Package leaflet: Information for the patient

Hemkortin-HC
5 mg + 5 mg, ointment
Hydrocortisoni acetas + Zinci sulfas
Please read this 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 doctor, pharmacist, or nurse.
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, pharmacist, or nurse. See section 4.
If there is no improvement after 3–4 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

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

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

Hemkortin-HC ointment contains hydrocortisone, which has anti-inflammatory action, and zinc sulfate, which has an astringent effect. The medicine reduces swelling and inflammation of the anus, inhibits bleeding, and relieves itching.
Hemkortin-HC ointment is indicated for the treatment of external and internal haemorrhoids, chronic and acute inflammatory conditions of the anus, anal fissures, and anal pruritus. It may be used in pre- and post-operative treatment.

2. Important information before using Hemkortin-HC

When not to use Hemkortin-HC:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the patient has diabetes, tuberculosis, glaucoma, osteoporosis, acute psychosis, fungal or viral infection, or venous thrombosis.

Warnings and precautions
Before starting treatment with Hemkortin-HC, discuss this with your doctor or pharmacist.
If any of the situations described below apply to the patient, they should discuss them with a doctor before starting Hemkortin-HC.
The patient should exercise particular caution when using Hemkortin-HC if:

they have a concurrent infection, allergy, or other symptoms – appropriate causal treatment should then be administered;
they are undergoing vaccinations or immunotherapy – this medicine should not be used at that time;
they experience symptoms of irritation – use of this medicine should then be discontinued;
they are using the medicine long-term – systemic effects characteristic of corticosteroids may occur with low probability;
they experience rectal bleeding – they should immediately consult a doctor;
they have previously used hydrocortisone – they should inform their doctor about this.
If the patient develops blurred vision or other visual disturbances, they should contact their doctor.

If treatment is ineffective, the patient should consult a doctor.
Children
Use of Hemkortin-HC in children under 12 years of age is contraindicated.
Hemkortin-HC and other medicines
The patient should inform their doctor about all medicines they are currently taking or have recently taken,
as well as any medicines they plan to take, including those available without a prescription.
Particular caution is required when using Hemkortin-HC concomitantly with any of the following medicines:
Nonsteroidal anti-inflammatory drugs or acetylsalicylic acid. These may cause gastric and duodenal ulcers, gastrointestinal ulceration, or bleeding. Caution is recommended in patients with hypoprothrombinemia when corticosteroids are used concomitantly with acetylsalicylic acid.
Phenytoin – the therapeutic effect of corticosteroids may be reduced due to enhanced metabolism and decreased plasma concentration of the drug. This is caused by phenytoin-induced induction of hepatic microsomal enzymes. In such cases, an increased dose of corticosteroids may be necessary.
Vaccines, live viruses, or other vaccinations. The use of corticosteroids during vaccination is not recommended due to increased risk of neurological complications after vaccination and possible reduction in antibody levels or lack of immune response.
Some medicines may enhance the effect of Hemkortin-HC, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Pregnancy and breastfeeding
Consult a doctor before using this medicine.
Animal studies have shown teratogenic and embryotoxic effects of hydrocortisone. There are unconfirmed data suggesting a risk of cleft palate, intrauterine growth retardation, and suppressive effects on the hypothalamic-pituitary-adrenal axis in fetuses exposed to hydrocortisone administered to pregnant women.
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.
Hemkortin-HC may be used during pregnancy only if absolutely necessary, following a thorough assessment by the doctor of the risks and benefits.
Hemkortin-HC should not be used during breastfeeding due to the risk of growth suppression in the infant caused by hydrocortisone.
Driving and operating machinery
The effect of Hemkortin-HC on the ability to drive and operate machinery has not been studied.

3. How to use Hemkortin-HC

Hemkortin-HC should always be used according to the instructions in the patient leaflet or as advised by a doctor. If in doubt, consult a doctor or pharmacist.
In adults, apply a small amount of the ointment into the anus and externally using the applicator, in the morning and evening, and after each bowel movement. Use for three to four days, until the inflammatory symptoms subside.
If there is no improvement after this period, or if the patient's condition worsens, medical advice should be sought.
Use of a higher than recommended dose of Hemkortin-HC
No cases of poisoning have been reported.
In case of accidental overdose, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
A burning sensation in the anal area may occasionally occur, especially if the skin is significantly damaged.
With prolonged use, side effects caused by the systemic action of hydrocortisone may occur.
Side effects with unknown frequency: blurred vision.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects 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.: 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Hemkortin-HC
Keep this medicine out of sight and reach of children.
Store at a temperature of 15–30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the specified month.

6. Contents of the package and other information

What Hemkortin-HC contains
The active substances in this medicine are: hydrocortisone acetate and zinc sulfate.
1 g of the 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
An aluminium tube containing 15 g or 30 g of ointment, supplied with an applicator in a cardboard box.

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

Manufacturer
Beltapharm S.r.l. S.p.A., Via Stelvio 66, 20095 Cusano MIL (MI), Italy

For further information, please contact the representative of the Marketing Authorisation Holder.