Properties
What is it?
RELIEF® No International Nonproprietary Name Trade Name: RELIEF Dosage Form: Rectal Ointment Description: Yellow ointment free of foreign matter, with a faint characteristic odor. Composition: Active Ingredients: Phenylephrine hydrochloride 2.5mg/g Excipients: Mineral oil, petrolatum, methylparaben (E218), propylparaben (E216), anhydrous lanolin, benzoic acid (E210), corn oil, glycerol, lanolin alcohols, hard paraffin (58/60), cod liver oil, Vitamin E, white beeswax, purified water. Pharmacotherapeutic Group: Other agents for the treatment of hemorrhoids and anal fissures for external use. ATC Code: C05AX. See Blog: RELIEF - Ointment and Suppositories for Hemorrhoid Treatment Pharmacological Properties: Phenylephrine hydrochloride is an alpha-adrenomimetic agent, exhibiting local vasoconstrictive action, which reduces exudation, tissue swelling, and itching in the anorectal area. Indications: As a symptomatic agent for hemorrhoids, anal fissures, and perianal itching. Method of Use and Dosage: The preparation is used after hygienic procedures. Remove the protective cap from the applicator, attach the applicator to the tube, and extrude a small amount of ointment to lubricate the applicator. Using the applicator, carefully apply the ointment to the affected areas, externally or into the rectum, up to 4 times a day (in the morning, before bedtime, and after each bowel movement). Wash the applicator thoroughly after each use and place it in the protective cap. For children under 12 years of age - as directed by a doctor. The dose used for self-treatment of hemorrhoids in adults and children from 12 years of age should not exceed 2mg of phenylephrine hydrochloride per day (1g of ointment contains 2.5mg of phenylephrine hydrochloride). Exceeding this dose without a doctor's recommendation is not advised. Side Effects: The following side effects may occur: Cardiovascular system: Reflex bradycardia, cardiac arrhythmias, increased blood pressure. Immune system: Hypersensitivity reactions, including cross-reactions in case of allergic reactions to other sympathomimetic agents, which may manifest as skin rash, itching, angioneurotic edema, contact dermatitis. Nervous system: Dizziness, nervousness, headache, tremor, insomnia, anxiety, possible development of seizures. Skin and subcutaneous tissue: Contact dermatitis, hyperemia, skin rash, itching, swelling, pain, burning. Reporting Adverse Reactions: If you experience any adverse reactions, consult your doctor. This recommendation applies to any adverse reaction, including those not described in the package insert. You can also report information on adverse drug reactions (effects) to the database of adverse reactions, including information on the ineffectiveness of medicinal products. By providing information on adverse reactions, you help to obtain more information about the safety of the drug. Contraindications: Hypersensitivity to the ingredients of the preparation, severe arterial hypertension, tachyarrhythmias, decompensated heart failure, conduction disorders of the heart, acute renal and/or hepatic failure, thyrotoxicosis, acute pancreatitis, thromboembolism (including history of), granulocytopenia, simultaneous administration with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuation of treatment with MAOIs. Overdose: Significant overdose of recommended single daily doses may lead to a tendency towards hypercoagulation. Overdose may manifest as: arterial hypertension, pain and discomfort in the cardiac region, palpitations, respiratory disorders, non-cardiogenic pulmonary edema, excitability, seizures, sleep disturbances, anxiety, irritability, psychosis with hallucinations, general weakness, anorexia, nausea, vomiting, oliguria, impaired urination, facial flushing, cold sensation in the extremities, paresthesia, hyperglycemia, hypokalemia, decreased blood supply to vital organs, which can lead to impaired blood supply to the kidneys, metabolic acidosis, increased cardiac workload due to increased total peripheral resistance. Treatment is symptomatic. Precautions: Patients with arterial hypertension, cardiovascular diseases, thyroid diseases, narrow-angle glaucoma, diabetes mellitus, liver disease, pancreatic disease, urinary retention (e.g., in case of benign prostatic hyperplasia) should use the medicinal product after consulting a doctor, and medical supervision is necessary during treatment. Before prescribing the preparation, the doctor should clarify the allergic history, including allergic reactions to other sympathomimetic agents. In case of profuse rectal bleeding during the use of the preparation or lack of therapeutic effect, consult a doctor immediately. Interactions with Other Medicinal Products: The preparation should not be used concurrently with other vasoconstrictive agents (regardless of the route of administration), as well as antihypertensive drugs (beta-blockers). Atropine sulfate blocks reflex bradycardia caused by phenylephrine and increases the vasopressor response to phenylephrine. Concurrent administration of phenylephrine and beta-blockers can cause arterial hypertension and pronounced bradycardia, which may lead to heart block. The medicinal product RELIEF should be prescribed with caution in relation to thyroid hormones, and with drugs affecting cardiac conduction (cardiac glycosides, antiarrhythmics). Its concurrent use with drugs that cause potassium excretion from the body (e.g., furosemide-type diuretics) may lead to increased hypokalemia and decreased sensitivity to vasopressor drugs such as phenylephrine. Concurrent use of phenylephrine with other sympathomimetic agents may cause additional stimulation of the central nervous system, accompanied by excitability, irritability, insomnia, and possible development of seizures. The use of RELIEF is not recommended when taking MAO inhibitors or within 14 days after discontinuing these drugs. Use During Pregnancy and Lactation: The medicinal product is not recommended for women during pregnancy and lactation. Effect on Driving and Operating Machinery: Caution is recommended due to possible side effects on the nervous system. Storage Conditions: At a temperature not exceeding 25°C, out of reach of children. Shelf Life: 2 years. Do not use after the expiry date indicated on the packaging. Packaging: 28.4g tube. The tube with applicator and package insert is placed in a cardboard box. Dispensing Conditions: Over-the-counter.