Procto-hemolan

Leaflet attached to the packaging: patient information

Procto-Hemolan 400 mg + 40 mg, suppositories

Tribenoside + Lidocaine

Please read the contents of the leaflet carefully 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 as directed by a doctor or pharmacist.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please contact a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of using the medicine or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Procto-Hemolan and what is it used for
• 2. Important information before using Procto-Hemolan
• 3. How to use Procto-Hemolan
• 4. Possible side effects
• 5. How to store Procto-Hemolan
• 6. Package contents and other information

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

Procto-Hemolan in the form of suppositories is a medicine used to treat external and internal hemorrhoids (piles).
The medicine contains two active substances: tribenoside and lidocaine.
Tribenoside reduces the permeability of blood vessels and improves vascular tone. It has anti-inflammatory effects.
Lidocaine is a local anesthetic that relieves symptoms caused by hemorrhoids, such as itching, burning, and pain.
The medicine works locally.

Indications for use:

Treatment of external and internal hemorrhoids (piles).

2. Important information before using Procto-Hemolan

When not to use Procto-Hemolan

• If the patient is allergic to tribenoside or lidocaine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Procto-Hemolan, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver function disorders.

While using this medicine, the patient should maintain personal hygiene in the anal area and prevent bowel disturbances (constipation, diarrhea).

Children

This medicine should not be used in children due to the lack of data on its safety.

Procto-Hemolan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There are no known cases of interaction between Procto-Hemolan administered rectally and other medicines.

Pregnancy and breastfeeding

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

Driving and operating machinery

Procto-Hemolan has no influence or a negligible influence on the ability to drive and operate machinery.

3. How to use Procto-Hemolan

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should contact their doctor or pharmacist.
Recommended dose
The medicine is for rectal use.
1 suppository in the morning and 1 suppository in the evening - use until the acute symptoms subside.
Then, the dose can be reduced to 1 suppository once a day.
The patient should wash their hands thoroughly after each use of the medicine.
Duration of treatment
If there is no improvement after 7 days of using the medicine, the patient should contact their doctor.
Children
This medicine should not be used in children.

Using a higher dose of Procto-Hemolan than recommended

In case of using a higher dose of the medicine than recommended, the patient should immediately contact their doctor or pharmacist.
There are no known cases of overdose.
In case of accidental ingestion of the medicine, the patient should contact their doctor immediately.

Missing a dose of Procto-Hemolan

The patient should not use a double dose to make up for a missed dose.
Treatment should be continued, following the recommended dosage regimen.
In case of any further doubts about using this medicine, the patient should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor or go to the nearest hospital emergency department if they experience:

• angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching and pain). Swelling in the head and neck area may cause difficulty swallowing and breathing.

The following side effects may occur

Rarely(occurring in 1 to 10 people out of 10,000):
skin reactions at the injection site, such as:

• burning;
• rash (itchy, red bumps on the skin);
• itching;
• urticaria (light pink, itchy blisters on the skin). These symptoms may also occur outside the injection site.

Very rarely(occurring in less than 1 person out of 10,000):

• allergic reactions (rash, severe swelling of the face, lips, or throat, making it difficult to breathe, speak, or swallow, decreased blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness, loss of consciousness, and respiratory and cardiac arrest);
• angioedema (swelling of the skin and mucous membranes without itching and pain).

If the patient experiences any of the above symptoms, they should stop using the medicine and contact their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Procto-Hemolan

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
Labels on the blister pack
Lot: Batch number.
EXP: Expiry date.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Procto-Hemolan contains

• The active substances of the medicine are: tribenoside, lidocaine. 1 suppository contains 400 mg of tribenoside and 40 mg of lidocaine.
• The other ingredients are: solid fat (Witepsol 35), solid fat (Witepsol E 85).

What Procto-Hemolan looks like and what the package contains

Procto-Hemolan is a white to light yellow suppository in the shape of a one-sided pointed torpedo.
The package contains 10 suppositories in a cardboard box.

Marketing authorization holder and manufacturer:

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancja 133/151
95-200 Pabianice
phone: (42) 22-53-100

Date of the last update of the leaflet: