Procto-glivenol

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

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

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

Tribenoside + Lidocaine hydrochloride

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 so that it can be read again if necessary.
• 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. Contents of the packaging and other information

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

Procto-Glyvenol rectal cream is a medicine 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:

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

Warnings and precautions

Before starting treatment with Procto-Glyvenol rectal cream in patients with liver function disorders, this should be discussed with 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 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 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 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 packaging of the medicine 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 leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their 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. It should be removed before using the cream and replaced after application.
The recommended doses of the medicine should not be exceeded.
Contact with the eyes should be avoided.
Hands should be washed thoroughly after each use of the medicine.
The medicine should not be taken orally.

Children

This medicine should not be used 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, the patient should consult their doctor 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 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, 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.
To assess the side effects, the following frequency definitions 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 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

of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl.
Reporting side effects helps to gather more information 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 in a temperature below 30°C 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 stated month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Procto-Glyvenol contains

The active substances of the medicine 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 (E 218), propyl parahydroxybenzoate (E 216), sorbitol solution, stearic acid, purified water.

What Procto-Glyvenol looks like and what the packaging contains

Procto-Glyvenol rectal cream is a white, homogeneous cream.
Available packaging: aluminum tube with a membrane, PE cap, and PE applicator in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

RECORDATI ROMÂNIA S.R.L.
Izvor Street no. 92 - 96, Office B, Rooms 2 - 8, 4th floor
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:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Cesky Tesin
Czech Republic

Repackaged by:

Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Krakow
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Authorization number in Romania, the country of export: 7350/2015/01

Parallel import authorization number: 43/22 Date of approval of the leaflet: 18.01.2022

[Information about the registered trademark]