Procto-glyvenol
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Procto-Glyvenol, (50 mg + 20 mg)/g, rectal cream
Tribenosidum + Lidocaini hydrochloridum
Please read the following information 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, so that you can read it again if necessary.
- 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, pharmacist or nurse. 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 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 has 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 hydrochloride, 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 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 hygiene of the anal area, perform appropriate physical exercises, and follow a suitable diet to ensure adequately 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 safety of use in this age group.
Procto-Glyvenol and other medicines
No interactions with other medicines have been reported to date.
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to use, 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 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 (including delayed-type reactions).
The 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 evening until acute symptoms subside. Afterwards, 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. This should be removed before using the cream and replaced 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 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 your doctor to exclude other potential causes of these complaints.
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 should not occur when the medicine is used according to the recommended dosing regimen.
In case of overdose, seek medical advice immediately.
Missed dose of Procto-Glyvenol
Do not use a double dose to make up for a missed dose.
Stopping Procto-Glyvenol treatment
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 frequency terms are used to assess 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 |
| Not known | frequency cannot be estimated from the available data |
Rare adverse reactions (occurring in more than 1 in 10,000 treated individuals, 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, 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 13 01
Fax: +48 22 492 13 09
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 month indicated.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the packaging 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.
- The other ingredients 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 cream for rectal use is a white, homogeneous cream.
Available packaging: an aluminium tube containing 30 g of rectal cream. Polyethylene applicator.
For more detailed 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:
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:
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
Marketing authorisation number in Romania, country of export: 7350/2015/01
Parallel import authorisation number: 190/15