Procto-glivenol

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Procto-Glyvenol

400 mg + 40 mg, suppositories
Tribenoside + Lidocaine

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a 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 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 to use Procto-Glyvenol in the form of suppositories in people with liver function disorders, it should be discussed with a doctor.
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 suitable 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 found so far.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any 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 leaflet or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
Rectal administration.
The recommended dose is 1 suppository in the morning and 1 suppository in the evening - until the acute symptoms disappear.
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 disappear.
If after 7 days of use there is no improvement or other, previously unobserved symptoms appear, a doctor should be consulted to rule out other potential causes of these symptoms.

Using a higher dose of Procto-Glyvenol than recommended

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 dosing schedule.
In case of overdose, a 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 any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

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 definitions have been used:

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 doctor or pharmacist should be informed. Side effects can be reported directly to the Department for 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 medicine.

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. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. 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 of the medicine are: solid fat (Witepsol E85) and solid 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 (2 PE-PP-Al blisters of 5 pieces each in a cardboard box).
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:

Delpharm Huningue SAS
26 rue de la Chapelle
68330 Huningue
France
Zeta Farmaceutici SpA
Via Galvani 10
36066 Sandrigo (Vicenza)
Italy
TEMMLER ITALIA S.R.L.
Via Delle Industrie, 2-20061 Carugate (Mi)
Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Romanian marketing authorization number, country of export:7351/2015/01
Parallel import authorization number:78/11
Date of leaflet approval: 30.01.2023
[Information about the trademark]