Procto-hemolan

Package leaflet: Information for the patient

Procto-Hemolan (50 mg+20 mg)/g, rectal cream
Tribenosidum + Lidocaini hydrochloridum monohydricum
Please read the entire 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 patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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 or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, contact your doctor.

Table of contents

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

Procto-Hemolan in the form of cream is intended for rectal use. It exerts a therapeutic and soothing effect on symptoms caused by haemorrhoids (pain, burning, itching, skin tension). The medicine reduces blood vessel permeability and improves vessel wall tone, and also reduces inflammation associated with haemorrhoids. The active ingredient lidocaine hydrochloride monohydrate provides local anaesthesia, thereby relieving the most troublesome symptoms. The active substances in this medicine act locally and do not produce systemic effects.
Indications

• External and internal haemorrhoids.

2. Information before using Procto-Hemolan

When not to use Procto-Hemolan

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6), and in particular if there is known hypersensitivity to local anaesthetics (e.g. those used in dental anaesthesia).

Warnings and precautions
Before starting treatment with Procto-Hemolan, consult your doctor or pharmacist.
If there is no improvement after 7 days of using the medicine, or if symptoms worsen,
consult your doctor to determine the cause of the condition.
During treatment with this medicine, maintain personal hygiene in the anal area and prevent
defecation disorders.

Procto-Hemolan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
There are no known cases of interaction between Procto-Hemolan administered rectally and other medicines.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
There is no data available on the influence of this medicine on the ability to drive or operate machinery.

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

Cetyl alcohol
The medicine may cause local skin reactions (e.g. contact dermatitis).

Methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Procto-Hemolan

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Method of administration
The medicine should be administered rectally.
Using the provided applicator, apply the medicine (a strip approximately 1 cm long) to the affected area twice daily, in the morning and evening.
After acute symptoms have subsided, the medicine may be used once daily.
Note: Before applying the medicine, the anal area should be carefully cleaned.
Use of a higher than recommended dose of Procto-Hemolan
If more than the recommended dose is used, consult your doctor or pharmacist immediately.
Cases of overdose are not known.
Missed dose of Procto-Hemolan
Do not use a double dose to make up for a missed dose.
Continue treatment according to the recommended dosing schedule.
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 everyone will experience them.
You should contact your doctor immediately if any of the following symptoms occur,
as urgent medical attention may be required:

• anaphylactic reactions including:
• angioedema (a severe allergic reaction – sudden swelling of the face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulty in swallowing and breathing.
• bronchospasm and cardiovascular disturbances – very rare (occurring in less than 1 in 10,000 people). Rare (occurring in 1 to 10 in 10,000 people)
• mild burning sensation;
• pain;
• increased intestinal peristalsis.

If any of the above symptoms occur, the medicine should be discontinued
and you should consult your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, consult your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Procto-Hemolan

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the tube and the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Procto-Hemolan contains

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

What Procto-Hemolan looks like and contents of the pack
Procto-Hemolan is a cream.
The medicine is packed in an aluminium tube with a protective membrane internally coated with epoxy-phenolic lacquer, fitted with a cap made of HDPE polyethylene and a cannula with a plug made of HDPE/LDPE, containing 20 g or 30 g of the medicine, in a cardboard box.

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