Belladonna extract

I N S T R U C T I O N for medical use of the medicinal product BELLADONNA EXTRACT (EXTRACTUM BELLADONNAE)

Composition:

Active substance: 1 suppository contains 0.23 mg – 0.015 g of dry extract of belladonna (Belladonnae extractum spissum) calculated as total alkaloids (1:5) (extractant 20% (v/v) ethanol);

Excipients: phenol, hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical characteristics: suppositories ranging from white with a creamy tint to light yellow with a brownish tint, with slight specks.

Pharmacotherapeutic group. Agents for the treatment of haemorrhoids and anal fissures for local use. ATC code C05A X03.

Pharmacological properties.

Pharmacodynamics.

Suppositories with belladonna extract exert a spasmolytic (cholinolytic) effect. The pharmacological action of the drug is due to a complex of alkaloids contained in its composition (atropine, scopolamine, etc.). Due to the M-cholinoblocking effect of alkaloids, spasm of intestinal smooth muscle is relieved and intestinal peristalsis is reduced.

Pharmacokinetics.

After administration of the suppository into the rectum, the effect of the drug appears within 15–90 minutes. The duration of the systemic action of alkaloids ranges from 2 to 6 hours. Phenol exerts bactericidal and antifungal effects.

Clinical characteristics.

Indications.

Hemorrhoids and anal fissures.

Contraindications.

Hypersensitivity to belladonna and other components of the drug. Cardiovascular disorders in which increased heart rate is undesirable: atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension. Glaucoma. Urinary retention or predisposition to it. Myasthenia. Gastrointestinal disorders associated with obstruction. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding.

Special precautions.

Use with caution in patients with prostatic hyperplasia without urinary tract obstruction, Down's syndrome, cerebral palsy, hepatic and renal insufficiency, reflux esophagitis, hiatal hernia associated with reflux esophagitis, inflammatory bowel diseases including ulcerative colitis and Crohn's disease, megacolon, patients with xerostomia, elderly or debilitated patients, chronic lung diseases without irreversible obstruction, chronic lung diseases associated with low production of difficult-to-expectorate sputum, especially in debilitated patients, autonomic (vegetative) neuropathy, brain injuries.

Interaction with other medicinal products and other forms of interaction.

When used with monoamine oxidase inhibitors, cardiac arrhythmia may occur; with quinidine, procainamide – summation of the anticholinergic effect is observed. The drug may reduce the duration and depth of action of anesthetics and weaken the analgesic effect of opioids.

Concomitant use with diphenhydramine or diprazine enhances the drug's effect; with nitrates, haloperidol, systemic corticosteroids – increases the risk of elevated intraocular pressure; with sertraline – the depressive effect of both drugs is enhanced; with spironolactone, minoxidil – reduces the effect of spironolactone and minoxidil; with penicillins – enhances the effect of both drugs; with nizatidine – enhances the action of nizatidine; with ketoconazole – reduces absorption of ketoconazole; with ascorbic acid and attapulgite – reduces the effect of atropine; with pilocarpine – reduces the effect of pilocarpine in glaucoma treatment; with oxprenolol – reduces the antihypertensive effect of the drug. Under the influence of octadine, a reduction in the hyposecretory effect of atropine is possible, which weakens the action of M-cholinomimetics and anticholinesterase agents. Concurrent use with sulfonamides increases the risk of kidney damage; with potassium-containing preparations – intestinal ulceration may occur; with nonsteroidal anti-inflammatory drugs – increased risk of gastric ulceration and bleeding.

The effect of the drug may be enhanced when used concomitantly with other drugs having antimuscarinic effects: M-cholinoblockers, antiparkinsonian agents (amantadine), spasmolytics, certain antihistamines, butyrophenone group drugs, phenothiazines, disopyramides, quinidine, and tricyclic antidepressants, nonselective inhibitors of neuronal reuptake of monoamines.

Reduced peristalsis under the influence of atropine may lead to altered absorption of other medicinal products.

Special precautions for use.

Use during pregnancy or breastfeeding.

The use of this medicinal product is not recommended during pregnancy and breastfeeding.

Ability to influence reaction speed when driving or operating machinery.
Given the possibility of experiencing dizziness as an adverse reaction, patients should refrain from driving or operating machinery while taking this medicinal product.

Method of Administration and Dosage.

For adult use. Remove the suppository from its packaging by cutting along the contour of the suppository with scissors, and insert deeply into the rectum one suppository 2–3 times daily.

The duration of treatment is determined individually by a physician, taking into account the course and severity of the disease, the therapeutic effect achieved, and the overall treatment strategy. The recommended duration of treatment is 5–7 days.

Children.

There are no data regarding the safety and efficacy of the drug in children.

Overdose.

Symptoms: intensified adverse reactions, nausea, vomiting, tachycardia, decreased arterial pressure, excitement, irritability, tremor, seizures, insomnia, drowsiness, hallucinations, hyperthermia, central nervous system depression, suppression of respiratory and vasomotor centers.

Treatment. Gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Symptomatic treatment.

Side effects.

Gastrointestinal tract: dry mouth, thirst, taste disturbances, dysphagia, decreased intestinal motility up to atony, reduced tone of bile ducts and gallbladder.

Renal and urinary system: difficulty and retention of urination.

Cardiac: palpitations, arrhythmia including extrasystoles, myocardial ischemia.

Vascular: facial flushing, sensation of hot flashes.

Nervous system: headache, dizziness.

Eyes: dilated pupils, photophobia, accommodation paralysis, increased intraocular pressure.

Respiratory system and mediastinal organs: decreased secretory activity and bronchial tone, leading to formation of viscous sputum that is difficult to expectorate.

Skin and subcutaneous tissue: skin rashes, urticaria, exfoliative dermatitis, hyperemia.

Immune system: anaphylactic reactions, anaphylactic shock.

Other: decreased sweating, dry skin, dysarthria.

Shelf life. 2 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 15 °C.

Keep out of reach of children.

Packaging.

5 suppositories per strip. 2 strips per cardboard box.

Availability.

Over-the-counter.

Manufacturer. JSC "Monfarm".

Manufacturer's address and location of business activity.

8, Zavodska Street, Avramivka village, Uman district, Cherkasy region, 19161, Ukraine.