Label: Information for the User

Abrasone Rectal, Rectal Cream

Fluocinonide/Ruscogenin/Hexetidine

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need advice or more information.
• If you experience any 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 you get worse or do not improve after 7 days.

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

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

Rectal Abrasone is indicated for adults 18 years of age and older.

• If you are allergic to fluocinonide, ruscogenin, hexetidine, or any of the other components of this medication (listed in section 6).
• If you currently have an infection caused by bacteria (for example, tuberculosis), virus (for example, herpes), or fungi 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 medications to which Abrasone rectal belongs) may cause skin atrophy, mucous membrane atrophy, and subcutaneous tissue atrophy. Additionally, its prolonged use or in large quantities or with occlusive clothing or materials may cause systemic effects in the body caused by the passage of the medication into the blood (such as adrenal gland impairment, with 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 around them and with other mucous membranes (e.g. the mouth).
• In case of irritation in the application area, you must suspend the use of the cream and if necessary, your doctor will establish an appropriate treatment.
• If you present an infection in the treated area, consult your doctor before starting treatment, who will indicate a specific treatment. If there is no rapid improvement, you must suspend treatment until the infection has been controlled.
• Older adults, patients with damaged mucous membranes, or weakened patients should be cautious, as they may be more sensitive to systemic adverse effects (by absorption of active principles 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 cause a positive result in the antidoping test.

Children and adolescents

This medication is not indicated for children or adolescents under 18 years old.

Other medications and Abrasone Rectal

Inform your doctor or pharmacist if you are using, have used recently, 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The complete safety of this medication has not been established in pregnant women. Its prolonged use or in extensive areas is not recommended in pregnant women or those who may become pregnant.

The use of Abrasone Rectal during pregnancy should be reserved for cases where the therapeutic benefit is greater than the possible risk.

Breastfeeding

The active principles of this medication are unknown to pass into breast milk. The risk assessment should be performed by your doctor, considering the treatment.

Driving and operating machines

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

Abrasone Rectal contains cetomacrogol, methyl parahydroxybenzoate (E-218), and propylene glycol

This medication may cause:

• Local skin reactions (such as contact dermatitis) due to cetomacrogol.
• Allergic reactions (possibly delayed) due to methyl parahydroxybenzoate (E-218).

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

Follow exactly the administration instructions for this medication as 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 make the applications after bowel evacuation and personal hygiene.

Do not use this medication for more than 2 consecutive weeks. In case of aggravation or persistence of symptoms within 7 days, consult your doctor.

Administration method:

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

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

For rectal applications (inside the rectum) use the cannula that comes with the package:

1. Twist the cannula onto the tube after removing the cap and perforating the tube (in case of first-time use) 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 removed slowly as it is emptied.
4. Then, wash the cannula carefully before storing it.

If you use more Abrasone Rectal than you should

Considering the administration route of this medication, it is unlikely to cause intoxication.

In case of accidental ingestion, symptoms such as palpitations and occasional hypertension may occur. It is recommended to drink a large amount 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 Toxicological Information Service, phone 91 562 04 20, or go to a medical center indicating the medication and the amount used/taken.

If you forgot to use Abrasone Rectal

Do not use a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

In the case of repeated administration of corticosteroids on the skin or with clothing or materials that do not allow the skin to breathe, the following local effects have been described: burning, itching, irritation, dryness, allergic or contact dermatitis, secondary infection, skin atrophy, striae, redness at the application site, dilation of small blood vessels, changes in skin color.

At the recommended doses, local application rarely associates with the appearance of generalized adverse effects that may affect other areas of the body (see also Advertencias and Precautions section).

The following may occur: secondary bacterial and fungal 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, striae, dryness, sensation of burning, and skin atrophy. (unknown frequency: the frequency cannot be estimated from the available data).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after

the CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

• The active principles 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 (polyethylene glycol ether of cetearilic alcohol), cetilic alcohol, cutina MD (glyceryl stearate), isopropyl myristate, menthol, propylene glycol (E-1520), liquid paraffin, methyl parahydroxybenzoate (E-218), and purified water.

Appearance of the product and content of the packaging

Abrasone Rectal is a rectal cream, white and shiny, with a menthol odor.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization : Anotaciones Farmacéuticas S.L.

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

Responsible for manufacturing : LABORATORIOS BOHM, C./ Molinaseca 23, industrial estate Cobo Calleja. 28947 Fuenlabrada (Madrid)

Last review date of this leaflet: November 2019.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.gob.aemps.es/)