Procto-glivenol

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Procto-Glyvenol, (50 mg + 20 mg)/g, rectal cream

Tribenoside + Lidocaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse after 7 days, consult a 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 medicine for the local treatment of external and internal hemorrhoids.
Tribenoside has anti-inflammatory, anti-edematous, analgesic, anti-itching, and anti-damage effects on vascular endothelium.
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, consult a doctor.
Procto-Glyvenol rectal cream should be used with caution in patients with severe liver damage.
In addition to the treatment of hemorrhoids with Procto-Glyvenol, it is recommended to maintain proper hygiene of the anal area, use appropriate physical exercises, and follow a suitable diet to maintain a soft stool consistency.
Do not take the medicine orally.
Avoid contact with the eyes.

Children

Do not use this medicine in children, as there are no data on the safety of use in this age group.

Procto-Glyvenol and other medicines

No interactions with other medicines have been reported.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult a doctor or pharmacist before using this medicine.
Procto-Glyvenol rectal cream should not be used during the first 3 months of pregnancy.
Procto-Glyvenol rectal cream can 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 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 medicine packaging contains latex. It may cause severe allergic reactions.

3. How to use Procto-Glyvenol

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Procto-Glyvenol rectal cream should be used in the morning and evening until the acute symptoms disappear. Then, the dose can be reduced to once a day.
In the case of 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.
Remove the cap before using the cream and replace it after application.
Do not exceed the recommended doses of the medicine.
Avoid contact of the medicine with the eyes.
Wash your hands thoroughly after each use of the medicine.
Do not take the medicine orally.

Children

Do not use this medicine in children, as there are no data 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 disappear.
If after 7 days of use there is no improvement or other, previously unobserved symptoms appear, consult a doctor to rule out other potential causes of these complaints.

Using more than the recommended dose of Procto-Glyvenol

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

Missing a dose of Procto-Glyvenol

Do not use a double dose to make up for a missed dose.

Stopping the use of Procto-Glyvenol

If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To assess the side effects, the following frequency categories have been used:
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 you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Procto-Glyvenol

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and tube after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Procto-Glyvenol contains

• The active substances are tribenoside and lidocaine hydrochloride. 1 g of cream contains 50 mg of tribenoside and 20 mg of lidocaine hydrochloride.
• The other ingredients are sorbitan stearate (Arlacel 60); macrogol cetostearyl ether (Cetomacrogol 1000); cetyl alcohol; isopropyl palmitate; liquid paraffin; methyl parahydroxybenzoate; propyl parahydroxybenzoate; non-crystallizing liquid sorbitol; stearic acid; purified water.

What Procto-Glyvenol looks like and contents of the pack

Procto-Glyvenol rectal cream is a white, homogeneous cream.
Available packages: Aluminum tube containing 30 g of rectal cream, with a polyethylene cap and latex seal. Polyethylene applicator.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Ireland Ltd.
Raheens East
Ringaskiddy, Co. Cork
Ireland

Manufacturer

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

Date of last revision of the leaflet: 09/2022