ANSO RECTAL OINTMENT

Introduction

Package Leaflet: Information for the User

ANSO Rectal Ointment

Lidocaine Hydrochloride/Pentosan Polysulfate Sodium/Triamcinolone Acetonide

Read this 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 a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What ANSO Rectal Ointment is and what it is used for
2. What you need to know before using ANSO Rectal Ointment
3. How to use ANSO Rectal Ointment
4. Possible side effects
5. Storage of ANSO Rectal Ointment
6. Package Contents and Additional Information

1. What ANSO Rectal Ointment is and what it is used for

It contains active ingredients for the relief of hemorrhoid symptoms, with anti-inflammatory activity, such as the corticosteroid triamcinolone acetonide; another that acts for pain or itching, the local anesthetic lidocaine; and pentosan polysulfate sodium, which is an anticoagulant and favors 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 burning.

ANSO Rectal Ointment is indicated for adults over 18 years of age.

2. What you need to know before using ANSO Rectal Ointment

Do not use ANSO Rectal Ointment:

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

• If the product causes irritation, you should stop its application and consult a doctor.
• Do not apply the medication if the area is irritated, infected, or wounded.
• Avoid contact with the eyes or areas close to them. Wash your hands well after application.
• Do not use ANSO Rectal Ointment in excessive doses or for prolonged periods, or with occlusive dressings or diapers (tight, non-breathable materials), as this significantly increases the risk of side effects (see section 4) due to increased absorption.
• If you develop an infection in the area to be treated, your doctor will indicate a specific treatment.
• You should be cautious if you are being treated with anticoagulant medications (which prevent clot formation) or non-steroidal anti-inflammatory drugs (NSAIDs, for pain and/or fever), to avoid possible bleeding, although no cases have been described with the use of ANSO Rectal Ointment.
• Cautious use is recommended if this ointment is used in elderly patients or those with damaged or weakened mucosa, as they may be more sensitive to the effects of absorption of the active ingredients.

There have been reports of perianal ulcers, which can be extensive, deep, and painful, mainly after prolonged use of the ointment (see section 4). To avoid their appearance, the instructions for use of this ointment should be followed (see section 3). In case of appearance of perianal ulcers, treatment should be suspended and a doctor consulted.

Use in Athletes

Athletes are warned that this medication contains a component that can result in a positive doping control test.

Children and Adolescents

ANSO Rectal Ointment should not be used in children under 18 years of age, as no studies have been conducted in this population.

Children are more susceptible to exogenous corticosteroid toxicity than adults and are more sensitive to the adverse effects of lidocaine.

Other Medications and ANSO Rectal Ointment

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

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

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.

During pregnancy, the use of ANSO Rectal Ointment is not recommended and should be reserved only for cases where the potential benefit outweighs the possible risk to the fetus or newborn.

A decision should be made to either discontinue breastfeeding or discontinue treatment with ANSO Rectal Ointment, considering the benefit of breastfeeding to the child and the benefit of treatment to the mother.

Driving and Using Machines

ANSO Rectal Ointment does not affect the ability to drive or use machinery.

ANSO Rectal Ointment contains cetostearyl alcohol, polyoxyethylene ricinoleate, butylhydroxyanisole (E320), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), and propylene glycol.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol and butylhydroxyanisole (E320), and may also cause eye and mucous membrane irritation because it contains butylhydroxyanisole (E320).

It may cause allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216).

It may cause skin reactions because it contains polyoxyethylene ricinoleate.

This medication contains 10 mg of propylene glycol.

3. How to Use ANSO Rectal Ointment

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

The recommended dose is:

• Adults over 18 years of age:

Anal and/or rectal use

Applications should be made after intestinal evacuation and personal hygiene.

Before applying ANSO, the affected area should be cleaned with warm water and mild soap.

Dry and apply the ointment.

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

The ointment should be applied to the anal region with a finger, using the fingertip to overcome the resistance of the sphincter. Wash your hands well after use.

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

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

If you use more ANSO Rectal Ointment than you should

Excessive use of topical corticosteroids (amounts greater than recommended) can produce side effects (see section 4).

With excessive application of lidocaine or with occlusive dressing or on irritated or wounded skin, absorption can occur, and reactions such as irregular heartbeats, convulsions, or difficulty breathing may appear.

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

If you forget to use ANSO Rectal Ointment

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

If you have any other doubts 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 experiences them.

The appearance of side effects is more likely with prolonged use or excessive doses and with application using occlusive materials (tight, non-breathable).

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

Uncommon: may affect up to 1 in 100 people.

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

Frequency not known: cannot be estimated from the available data.

Uncommon:

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

Rare:

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

Frequency not known:

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 contraction of the larynx, hives, itching, and shock.

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

Side effects can occur not only in the treated area but also in completely different parts of the body, due to absorption of the active ingredients through the skin. For example, a condition characterized by a rounded face, obesity, fat accumulation in the cervical area, delayed healing, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), cataracts, hair loss.

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

5. Storage of ANSO Rectal Ointment

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 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 medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ANSO Rectal Ointment

• The active ingredients 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: cetostearyl alcohol, sodium cetostearyl sulfate, polyoxyethylene ricinoleate, butylhydroxyanisole (E320), citric acid (E330), macrogol cetostearyl ether, decyl oleate, ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate, sorbitol (E420), propylene glycol, disodium edetate, thymol, hexetidine, and purified water.

Appearance of the Product and Package Contents

ANSO is a rectal ointment, white in color.

It is presented in tubes containing 50 g of rectal ointment. The packaging includes an applicator for rectal application when necessary.

Marketing Authorization Holder and Manufacturer

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Date of the Last Revision of this Leaflet:December 2022.

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