ABRILAR SYRUP

Introduction

Leaflet: Information for the user

Abrasone Rectal, Rectal Cream

Fluocinonide/Ruscogenine/Hexetidine

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

Follow exactly the administration instructions of the medicine 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 side effects not listed in this leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

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

It belongs to the group of topical medicines 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 in 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 medicine (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.

The prolonged use of corticosteroids on the skin (the group of medicines to which Abrasone Rectal belongs) can produce skin atrophy, mucous membrane atrophy, and subcutaneous tissue atrophy. Similarly, prolonged or excessive use, or use with occlusive dressings or materials, can cause generalized effects on the body due to the passage of the medicine into the bloodstream (such as adrenal gland disorders, 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 the 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 a specific treatment. If there is no rapid improvement, you should discontinue treatment until the infection is controlled.
• Elderly patients, patients with damaged or weakened mucous membranes, 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 medicine contains a component, fluocinonide, which may cause a positive result in doping tests.

Children and adolescents

This medicine is not indicated in children and adolescents under 18 years of age.

Other medicines and Abrasone Rectal

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

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 medicine.

Pregnancy

Its complete safety 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 medicine pass into breast milk. The risk assessment should be performed by the doctor when considering treatment.

Driving and using machines

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

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

This medicine may cause:

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

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

3. How to use Abrasone Rectal

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Use the product 2 to 3 times a day. It is recommended to apply after bowel movements and personal hygiene.

Do not use this medicine for more than 2 weeks continuously. If symptoms worsen or persist after 7 days, consult your doctor.

Method of administration:

This medicine 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 the cream in a thin layer, equivalent to 0.5-1 cm, with a gentle massage.

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

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 full.
2. Before inserting it, 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 medicine, overdose 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 medicine 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 other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Abrasone Rectal

Keep this medicine out of the sight and reach of children. It does not require special storage conditions, although heat exposure should be avoided.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. 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 ingredients are Eumulgin B-1 (polyethylene glycol ether of cetyl alcohol), cetyl alcohol, Cutina MD (glycerol 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 for rectal application is included.

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 medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.gob.aemps.es/)