Label: information for the user

ANSO rectal ointment

Lidocaine hydrochloride/pentosan polysulfate sodium/triamcinolone acetonide

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

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, 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 not listed in this label. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contains active principles for the relief of symptoms of hemorrhoids, with anti-inflammatory activity, such as the corticosteroid triamcinolone acetonide; another that acts for pain or itching, the local anesthetic lidocaine; and sodium pentosan polysulfate, which is an anticoagulant and promotes the dissolution of small blood clots.

Anso rectal ointment is indicated for the local symptomatic treatment of manifestations associated with hemorrhoids, such as inflammation, pain, itching or stinging.

Anso rectal ointment is indicated for adults over 18 years old.

Do not use Anso rectal cream:

• If you are allergic to lidocaine or other local anesthetics of the amide type, pentosan polysulfate sodium, or related compounds, triamcinolone, or any of the other ingredients in this medication (listed in section 6).
• If you have bleeding hemorrhoids.
• If you have any infection in the affected area.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Anso rectal cream.

• If the product causes irritation, discontinue its application and consult your doctor.
• Do not apply the medication if the area is irritated, infected, or injured.
• Avoid contact with the eyes or areas close to them. Wash your hands thoroughly after application.
• Do not use Anso rectal cream in excessive doses or for prolonged periods, or with occlusive dressings or diapers (tight, non-breathable materials), as this significantly increases the risk of adverse effects (see section 4).
• If you develop an infection in the treated area, your doctor will prescribe a specific treatment.
• Be cautious if you are taking anticoagulant medications (which prevent blood clotting) or nonsteroidal anti-inflammatory drugs (NSAIDs, for pain and/or fever), as this may increase the risk of bleeding, although cases have not been described with the use of Anso rectal cream.
• Use caution if you are using this cream in elderly or debilitated patients with damaged or weakened mucosa, as they may be more sensitive to the absorption effects of the active ingredients.

Cases of perianal ulcers, which may be extensive, deep, and painful, have been reported, mainly after prolonged use of the cream (see section 4). To prevent their occurrence, follow the usage instructions for this cream (see section 3). If ulcers appear, discontinue treatment and consult your doctor.

Use in athletes

Warning to athletes: This medication contains a component that may result in a positive analytical test for doping control.

Children and adolescents

Anso rectal cream should not be used in children under 18 years old, as no studies have been conducted in this age group.

Children are more sensitive to the toxic effects of exogenous corticosteroids and are more sensitive to the adverse effects of lidocaine.

Other medications and Anso rectal cream

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

Although unlikely, if sufficient absorption occurs, this medication may interact with antiarrhythmic medications (for the heart).

Pregnancy, breastfeeding, and fertility

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

During pregnancy, the use of Anso rectal cream is not recommended and should be reserved for cases where the potential benefit outweighs the possible risk to the fetus or newborn.

Decide whether to interrupt breastfeeding or discontinue treatment with Anso rectal cream, considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery

Anso rectal cream does not affect the ability to drive or operate machinery.

Anso rectal cream contains alcohol cetoestearate, ricinoleate polyoxethylene, butylhydroxyanisole (E320), ethylparaben (E214), propylparaben (E216), and propylene glycol.

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of alcohol cetoestearate and butylhydroxyanisole (E320), and may cause eye and mucous membrane irritation due to butylhydroxyanisole (E320).

It may cause allergic reactions (possibly delayed) due to the presence of ethylparaben (E214) and propylparaben (E216).

It may cause skin reactions due to the presence of ricinoleate polyoxethylene.

This medication contains 10 mg of propylene glycol.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults over 18 years:

Anal and/or rectal use

It is recommended to make the applications after intestinal evacuation and personal hygiene.

Before applying Anso, clean the affected area with warm water and a mild soap.

Dry and apply the ointment.

As a general rule, apply 1 to 3 times a day a quantity of ointment of 1-2 cm on the area to be treated.

Apply the amount of ointment in the anal region with a finger, using the tip of the finger to overcome the resistance of the sphincter. Wash your hands thoroughly after use.

If the ointment is to be applied inside the rectum, screw the applicator attached to the tube and insert the tip into the anus. Then, apply a small amount of ointment while exerting gentle pressure on the tube.

If symptoms worsen or last more than 7 days, discontinue application and consult your doctor.

If you use more Anso rectal ointment than you should

The excessive use of topical corticosteroids (amounts greater than recommended) may cause adverse effects (see section 4).

With excessive application of lidocaine or with occlusive dressing or on irritated or wounded skin, it may be absorbed and reactions such as irregular heartbeats, convulsions, respiratory difficulty may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Phone 915 62 04 20, or go to a medical center indicating the medication and the amount ingested.

If you forgot to use Anso rectal ointment

Do not apply 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.

The appearance of adverse effects is more likely with prolonged use or excessive doses and with application with occlusive materials (adjusted and poorly breathable).

The assessment of adverse effects is based on the following frequencies:

Rare: may affect up to 1 in 100 people.

Uncommon: may affect up to 1 in 1,000 people.

Frequency not known: cannot be estimated based on available data.

With low frequency:

Adverse reactions may appear at the application site, such as burning, itching, irritation.

With rare frequency:

Thinning of the skin (atrophy), small and dilated blood vessels in the skin (telangiectasia), skin striations, acne, specific skin inflammation around the mouth (perioral dermatitis), redness, loss of skin coloration (hypopigmentation).

With unknown frequency:

Hypersensitivity, especially to lidocaine, with allergic reaction or anaphylactic reactions that could produce swelling under the skin, difficulty breathing due to bronchial constriction, skin inflammation, involuntary laryngeal contraction, hives, itching, and shock.

Allergic contact dermatitis, dryness, skin maceration, perianal ulcers (see section 2).

Adverse effects may occur not only in the treated area, but also in completely distinct areas of the body, through skin absorption of the active principles. For example, it could produce a condition characterized by rounded face, obesity, accumulation of fat in the cervical area, delayed healing, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), cataracts, hair loss.

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:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Keep the tube perfectly closed.

Do not use this medication after the expiration date that appears on the packaging after 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 packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Anso rectal ointment

• The active principles are: lidocaine hydrochloride, pentosan polysulfate sodium, and triamcinolone acetonide. Each gram of ointment contains 20 mg of lidocaine hydrochloride (2%), 10 mg of pentosan polysulfate sodium (1%), and 0.1 mg of triamcinolone acetonide (0.01%).

• The other components (excipients) are: cetearyl alcohol, cetearyl sulfate sodium, polyoxylated ricinoleate, butylhydroxyanisole (E320), citric acid (E330), cetearyl macrogol ether, decyl oleate, ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate, sorbitol (E420), propylene glycol, disodium edetate, thymol, hexetidine, and purified water.

Appearance of the product and content of the packaging

Anso is a rectal ointment, white in color.

It is presented in tubes containing 50 g of rectal ointment. The packaging is provided with a cannula for rectal application when appropriate.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Last review date of this leaflet: December 2022.

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