Procto-glivenol

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Procto-Glyvenol, (50 mg + 20 mg)/g, Rectal Cream

Tribenoside + Lidocaine Hydrochloride

Before Using the Medication, Carefully Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Procto-Glyvenol and what is it used for
• 2. Important information before using Procto-Glyvenol
• 3. How to use Procto-Glyvenol
• 4. Possible side effects
• 5. How to store Procto-Glyvenol
• 6. Package contents and other information

1. What is Procto-Glyvenol and what is it used for

Procto-Glyvenol rectal cream is a medication intended for the local treatment of external and internal hemorrhoids. Tribenoside has anti-inflammatory, anti-edematous, analgesic, anti-itching effects, and also counteracts vascular endothelial damage. Lidocaine is a local anesthetic and relieves symptoms caused by hemorrhoids, such as itching, burning, and pain. Procto-Glyvenol rectal cream acts locally, practically without systemic action.

2. Important information before using Procto-Glyvenol

When not to use Procto-Glyvenol:

Warnings and precautions

Before starting treatment with Procto-Glyvenol rectal cream in patients with liver function disorders, the doctor should be consulted. Procto-Glyvenol rectal cream should be used with caution in patients with severe liver damage. In addition to treating hemorrhoids with Procto-Glyvenol, it is recommended to maintain proper hygiene of the anal area, use appropriate physical exercises, and follow a diet to maintain a soft stool consistency. The medication should not be taken orally. Contact with the eyes should be avoided.

Children

This medication should not be used in children, as there is no data available on the safety of use in this age group.

Procto-Glyvenol and other medications

No interactions with other medications have been reported. The doctor or pharmacist should be informed about all medications currently or recently used by the patient, as well as any medications planned for use, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication. Procto-Glyvenol rectal cream should not be used during the first 3 months of pregnancy. Procto-Glyvenol rectal cream may be used from the 4th month of pregnancy and during breastfeeding, provided that the recommended doses are not exceeded.

Driving and using machines

Procto-Glyvenol rectal cream has no influence or negligible influence on the ability to drive and use machines.

Procto-Glyvenol contains cetyl alcohol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

Cetyl alcohol may cause local skin reactions (e.g., contact dermatitis). Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late reactions). The medication packaging contains latex. It may cause severe allergic reactions.

3. How to use Procto-Glyvenol

This medication should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted. Procto-Glyvenol rectal cream should be used in the morning and evening until the acute symptoms subside. Then, the dose can be reduced to once a day. When treating internal hemorrhoids, the cream should be applied using the enclosed applicator, which should be screwed onto the tube. The applicator is equipped with a protective cap. It should be removed before using the cream and replaced after application. The recommended doses should not be exceeded. Contact with the eyes should be avoided. Hands should be washed thoroughly after each use. The medication should not be taken orally.

Children

This medication should not be used in children, as there is no data available on the safety of use in this age group.

How long to use Procto-Glyvenol

Procto-Glyvenol rectal cream should be used until the symptoms subside. If there is no improvement or new symptoms appear after 7 days of use, the doctor should be consulted to rule out other potential causes of these symptoms.

Using more than the recommended dose of Procto-Glyvenol

No cases of Procto-Glyvenol rectal cream overdose have been reported. There is no specific antidote for lidocaine. Overdose should not occur when using the medication according to the recommended dosage regimen. In case of overdose, the doctor should be consulted immediately.

Missing a dose of Procto-Glyvenol

A double dose should not be used to make up for a missed dose.

Stopping the use of Procto-Glyvenol

In case of further doubts about using this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Procto-Glyvenol can cause side effects, although not everybody gets them. The following terms are used to describe the frequency of side effects: Rare side effects(more than 1 person in 10,000, less than 1 person in 1,000):

• urticaria,
• itching at the application site, rash at the application site, pain at the application site.

Very rare side effects(may occur in up to 1 person in 10,000):

• anaphylactic reaction,
• cardiovascular disorders,
• bronchospasm,
• angioedema,
• facial edema.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products

of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Procto-Glyvenol

The medication should be stored out of sight and reach of children. Store at a temperature below 30°C, in the original packaging. Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medications should not be disposed of in the sewage system or household waste containers. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Procto-Glyvenol contains

• The active substances of the medication are tribenoside and lidocaine hydrochloride. 1 g of cream contains 50 mg of tribenoside and 20 mg of lidocaine hydrochloride.
• Other ingredients are: cetomacrogol 1000, cetyl alcohol, isopropyl palmitate, liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, arlacel 60, sorbitol, solution, stearic acid, purified water.

What Procto-Glyvenol looks like and what the package contains

Procto-Glyvenol rectal cream is a white, homogeneous cream. Available packaging: aluminum tube containing 30 g of rectal cream. Polyethylene applicator. For more detailed information, the marketing authorization holder or parallel importer should be contacted:

Marketing authorization holder in Romania, the country of export:

Recordati România S.R.L. Str. Izvor nr. 92 - 96, Biroul B, Camerele 2 - 8, Etaj 4 Sector 5, Bucharest, Romania

Manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali 1-20148 Milan Italy VAMFARMA S.R.L. Via Kennedy, 5 26833 Comazzo (LO) Italy

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Romanian export authorization number: 7350/2015/01

Parallel import authorization number: 190/15

Date of leaflet approval: 04.04.2025

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