Patient Information Leaflet

Procto-Hemolan 400 mg + 40 mg, suppositories
Tribenosidum + Lidocainum
Please read the entire leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Table of Contents

What Procto-Hemolan is and what it is used for
Important information before using Procto-Hemolan
How to use Procto-Hemolan
Possible side effects
How to store Procto-Hemolan
Contents of the pack and other information

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

Procto-Hemolan suppositories are a medicine intended for the treatment of external and internal hemorrhoids.
The product contains two active substances: tribenoside and lidocaine.
Tribenoside reduces capillary permeability and improves vascular tone. It has anti-inflammatory properties.
Lidocaine is a local anesthetic that relieves discomfort caused by hemorrhoids, such as itching, burning, and pain.
The medicine acts locally.
Indications:
Treatment of external and internal hemorrhoids.

2. Information before using Procto-Hemolan

When not to use Procto-Hemolan

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

Warnings and precautions
Before using Procto-Hemolan, consult a doctor or pharmacist if:

The patient has impaired liver function.

While using this medicine, maintain personal hygiene in the anal area and prevent disturbances of bowel movements (constipation, diarrhoea).
Children
This medicine should not be used in children due to lack of safety and efficacy data.
Procto-Hemolan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Procto-Hemolan should not be used during the first 3 months of pregnancy.
This medicine may be used from the 4th month of pregnancy and during breastfeeding, provided the recommended doses are not exceeded.
Driving and operating machinery
Procto-Hemolan has no effect or has negligible effect on the ability to drive and operate machinery.

3. How to use Procto-Hemolan

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
This medicine is for rectal use only.
1 suppository in the morning and 1 suppository in the evening – continue until acute symptoms subside.
Afterwards, the dose may be reduced to 1 suppository once daily.
Hands should be thoroughly washed after each application of the medicine.
Duration of treatment
If there is no improvement after 7 days of treatment, consult a doctor.
Children
This medicine should not be used in children.
Use of a higher than recommended dose of Procto-Hemolan
If a higher than recommended dose is used, consult a doctor or pharmacist immediately.
Cases of overdose are not known.
In case of accidental ingestion of the medicine, seek medical advice immediately.
Missed dose of Procto-Hemolan
Do not use a double dose to make up for a missed dose.
Continue treatment according to the prescribed dosing schedule.
If you have any further questions concerning 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 experiences them.
You must immediately contact a doctor or go to the nearest hospital emergency department if any of the following occur:

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.

The following adverse reactions may occur
Rare (occur in 1 to 10 out of 10,000 people):
skin reactions at the application site, such as:

burning sensation;
rash (itchy, red bumps on the skin);
itching;
urticaria (pinkish, itchy blisters on the skin). These symptoms may also occur outside the area where the medicine was applied.

Very rare (occur in less than 1 out of 10,000 people):

hypersensitivity reactions (rash, severe swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest and cardiac arrest);
angioedema (swelling of the skin and mucous membranes without itching or pain).

If any of the above symptoms occur, the medicine should be discontinued and medical advice should be sought immediately.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Procto-Hemolan

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Markings on the blister
Lot: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Procto-Hemolan contains

The active substances are: tribenoside, lidocaine. Each suppository contains 400 mg of tribenoside and 40 mg of lidocaine.
Other ingredients: hard fat (Witepsol 35), hard fat (Witepsol E 85).

What Procto-Hemolan looks like and contents of the pack
Procto-Hemolan is white-cream to slightly yellow, torpedo-shaped suppositories, pointed at one end.
Pack: 10 suppositories in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzantów 133/151
95-200 Pabianice
tel.: (42) 22-53-100