Procto-glyvenol
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Procto-Glyvenol, (50 mg + 20 mg)/g, rectal cream
Tribenoside + Lidocaine hydrochloride
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.
- Keep this leaflet, so that it can be consulted again if necessary.
- If advice or further information is needed, please contact a pharmacist.
- If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
- If there is no improvement within 7 days or if the patient feels worse, consult a doctor.
Table of contents of the leaflet
- What Procto-Glyvenol is and what it is used for
- Important information before using Procto-Glyvenol
- How to use Procto-Glyvenol
- Possible side effects
- How to store Procto-Glyvenol
- Contents of the pack and other information
1. What Procto-Glyvenol is and what it is used for
Procto-Glyvenol rectal cream is a medicine intended for local treatment of external and internal hemorrhoids.
Tribenoside exerts anti-inflammatory, anti-edematous, analgesic, anti-pruritic effects and also protects vascular endothelium from damage.
Lidocaine is a local anesthetic agent that relieves discomfort caused by hemorrhoids, such as itching, burning, and pain.
Procto-Glyvenol rectal cream acts locally and practically does not exert systemic effects.
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 anaesthetics of amide-type structure.
Warnings and precautions
Before using Procto-Glyvenol cream for rectal application in patients with impaired liver function, consult a doctor.
Procto-Glyvenol rectal cream should be used with caution in patients with severe liver impairment.
As an adjunct to the treatment of haemorrhoids with Procto-Glyvenol, proper hygiene of the anal area, appropriate physical exercises, and a suitable diet to maintain soft stool consistency are recommended.
Do not take this medicine by mouth.
Avoid contact with the eyes.
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 with other medicines
No interactions with other medicines have been reported so far.
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or might take, including those available without a prescription.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should 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 may be used from the 4th month of pregnancy and during breastfeeding, provided the recommended doses are not exceeded.
Driving and operating machinery
Procto-Glyvenol rectal cream has no effect or has a negligible effect on the ability to drive and operate machinery.
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 (including delayed-type reactions).
The medicine packaging contains latex rubber. 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
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Procto-Glyvenol cream for rectal use should be applied in the morning and evening until acute
symptoms subside. Afterwards, the dose may be reduced to once daily. In the treatment of internal
haemorrhoids, the cream should be applied using the provided applicator, which should be screwed
onto the thread of the tube. The applicator is equipped with a protective cap. This cap should be
removed before using the cream and replaced after application.
Do not exceed the recommended doses of the medicine.
Avoid contact of the medicine with the eyes.
Hands should be thoroughly washed after each application.
Do not take this medicine orally.
Children
This medicine should not be used in children, as there are no data available on safety of use in this
age group.
How long to use Procto-Glyvenol
Procto-Glyvenol rectal cream should be used until symptoms resolve.
If there is no improvement after 7 days of treatment, or if new, previously unobserved symptoms
occur, consult a doctor to exclude other potential causes of the condition.
Use of a higher than 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 the medicine is used according to the recommended dosing
regimen.
In case of overdose, seek immediate medical advice.
Missed dose of Procto-Glyvenol
Do not use a double dose to make up for a missed dose.
Stopping Procto-Glyvenol
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following terms are used to describe the frequency of adverse reactions:
| Very common | affects more than 1 in 10 people |
| Common | affects 1 to 10 in 100 people |
| Uncommon | affects 1 to 10 in 1,000 people |
| Rare | affects 1 to 10 in 10,000 people |
| Very rare | affects less than 1 in 10,000 people |
| Not known | frequency cannot be estimated from the available data |
Rarely occurring adverse reactions (more than 1 person in every 10,000 treated, less
than 1 person in every 1,000 treated):
- urticaria,
- itching at the application site, rash at the application site, pain at the application site.
Very rarely occurring adverse reactions (may occur in no more than 1 person in 10,000):
- anaphylactic reaction,
- cardiovascular disorders,
- bronchospasm,
- angioedema,
- facial swelling.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.
5. How to store Procto-Glyvenol
Keep this medicine out of sight and reach of children.
Store 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 must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the packaging 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.
- Other components: sorbitan stearate (Arlacel 60), cetostearyl alcohol polyglycol 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 contents of the pack
Procto-Glyvenol is a white, homogeneous cream for rectal use.
Available pack: aluminium tube with membrane, PE cap and PE applicator, in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, 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:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic
Repackaged in:
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
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
Romania, country of export, marketing authorization number: 7350/2015/01
Parallel import authorization number: 43/22
[Trademark registration information]