Belladonna extract

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BELLADONNA EXTRACT

Composition:

Active substance: belladonna extract dense;

1 suppository contains: belladonna extract, dry ((4.8–5.2):1) (Belladonnae extractum spissum), extracted with 20% (v/v) ethanol (calculated as total alkaloids 0.00023 g) – 0.015 g (15 mg);

Excipients: phenol, hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: suppositories from white with a creamy shade to light brown in color, bullet-shaped. A surface bloom may be present.

Pharmacotherapeutic group. Agents for the treatment of haemorrhoids and anal fissures for local use. ATC code C05AX.

Pharmacological properties.

Pharmacodynamics.

A drug for local treatment of hemorrhoids. The drug exerts analgesic, anti-inflammatory, and spasmolytic effects.

Belladonna extract exerts a cholinolytic effect, reduces spasm of intestinal musculature, and decreases intestinal peristalsis.

Clinical characteristics.

Indications.

Hemorrhoids, anal fissures.

Contraindications.

Hypersensitivity to belladonna or to any component of the drug. Cardiovascular disorders 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 predisposition to it. Myasthenia gravis. Gastrointestinal disorders associated with obstruction. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding.

Interaction with other medicinal products and other forms of interaction.

When used with monoamine oxidase inhibitors, cardiac arrhythmias may occur; with quinidine, procainamide – summation of the anticholinergic effect is observed. May reduce the duration and depth of action of narcotic agents, weaken the analgesic effect of opioids.

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

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

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

Special precautions for use.

Use with caution in patients with hypertrophy of the prostate gland without urinary tract obstruction, Down's disease, cerebral palsy, hepatic and renal insufficiency, reflux esophagitis; hiatal hernia associated with reflux esophagitis, inflammatory bowel diseases including non-specific ulcerative colitis and Crohn's disease, megacolon; in patients with xerostomia, elderly patients or debilitated patients, chronic lung diseases without reversible obstruction, chronic lung diseases accompanied by low sputum production which is difficult to expel, especially in debilitated patients, autonomic (vegetative) neuropathy, and brain injuries.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the drug should be used only as prescribed by a physician and only when the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction rate while driving or operating machinery.

While being treated with this drug, it is recommended to avoid driving vehicles or operating machinery that requires heightened attention and precise coordination.

Method of administration and dosing.

For adults, apply rectally 1 suppository 2–3 times a day. If necessary, the dosage may be increased (as directed by a physician).

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 manifestations of adverse reactions, nausea, vomiting, tachycardia, decreased arterial pressure, excitement, irritability, tremor, seizures, insomnia, drowsiness, hallucinations, hyperthermia, central nervous system depression, and suppression of respiratory and vasomotor center activity.

Treatment: Parenteral administration of cholinomimetics and anticholinesterase agents. Symptomatic treatment.

Side effects.

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

Renal and urinary tract disorders: difficulty and retention of urination.

Cardiac disorders: palpitations; arrhythmia, including extrasystoles; myocardial ischemia.

Vascular disorders: facial flushing, hot flashes.

Neurological disorders: headache, dizziness.

Eye disorders: pupil dilation, photophobia, accommodation paralysis, increased intraocular pressure.

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

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

Immune system disorders: anaphylactic reactions, anaphylactic shock.

Other: decreased sweating, dry skin, dysarthria.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 suppositories per blister, 2 blisters per carton.

Availability.

Over-the-counter.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and place of business.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.