Procto-glyvenol
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Procto-Glyvenol
400 mg + 40 mg, suppositories
Tribenosidum + Lidocainum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to
the instructions provided by the doctor or pharmacist.
- Keep this leaflet for future reference.
- If advice or further information is needed, consult your pharmacist.
- If any adverse reactions occur, 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 symptoms worsen, consult 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.
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 practically do 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, or any of the other ingredients of this medicine (listed in section 6), or to other local anaesthetic medicines of amide-type 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 anal hygiene, 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 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 or have recently taken, as well as any medicines you plan to 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 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 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 your doctor or pharmacist.
Rectal administration.
The recommended dose is 1 suppository in the morning and 1 suppository in the evening – until acute symptoms subside.
Afterwards, the dose may be reduced to 1 suppository once daily.
Do not exceed the recommended doses of the medicine.
Hands should be washed thoroughly after each application.
Children
This medicine should not be used in children, as there are no data available on its 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 the symptoms.
Overdose of Procto-Glyvenol
There have been no reported cases of overdose with Procto-Glyvenol suppositories. 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following terms have been used to assess the frequency of adverse reactions:
| Very common | affects more than 1 in 10 people |
| Common | affects 1 to 10 people in 100 |
| Uncommon | affects 1 to 10 people in 1,000 |
| Rare | affects 1 to 10 people in 10,000 |
| Very rare | affects less than 1 in 10,000 people |
| Frequency not known | frequency cannot be determined 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 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 Reactions of Medicinal Products at 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 packaging. The expiry date refers to the last day of the specified 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. Package contents and other information
What Procto-Glyvenol contains
- The active substances in this medicine are tribenoside and lidocaine. Each suppository contains 400 mg of tribenoside and 40 mg of lidocaine.
- Other ingredients: 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 available: 10 suppositories in PE-PP-Al blisters in a cardboard carton.
For more detailed information, please contact the responsible party 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 S.p.A.
Via Galvani, 10
36066 Sandrigo (VI), Italy
TEMMLER ITALIA S.R.L.
Via Delle Industrie
2-20061 Carugate (Mi), 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
Marketing Authorisation number in Romania, country of export: 7351/2015/01
Parallel import licence number: 427/19