Patient Information Leaflet

PROCTOMINA
(S antihaemorrhoidal suppositories)
Bismuthi subgallas + Zinci oxidum + Tanninum
(200 mg + 100 mg + 150 mg) / suppository
Suppositories
Please read the entire leaflet carefully before using this medicine, because 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.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after a few days, or if symptoms worsen, consult your doctor.

Table of Contents

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

1. What Proctomina is and what it is used for

Proctomina is an astringent medicine used to treat symptoms such as pain and itching associated with haemorrhoidal disease (haemorrhoids). The medicine helps relieve inflammation and irritation of the mucous membrane of the anus.

2. Important information before using Proctomina

When not to use Proctomina
If the patient is allergic to bismuth subgallate, zinc oxide or tannin, or
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Proctomina, discuss it with your doctor or
pharmacist.
If rectal bleeding occurs or if pain symptoms significantly worsen, consult a doctor.
A change in stool color to black may occur due to the presence of bismuth subgallate in the product.

Children and adolescents
Proctomina may be used in children and adolescents after consultation with a doctor.

Proctomina and other medicines
Proctomina can be used simultaneously with orally administered medicines.
The use of Proctomina may affect the absorption of other medicines administered rectally.
If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Proctomina has no influence on the ability to drive or operate machinery.

3. How to use Proctomina

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Proctomina should be administered rectally.
Adults: 1 suppository 1-2 times daily.
Hands should be washed before and after inserting the suppository. If symptoms worsen or do not
improve, consult a doctor.
Use of a higher than recommended dose of Proctomina
Cases of overdose have not been reported.
Missed dose of Proctomina
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
During treatment, hypersensitivity symptoms may occur, manifesting as irritation of the rectal mucosa.

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, 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 the medicine.

5. How to store Proctomina

Store at a temperature not exceeding 25°C. Keep in a place invisible and
inaccessible to children.
Do not use after the expiry date stated on the packaging.
Labels on the immediate packaging:
Expiry date (EXP)
Batch number (Lot)

6. Contents of the packaging and other information

What Proctomina contains
1 suppository contains the following active substances: 200 mg basic bismuth gallic acid salt +
100 mg zinc oxide + 150 mg tannin.
The excipient is hard fat.

What Proctomina looks like and contents of the pack
Proctomina is registered in the following pack sizes:
6, 10, 12 suppositories in PVC/PE or Aluminium/LDPE foil, packed in a cardboard box with a leaflet.

Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
[Logo]
[Graphic illustration showing how to remove the suppository from the blister]