RUSCUS LLORENS RECTAL OINTMENT

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ruscus Llorens rectal ointment

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 those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further 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 you 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 using Ruscus Llorens
3. How to use Ruscus Llorens
4. Possible adverse effects
5. How to store Ruscus Llorens
6. Contents of the pack and other information

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

Ruscus Llorens rectal ointment belongs to the group of topical medications used for the treatment of haemorrhoids that contain corticosteroids. It contains active ingredients that help relieve haemorrhoid symptoms: prednisolone, a corticosteroid with anti-inflammatory activity; ruscogenin, which tones blood vessels and helps prevent clot formation; cinecocaine, a local anaesthetic for pain relief; zinc oxide, a skin protectant; and levomenthol, to relieve itching.

Ruscus Llorens is indicated for the local symptomatic treatment of ano-rectal inflammation and anal itching (pruritus) associated with haemorrhoids in adults.

2. What you need to know before using 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 medicine (listed in section 6).
• If you have bleeding hemorrhoids.
• If you have bacterial infections (e.g., tuberculosis), viral infections (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.

• If irritation occurs at the application site, you must stop using the ointment and, if necessary, your doctor will initiate appropriate treatment.

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

• Applying corticosteroids over large areas, prolonged use, or use under occlusive dressings or diapers may lead to systemic effects in parts of the body other than the treated area (such as affecting glands located near the kidneys, causing symptoms of Cushing's syndrome—characterized by a rounded face, fat accumulation, delayed wound healing, etc.—high blood pressure, etc.), due to increased absorption.

• 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 should be discontinued until the infection is under control.

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

• Elderly individuals, debilitated patients, or those with damaged mucosa should exercise caution, as they may be more sensitive to systemic adverse effects (due to internal absorption of the active ingredients).

Use in athletes

This medicine contains a component, prednisolone (a glucocorticoid), which may result in a positive outcome in doping control tests.

Children and adolescents

Do not administer to children under 18 years of age.

Other medicines and Ruscus Llorens

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

Do not apply other products simultaneously with this medicine.

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 medicine.

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 breastfeeding should be interrupted or treatment with Ruscus Llorens discontinued, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

The use of this medicine does not affect the ability to drive or operate machinery.

Ruscus Llorens contains parahydroxybenzoate esters and cetyl alcohol

May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214), and propyl parahydroxybenzoate (E-216).

This medicine may cause local skin reactions (such as contact dermatitis) as it contains cetyl alcohol.

3. How to use Ruscus Llorens

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

Cutaneous and/or rectal use.

Adults:

Applications are recommended after bowel movement and personal hygiene.

Before application, the affected area should be carefully washed with lukewarm water and mild soap, and dried. Then, apply with a clean gauze a quantity 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 daily.

In case of internal haemorrhoids, use the applicator nozzle supplied 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) by exerting gentle pressure on the tube. The applicator should be slowly withdrawn as its contents are dispensed.

Do not use Ruscus Llorens for longer 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 overdosing) may cause adverse effects (see section 4).

In case of accidental ingestion of the tube contents, symptoms such as vomiting, diarrhoea, dizziness, among others, may occur. It is recommended to drink a large amount of water or other 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 centre, indicating the medicine 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 according to the usual schedule.

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 experiences them.

At the recommended doses, topical application as directed rarely leads to systemic adverse effects (occurring in areas other than the site of application).

In isolated cases, local adverse reactions may occur, mainly due to hypersensitivity to the preparation, including sensitivity to sunlight (photosensitivity), especially when used over extensive areas of skin or during prolonged treatment.

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

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

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

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

Frequency not exactly known from available data, especially with treatment over extensive areas or under occlusive dressing: skin infection; skin atrophy, dilation of small blood vessels, cutaneous striae, acne, redness, tingling in hands, feet or other areas, inflammation around the mouth (perioral dermatitis), changes in skin color, cataracts, decreased heart rate.

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ruscus Llorens

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

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

Keep the container tightly closed to protect it from light.

Do not use this medicine after the expiry date stated on the container 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. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ruscus Llorens

• The active substances 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, a mixture of parahydroxybenzoate esters (methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216)), and purified water.

Appearance of the product and contents of the container

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

Each tube contains 30 grams of ointment and includes an applicator nozzle for rectal administration when appropriate.

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 latest review of this leaflet: December 2023

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