Instructions for Belladonna extract rectal suppositories No. 10
Composition
active ingredient: belladonna extract dense;
1 suppository contains: thick belladonna extract ((4.8-5.2) : 1) (Belladonnae extractum spissum) extractant 20% (v/v) ethanol)) (calculated as the sum of alkaloids 0.00023 g) – 0.015 g (15 mg);
excipients: phenol, solid fat.
Dosage form
Rectal suppositories.
Main physicochemical properties: suppositories from white with a creamy tint to light brown, spherical in shape. The presence of a coating on the surface of the suppository is allowed.
Pharmacotherapeutic group
Means for the treatment of hemorrhoids and anal fissures for topical use. ATX code C05A X.
Pharmacological properties
Pharmacodynamics
A drug for the local treatment of hemorrhoids. The drug has an analgesic, anti-inflammatory and antispasmodic effect.
Belladonna extract has an anticholinergic effect, reduces intestinal muscle spasm, and reduces intestinal peristalsis.
Indication
Hemorrhoids, anal fissures.
Contraindication
Hypersensitivity to belladonna or to the components of the drug. Cardiovascular diseases in which an increase in heart rate may be undesirable: atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension. Glaucoma. Urinary retention or tendency to it. Myasthenia gravis. Gastrointestinal diseases accompanied by obstruction. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding.
Interaction with other medicinal products and other types of interactions
When used with monoamine oxidase inhibitors, cardiac arrhythmias occur; with quinidine, novocainamide - summation of the anticholinergic effect is observed. May reduce the duration and depth of action of narcotic drugs, weakens the analgesic effect of opiates.
When used simultaneously with diphenhydramine or diprazine, the effect of the drug is enhanced; with nitrates, haloperidol, corticosteroids for systemic use - the likelihood of increasing intraocular pressure increases; with sertraline - the depressive effect of both drugs is enhanced; with spironolactone, minoxidil - the effect of spironolactone and minoxidil is reduced; with penicillins - the effect of both drugs is enhanced; with nizatidine - the effect of nizatidine is enhanced; with ketoconazole - the absorption of ketoconazole is reduced; with ascorbic acid and attapulgite - the effect of atropine is reduced; with pilocarpine - the effect of pilocarpine in the treatment of glaucoma is reduced; with oxprenolone - the antihypertensive effect of the drug is reduced. Under the influence of Octadine, a decrease in the hyposecretory effect of atropine is possible, which weakens the effect of M-cholinomimetics and anticholinesterase agents. When used simultaneously with sulfonamide drugs, the risk of kidney damage increases; with drugs containing potassium, 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 may be enhanced by the simultaneous use of other drugs with antimuscarinic effect: M-cholinoblockers, antiparkinsonian drugs (amantadine), antispasmodics, some antihistamines, butyrophenone drugs, phenothiazines, dispyramides, quinidine and tricyclic antidepressants, non-selective inhibitors of neuronal monoamine reuptake.
Inhibition of peristalsis by atropine may alter the absorption of other drugs.
Application features
Use with caution in patients with prostatic hypertrophy without urinary tract obstruction, Down syndrome, cerebral palsy, hepatic and renal insufficiency, reflux esophagitis; hiatal hernia associated with reflux esophagitis, inflammatory bowel diseases, including nonspecific ulcerative colitis and Crohn's disease, megacolon; patients with xerostomia, elderly or debilitated patients, chronic lung diseases without reversible obstruction, chronic lung diseases accompanied by low sputum production that is difficult to clear, especially in debilitated patients, autonomic neuropathy, brain damage.
Ability to influence reaction speed when driving vehicles or other mechanisms
When treating with the drug, it is recommended to refrain from driving vehicles or performing work that requires increased attention and precise coordination.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be used only as prescribed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus/child.
Method of administration and doses
The duration of the course of treatment is determined by the doctor individually, taking into account the course and severity of the disease, the achieved therapeutic effect, and the general treatment tactics. The recommended duration of the course of treatment is 5-7 days.
Children
There is no data on the safety and effectiveness of the drug in children.
Overdose
Symptoms: increased manifestations of adverse reactions, nausea, vomiting, tachycardia, decreased blood pressure, agitation, irritability, tremor, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, depression of the central nervous system, depression of the activity of the respiratory and vasomotor centers.
Treatment: Parenteral administration of cholinomimetics and anticholinesterase agents. Treatment is symptomatic.
Adverse reactions
Gastrointestinal disorders: dry mouth, thirst, taste disturbances, dysphagia, decreased intestinal motility up to atony, decreased tone of the biliary tract and gallbladder.
Renal and urinary disorders: difficulty and retention of urination.
Cardiac: palpitations; arrhythmia, including extrasystole; myocardial ischemia.
Vascular: facial flushing, hot flashes.
Neurological disorders: headache, dizziness.
On the part of the organs of vision: dilated pupils, photophobia, accommodation paralysis, increased intraocular pressure.
On the part of the respiratory system and mediastinal organs: a decrease in secretory activity and bronchial tone, which leads to the formation of viscous sputum, which is difficult to cough up.
Skin and subcutaneous tissue disorders: skin rash, urticaria, exfoliative dermatitis, hyperemia.
Immune system disorders: anaphylactic reactions, anaphylactic shock.
Others: decreased sweating, dry skin, dysarthria.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
5 suppositories in a blister, 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
Private Joint-Stock Company "Lekhim-Kharkiv".
Location of the manufacturer and its business address
Ukraine, 61115, Kharkiv region, Kharkiv city, Severyna Pototskoho street, building 36.
