Procto-glyvenol
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
Please read this leaflet carefully 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
physician or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement within 7 days, or if your condition worsens, consult your doctor.
Table of contents
- 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 haemorrhoids.
Tribenoside exerts anti-inflammatory, anti-oedematous, analgesic, anti-pruritic effects, and also protects against vascular endothelial damage.
Lidocaine is a local anaesthetic agent that relieves discomfort caused by haemorrhoids, such as itching, burning, and pain.
Procto-Glyvenol rectal cream acts locally and practically does not produce systemic effects.
2. 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 anaesthetic drugs of the amide type.
Warnings and precautions
Before using Procto-Glyvenol as a rectal cream in patients with liver function disorders, 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, it is recommended to maintain proper anal hygiene, perform appropriate physical exercises, and follow a suitable diet to ensure appropriately soft stool consistency.
This medicine must not be taken orally.
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 and other medicines
No interactions with other medicines have been reported so far.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or are planning to take, including those obtained without a prescription.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Procto-Glyvenol rectal cream should not be used during the first three months of pregnancy.
Procto-Glyvenol rectal cream may be used from the fourth 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 (delayed-type reactions possible).
The 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 information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician 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. Remove the cap before using the cream and replace it after application.
Do not exceed the recommended doses of the medicine.
Avoid contact of the medicine with the eyes.
Wash hands thoroughly 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 physician to exclude other potential causes of the symptoms.
Use of a higher than recommended dose of Procto-Glyvenol
There have been no reported cases of overdose with Procto-Glyvenol rectal cream. There is no specific antidote against lidocaine.
Overdose should not occur when the medicine is used according to the recommended dosage 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 treatment with Procto-Glyvenol
If you have any further questions about the use of this medicine, consult your physician or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following terms are used to describe the frequency of occurrence when assessing adverse reactions:
| Very common | occurs in more than 1 in 10 people |
| Common | occurs in 1 to 10 in 100 people |
| Uncommon | occurs in 1 to 10 in 1,000 people |
| Rare | occurs in 1 to 10 in 10,000 people |
| Very rare | occurs in 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 for 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 medicine.
5. How to store Procto-Glyvenol
Keep the 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 carton and tube.
The expiry date refers to the last day of the stated month.
Medicines should 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 pack 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 are: cetostearyl alcohol polyether (Cetomacrogol 1000), cetyl alcohol, isopropyl palmitate, liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitan stearate (Arlacel 60), sorbitol solution, stearic acid, purified water.
What Procto-Glyvenol looks like and contents of the pack
Procto-Glyvenol is a white, homogeneous rectal cream.
Available pack: An aluminium tube containing 30 g of rectal cream, with a polyethylene cap and a polyethylene applicator, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
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 authorisation number in Romania, the country of export: 7350/2015/01
Parallel import authorisation number: 300/18