Proktosedon

Poland
Brand name Proktosedon
Form ointment
Active substance / Dosage
hydrocortisone acetate · 5 mg/g
cinchocaine hydrochloride · 5 mg/g
esculin · 10 mg/g
neomycin sulfate · 10 mg/g
Prescription type Over-the-counter
ATC code
C05AB
Registration number 100055185
Manufacturer Beltapharm S.r.l.
Proktosedon ointment

Table of Contents

Package leaflet: Information for the patient

Proktosedon
5 mg + 5 mg + 10 mg + 10 mg, ointment
Hydrocortisonum + Cinchocaini hydrochloridum + Esculinum + Neomycini 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 side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
  • If there is no improvement or if symptoms worsen after 3–6 days, consult your doctor.

Table of contents of the leaflet:

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

1. What Proktosedon is and what it is used for

Proktosedon is a medicine with combined active ingredients. Hydrocortisone exerts an anti-inflammatory effect, cinchocaine provides local anaesthesia. Neomycin – a broad-spectrum antibiotic – prevents secondary infections and treats local infections caused by staphylococci and susceptible Gram-negative bacteria. Esculin inhibits bleeding from blood vessels and reduces oedema. The medicine reduces symptoms associated with haemorrhoids, such as inflammation, pain, itching, swelling, and bleeding. Proktosedon 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 the pre- and post-operative period.

2. Important information before using Proktosedon

When not to use Proktosedon:

  • if the patient is allergic to the active substances or 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 Proktosedon, discuss this with your doctor or pharmacist.
If any of the situations described below apply to the patient, he or she should consult a doctor before starting treatment with Proktosedon.
The patient should exercise particular caution when using Proktosedon if:

  • he or she has a concurrent infection, allergy, or other symptoms – in such cases, appropriate causal treatment should be administered;
  • he or she is undergoing vaccinations or immunotherapy – in such cases, the medicine should not be used;
  • he or she experiences symptoms of irritation – in such cases, use of the medicine should be discontinued;
  • he or she uses the medicine long-term – in rare cases, systemic effects characteristic of corticosteroids may occur;
  • he or she experiences rectal bleeding – in such cases, medical advice should be sought immediately;
  • he or she has previously used hydrocortisone – this should be reported to the doctor.

If treatment is ineffective, the patient should consult a doctor.
Children
The use of Proktosedon in children under 12 years of age is contraindicated.
Proktosedon and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Particular caution is required when using Proktosedon together with any of the following medicines:
Nonsteroidal anti-inflammatory drugs or acetylsalicylic acid. These may cause gastric and duodenal ulcers, gastrointestinal ulceration, or bleeding. In patients with hypoprothrombinemia, caution is advised 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 induction of hepatic microsomal enzymes by phenytoin. In such cases, an increased dose of corticosteroids may be necessary.

  • Vaccines, live viruses, or other vaccinations. The use of corticosteroids during vaccination periods is not recommended due to increased risk of neurological complications after vaccination and possible reduction in antibody levels or lack of response to vaccination.

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.
Animal studies have shown hydrocortisone to have teratogenic and embryotoxic effects. There are unconfirmed data indicating a risk of cleft palate, intrauterine growth retardation of fetuses, and suppressive effects on the hypothalamic-pituitary-adrenal axis in fetuses exposed to hydrocortisone administered to pregnant women. Therefore, Proktosedon should be used in pregnant women only if absolutely necessary, following careful assessment by a doctor of the risks and benefits.
Proktosedon 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 the medicine on the ability to drive vehicles and operate machinery has not been studied.

3. How to use Proktosedon

Proktosedon should always be used exactly as described in the patient information leaflet or as directed by a physician.
If in doubt, consult a doctor or pharmacist.
In adults, the ointment is usually used for three to six days, until the inflammatory condition subsides. If there is no improvement after this period, or if the patient's condition worsens, medical advice should be sought.
Method of administration
Using the applicator, apply a small amount of ointment into the rectum and externally, in the morning and evening, and after each bowel movement.
Use of a higher than recommended dose of Proktosedon
No cases of poisoning have been reported.
If a larger than recommended dose has been used, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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, adverse effects caused by systemic action of hydrocortisone may occur.
The medicine may cause local skin reactions (e.g. contact dermatitis).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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,
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 Proktosedon
Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Proktosedon contains
The active substances in this medicine are: hydrocortisone acetate, cinchocaine hydrochloride, esculin, and neomycin sulfate.
1 g of the ointment contains:
Active substances:
5 mg hydrocortisone as acetate (Hydrocortisonum)
5 mg cinchocaine hydrochloride (Cinchocaini hydrochloridum)
10 mg neomycin sulfate (Neomycini sulfas)
10 mg esculin as monohydrate (Esculinum)
Inactive substances: liquid paraffin, white vaseline, anhydrous lanolin.

What Proktosedon looks like and contents of the pack
Aluminium tubes containing 15 g or 30 g of ointment, packed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław
tel. +48 (22) 543 60 00

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