Procto-glyvenol

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Procto-Glyvenol
400 mg + 40 mg, suppositories
Tribenosidum + Lidocainum
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 advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement within 7 days, or if the patient feels worse, consult a physician.

Table of contents of the leaflet:

1. What Procto-Glyvenol is and what it is 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 package 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.
Tribenosidum exerts anti-inflammatory, anti-oedematous, analgesic, anti-pruritic effects, and also protects against damage to the vascular endothelium.
Lidocainum is a local anaesthetic substance that relieves discomfort caused by haemorrhoids, such as itching, burning, and pain.
Procto-Glyvenol suppositories act locally and have practically no 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.
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 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 if the patient is currently taking, has recently taken, or plans to take any other medicines, 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 have a baby, she should consult a 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 vehicles and operate machinery.

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 doctor or pharmacist.
For rectal use only.
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 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 occur, consult a doctor to exclude other potential causes of these symptoms.

Use of a higher than recommended dose of Procto-Glyvenol
Cases of overdose with Procto-Glyvenol suppositories have not 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.

Discontinuation of 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:

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 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 medicine.

5. How to store Procto-Glyvenol
Keep this medicine out of the 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 package and other information

What Procto-Glyvenol contains

• The active substances in this medicinal product are tribenoside and lidocaine. Each suppository contains 400 mg of tribenoside and 40 mg of lidocaine.
• Other components of the medicinal product are: hard fat (Witepsol E85) and hard fat (Witepsol W35).

What Procto-Glyvenol looks like and contents of the pack
Procto-Glyvenol is available as conical-shaped suppositories – white to slightly yellowish.
Pack sizes: 10 suppositories (2 blisters PE-PP-Al containing 5 pieces each, in a cardboard box).
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder 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 SpA
Via Galvani, 10, 36066 Sandrigo (VI), Italy
TEMMLER ITALIA S.R.L.
Via delle Industrie, 2-20061 Carugate (MI), 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
Marketing authorisation number in Romania, country of export: 7351/2015/01
Parallel import authorisation number: 78/11