Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
PROCTO-GLYVENOL
400 mg + 40 mg, suppositories
Tribenosidum + Lidocainum
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
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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement within 7 days, or if your condition worsens, contact your 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 suppositories are a medicine intended for local treatment of
external and internal haemorrhoids.
Tribenoside has anti-inflammatory, anti-oedematous, analgesic, anti-pruritic properties and also
protects against endothelial vascular damage.
Lidocaine is a local anaesthetic substance that relieves discomfort caused by haemorrhoids,
such as itching, burning, and pain.
Procto-Glyvenol suppositories act locally and practically do not produce systemic effects.

2. Important information before using Procto-Glyvenol

When not to use Procto-Glyvenol:

if the patient is allergic to tribenoside, lidocaine, or any of the other ingredients of this medicine (listed in section 6), or to other local anaesthetic medicines with an amide structure.

Warnings and precautions
Before starting treatment with Procto-Glyvenol suppositories in patients with liver function disorders, consult a doctor.
Procto-Glyvenol suppositories should be used with caution in patients with severe liver impairment.
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As an adjunct to the treatment of haemorrhoids with Procto-Glyvenol, it is recommended to maintain proper hygiene of the anal area, perform appropriate physical exercises, and follow a suitable diet to ensure adequately soft stool consistency.
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 safety in this age group.

Procto-Glyvenol and other medicines
No interactions with other medicines have been reported so far.
Tell your doctor or pharmacist if the patient is currently taking or has recently taken any other medicines, including those obtained without a prescription, or if they plan to take any other medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Procto-Glyvenol suppositories must not be used during the first 3 months of pregnancy.
Procto-Glyvenol suppositories 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 has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to use Procto-Glyvenol

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Rectal administration.
The recommended dose is 1 suppository in the morning and 1 suppository in the evening – until acute symptoms subside.
Thereafter, the dose may be reduced to 1 suppository once daily.
Do not exceed the recommended doses of the medicine.
Hands should be thoroughly washed after each application of the medicine.

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 suppositories should be used until symptoms resolve.
If there is no improvement after 7 days of treatment, or if new, previously unobserved symptoms appear, consult a doctor to exclude other potential causes of the symptoms.
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Use of more than the recommended dose of Procto-Glyvenol
There have been no reported cases of overdose with Procto-Glyvenol suppositories. 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 not everybody gets them.
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
Frequency not known	frequency cannot be estimated from the available data

Rare 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 rare 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 22 492 1301
Fax: +48 22 492 1309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
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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 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 pack and other information

What Procto-Glyvenol contains

The active substances in the medicine are tribenoside and lidocaine. Each suppository contains 400 mg of tribenoside and 40 mg of lidocaine.
Other ingredients are: fat (Witepsol E85) and fat (Witepsol W35).

What Procto-Glyvenol looks like and contents of the pack
Procto-Glyvenol is available as yellowish-white, conical-shaped suppositories,
homogeneous, without cracks, slightly greasy, non-softening.
Available pack sizes: 10 suppositories in blisters made of PE-PP-Al foil, in a cardboard box.
For further information, please contact the responsible party or 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:
DELPHARM HUNINGUE SAS
26 rue de la Chapelle
68330 Huningue
France
ZETA FARMACEUTICI S.p.A.
Via Galvani, 10
36066 Sandrigo (VI)
Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Romanian marketing authorization number, country of export: 7351/2015/01
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Parallel import authorization number: 194/13
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