BETIOL®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETHIOL® (Vethiolum®)

Composition:

Active substances: belladonnae extract dense, ichthammol;

1 suppository contains: belladonna extract, dense ((4.8–5.2):1) (Belladonnae extractum spissum), extractant 20% (v/v) ethanol) (calculated as total alkaloids 0.00023 g) – 0.015 g (15 mg), ichthammol – 0.2 g (200 mg);

Excipient: hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: dark brown suppositories with a characteristic ichthammol odor, bullet-shaped. A surface film on the suppository is permissible.

Pharmacotherapeutic group. Agents for the treatment of hemorrhoids and anal fissures for local use. ATC code C05AX03.

Pharmacological properties.

Pharmacodynamics.

A combined agent for local treatment of hemorrhoids. Exerts analgesic, anti-inflammatory, and spasmolytic effects – reduces intestinal muscle spasm. Belladonna extract produces a spasmolytic effect and decreases intestinal peristalsis. Ichthammol has anti-inflammatory and local anesthetic properties.

Pharmacokinetics.

No data available.

Clinical characteristics.

Indications.

Hemorrhoids and anal fissures.

Contraindications.

Hypersensitivity to belladonna or to any of the other components 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, benign prostatic hyperplasia. Myasthenia gravis. Gastrointestinal disorders associated with obstruction. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding.

Interaction with other medicinal products and other forms of interaction.

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

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

Reduced 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 without urinary tract obstruction; in patients with 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 patients or debilitated patients; chronic lung diseases without reversible obstruction; chronic lung diseases associated with low production of difficult-to-expectorate sputum, especially in debilitated patients; autonomic (autonomic) neuropathy, and brain injuries.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, the use of the drug is possible only on a physician's prescription when the expected benefit to the woman 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 refrain from driving vehicles or performing tasks that require heightened attention and precise coordination.

Method of Administration and Dosage

For adults, administer rectally 1 suppository 1–3 times daily. The duration of treatment is determined individually by a physician, depending on the nature and severity of the disease and the therapeutic effect achieved. More frequent administration is permitted if prescribed by a physician.

Children. There are no data regarding the use of the drug in children.

Overdose.

Symptoms: intensification of 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 center activity, dry mouth, thirst, constipation, dilated pupils.

Poisoning leads to delirium with psychomotor agitation, requiring specific therapy.

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

Adverse reactions.

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 flushes.

Neurological disorders: headache, dizziness.

Eye disorders: mydriasis, photophobia, paralysis of accommodation, increased intraocular pressure.

Respiratory and mediastinal disorders: decreased secretory activity and tone of bronchi, leading to formation of thick mucus 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.

In such cases, the drug must be discontinued and medical advice should be sought.

Shelf life.

2 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 pack.

Pharmaceutical category.

Over-the-counter.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address.

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