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BELADONNA EXTRACT
Release form
Rectal suppositories.
For children
According to the doctor's recommendation
For pregnant women
Contraindicated
For nursing mothers
Contraindicated
For drivers
Contraindicated
Storage temperature
until 15 °C
INSTRUCTION
storage
active substance: 1 suppository contains thick belladonna extract (Belladonnae extractum spissum) calculated by the sum of alkaloids (1:5) (extractant 20% (v/v) ethanol) 0.23 mg – 0.015 g; excipients: phenol, solid fat.
Medicinal form
Rectal suppositories. Main physico-chemical properties: suppositories from white with a creamy shade to light yellow with a brownish shade, with minor inclusions.
Pharmacotherapeutic group
Means for the treatment of hemorrhoids and anal fissures for local use. ATX code C05A X03.
Pharmacological properties
Pharmacodynamics. Suppositories with belladonna extract have an antispasmodic (cholinolytic) effect. The pharmacological effect of the drug is due to the complex of alkaloids included in its composition (atropine, scopolamine, etc.). As a result of the M-choline-blocking effect of alkaloids, intestinal muscle spasm is eliminated, intestinal peristalsis is reduced. Pharmacokinetics. When a suppository is inserted into the rectum, the effect of the drug manifests itself after 15–90 minutes. The duration of resorption of alkaloids ranges from 2 to 6 hours. Phenol has a bactericidal and antifungal effect.
Indication
Hemorrhoids and anal fissures.
Contraindication
Hypersensitivity to belladonna and other components of the drug. Diseases of the cardiovascular system, in which an increase in heart rate is undesirable: atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension. Glaucoma. Urinary retention or tendency to it. Myasthenia. Disease of the gastrointestinal tract accompanied by obstruction. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding. Special security measures. Use with caution in patients with prostatic hypertrophy without obstruction of the urinary tract, with Down's disease, with cerebral palsy, liver and kidney failure, reflux esophagitis, hernia of the esophageal opening of the diaphragm combined with reflux esophagitis, inflammatory bowel diseases, including nonspecific ulcerative colitis and Crohn's disease, megacolon, patients with xerostomia, elderly or debilitated patients, in chronic lung diseases without reversible obstruction, in chronic lung diseases accompanied by low production of sputum that is difficult to separate, especially in debilitated patients, in vegetative (autonomic) neuropathy, brain damage.
Interaction with other medicinal products and other forms of interaction
When used with monoamine oxidase inhibitors, heart arrhythmia occurs, with quinidine, novocainamide - a summation of the cholinolytic effect is observed. The drug can reduce the duration and depth of action of narcotic drugs, weakens the analgesic effect of opiates. With simultaneous use with diphenhydramine or diprazine, the effect of the drug increases, with nitrates, haloperidol, corticosteroids for systemic use - the likelihood of an increase in intraocular pressure increases, with sertraline - the depressive effect of both drugs increases, with spironolactone, minoxidil - the effect of spironolactone and minoxidil decreases, with penicillins - the effect of both drugs increases, with nizatidine - the effect of nizatidine increases, with ketoconazole - the absorption of ketoconazole decreases, with ascorbic acid and attapulgite - the effect of atropine decreases, with pilocarpine - the effect of pilocarpine in the treatment of glaucoma decreases, with oxprenolone - the antihypertensive effect of the drug decreases. Under the influence of Octadin, it is possible to reduce the hyposecretory effect of atropine, which weakens the effect of M-cholinemimetics and anticholinesterase agents. With simultaneous use with sulfonamide drugs, the risk of kidney damage increases, with potassium-containing drugs, the formation of intestinal ulcers is possible, with nonsteroidal anti-inflammatory drugs, the risk of stomach ulcers and bleeding increases. The effect of the drug can be enhanced with the simultaneous use of other drugs with an antimuscarinic effect: M-cholinoblockers, antiparkinsonian drugs (amantadine), antispasmodics, some antihistamines, drugs of the butyrophenone group, phenothiazines, dispyramides, quinidine and tricyclic antidepressants, non-selective inhibitors of neuronal reuptake of monoamines. Suppression of peristalsis under the influence of atropine can lead to changes in the absorption of other drugs.
Features of use
Use during pregnancy or breastfeeding. It is not recommended to use during pregnancy and breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Taking into account the possibility of the appearance of such a side reaction as dizziness, during the use of the drug you should refrain from driving a motor vehicle or working with other mechanisms.
Methods of application
Used for adults. The suppository is freed from the packaging by cutting it with scissors along the contour of the suppository, and is injected deep into the rectum, 1 suppository 2-3 times a day. The duration of the treatment course is determined by the doctor individually, taking into account the course and severity of the disease, the achieved therapeutic effect, and general treatment tactics. The recommended duration of the treatment course is 5–7 days. Children. There are no data on the safety and efficacy of the drug for children.
Overdose
Symptoms: increased side effects, nausea, vomiting, tachycardia, decreased blood pressure, excitement, irritability, tremors, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, suppression of the central nervous system, suppression of the activity of the respiratory and vascular centers. Treatment. Gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Treatment is symptomatic.
Side effects
On the part of the gastrointestinal tract: dry mouth, thirst, taste disturbances, dysphagia, decreased intestinal motility up to atony, decreased tone of biliary tract and gallbladder. From the kidneys and urinary tract: difficulty and delay in urination. From the side of the heart: palpitations, arrhythmia, including extrasystole, myocardial ischemia. On the part of blood vessels: redness of the face, feeling of hot flashes. From the side of the nervous system: headache, dizziness. On the part of the organs of vision: pupil dilation, photophobia, paralysis of accommodation, increased intraocular pressure. On the part of the respiratory system and mediastinal organs: a decrease in secretory activity and tone of the bronchi, which leads to the formation of viscous sputum that is difficult to cough up. From the side of the skin and subcutaneous tissue: skin rashes, urticaria, exfoliative dermatitis, hyperemia. From the side of the immune system: anaphylactic reactions, anaphylactic shock. Others: decreased sweating, dry skin, dysarthria.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not higher than 15 ºС. Keep out of the reach of children.
Packaging
5 suppositories in strips. 2 strips in a cardboard pack.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.