Procto-hemolan

Package Leaflet: Information for the Patient

Procto-Hemolan(50 mg+20 mg)/g, rectal cream
Tribenosidum + Lidocainihydrochloridum monohydricum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or 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. Contents of the pack and other information

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

Procto-Hemolan in the form of a cream is intended for rectal use. It has a therapeutic and soothing effect on symptoms caused by hemorrhoids (pain, burning, itching, skin tension).
The medicine reduces the permeability of blood vessels and improves the tension of the vascular wall, also reducing the inflammatory state accompanying hemorrhoids. The lidocaine hydrochloride monohydrate present in the medicine has a local anesthetic effect, which soothes the most troublesome symptoms. The active substances contained in the medicine work locally and do not have a general effect.

Indications for use

• external and internal hemorrhoids.

2. Important information before using Procto-Hemolan

When not to use Procto-Hemolan

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6), and in particular in case of known hypersensitivity to local anesthetics (used, for example, for anesthesia in dentistry).

Warnings and precautions

Before starting to use Procto-Hemolan, the patient should discuss it with their doctor or pharmacist.
If after 7 days of using the medicine there is no improvement or the symptoms of the disease have worsened, the patient should consult their doctor to determine the cause of the disease.
During the use of this medicine, the patient should take care of personal hygiene in the anal area and prevent bowel movement disorders.

Procto-Hemolan and other medicines

The patient should tell 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.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Procto-Hemolan contains cetyl alcohol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

Cetyl alcohol

The medicine may cause a local skin reaction (e.g., contact dermatitis).

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

3. How to use Procto-Hemolan

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Method of administration
The medicine should be used rectally.
Using the enclosed applicator, apply the medicine (a strip about 1 cm long) to the affected area twice a day, in the morning and evening.
After the acute symptoms have subsided, the medicine can be used once a day.
Note: before using the medicine, the patient should carefully wash the anal area.

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 consult their doctor or pharmacist.
There are no known cases of overdose.

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 the use of this medicine, the patient should consult 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 contact their doctor if they experience any of the following symptoms, as they may need urgent medical attention:

• anaphylactic reactions, including:
• 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.
• bronchospasm and cardiovascular disorders - very rare (occurring in less than 1 in 10,000 people). Rare(occurring in 1 to 10 people in 10,000)
• a feeling of mild burning;
• pain;
• increased intestinal peristalsis.

If any of the above symptoms occur, the patient should stop using the medicine and consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should consult 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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. Do not freeze.
Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month.
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. Contents of the pack and other information

What Procto-Hemolan contains

• The active substances of the medicine are: tribenoside and lidocaine hydrochloride monohydrate.
• 1 g of cream contains 50 mg of tribenoside and 20 mg of lidocaine hydrochloride monohydrate.
• The other ingredients are: cetyl alcohol, stearic acid, liquid paraffin, isopropyl palmate, macrogol cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, non-crystallizing liquid, purified water.

What Procto-Hemolan looks like and what the pack contains

Procto-Hemolan is a cream.
The medicine pack is an aluminum tube with a protective membrane, internally coated with an epoxy-phenolic varnish, with a polyethylene HDPE cap and an HDPE/LDPE applicator, containing 20 g or 30 g of the medicine, in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: +48 42 22-53-100

Date of the last update of the leaflet: