Instructions Relief Advance ointment rectal tube with applicator 28.4 g
Composition
1 g of ointment contains
active ingredient: benzocaine 200 mg;
excipients: shark liver oil, light mineral oil, white soft paraffin, propylene glycol, methylparaben (E 218), propylparaben (E 216), sorbitan stearate.
Dosage form
Rectal ointment.
Main physicochemical properties: white to yellowish ointment without foreign inclusions.
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, erosions, fissures, rectal diseases accompanied by severe pain, itching, burning in the anorectal area; in the postoperative period in patients who have undergone proctological operations; for anesthesia during diagnostic procedures.
Contraindication
Increased individual sensitivity to any component 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 under the supervision of a doctor 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 are present within 7 days of treatment, additional consultation with a proctologist is necessary.
Use with caution as prescribed by a doctor in the following conditions: 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 use of products containing benzocaine can cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips and nail beds, headache, dizziness, shortness of breath (difficulty breathing), weakness, tachycardia, which may occur during treatment, may indicate methemoglobinemia, which is potentially life-threatening and requires urgent medical intervention.
Propylene glycol may cause skin irritation. Methylparaben and propylparaben may cause allergic reactions (possibly delayed).
Use during pregnancy or breastfeeding
Pregnant and breastfeeding women may use the drug if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus and child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Adults and children over 12 years of age should use the drug after performing hygiene procedures. Remove the protective cap from the applicator. Attach the applicator to the tube and squeeze out a small amount of ointment to lubricate the applicator. The ointment is carefully applied through the applicator to the affected areas outside or inside the anus up to 4 times a day, especially in the evening, morning or after each bowel movement.
Use until symptoms disappear. After each use, thoroughly rinse the applicator and place it in the protective cap.
Children
Children under 12 years of age should only use as directed by a doctor.
Overdose
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
Rarely, contact dermatitis, allergic reactions, including flushing, skin rashes, itching; changes at the injection site may occur. When using the drug, methemoglobinemia is possible (cyanosis of the skin, lips and nail beds, headache, dizziness, shortness of breath, weakness, tachycardia).
Expiration date
2 years.
Opening the tube and starting to use the drug does not affect the shelf life, provided that the cap is tightly closed each time after use. Do not use after the expiration date indicated on the package.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 ºС.
Packaging
28.4 g of ointment in a tube. The tube is placed in a cardboard package. Each package contains an applicator in the form of a tube with holes for introducing the ointment and instructions for medical use of the drug.
Vacation category
Without a prescription.
Producer
Famar AVE Avlon Plant, Greece.
Location of the manufacturer and its business address.
49th km National Road Athens - Lamia, Avlona Attiki, 19011, Greece.
Applicant
Bayer Consumer Care AG, Switzerland.
Location of the applicant and/or the applicant's representative.
Peter Merian-Strasse 84, 4052 Basel, Switzerland.
