Hemorol

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEMOROL (HEMOROL)

Composition:

Active substances: 1 suppository contains:

benzocaine 100 mg;

thick extract of chamomile flowers (Matricariae extractum spissum) (3 : 1) – 50 mg,
(extractant: purified water);

thick extract of belladonna root (Belladonnae radicis extractum spissum) (4 : 1) – 20 mg,
(extractant: ethanol 70 %);

thick complex extract (4 : 1), obtained according to the formula (1 : 1 : 1 : 1) from:

herb of cytisus (Cytisi scoparii herba) – 20 mg,
bark of horse chestnut (Hippocastani corticis) – 20 mg,
rhizomes of tormentil (Tormentillae rhizomae) – 20 mg,
herb of yarrow (Millefolii herbae) – 20 mg;
(extractant: ethanol 40 %);

Excipients: glycerol, hard fat.

Pharmaceutical form. Suppositories.

Main physicochemical properties:

Torpedo-shaped suppositories, brown in color, with a characteristic odor, with a permissible lighter elliptical tip and a white coating on the surface of the suppository.

Pharmacotherapeutic group.

Preparations for treatment of haemorrhoids and anal fissures for local use. Local anaesthetics. ATC code C05AD.

Pharmacological Properties.

Pharmacodynamics. Hemorol is a combination medicinal product whose therapeutic effect is determined by the pharmacological properties of the active components contained in its formulation. The drug exerts anti-edematous and anti-inflammatory effects, improves venous circulation, and reduces capillary permeability of the mucous membrane of the anal canal. In addition, it produces spasmolytic and local analgesic actions.

Benzocaine provides antipruritic and local anesthetic effects.

The thick extract of chamomile flowers, the extract of tormentil rhizome, and the extract of yarrow herb exert anti-inflammatory and astringent effects.

The thick extract of horse chestnut bark, which contains aesculin and a small amount of aescine, increases venous elasticity.

The thick extract of belladonna root exerts a spasmolytic effect on smooth muscles.

Clinical characteristics.

Indications.

Hemorrhoids, chronic proctitis, anal fissures.

Contraindications.

Hypersensitivity to the components of the drug, other amide-type local anesthetics, or to plants of the Asteraceae family (Asteraeae).

Oncological diseases of the rectum and anal canal.

Granulocytopenia, increased blood coagulability, thromboembolic disease.

Glaucoma.

Severe renal insufficiency.

Cardiovascular diseases 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 predisposition to it.

Myasthenia.

Gastrointestinal disorders accompanied by obstruction.

Hyperthermic syndrome.

Thyrotoxicosis.

Acute bleeding.

Interaction with other medicinal products and other forms of interactions.

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

When used simultaneously with diphenhydramine or diprazine, the drug's effect is enhanced; with nitrates, haloperidol, and systemic corticosteroids – the risk of increased intraocular pressure rises; with sertraline – the depressant effect of both drugs is enhanced; with spironolactone and minoxidil – the effect of spironolactone and minoxidil is reduced; with penicillins – the effect of both drugs is enhanced; with nizatidine – the action of nizatidine is enhanced; with ketoconazole – absorption of ketoconazole is reduced; with ascorbic acid and attapulgite – the action of atropine is reduced; with pilocarpine – the effect of pilocarpine in glaucoma treatment is reduced; with oxprenolol – the antihypertensive effect of the drug is reduced. Under the influence of octadine, a decrease in the antisecretory action 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; with nonsteroidal anti-inflammatory drugs – the risk of gastric ulceration and bleeding increases.

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

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

The drug may enhance the effect of antithrombotic agents. Cephalosporin antibiotics increase the concentration of free escin in blood and the risk of adverse effects. Concomitant use of the drug with aminoglycoside antibiotics should be avoided due to increased nephrotoxicity of aminoglycosides.

Special precautions for use

In the presence of large hemorrhoidal nodes, pain may occur after administration of the suppository due to pressure of the suppository on the hemorrhoidal node. The pain may persist for 5–10 minutes until the suppository dissolves.

Renal function should be monitored during treatment with this drug.

Use with caution in patients with prostatic hypertrophy without urinary tract obstruction, Down's syndrome, cerebral palsy, hepatic or renal insufficiency, reflux esophagitis; in patients with hiatal hernia associated with reflux esophagitis, inflammatory bowel diseases including ulcerative colitis and Crohn's disease, megacolon; in 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, particularly in debilitated patients, autonomic neuropathy, or brain injury.

Use during pregnancy or breastfeeding

The drug is contraindicated during pregnancy due to the risk of abortifacient effects (Scoparia herb extract, escin).

During breastfeeding, use only if the benefit justifies the potential risk to the infant (risk/benefit assessment).

Ability to affect reaction speed when driving or operating machinery

If adverse reactions involving the nervous system or visual organs occur, patients should refrain from driving or operating machinery.

Method of Administration and Dosage

Administered rectally.

Adults are prescribed 1 suppository at night; in more severe cases – 2–3 suppositories during the day.

Treatment should continue until pain symptoms disappear, but not longer than 7 days.

Children.

There is no experience with the use of the drug in children; therefore, it is not administered to this age group of patients.

Overdose.

Symptoms: increased manifestations of adverse reactions, nausea, vomiting, excitement, irritability, tremor, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, depression of the central nervous system, depression of respiratory and vasomotor center activity.

Treatment: gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Symptomatic therapy.

Adverse reactions.

Local changes at the injection site may occur during administration of the drug, including itching at the application site, rash, and skin hyperemia.

Immune system disorders: allergic reactions, including angioneurotic edema, anaphylactic reactions, anaphylactic shock.

Skin and subcutaneous tissue disorders: skin rashes, pruritus, hyperemia, urticaria, skin edema, sensation of heat, exfoliative dermatitis.

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

Eye disorders: mydriasis, photophobia, accommodation paralysis, increased intraocular pressure, transient visual disturbances.

Respiratory system disorders: reduced bronchial secretory activity and bronchial tone, leading to formation of thick mucus that is difficult to expectorate.

Nervous system disorders: psychomotor agitation, seizures, headache, dizziness.

Cardiovascular system disorders: palpitations, tachycardia, arrhythmia including extrasystoles; myocardial ischemia; arterial hypotension, facial flushing, hot flushes.

Urinary system disorders: difficulty and retention of urination.

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.

6 suppositories in a blister; 2 blisters in a cardboard package.

Availability. Over-the-counter (without prescription).

Manufacturer.

Wroclaw Herbal Pharmaceuticals Enterprise "Herbapol" S.A.

Manufacturer's address and place of business.

1 Hetmanska Street, 59-220 Legnica, Poland.