Hemkortin-hc

Package Leaflet: Information for the Patient

Hemkortin-HC

10 mg + 10 mg, suppositories
Hydrocortisone acetate + Zinc sulfate
You should carefully read the contents of the leaflet 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 your doctor, pharmacist, or nurse.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse. See section 4.
• If after 3-4 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Hemkortin-HC and what is it used for
• 2. Important information before using Hemkortin-HC
• 3. How to use Hemkortin-HC
• 4. Possible side effects
• 5. How to store Hemkortin-HC
• 6. Contents of the pack and other information

1. What is Hemkortin-HC and what is it used for

Hemkortin-HC suppositories contain hydrocortisone, which has anti-inflammatory properties, and zinc sulfate, which has astringent properties. The medicine reduces swelling and inflammation of the anus, stops bleeding, and has an anti-itching effect.
Hemkortin-HC suppositories are indicated for the treatment of hemorrhoids, anal inflammation, anal fissure, and anal itching. They can be used for pre- and post-operative treatment.

2. Important information before using Hemkortin-HC

When not to use Hemkortin-HC:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have diabetes, tuberculosis, glaucoma, osteoporosis, acute psychosis, fungal or viral infections, or venous thrombosis.

Warnings and Precautions

Before starting to use Hemkortin-HC, you should discuss it with your doctor or pharmacist.
If you have any of the following conditions, you should discuss it with your doctor before starting to use Hemkortin-HC.

You should be particularly careful when using Hemkortin-HC if:

• you have an infection, allergy, or other symptoms - you should then receive appropriate causal treatment;
• you are being vaccinated or receiving immunization treatment - you should not use the medicine then;
• you experience irritation symptoms - you should then stop using the medicine;
• you use the medicine for a long time - it is unlikely that systemic changes characteristic of corticosteroids may occur;
• you experience anal bleeding - you should then immediately contact your doctor;
• you have previously used hydrocortisone - you should tell your doctor about it.
• If you experience blurred vision or other vision disturbances, you should contact your doctor.

If the treatment is not effective, you should consult your doctor.

Children

The use of the medicine in children under 12 years of age is contraindicated.

Pregnancy

Before using the medicine, you should consult your doctor.
Animal studies have shown that hydrocortisone has teratogenic and embryotoxic effects. There are unconfirmed data indicating a risk of cleft palate, intrauterine growth retardation, and suppressive effects on the hypothalamic-pituitary-adrenal axis in fetuses under the influence of hydrocortisone. Therefore, Hemkortin-HC can be used in pregnant women only if there is an absolute need to use this medicine, after a thorough assessment of the risk and benefits by the doctor.
Breastfeeding
Before using the medicine, you should consult your doctor.
Hemkortin-HC should not be used during breastfeeding due to the risk of growth inhibition in the child by hydrocortisone.
Driving and using machines:
The effect of the medicine on the ability to drive vehicles and operate machinery has not been studied.

Hemkortin-HC and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.

You should be particularly careful when using Hemkortin-HC with any of the following medicines.
Non-steroidal anti-inflammatory drugs or acetylsalicylic acid. This may cause stomach and duodenal ulcers, erosion, or gastrointestinal bleeding. In patients with hypoprothrombinemia, caution is recommended when using corticosteroids with acetylsalicylic acid.
Phenytoin - the therapeutic effect of corticosteroids may be reduced due to increased metabolism and reduced serum concentration. This is due to the induction of liver microsomal enzymes by phenytoin. In this situation, it may be necessary to increase the dose of corticosteroids;
Vaccines, live viruses, or other vaccinations. The use of corticosteroids during vaccination is not recommended due to the increased risk of neurological complications after vaccination and possible reduction of antibody levels or lack of response to vaccination.
Some medicines may enhance the effect of Hemkortin-HC, and your doctor may want to carefully monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Hemkortin-HC can be used in pregnant women only if there is an absolute need to use this medicine, after a thorough assessment of the risk and benefits by the doctor.
Hemkortin-HC should not be used during breastfeeding due to the risk of growth inhibition in the child by hydrocortisone.

Driving and using machines

The effect of the medicine on the ability to drive vehicles and operate machinery has not been studied.

3. How to use Hemkortin-HC

always use exactly as described in the patient leaflet or as directed by your doctor. In case of doubt, you should consult your doctor or pharmacist.
Adults usually use one suppository in the morning, one in the evening, and after each bowel movement.
Use for three to four days, until the inflammation subsides. If after this time there is no improvement or you feel worse, you should contact your doctor.
Method of administration
Open the suppository packaging, remove the suppository, and gently insert it into the anus with the pointed end.

Using a higher dose of Hemkortin-HC than recommended

No cases of poisoning have been reported. In case of accidental ingestion of suppositories, gastric lavage is recommended.
In case of taking a higher dose of the medicine than recommended or accidental ingestion of suppositories, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasionally, anal burning may occur, especially if the mucous membrane is severely damaged.
During
long-term
use
of
the
medicine,
side
effects
may
occur
due
to
the
systemic
effect
of
hydrocortisone.
Side effects with unknown frequency: blurred vision
In some people, during the use of the medicine, other side effects may occur.
If you experience other side effects not mentioned in this leaflet, you should inform your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Hemkortin-HC

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date (EXP) means the last day of the specified month.

6. Contents of the pack and other information

What Hemkortin-HC contains

The active substances of the medicine are: hydrocortisone acetate and zinc sulfate.
One suppository contains:
active substances:
10 mg hydrocortisone acetate
10 mg zinc sulfate monohydrate
excipient:
hard fat (Witepsol)

What Hemkortin-HC looks like and contents of the pack

A cardboard box containing 12 suppositories in 2 blisters of 6 pieces each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polmex Pharma Biniecki sp. k., ul. Pokorna 2 lok. 1027, 00-199 Warsaw
tel. 22 636 23 79

Manufacturer

Fulton Medicinali S.p.A., Via Marconi 28/9, Arese (MI), Italy
To obtain more detailed information, you should contact the representative of the marketing authorization holder
Date of last revision of the leaflet:11/2024