Abrasonе rectal cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Abrasone Rectal, Rectal Cream
Fluocinonide/Ruscogenin/Hexetidine
Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult your doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Abrasone Rectal is and what it is used for
- What you need to know before using Abrasone Rectal
- How to use Abrasone Rectal
- Possible adverse effects
- How to store Abrasone Rectal
- Contents of the pack and other information
1. What Abrasone Rectal is and what it is used for
It belongs to the group of topical medications used for the treatment of hemorrhoids, which contain corticosteroids. The active ingredients help relieve hemorrhoid symptoms: flucinonide, a corticosteroid with anti-inflammatory activity; ruscogenin, which tones 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 use in adults over 18 years of age.
2. What you need to know before using Abrasone Rectal
- If you are allergic to fluocinonide, ruscogenin, 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.
Prolonged use of corticosteroids on the skin (the group of medicines to which Abrasone Rectal belongs) may cause atrophy of the skin, mucous membranes, and subcutaneous tissue. In addition, prolonged use, large amounts, or use under occlusive clothing or materials may lead to generalized effects in the body caused by the passage of the medicine into the bloodstream (such as affecting glands located near the kidneys, symptoms of Cushing's syndrome—characterized by 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., mouth).
- If irritation occurs at the application site, discontinue use of the cream and, if necessary, your doctor will initiate appropriate treatment.
- If you have an infection in the area to be treated, consult your doctor first, who will prescribe specific treatment. If rapid improvement does not occur, treatment must be discontinued until the infection is under control.
- Caution is advised in elderly patients, or those with damaged or weakened mucosa, as they may be more sensitive to systemic adverse effects (due to absorption of 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 result in a positive anti-doping test.
Children and adolescents
This medicine is not indicated for use in children or adolescents under 18 years of age.
Other medicines and Abrasone Rectal
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Other products should not be applied simultaneously to the same treated area.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The full safety of this medicine in pregnant women has not been established. Its use over long periods or on large skin areas is not recommended in pregnant women or women who may become pregnant.
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 made by the doctor when considering treatment.
Driving and using machines
The use of this medicine does not affect the ability to drive or operate machinery.
Abrasone Rectal contains cetyl alcohol, methyl parahydroxybenzoate (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 methyl parahydroxybenzoate (E-218).
This medicine contains 10 mg of propylene glycol per gram of cream.
3. How to use Abrasone Rectal
Follow exactly the instructions for administration of this medicine as given 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 are recommended after bowel movement and personal hygiene.
Do not use this medicine for more than 2 consecutive weeks. If symptoms worsen or persist for more than 7 days, consult your doctor.
Method of administration:
This medicine is for cutaneous use in the anal area and/or rectal use.
Carefully clean the affected area with lukewarm water and a mild soap, and apply a thin layer of cream in an amount equivalent to 0.5–1 cm with gentle massage.
For intrarectal applications (inside the rectum), use the cannula provided in the package:
- Screw the cannula onto the tube after removing the cap and piercing the tube (in case of first use), and press the tube until the entire cannula is filled.
- Before insertion, lubricate the anal sphincter with the same cream to facilitate penetration.
- Apply the cream using the cannula to a depth of approximately 1–2 cm. The cannula should be slowly withdrawn as it empties.
- Afterwards, carefully wash the cannula before storing it.
If you use more Abrasone Rectal than you should
Given the route of administration of this medicine, intoxication is unlikely.
In case of accidental ingestion, symptoms such as palpitations and occasionally increased blood pressure may occur. It is recommended to drink a large amount of water or another aqueous liquid and receive symptomatic treatment.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, or go to a medical center, indicating the medicine and the amount used or ingested.
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 medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
With repeated administration of corticosteroids to the skin, or when used with clothing or materials that do not allow the skin to breathe, the following local effects have been reported: burning, itching, irritation, dryness, allergic or contact dermatitis, secondary infection, skin atrophy, striae, redness at the application site, dilation of small blood vessels, and changes in skin pigmentation.
At recommended doses, local application rarely leads to systemic adverse effects affecting other parts of the body (see also section Warnings and precautions).
Possible adverse effects include: secondary bacterial and fungal infections; hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome; blurred vision, cataracts; contact dermatitis, allergic dermatitis; hypopigmentation, pruritus and erythema at the application site, telangiectasia, striae, dryness, burning sensation, and skin atrophy. (Frequency not known: frequency cannot be estimated from the available data).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Abrasone Rectal
Keep this medicine out of sight and reach of children. No special storage conditions are required, although exposure to heat should be avoided.
Do not use this medicine after the expiry date stated on the packaging after
EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
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The active substances are fluocinonide, ruscogenin, and hexetidine. Each gram of cream contains 0.25 mg of fluocinonide (0.025%), 8 mg of ruscogenin (0.8%), and 1 mg of hexetidine (0.1%).
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The other components are Eumulgin B-1 (cetyl alcohol polyethylene glycol ether), cetyl alcohol, Cutina MD (glyceryl stearate), isopropyl myristate, menthol, propylene glycol (E-1520), liquid paraffin, methylparaben (E-218), and purified water.
Nature of the product and pack size
Abrasone Rectal is a rectal cream, bright white in colour, with a menthol odour.
Each tube contains 30 g of cream. A rectal cannula for application via the rectal route, when required, 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 most recent review of this leaflet: November 2019.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.gob.aemps.es/)