Procto-glivenol

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Procto-Glyvenol (50 mg + 20 mg)/g, Rectal Cream
Tribenoside + Lidocaine Hydrochloride

You Should Carefully Read the Contents of the Leaflet Before Using the Medication Because it Contains Important Information for the Patient.

This Medication Should Always Be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• You Should Keep This Leaflet, So That You Can Read it Again if Necessary.
• If You Need Advice or Additional Information, You Should Consult a Pharmacist.
• If the Patient Experiences Any Adverse Reactions, Including Any Possible Adverse Reactions Not Listed in the Leaflet, They Should Inform Their Doctor or Pharmacist. 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 Adverse Reactions
• 5. How to Store Procto-Glyvenol
• 6. Package Contents 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 Medication Intended for Local Treatment of External and Internal Hemorrhoids.
Tribenoside Acts as an Anti-Inflammatory, Anti-Edematous, Analgesic, Anti-Itch, 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 Medication (Listed in Section 6), or to Other Local Anesthetics of the Amide Type.

Warnings and Precautions

Before Starting to Use Procto-Glyvenol in the Form of a Rectal Cream in Patients with Liver Function Disorders, the Doctor Should be Consulted.
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 Diet to Maintain a Soft Stool Consistency.
The Medication Should Not be Taken Orally.
Contact with the Eyes Should be Avoided.

Children

This Medication Should Not be Used in Children, as There is No Data on the Safety of Use in this Age Group.

Procto-Glyvenol and Other Medications

No Interactions with Other Medications Have Been Found.
The Patient Should Inform the Doctor or Pharmacist About All Medications Currently Being Used, Recently Used, or Planned to be Used, Including Those Available Without a Prescription.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant, or is Planning to Have a Child, She Should Consult a Doctor or Pharmacist Before Using this Medication.
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 the Recommended Doses are Not Exceeded.

Driving and Operating Machinery

Procto-Glyvenol in the Form of a Rectal Cream Has No Influence or a Negligible Influence on the Ability to Drive and Operate Machinery.

Procto-Glyvenol Contains Cetostearyl Alcohol, Methyl Parahydroxybenzoate (E 218), and Propyl Parahydroxybenzoate (E 216)

Cetostearyl Alcohol May Cause Local Skin Reactions (e.g., Contact Dermatitis).
Methyl Parahydroxybenzoate (E 218) and Propyl Parahydroxybenzoate (E 216) May Cause Allergic Reactions (Possible Late-Stage Reactions).
The Medication Packaging Contains Latex. It May Cause Severe Allergic Reactions.

3. How to Use Procto-Glyvenol

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, 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 Subside. Then the Dose Can be Reduced to Once a Day.
In the Case of Internal Hemorrhoids, the Cream Should be Applied Using the Enclosed Applicator, Which Should be Screwed onto the Tube. The Applicator is Equipped with a Protective Cap.
The Cap Should be Removed Before Using the Cream and Replaced After Application.
The Recommended Doses of the Medication Should Not be Exceeded.
Contact with the Eyes Should be Avoided.
Hands Should be Washed Thoroughly After Each Use of the Medication.
The Medication Should Not be Taken Orally.

Children

This Medication Should Not be Used in Children, as There is No Data 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 Subside.
If After 7 Days of Use There is No Improvement or New, Previously Unobserved Symptoms Appear, the Doctor Should be Consulted to Rule Out Other Potential Causes of These Complaints.

Using a Higher Than Recommended Dose of Procto-Glyvenol

No Cases of Overdose of Procto-Glyvenol in the Form of a Rectal Cream Have Been Reported. There is No Specific Antidote for Lidocaine.
Overdose Should Not Occur if the Medication is Used 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 Any Further Doubts Regarding the Use of this Medication, the Doctor or Pharmacist Should be Consulted.

4. Possible Adverse Reactions

Like All Medications, this Medication Can Cause Adverse Reactions, Although Not Everybody Gets Them.
To Assess Adverse Reactions, the Following Frequency Definitions Have Been Used:
Rare Adverse Reactions(More Than 1 Person in 10,000, Less Than 1 Person in 1,000):

• Hives,
• Itching at the Application Site, Rash at the Application Site, Pain at the Application Site.

Very Rare Adverse Reactions(May Occur in Less Than 1 in 10,000):

• Anaphylactic Reaction,
• Cardiovascular Disorders,
• Bronchospasm,
• Angioedema,
• Facial Edema.

Reporting Adverse Reactions

If Any Adverse Reactions Occur, Including Any Adverse Reactions Not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. Adverse Reactions Can be Reported Directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products,

Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
By Reporting Adverse Reactions, More Information on the Safety of the Medication Can be Collected.

5. How to Store Procto-Glyvenol

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
Store in a Temperature Below 30°C in the Original Packaging.
Do Not Use this Medication After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should Not be Disposed of in Sewers or Household Waste Containers. The Pharmacist Should be Asked How to Dispose of Unused Medications. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Procto-Glyvenol Contains

• The Active Substances of the Medication are: Tribenoside and Lidocaine Hydrochloride. 1 g of Cream Contains 50 mg of Tribenoside and 20 mg of Lidocaine Hydrochloride.
• Other Ingredients are: Sorbitan Stearate (Arlacel 60), Macrogol Stearate (Cetomacrogol 1000), Cetostearyl Alcohol, Isopropyl Palmitate, Liquid Paraffin, Methyl Parahydroxybenzoate (E 218), Propyl Parahydroxybenzoate (E 216), Sorbitol, Solution, 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 Containing 30 g of Rectal Cream, with a Membrane, PE Cap, and PE Applicator, in a Cardboard Box.
For More Detailed Information, the Marketing Authorization Holder or Parallel Importer Should be Consulted.

Marketing Authorization Holder in Romania, the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Authorization Number in Romania, the Country of Export:7350/2015/01
Parallel Import Authorization Number:283/18
Date of Leaflet Approval: 26.05.2023
[Information on the Reserved Trademark]