ABRASONE RECTAL, RECTAL CREAM

Introduction

Leaflet: information for the user

Abrasone Rectal, Rectal Cream

Fluocinonide/Ruscogenine/Hexetidine

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 7 days.

Contents of the leaflet

1. What Abrasone Rectal is and what it is used for
2. What you need to know before starting to use Abrasone Rectal
3. How to use Abrasone Rectal
4. Possible side effects
5. Storage of Abrasone Rectal
6. Package contents and additional information

1. What Abrasone Rectal is and what it is used for

It belongs to the group of topical medications for the treatment of hemorrhoids, which contain corticosteroids. The active ingredients contribute to the relief of hemorrhoid symptoms: fluocinonide, a corticosteroid with anti-inflammatory activity; ruscogenine, which tones the blood vessels and prevents clot formation, and hexetidine, an antiseptic.

Abrasone Rectal is indicated for the local symptomatic treatment of anorectal inflammation and anal pruritus (itching) associated with hemorrhoids.

Abrasone Rectal is indicated for adults over 18 years of age.

2. What you need to know before starting to use Abrasone Rectal

• If you are allergic to fluocinonide, ruscogenine, hexetidine, or any of the other components of this medication (listed in section 6).
• If you currently have a bacterial (e.g., tuberculosis), viral (e.g., herpes), or fungal infection in the area to be treated.
• If you have bleeding hemorrhoids.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Abrasone Rectal.

Prolonged use of corticosteroids on the skin (the group of medications to which Abrasone Rectal belongs) can cause skin atrophy, mucous membrane atrophy, and subcutaneous tissue atrophy. Similarly, prolonged or excessive use, or use with occlusive dressings or materials, can lead to systemic effects (such as adrenal gland problems, with symptoms of Cushing's syndrome - characterized by a rounded face, fat accumulation, delayed wound healing, etc. - high blood pressure, etc.).

• Avoid contact with the eyes or surrounding areas and with other mucous membranes (e.g., the mouth).
• In case of irritation in the application area, you should discontinue use of the cream and, if necessary, your doctor will prescribe appropriate treatment.
• If you have an infection in the area to be treated, consult your doctor before use, who will indicate specific treatment. If there is no rapid improvement, you should discontinue treatment until the infection is controlled.
• Elderly patients, patients with damaged mucous membranes, or weakened patients should be cautious, as they may be more sensitive to systemic side effects (due to absorption of the active ingredients into the body).
• Contact your doctor if you experience blurred vision or other visual disturbances.
• In case of bleeding, consult your doctor and/or pharmacist as soon as possible. Use in athletes

This medication contains a component, fluocinonide, which may result in a positive doping test result.

Children and adolescents

This medication is not indicated for children and adolescents under 18 years of age.

Other medications and Abrasone Rectal

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not apply other products to the same area at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The complete safety of this medication in pregnant women has not been established. Prolonged use or use on large areas in pregnant women or women who may become pregnant is not recommended.

The use of Abrasone Rectal during pregnancy should be reserved for cases where the therapeutic benefit outweighs the potential risk.

Breastfeeding

It is unknown whether the active ingredients of this medication pass into breast milk. The risk assessment should be performed by the doctor when considering treatment.

Driving and using machines

The use of this medication does not affect the ability to drive or operate machines.

Abrasone Rectal contains cetyl alcohol, methylparaben (E-218), and propylene glycol

This medication may cause:

• Local skin reactions (such as contact dermatitis) due to cetyl alcohol.
• Allergic reactions (possibly delayed) due to methylparaben (E-218).

This medication contains 10 mg of propylene glycol per gram of cream.

3. How to use Abrasone Rectal

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Use the product 2 to 3 times a day. Applications should be made after bowel movements and personal hygiene.

Do not use this medication for more than 2 weeks continuously. If your condition worsens or does not improve within 7 days, consult your doctor.

Method of administration:

This medication is for cutaneous use in the anal area and/or rectal use.

Clean the affected area carefully with warm water and mild soap, and apply a thin layer of cream, equivalent to 0.5-1 cm, with gentle massage.

For intrarectal applications (inside the rectum), use the cannula provided with the packaging:

1. Screw the cannula onto the tube after removing the cap and piercing the tube (if using for the first time), and press the tube until the cannula is filled.
2. Before insertion, lubricate the anal sphincter with the same cream to facilitate penetration.
3. Apply the cream with the cannula, approximately 1-2 cm. The cannula should be slowly withdrawn as it empties.
4. Then, wash the cannula carefully before storing it.

If you use more Abrasone Rectal than you should

Given the route of administration of this medication, intoxication is unlikely.

In case of accidental ingestion, symptoms such as palpitations and occasionally high blood pressure may occur. It is recommended to drink plenty of water or other aqueous liquid and perform symptomatic treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, or go to a medical center, indicating the medication and the amount used/taken.

If you forget to use Abrasone Rectal

Do not use a double dose to make up for forgotten doses.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In case of repeated administration of corticosteroids on the skin or with occlusive dressings or materials, the following local effects have been described: burning, itching, irritation, dryness, allergic or contact dermatitis, secondary infection, skin atrophy, stretch marks, redness at the application site, dilation of small blood vessels, changes in skin color.

At the recommended doses, local application is rarely associated with the appearance of generalized side effects that can affect other areas of the body (see also the Warnings and precautions section).

The following may occur: Bacterial and fungal secondary infections; suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome; Blurred vision, cataracts; Contact dermatitis, allergic dermatitis; Hypopigmentation, pruritus, and erythema at the application site, telangiectasia, stretch marks, dryness, burning sensation, and skin atrophy. (Frequency not known: cannot be estimated from available data).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Abrasone Rectal

Keep this medication out of the sight and reach of children. It does not require special storage conditions, although it should be protected from heat.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

• The active ingredients are fluocinonide, ruscogenine, and hexetidine. Each gram of cream contains 0.25 mg of fluocinonide (0.025%), 8 mg of ruscogenine (0.8%), and 1 mg of hexetidine (0.1%).

• The other components are Eumulgin B-1 (polyethylene glycol ether of cetyl alcohol), cetyl alcohol, Cutina MD (glyceryl stearate), isopropyl myristate, menthol, propylene glycol (E-1520), liquid paraffin, methylparaben (E-218), and purified water.

Appearance of the product and package contents

Abrasone Rectal is a rectal cream, white in color, with a menthol odor.

Each tube contains 30 g of cream. A cannula is included for rectal application when necessary.

Marketing authorization holder and manufacturer

Marketing authorization holder: Anotaciones Farmacéuticas S.L.

Ctra. de Rubí a Sant Cugat, Km 1, nº 40-50. 08174 - Sant Cugat del Vallés. Barcelona (Spain)

Manufacturer: LABORATORIOS BOHM, C./ Molinaseca 23, polígono industrial Cobo Calleja. 28947 Fuenlabrada (Madrid)

Date of the last revision of this leaflet:November 2019.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.gob.aemps.es/)