Label: Information for the User

Ruscus Llorens Rectal Ointment

Read this entire label carefully before using this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those given 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 your doctor if you worsen or do not improve after 7 days.

1. What is Ruscus Llorens and how it is used

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

3. How to use Ruscus Llorens

4. Possible adverse effects

5. Storage of Ruscus Llorens

6. Contents of the package and additional information

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

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

Do not use Ruscus Llorens:

• If you are allergic to prednisolone, ruscogenin, benzocaine hydrochloride, zinc oxide, or menthol, or to any of the other components of this medication (listed in section 6).
• If you have bleeding hemorrhoids.
• If you have bacterial infections (such as tuberculosis), viral infections (such as herpes), or fungal infections in the area being treated.

Warnings and precautions

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

- In case of irritation in the application area, you must suspend the use of the ointment and, if necessary, your doctor will establish an appropriate treatment.

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

- The application of corticosteroids in large areas, prolonged use, or with occlusive dressing or diapers, may lead to the appearance of effects in other parts of the body different from the treated area (such as the involvement of glands near the kidneys, with symptoms of Cushing's syndrome - characterized by rounded face, fat accumulation, delayed healing, etc. - high blood pressure, etc.), due to the greater amount absorbed.

- If you present an infection in the treated area, consult your doctor first, who will indicate a specific treatment. If there is no rapid improvement, you must suspend treatment until the infection has been controlled.

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

- People of advanced age and those who are weakened or have damaged mucous membranes should be cautious, as they may be more sensitive to systemic adverse effects (due to the absorption of active principles into the body).

Use in athletes

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

Children and adolescents

Do not administer to children under 18 years old.

Other medications and Ruscus Llorens

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 at the same time as this medication.

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.

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

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

Driving and operating machinery

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

Ruscus Llorens contains esters of parahydroxybenzoates and cetyl alcohol

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

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

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

Cutaneous and/or rectal use.

Adults:

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

Before the application, the affected area must be carefully washed with warm 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 a day.

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

The excessive use of topical corticosteroids (repeated overdoses) may cause adverse effects (see section 4).

In case of accidental ingestion of the tube contents, symptoms such as vomiting, diarrhea, dizziness, etc. may occur. It is recommended to drink a good 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 ingested.

If you forgot to use Ruscus Llorens

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

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

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

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

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

In isolated cases, local adverse reactions may appear due mainly to hypersensitivity to the preparation, including sensitivity to sunlight (photosensitivity), especially when used on extensive areas of the skin 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 appear, discontinue treatment and consult your doctor or pharmacist.

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

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

Frequency unknown exactly from available data, especially in treatment of extensive areas or with occlusive bandaging: skin infection; skin atrophy, dilation of small blood vessels, striae, acne, redness, tingling in hands, feet, or other areas, inflammation around the mouth (perioral dermatitis), skin color changes, cataracts, decreased heart rate.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

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 that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Ruscus Llorens

• The active principles are:zinc oxide, prednisolone, ruscogenin, zinc cocaine 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 zinc cocaine 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 parahydroxybenzoates (parahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid ethyl ester (E214), parahydroxybenzoic acid propyl ester (E216)), and purified water.

Appearance of the product and contents of the packaging

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 its application via the rectal route 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

Last review date of this leaflet:December 2023

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