RUSCUS LLORENS RECTAL OINTMENT

Introduction

Leaflet: Information for the user

Ruscus Llorens rectal ointment

Read the 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 side effects not listed in this leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve after 7 days.

Contents of the leaflet

1. What Ruscus Llorens is and what it is used for
2. What you need to know before starting to use Ruscus Llorens
3. How to use Ruscus Llorens
4. Possible side effects
5. Storage of Ruscus Llorens
6. Package contents and additional information

1. What Ruscus Llorens is and what it is used for

Ruscus Llorens rectal ointment belongs to the group of topical medications for the treatment of hemorrhoids, which contain corticosteroids. It contains active ingredients that contribute to the relief of hemorrhoid symptoms: prednisolone, a corticosteroid with anti-inflammatory activity; ruscogenin, which tones the blood vessels and prevents clot formation; cinchocaine, a local anesthetic for pain; zinc oxide, a skin protector; and levomenthol, to relieve itching.

Ruscus Llorens is indicated for the local symptomatic treatment of anorectal inflammation and itching (pruritus) associated with hemorrhoids in adults.

2. What you need to know before starting to use Ruscus Llorens

Do not use Ruscus Llorens:

• If you are allergic to prednisolone, ruscogenin, cinchocaine hydrochloride, zinc oxide, or levomenthol, or to any of the other components of this medication (listed in section 6).
• If you have bleeding hemorrhoids.
• If you have bacterial (e.g., tuberculosis), viral (e.g., herpes), or fungal infections in the area to be treated.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ruscus Llorens.

• In case of irritation in the application area, you should discontinue the use of the ointment and, if necessary, your doctor will prescribe appropriate treatment.

• Avoid contact with the eyes or around the eyes and with other mucous membranes (e.g., the mouth).

• The application of corticosteroids to extensive areas, prolonged use, or use with occlusive dressings or diapers, may lead to effects in other parts of the body (such as adrenal gland problems, with symptoms of Cushing's syndrome - characterized by a rounded face, fat accumulation, delayed healing, etc. - high blood pressure, etc.), due to the greater amount absorbed.

• If you have an infection in the area to be treated, consult your doctor before using the medication, who will indicate a specific treatment. If there is no rapid improvement, you should discontinue treatment until the infection is controlled.

• Contact your doctor if you experience blurred vision or other visual disturbances.

• Elderly people and debilitated patients or those with damaged mucous membranes should be cautious, as they may be more sensitive to systemic side effects (due to absorption into the body of the active ingredients).

Use in athletes

This medication contains a component, prednisolone, (glucocorticoid) that may produce a positive result in doping tests.

Children and adolescents

Do not administer to children under 18 years of age.

Other medications and Ruscus Llorens

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

Do not apply other products at the same time as this medication.

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.

The use of Ruscus Llorens ointment during pregnancy should be reserved for cases where the therapeutic benefit outweighs the potential risk.

Your doctor will decide whether it is necessary to interrupt breastfeeding or treatment with Ruscus Llorens after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

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

Ruscus Llorens contains parahydroxybenzoates and cetyl alcohol

It may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214), and propyl parahydroxybenzoate (E-216).

This medication may produce local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

3. How to use Ruscus Llorens

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.

Cutaneous and/or rectal use.

Adults:

Applications are recommended after intestinal evacuation and personal hygiene.

Before application, wash the affected area carefully with warm water and mild soap, and dry it. Then, apply a amount of ointment the size of 1 or 2 peas (equivalent to 0.5 - 1 cm) to the anal and/or rectal area, one or two times a day.

In case of internal hemorrhoids, use the cannula that comes with the package by screwing it onto the tube and inserting the tip into the anus. Then, apply a small amount of ointment (1 - 2 cm) exerting gentle pressure on the tube. The cannula will be slowly removed as its contents are emptied.

Do not use Ruscus Llorens for more than 7 days.

If symptoms worsen or persist after 7 days, consult your doctor or pharmacist.

If you use more Ruscus Llorens than you should

Excessive use of topical corticosteroids (repeated overdoses) may produce side effects (see section 4).

In case of accidental ingestion of the tube contents, symptoms such as vomiting, diarrhea, dizziness, among others, 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 Toxicology Information Service, phone 91 562 04 20, or go to a medical center indicating the medication and the amount ingested.

If you forget to use Ruscus Llorens

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

If you forget to use the rectal ointment at the scheduled time, apply it as soon as possible and continue with the usual routine.

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 produce side effects, although not everyone experiences them.

At the recommended doses, local application as recommended is rarely associated with the appearance of systemic side effects (in areas other than the application area).

In isolated cases, local adverse reactions may occur due to hypersensitivity to the preparation, including sensitivity to sunlight (photosensitivity), especially when used on extensive skin areas or in prolonged treatments.

Burning, itching, irritation, dryness, allergic contact dermatitis, skin maceration (softening), etc. may appear in the area around the anus.

If any of the mentioned adverse reactions occur, discontinue treatment and consult your doctor or pharmacist.

With topical corticosteroids, such as one of the components of this medication, other side effects may also occur:

Uncommonly (may affect up to 1 in 100 people): blurred vision.

With a frequency not exactly known from the available data, especially in treatment of extensive areas or with occlusive dressings: skin infection; skin atrophy, dilation of small blood vessels, stretch marks, acne, redness, tingling in hands, feet, or other areas, inflammation around the mouth (perioral dermatitis), changes in skin color, cataracts, decreased heart rate.

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 Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ruscus Llorens

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

Store in the refrigerator (between 2°C and 8°C).

Keep the container perfectly closed to protect it from light.

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

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Ruscus Llorens composition

• The active ingredients are: zinc oxide, prednisolone, ruscogenin, cinchocaine hydrochloride, and levomenthol. Each gram of ointment contains 100 mg of zinc oxide (10%), 1.5 mg of prednisolone (0.15%), 8 mg of ruscogenin (0.8%), 5 mg of cinchocaine hydrochloride (0.5%), and 2 mg of levomenthol (0.2%).

• The other components (excipients) are: macrogol 4000, macrogol 400, cetyl alcohol, disodium edetate, mixture of parahydroxybenzoates (methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216)), and purified water.

Product appearance and package contents

Ruscus Llorens is a rectal ointment; white, semi-solid, and homogeneous in appearance.

Each tube contains 30 grams of ointment and includes a cannula for rectal application when necessary.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Manufacturer

Laboratorios Llorens, S.L.

Llacuna, 19-21,

08005 Barcelona

Spain

Date of the last revision of this leaflet:December 2023

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/