Instructions for Relief Advance rectal suppositories No. 12
Composition
active ingredient: 1 suppository contains benzocaine 206 mg;
Excipients: cocoa butter, corn starch, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).
Dosage form
Rectal suppositories.
Main physicochemical properties: pale white to light yellow opaque torpedo-shaped suppositories.
Pharmacotherapeutic group
Means for the treatment of hemorrhoids and anal fissures for topical use. Local anesthetics. ATX code C05A D03.
Pharmacological properties
Pharmacodynamics
Benzocaine reversibly stabilizes the neuronal membrane, which reduces its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited, and thus the generation and conduction of nerve impulses are blocked. Thus, benzocaine exhibits a pronounced local analgesic effect.
Pharmacokinetics
A drug for topical use. Benzocaine, which is part of its composition, is excreted in mucus or, in extremely small quantities, by the kidneys.
Indication
External and internal hemorrhoids, fissures, erosion and microtraumas in the anus, perianal itching with severe pain. As an anesthetic after proctological surgical interventions.
Contraindication
Increased individual sensitivity to any of the components of the drug and other amide local anesthetics, thromboembolic disease, granulocytopenia.
Interaction with other medicinal products and other types of interactions
It is not recommended to use the drug without strict medical indications and medical supervision while regularly taking monoamine oxidase inhibitors (MAO), antidepressants, and antihypertensives due to the theoretical possibility of reducing the effect of MAO inhibitors or enhancing the effect of antihypertensives due to interaction with benzocaine in cases of significantly exceeding the recommended doses and duration of administration.
Application features
In case of heavy bloody discharge from the anus or if symptoms of the disease or deterioration of the condition occur within 7 days of treatment, additional consultation with a proctologist is necessary.
You should consult a doctor before using this drug in the following cases: severe arterial hypertension, severe heart rhythm disturbances, clinically pronounced thyrotoxicosis, urination disorders.
The smallest amount of the drug necessary should be used. There are reports that the administration of products containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips and nail beds, headache, dizziness, dyspnea (difficulty breathing), weakness, tachycardia, which may occur during treatment, may indicate methemoglobinemia, which is potentially life-threatening and requires urgent medical intervention.
Unless otherwise directed by a physician, do not exceed the recommended daily dose to minimize systemic adverse reactions. It is not recommended to apply to damaged skin, as this may contribute to systemic absorption.
If you have rectal bleeding, you should see a doctor as soon as possible.
Use during pregnancy or breastfeeding
During pregnancy, the drug should be used only if absolutely necessary after a careful assessment by the doctor of the benefit to the mother/risk to the fetus or child.
During breastfeeding, a decision should be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
The drug should be used after hygiene procedures. Insert 1 suppository into the anus in the morning, after each bowel movement and before bedtime. Daily dose - no more than 4 times a day. Regular use of the drug allows you to provide a stable therapeutic effect, relieves symptoms of hemorrhoids. The duration of treatment is usually 1 week. If necessary, it can be extended to 3 weeks or more (after consulting a doctor).
Children
Children under 12 years of age should only be prescribed the medicine by a doctor if absolutely necessary.
Overdose
Symptoms of overdose may be related to the pharmacological effects of benzocaine. Its systemic absorption in overdose may manifest as drowsiness, anxiety, cardiac arrhythmias, agitation, and in severe cases, convulsions, coma, decreased respiratory rate, or respiratory failure. There are reports that the administration of products containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips, and nail beds, headache, dizziness, dyspnea (difficulty breathing), weakness, and tachycardia, which may occur during treatment, may indicate methemoglobinemia, which is potentially life-threatening and requires immediate medical intervention.
Emergency care for overdose and development of methemoglobinemia consists of intravenous administration of methylene blue. Other symptoms of overdose require discontinuation of the drug and symptomatic treatment.
Adverse reactions
From the side of the blood and lymphatic system. When using the drug, methemoglobinemia is possible (cyanosis of the skin, lips and nail beds, headache, dizziness, shortness of breath, weakness, tachycardia).
General disorders and administration site conditions: allergic reactions, including flushing, skin rash, itching; injection site conditions (irritation, swelling, pain).
Skin and subcutaneous tissue disorders: allergic dermatitis, contact dermatitis.
The excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Expiration date
2 years.
Do not use the drug if the protective plastic cover is missing or damaged.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
2 strips of 6 suppositories in a cardboard box.
Vacation category
Without a prescription.
Producer
Istituto De Angeli Srl / Istituto De Angeli Srl
Location of the manufacturer and address of its place of business
Località Prulli n. 103/c - 50066 Reggello (FI), Italy.
