Procto-glivenol

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Procto-Glyvenol, (50 mg + 20 mg)/g, rectal cream

Tribenoside + Lidocaine hydrochloride

It is necessary to carefully read the contents of the leaflet before using the 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 doctor's or pharmacist's instructions.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Procto-Glyvenol and what is it 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 packaging and other information

1. What is Procto-Glyvenol and what is it used for

Procto-Glyvenol in the form of a rectal cream is a medicine intended for the local treatment of external and internal hemorrhoids. Tribenoside has anti-inflammatory, anti-edematous, analgesic, anti-itching effects, and also counteracts damage to the vascular endothelium. Lidocaine is a local anesthetic and relieves symptoms caused by hemorrhoids, such as itching, burning, and pain. Procto-Glyvenol in the form of a rectal cream acts locally, practically without systemic action.

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 anesthetics with an amide structure.

Warnings and precautions

Before starting to use Procto-Glyvenol in the form of a rectal cream in patients with liver function disorders, it should be discussed with a doctor. Procto-Glyvenol in the form of a rectal cream should be used with caution in patients with severe liver damage. In addition to the treatment of hemorrhoids with Procto-Glyvenol, it is recommended to maintain proper hygiene of the anal area, use appropriate physical exercises, and follow a suitable diet to maintain a soft stool consistency. The medicine should not be taken orally. Contact with the eyes should be avoided.

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. The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Procto-Glyvenol in the form of a rectal cream should not be used during the first 3 months of pregnancy. Procto-Glyvenol in the form of a rectal cream may be used from the 4th month of pregnancy and during breastfeeding, provided that the recommended doses are not exceeded.

Driving and using machines

Procto-Glyvenol in the form of a rectal cream has no influence or negligible influence on the ability to drive and use machines.

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 (possible late reactions). The packaging of the medicine contains latex. It 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 according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted. Procto-Glyvenol in the form of a rectal cream should be used in the morning and evening until the acute symptoms disappear. Then the dose can be reduced to using the cream once a day. In the case of treating internal hemorrhoids, the cream should be applied using the attached applicator, which should be screwed onto the thread of the tube. The applicator is equipped with a protective cap. It should be removed before using the cream and put back in place after application. The recommended doses of the medicine should not be exceeded. Contact with the eyes should be avoided. Hands should be washed thoroughly after each use of the medicine. The medicine should not be taken orally.

Children

This medicine should not be used in children, as there are no data available on the safety of use in this age group.

How long to use Procto-Glyvenol

Procto-Glyvenol in the form of a rectal cream should be used until the symptoms disappear. If after 7 days of use there is no improvement or other, previously unobserved symptoms appear, the doctor should be consulted to rule out other potential causes of these complaints.

Using a higher dose of Procto-Glyvenol than recommended

No cases of overdose with Procto-Glyvenol in the form of a rectal cream have been reported. There is no specific antidote for lidocaine. Overdose should not occur when using the medicine according to the recommended dosage regimen. In case of overdose, the doctor should be consulted immediately.

Missing a dose of Procto-Glyvenol

A double dose should not be used to make up for a missed dose.

Stopping the use of Procto-Glyvenol

In case of further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following terms are used to describe the frequency of side effects: rare side effects(more than 1 person in 10,000, less than 1 person in 1,000):

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

Very rare side effects(may occur in up to 1 person in 10,000):

• anaphylactic reaction,
• cardiovascular disorders,
• bronchospasm,
• angioedema,
• facial edema.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products

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 By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Procto-Glyvenol

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°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 wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Procto-Glyvenol contains

• The active substances of the medicine are tribenoside and lidocaine hydrochloride. 1 g of cream contains 50 mg of tribenoside and 20 mg of lidocaine hydrochloride.
• The other ingredients are: cetomacrogol 1000, cetyl alcohol, isopropyl palmitate, liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, arlacel 60, sorbitol liquid non-crystallizing, stearic acid, purified water.

What Procto-Glyvenol looks like and what the packaging contains

Procto-Glyvenol in the form of a rectal cream is a white, homogeneous cream. Available packaging: aluminum tube with a PE cap, which contains 30 g of rectal cream. Applicator made of LDPE. For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Bulgaria, the country of export:

Haleon Hungary Kft. Csörsz utca 43 1124 Budapest Hungary

Manufacturer:

Haleon Germany GmbH Barthstraße 4 80339 Munich Germany

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Nr of the permit in Bulgaria, the country of export: 20000821

Number of the parallel import permit: 75/20

Date of approval of the leaflet: 06.12.2024

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