Procto-glivenol

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

Attention! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Procto-Glyvenol

(50 mg + 20 mg)/g, rectal cream
Tribenoside + Lidocaine hydrochloride

You should 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.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell 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 in the form of a rectal cream 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 damage to the vascular endothelium.
Lidocaine is a local anesthetic and relieves symptoms caused by hemorrhoids, such as itching, burning, and pain.
Procto-Glyvenol in the form of a 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 with an amide structure.

Warnings and precautions

Before starting to use Procto-Glyvenol in the form of a rectal cream in people with liver function disorders, you should discuss this with your doctor.
Procto-Glyvenol in the form of a 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.
The medicine must not be taken orally.
Eye contact 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.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as about medicines you plan to take, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Procto-Glyvenol in the form of a rectal cream should not be used during the first 3 months of pregnancy.
Procto-Glyvenol in the form of a 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 in the form of a 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 doubts, you should consult a doctor or pharmacist.
Procto-Glyvenol in the form of a rectal cream should be used in the morning and evening until the acute symptoms disappear. Then the dose can be reduced to using the cream once a day.
In the case of treating internal hemorrhoids, the cream should be applied using the attached applicator, which should be screwed onto the thread of the tube. The applicator is equipped with a protective cap.
It should be removed before using the cream and put back in place after application.
You should not exceed the recommended doses of the medicine.
Eye contact should be avoided.
Hands should be washed thoroughly after each use of the medicine.
The medicine must not be taken orally.

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 a 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, you should consult a doctor to rule out other potential causes of these complaints.

Using a higher dose of Procto-Glyvenol than recommended

No cases of overdose with Procto-Glyvenol in the form of a 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, you should immediately consult a 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 regarding the use of this medicine, you should 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 definitions have been used:
Rare side effects(more than 1 person in 10,000 treated, less than 1 person in 1,000 treated):

• 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 any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Procto-Glyvenol

The medicine should be stored out of the 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 carton and tube.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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: 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 pack contains

Procto-Glyvenol in the form of a rectal cream is a white, homogeneous cream.
Available packaging: Aluminum tube containing 30 g of rectal cream, with a polyethylene cap and a polyethylene applicator, in a cardboard box.
For more detailed information, you should consult the marketing authorization holder or the parallel importer.

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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
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
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 7350/2015/01
Parallel import authorization number: 300/18

Date of leaflet approval: 30.08.2023

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