Instructions for Hemorol suppositories blister No. 12
Composition
Active ingredients: 1 suppository contains:
benzocaine 100 mg;
thick chamomile flower extract (Matricariae extractum spissum) (3:1) – 50 mg,
(extractant purified water);
thick belladonna root extract (Belladonnae radicis extractum spissum) (4:1) – 20 mg,
(extractant ethyl alcohol 70%);
complex thick extract (4:1), obtained according to the recipe (1:1:1:1) from:
sea buckthorn herb (Cytis scopari herba) – 20 mg,
Horse chestnut bark (Nirocastani corticis) – 20 mg,
Tormentillae rhizomes (Tormentillae rhizomae) – 20 mg,
yarrow herb (Millefolii herbae) – 20 mg;
(extractant ethyl alcohol 40%);
excipients: glycerin, solid fat.
Dosage form
Suppositories.
Main physicochemical properties:
Suppositories are torpedo-shaped, brown in color, with a peculiar odor, with an acceptable lighter elliptical end and a white coating on the surface of the suppository.
Pharmacotherapeutic group
Means for the treatment of hemorrhoids and anal fissures for topical use. Local anesthetics. ATX code C05A D.
Pharmacological properties
Pharmacodynamics. Hemorol is a complex drug, the therapeutic effect of which is due to the pharmacological properties of the active components that make up its composition. The drug has an anti-edematous, anti-inflammatory effect, improves venous circulation and reduces the permeability of capillary vessels of the anal mucosa. In addition, it has an antispasmodic and local analgesic effect.
Benzocaine has an antipruritic and local anesthetic effect.
Thick extract of chamomile inflorescences, extract from cinquefoil rhizome and extract from yarrow herb have anti-inflammatory and astringent effects.
Thick horse chestnut bark extract, which contains esculin with a small amount of escin, increases the elasticity of veins.
A thick extract from belladonna roots has an antispasmodic effect on smooth muscles.
Indication
Hemorrhoids, chronic proctitis, anal fissures.
Contraindication
Hypersensitivity to the components of the drug, other amide anesthetics, and plants of the Asteraceae family (Asteraeae).
Oncological diseases of the rectum and anus.
Granulocytopenia, increased blood clotting, thromboembolic disease.
Glaucoma.
Severe renal failure.
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.
Urinary retention or tendency to it.
Myasthenia gravis.
Diseases of the digestive tract 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. The drug can 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, which weakens the effect of M-cholinomimetics and anticholinesterase agents, is possible. 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.
The drug may enhance the effect of antithrombotic agents. Cephalosporin antibiotics increase the concentration of free escin in the blood and the risk of side effects. The simultaneous use of the drug with aminoglycoside antibiotics should be avoided due to increased toxic effects of aminoglycosides on the kidneys.
Application features
If you have large hemorrhoids, pain may occur after inserting the suppository due to the pressure of the suppository on the hemorrhoid; the pain may last for 5-10 minutes until the suppository dissolves.
When using the drug, kidney function should be monitored.
Use with caution in patients with prostatic hypertrophy without urinary tract obstruction, Down syndrome, cerebral palsy, patients with 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 separate, especially in debilitated patients, autonomic neuropathy, brain damage.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy due to the risk of abortifacient action (sea buckthorn herb extract, escin).
During breastfeeding, use taking into account the risk/benefit ratio.
Ability to influence reaction speed when driving vehicles or other mechanisms
In case of side effects from the nervous system or visual organs, you should refrain from driving or working with other mechanisms.
Method of administration and doses
It is applied rectally.
Adults are prescribed 1 suppository at night, in more severe cases - 2–3 suppositories during the day.
Treatment should continue until the pain symptoms disappear, but not longer than 7 days.
Children
There is no experience with the drug in children, so it is not used in this age group of patients.
Overdose
Symptoms: increased manifestations of adverse reactions, nausea, vomiting, agitation, irritability, tremor, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, central nervous system depression, depression of the activity of the respiratory and vasomotor centers.
Treatment: gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Symptomatic therapy.
Adverse reactions
When using the drug, changes at the injection site are possible, including itching at the application site, rash, and skin hyperemia.
Immune system disorders: allergic reactions, including angioedema, anaphylactic reactions, anaphylactic shock.
Skin and subcutaneous tissue disorders: skin rash, itching, flushing, urticaria, skin swelling, feeling of heat, exfoliative dermatitis.
On the part of the digestive tract: dry mouth, thirst, taste disturbances, dysphagia, decreased intestinal motility up to atony, constipation, decreased tone of the biliary tract and gallbladder.
On the part of the organs of vision: pupil dilation, photophobia, accommodation paralysis, increased intraocular pressure, temporary visual disturbances.
On the part of the respiratory system: a decrease in secretory activity and bronchial tone, which leads to the formation of viscous sputum, which is difficult to cough up.
From the nervous system: psychomotor agitation, convulsions, headache, dizziness.
From the cardiovascular system: palpitations, tachycardia, arrhythmia, including extrasystole; myocardial ischemia; hypotension, facial flushing, hot flashes.
On the part of the urinary system: difficulty and delay in urination.
Others: decreased sweating, dry skin, dysarthria.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
6 suppositories in a blister; 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Wroclaw Medicinal Herbs Enterprise "Herbapol" JSC.
Location of the manufacturer and its business address
1 Getmanska Street, 59-220 Legnica, Poland.
