Hemkortin-hc

Package Leaflet: Information for the Patient

Hemkortin-HC

5 mg + 5 mg, ointment
Hydrocortisone acetate + Zinc sulfate
Read the leaflet carefully 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 advised by a doctor, pharmacist, or nurse.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist or nurse. See section 4.
• If after 3-4 days there is no improvement or you feel worse, consult a 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 ointment contains 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 ointment is indicated for the treatment of external and internal hemorrhoids, chronic and acute anal inflammation, anal fissure, and anal itching. It 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, discuss it with your doctor or pharmacist.
If you are in any of the situations described below, before starting to use Hemkortin-HC, you should discuss it with your doctor.

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

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

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

Children

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

Hemkortin-HC and other medicines

Tell your doctor about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.

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, ulceration, 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

Before using the medicine, consult your doctor.
Animal studies have shown that hydrocortisone has teratogenic and embryotoxic effects. There are unconfirmed data indicating the risk of cleft palate, intrauterine growth retardation, and suppressive effects on the hypothalamic-pituitary-adrenal axis in fetuses under the influence of hydrocortisone in pregnant women.
Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Hemkortin-HC should only be used in pregnant women if absolutely necessary, 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 on the ability to drive and use machines has not been studied.

3. How to use Hemkortin-HC

Hemkortin-HC should always be used as described in the patient leaflet or as advised by a doctor. If you are unsure, consult a doctor or pharmacist.
In adults, use the applicator to apply a small amount of ointment to the anus and outside, in the morning and 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, consult a doctor.

Using more than the recommended dose of Hemkortin-HC

No cases of overdose have been reported.
If you have taken more than the recommended dose of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, anal burning may occur, especially if the skin is severely damaged.
During long-term use, side effects may occur due to the systemic effect of hydrocortisone.
Side effects with unknown frequency: blurred vision.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, 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.
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 this medicine.

5. How to store Hemkortin-HC

Keep the medicine out of the sight and reach of children.
Store at a temperature between 15-30°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date (EXP) is the last day of the month stated.

6. Contents of the pack and other information

What Hemkortin-HC contains

The active substances are: hydrocortisone acetate and zinc sulfate.
1 g of ointment contains:
active substances:
5 mg hydrocortisone acetate
5 mg zinc sulfate monohydrate
excipients:
liquid paraffin,
vaseline

What Hemkortin-HC looks like and contents of the pack

Aluminum tube containing 15 g or 30 g of ointment, together with an applicator, in a cardboard box.

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

Beltapharm S.p.A., Via Stelvio 66, 20095 Cusano MIL (MI), Italy
To obtain more detailed information, please contact the representative of the marketing authorization holder.
Date of last revision of the leaflet:11/2024