jointly used drugs and other drugs due to the suppression of the motor function of the gastrointestinal tract.

Influence on the ability to drive vehicles, mechanisms

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration, rapid psychomotor reactions and good vision.

Release form

Rectal suppositories of 15 mg.

5 suppositories are placed in a contour cell packaging made of polyvinyl chloride film, laminated with polyethylene.

Two contour cell packages together with the instructions for the use of the drug are placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Expiration date

2 years.

Do not use the drug after the expiration date.

Conditions of supply of pharmacies

They are released without a prescription.