Relief® advance

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Relif® Advance

Composition:

Active ingredient: 1 suppository contains benzocaine 206 mg;

Excipients: cocoa butter, corn starch, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216).

Dosage form. Rectal suppositories.

Main physico-chemical characteristics: opaque, torpedo-shaped suppositories of pale white to light yellow color.

Pharmacotherapeutic group. Agents for the treatment of haemorrhoids and anal fissures for local use. Local anesthetics. ATC code C05AD03.

Pharmacological Properties

Pharmacodynamics

Benzocaine reversibly stabilizes the neuronal membrane, thereby reducing its permeability to sodium ions. As a result, neuronal membrane depolarization is inhibited, thus preventing the generation and conduction of nerve impulses. In this way, benzocaine exerts a pronounced local anesthetic effect.

Pharmacokinetics

The drug is intended for topical use. Benzocaine contained in the formulation is released as part of mucus or, in extremely small amounts, via the kidneys.

Clinical characteristics.

Indications.

External and internal hemorrhoids, fissures, erosion and microtraumas in the anal area, perianal pruritus with pronounced pain syndrome. As an anesthetic following proctological surgical procedures.

Contraindications.

Hypersensitivity to any component of the drug or to other amide-type local anesthetics, thromboembolic disease, granulocytopenia.

Interaction with other medicinal products and other forms of interaction.

The use of the drug is not recommended, without strict medical indications and physician supervision, concomitantly with regular use of monoamine oxidase inhibitors (MAOIs), antidepressants, and antihypertensive agents, due to the theoretical possibility of reduced MAOI effect or potentiation of antihypertensive effects resulting from interaction with benzocaine, particularly in cases of significant exceeding of recommended doses and duration of treatment.

Special precautions for use.

In case of profuse bloody discharge from the anus or presence of disease symptoms or worsening condition during 7 days of treatment, additional consultation with a proctologist is necessary.

A physician should be consulted before starting use of this medicinal product in the following cases: pronounced arterial hypertension, severe cardiac rhythm disorders, clinically evident thyrotoxicosis, urinary retention.

The smallest necessary amount of the medicinal product should be used. There have been reports that 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, could indicate potentially life-threatening methemoglobinemia and require immediate medical intervention.

Unless otherwise directed by a physician, the recommended daily dose should not be exceeded in order to minimize systemic adverse reactions. Application to damaged skin is not recommended, as it may promote systemic absorption.

In case of bleeding from the anus, prompt medical advice should be sought.

Use during pregnancy or breastfeeding.

During pregnancy, the medicinal product should be used only if absolutely necessary, after a careful assessment by the physician of the benefit-risk ratio for the mother and fetus or child.

During breastfeeding, a decision should be made whether to discontinue breastfeeding or to refrain from using the medicinal product, taking into account the importance of the drug for the mother.

Ability to affect reaction speed when driving or operating machinery. Unknown.

Method of Administration and Dosage.

The medication should be used after hygiene procedures. Insert 1 suppository into the rectum in the morning, after each bowel movement, and before bedtime. The daily dose should not exceed 4 times per day. Regular use of the medication ensures a sustained therapeutic effect and alleviates symptoms of hemorrhoids. The usual duration of treatment is 1 week. If necessary, it may be extended to 3 weeks or longer (after consultation with a physician).

Children. For children under 12 years of age, the medication should be prescribed by a physician only if absolutely necessary.

Overdose.

Symptoms of overdose may be related to the pharmacological effects of benzocaine. Systemic absorption in overdose may manifest as drowsiness, restlessness, cardiac arrhythmia, excitation; in severe cases, seizures, coma, reduced respiratory rate, or respiratory failure may occur. There have been reports that 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 observed during treatment may indicate potentially life-threatening methemoglobinemia requiring immediate medical intervention.

Emergency treatment for overdose and development of methemoglobinemia consists of intravenous administration of methylene blue. Management of other overdose symptoms includes discontinuation of the medication and symptomatic therapy.

Adverse reactions.

Blood and lymphatic system disorders. Methemoglobinemia is possible during the use of the medicinal product (skin, lips, and nail beds cyanosis, headache, dizziness, dyspnea, weakness, tachycardia).

General disorders and administration site conditions: allergic reactions, including hyperemia, skin rashes, itching; changes at the site of administration (irritation, swelling, pain).

Skin and subcutaneous tissue disorders: allergic dermatitis, contact dermatitis.

Excipients methylparahydroxybenzoate and propylparahydroxybenzoate may cause allergic reactions (possibly delayed).

Shelf life.

2 years.

Do not use the medicinal product if the protective plastic overwrap is missing or damaged.

Storage conditions.

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Packaging.

2 strips of 6 suppositories in a cardboard box.

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

Manufacturer.

Istituto De Angeli S.r.l. /
Istituto De Angeli S.r.l.

Manufacturer's address and place of business.

Località Prulli n. 103/c - 50066 Reggello (FI), Italy /
Località Prulli n. 103/c - 50066 Reggello (FI), Italy.