Procto-glivenol

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Procto-Glyvenol, 400 mg + 40 mg, suppositories

Tribenoside + Lidocaine

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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 in the form of suppositories is a medicine intended for 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 in the form of suppositories acts locally, practically without systemic action.

2. Important information before using Procto-Glyvenol

When not to use Procto-Glyvenol:

• if the patient is allergic to tribenoside, lidocaine, or any of the other ingredients of this medicine (listed in section 6), or to other local anesthetics with an amide structure.

Warnings and precautions

Before starting treatment with Procto-Glyvenol in the form of suppositories in patients with liver function disorders, the doctor should be consulted.
Procto-Glyvenol in the form of suppositories 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 diet to maintain a soft stool consistency.
The medicine should not be taken orally.
Contact with the eyes should be avoided.

Children

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

Procto-Glyvenol and other medicines

No interactions with other medicines have been reported so far.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Procto-Glyvenol in the form of suppositories should not be used during the first 3 months of pregnancy.
Procto-Glyvenol in the form of suppositories 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 has no influence or negligible influence on the ability to drive and use machines.

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. In case of doubts, the patient should consult their doctor or pharmacist.
Rectal administration.
The recommended dose is 1 suppository in the morning and 1 suppository in the evening - until the acute symptoms subside.
Then the dose can be reduced to 1 suppository once a day.
The recommended doses of the medicine should not be exceeded.
Hands should be washed thoroughly after each use of the medicine.

Children

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

How long to use Procto-Glyvenol

Procto-Glyvenol in the form of suppositories should be used until the symptoms subside.
If after 7 days of use there is no improvement or new, previously unobserved symptoms appear, the patient should consult their doctor to rule out other potential causes of these symptoms.

Using more than the recommended dose of Procto-Glyvenol

No cases of overdose with Procto-Glyvenol in the form of suppositories 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, the patient should immediately consult their doctor.

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 any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 in 10,000 people, less than 1 in 1,000 people):

• urticaria,
• itching at the site of administration, rash at the site of administration, pain at the site of administration.

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

• 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 patient should inform their 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, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Procto-Glyvenol

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton after "Expiry Date" and on the blister after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Procto-Glyvenol contains

• The active substances of the medicine are tribenoside and lidocaine. One suppository contains 400 mg of tribenoside and 40 mg of lidocaine.
• The other ingredients are: fat (Witepsol E85) and fat (Witepsol W35).

What Procto-Glyvenol looks like and what the package contains

Procto-Glyvenol is available in the form of yellowish-white, cone-shaped suppositories, uniform, without cracks, slightly greasy, not soft.
Available packages: 10 suppositories in aluminum blisters, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Ireland Ltd.
Raheens East
Ringaskiddy
Co. Cork
Ireland

Manufacturer

Delpharm Huningue S.A.S.
Site Industrial d’Huningue
26 Rue de la Chapelle
F-68333 Huningue
France
Zeta Farmaceutici S.p.A.
Via Galvani, 10
36066 Sandrigo (VI)
Italy
Temmler Italia Srl
Via delle Industrie 2
20061 Carugate (MI)
Italy

Date of last revision of the leaflet: 02/2022