Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Procto-Glyvenol, (50 mg + 20 mg)/g, rectal cream
Tribenoside + Lidocaine hydrochloride
Please read the entire 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 the
physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects 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 protects vascular endothelium from damage.
Lidocaine is a local anaesthetic substance that relieves discomfort caused by haemorrhoids, such as itching, burning, and pain.
Procto-Glyvenol rectal cream acts locally and has virtually no 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 as a rectal cream in patients with liver function disorders, consult a physician.
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, adequate hygiene of the anal area, appropriate physical exercises, and an appropriate diet to maintain soft stool consistency are recommended.
This medicine must not be taken orally.
Avoid contact with the eyes.
Children
This medicine should not be used in children, as safety data in this age group are not available.
Procto-Glyvenol and other medicines
No interactions with other medicines have been reported to date.
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take, including those obtained 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 or operate machinery.
Procto-Glyvenol contains cetyl alcohol, methyl parahydroxybenzoate (E 218), and
propyl parahydroxybenzoate (E 216)
Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (including delayed-type reactions).
The medicine packaging contains latex rubber, which 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 recommended by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Procto-Glyvenol cream for rectal use should be applied in the morning and in the evening until acute symptoms subside. After that, the dose may be reduced to once daily.
When treating 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 by mouth.

Children
This medicine should not be used in children, as there are no data available on safety and efficacy 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 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 for lidocaine.
Overdose is unlikely 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 may cause adverse reactions, although not everybody will get them.
The following frequency terms have been used to assess 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 fewer than 1 in 10,000 people
Not known	frequency cannot be estimated from the available data

Rare adverse reactions (occurring in more than 1 in 10,000 treated individuals,
and less than 1 in 1,000 treated individuals):

urticaria,
itching at the application site, rash at the application site, pain at the application site.

Very rare adverse reactions (may occur in no more than 1 in 10,000 individuals):

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, phone: +48 22 4921301, fax: +48 22 4921309, 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Procto-Glyvenol contains

The active substances are: tribenozide and lidocaine hydrochloride. 1 g of cream contains 50 mg of tribenozide and 20 mg of lidocaine hydrochloride.
Other ingredients: 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 cream for rectal use is a white, homogeneous cream.
Available pack: An aluminum tube containing 30 g of rectal cream, with a 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
Marketing authorization number in Romania, country of export: 7350/2015/01
Parallel import authorization number: 283/18