Hemorron

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEMORRON (HEMORRON)

Composition:

Active substances: phenylephrine hydrochloride, shark liver oil (vitamin A);

1 g of ointment contains: phenylephrine hydrochloride 2.5 mg, shark liver oil (vitamin A) 30.0 mg (500 IU);

Excipients: petrolatum (vaseline), mineral oil, lanolin, white wax, paraffin, microcrystalline wax, lanolin alcohol, purified water, glycerin, corn oil, methylparaben (E 218), propylparaben (E 216), benzoic acid (E 210), butylated hydroxyanisole (E 320), tocopherol (vitamin E), thyme oil.

Pharmaceutical form. Ointment for external and rectal use.

Main physicochemical properties: homogeneous transparent yellowish oily ointment with the odor of fish oil.

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

ATC code C05AX03.

Pharmacological properties.

Pharmacodynamics.

A combination drug whose action is determined by the properties of its constituent components, promoting the resolution of hemorrhoidal nodes and providing rapid relief from pain, burning, itching, and other discomforts inside and around the anus.

Shark liver oil (vitamin A) has pronounced anti-inflammatory and hemostatic effects, stimulates reparative processes, and promotes healing of wounds and microfissures.

Phenylephrine hydrochloride is an alpha-adrenomimetic agent that exerts local vasoconstrictive action, reduces swelling and itching, and normalizes the balance between blood inflow and outflow in the rectal cavernous bodies.

Pharmacokinetics.

The effect of the drug develops very quickly after administration and lasts from 30 minutes to 4 hours. Biotransformation of the drug that enters the systemic circulation occurs in the liver. The drug is excreted by the kidneys and with feces.

Clinical characteristics.

Indications.

Hemorrhoids accompanied by symptoms of burning, itching, and discomfort.

Contraindications.

Hypersensitivity to the components of the drug, severe arterial hypertension, tachyarrhythmia, conduction disorders, decompensated heart failure, severe renal and hepatic insufficiency, thyrotoxicosis, acute pancreatitis, concomitant use with monoamine oxidase inhibitors or within 15 days after discontinuation of MAO inhibitors, thromboembolic disease, granulocytopenia.

Interaction with other medicinal products and other forms of interaction.

Should not be used concomitantly with other vasoconstrictive agents (by any route of administration), or with antihypertensive drugs (ß-adrenoblockers), as phenylephrine may cause severe hypertension in some individuals due to stimulation of α-adrenergic receptors, and excessive bradycardia with possible cardiac block.

Atropine sulfate blocks the reflex bradycardia caused by phenylephrine and enhances the vasopressor response to phenylephrine.

Use with caution together with thyroid hormones and drugs affecting cardiac conduction (cardiac glycosides, antiarrhythmic agents).

When used concomitantly with drugs causing potassium excretion, such as certain diuretics like furosemide, hypokalemia may be intensified and arterial sensitivity to vasopressor agents such as phenylephrine may be reduced.

Concomitant use of phenylephrine and other sympathomimetics may lead to additive stimulation of the central nervous system to an extremely high level, resulting in nervousness, irritability, insomnia, and possibly seizures.

If a patient has been taking monoamine oxidase inhibitors prior to starting phenylephrine in the anorectal area, medical advice should be sought. MAO inhibitors taken before starting phenylephrine therapy potentiate the cardiac and pressor effects of phenylephrine due to reduced metabolism of phenylephrine.

When applying the Hemorron preparation locally in the anal area, the excipient paraffin may reduce the strength and safety of latex condoms used simultaneously with the medicinal product.

Special precautions for use

It is not recommended to exceed the dose specified in the instructions.

Do not use the applicator if its insertion causes pain or if bleeding occurs after applying the medication.

In case of significant bloody discharge from the rectum or presence of disease symptoms during 7 days of treatment, or if the condition worsens, additional consultation with a physician is required.

This medicinal product should be used with caution in patients with arterial hypertension, cardiovascular or cerebrovascular diseases, hyperthyroidism (phenylephrine may cause adverse cardiovascular effects, especially when high doses are used or in sensitive individuals), or closed-angle glaucoma.

Patients with diabetes mellitus should use this medicinal product cautiously: phenylephrine may increase blood glucose concentration. These effects are usually temporary and mild but may increase if recommended doses are exceeded. Blood glucose levels should therefore be monitored more carefully.

In patients with urinary retention due to prostate hypertrophy or neoplasms, phenylephrine may worsen urination due to smooth muscle spasm of the bladder neck caused by stimulation of α1-adrenoceptors.

Use of the drug in patients with hepatitis or urinary disorders is permissible only after careful assessment of benefit versus risk, as determined by the physician.

Potential interactions of phenylephrine applied locally in the anorectal area should be considered, particularly if sufficient systemic absorption occurs. Concurrent use with monoamine oxidase inhibitors (MAOIs) may potentiate hypertensive effects.

It should be noted that phenylephrine applied locally in the anorectal area may cause severe hypertension due to stimulation of α-adrenoceptors, particularly when used concomitantly with antihypertensive medications.

Methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed), and in some cases bronchospasm. Lanolin may cause local skin reactions, such as contact dermatitis. Benzoic acid (E 210) has moderate irritant effects on the skin, eyes, and mucous membranes. Butylhydroxyanisole (E 320) may cause local skin reactions, such as contact dermatitis, or irritation of the eyes and mucous membranes.

To minimize systemic effects, the recommended dose should not be exceeded unless otherwise directed by a physician.

Use during pregnancy or breastfeeding

The safety of using this medicinal product during pregnancy or breastfeeding has not been studied. Use in these patient groups is possible only if, in the physician’s opinion, the benefit to the mother outweighs the potential risk to the fetus or nursing infant.

Pregnant women should consult a physician before starting treatment with this product.

Studies on the effect of the medicinal product on fertility have not been conducted.

Ability to affect reaction speed when driving or operating machinery

There are currently no data on the effect of this medicinal product on reaction speed. However, caution is advised when driving or operating machinery, due to the potential for adverse reactions affecting the nervous system.

Method of Administration and Dosage

The drug is intended for external and intrarectal use in adults and children aged 12 years and older.

External use. Wash and dry the areas affected by hemorrhoids with a tissue or toilet paper, then apply a thin layer of ointment. Apply in the morning, before bedtime, and after defecation, up to 4 times daily.

Intrarectal use. Remove the protective cap from the applicator. Attach the applicator to the threaded nozzle of the ointment tube. Squeeze out a small amount of ointment to fill the applicator. Lubricate the applicator well with ointment and carefully insert it into the anal canal. Press the tube to expel the ointment from the applicator, remove the applicator, and apply the ointment in a thin layer to the skin around the anus. After each use, the applicator must be thoroughly cleaned and covered with the protective cap.

Regular use of the drug ensures relief of disease symptoms. There are no restrictions regarding duration of treatment; however, if there is no improvement after 7 days, treatment should be discontinued.

Children.

Use is not recommended in children under 12 years of age.

Overdose.

No cases of overdose have been reported with topical application. There is a lack of data on systemic, including toxic, reactions of the body in response to rectal administration of the drug. However, in case of overdose, an intensification of adverse reactions may occur, especially with prolonged use. Possible symptoms include arterial hypertension, chest pain and discomfort, palpitations, dyspnea, non-cardiogenic pulmonary edema, excitation, seizures, sleep disturbances, anxiety, irritability, psychoses with hallucinations, paranoia, weakness, anorexia, nausea, vomiting, oliguria, urinary retention, facial flushing, cold sensation in extremities, paresthesia, increased sensitivity, hyperglycemia, hypokalemia, reduced blood flow to vital organs, which may lead to impaired renal perfusion, metabolic acidosis, and increased cardiac workload due to elevated total peripheral vascular resistance.

Treatment is symptomatic. In case of significant exceeding of recommended single and daily doses, a tendency towards hypercoagulability may occur.

Adverse Reactions.

Cardiovascular system: reflex bradycardia, arrhythmia, cardiac rhythm disturbances, increased blood pressure, sensation of facial flushing.

Immune system: allergic reactions, including cross-reactions in case of allergy to other sympathomimetics, which may manifest as rashes, itching, angioneurotic edema, contact dermatitis.

Nervous system: dizziness, nervousness, headache, tremor, insomnia, feeling of fear.

Endocrine system: worsening of hyperthyroidism symptoms.

Application site: possible irritation, hyperemia, rash, itching, swelling, moderate pain/burning sensation in case of injury or bleeding from the rectum.

Shelf life. 4 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging. 57 g in a tube, 1 tube with an applicator in a cardboard box.

Availability category. Over-the-counter.

Manufacturer. Pharmascience Inc.

Manufacturer's address.

6111 Royalmount Avenue, 100, Montreal, Quebec H4P 2T4, Canada.

6111 Royalmount Avenue, 100, Montreal, Quebec H4P 2T4, Canada.