Proktosedon

Proktosedon
5 mg + 5 mg + 10 mg + 10 mg, suppositories
Hydrocortisonum + Cinchocaini hydrochloridum + Esculinum + Neomycini sulfas
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Always use this medicine exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse.
• Keep this leaflet, so you can read it again if needed.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 3–6 days, or if your condition worsens, consult your doctor.

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 action of its ingredients. Hydrocortisone exerts an anti-inflammatory effect, cinchocaine provides local anaesthesia. Neomycin—an antibiotic with broad-spectrum activity—prevents secondary infections and treats local infections caused by staphylococci and susceptible Gram-negative bacteria. Esculin reduces bleeding from blood vessels and decreases oedema. The medicine alleviates symptoms associated with haemorrhoids, such as inflammation, pain, itching, swelling, and bleeding.
Proktosedon suppositories are indicated for the treatment of external and internal haemorrhoids, chronic and acute inflammatory conditions of the anus, anal fissures, and anal itching. They may be used in the pre- and postoperative periods.

2. Important information before using Proktosedon

When not to use Proktosedon:

• 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 treatment with Proktosedon, discuss it with your doctor or pharmacist.
If any of the situations described below apply to you, you should consult your doctor before using Proktosedon.
You should exercise particular caution when using Proktosedon if:

• you have a concurrent infection, allergy, or other symptoms—appropriate causal treatment should then be administered;
• you are undergoing vaccinations or immunotherapy—do not use the medicine at that time;
• you experience symptoms of irritation—discontinue use of the medicine;
• you use the medicine long-term—systemic effects characteristic of corticosteroids may occur, although with low probability;
• you experience rectal bleeding—seek immediate medical advice;
• you have previously used hydrocortisone—inform your doctor about this.
• If you experience blurred vision or other visual disturbances, contact your doctor. If treatment is ineffective, consult your doctor.

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

Proktosedon with other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Exercise particular caution when using Proktosedon together with any of the following medicines:
Non-steroidal anti-inflammatory drugs or acetylsalicylic acid. This may cause gastric and duodenal ulcers, gastrointestinal ulceration, or gastrointestinal bleeding. Caution is advised when using corticosteroids together with acetylsalicylic acid in patients with hypoprothrombinemia.
Phenytoin – the therapeutic effect of corticosteroids may be reduced due to enhanced metabolism and decreased plasma concentration of the drug, 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 immunizations. The use of corticosteroids during vaccination is not recommended due to an 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 Proktosedon, and your doctor may wish to closely monitor your condition if you are taking such medicines (including certain HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Animal studies have shown hydrocortisone to have teratogenic and embryotoxic effects. There are unconfirmed data suggesting 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 may be used during pregnancy only if absolutely necessary, following a careful assessment by the doctor of the risks and benefits.
Proktosedon should not be used during breastfeeding due to the potential risk of growth suppression in the infant caused by hydrocortisone.

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

3. How to use Proktosedon

Proktosedon should always be used exactly as described in the patient leaflet or as directed by a physician.
If in doubt, consult a doctor or pharmacist.
In adults, one suppository is usually administered in the morning, one in the evening, and after each bowel movement.
Use for three to six days, until the inflammatory condition subsides. If there is no improvement after this period, or if the patient feels worse, consult a doctor.
Method of administration
Tear open the suppository packaging, remove the suppository, and gently insert it into the rectum with the tapered end first.
Overdose of Proktosedon
No cases of poisoning have been reported. In case of accidental ingestion of suppositories, gastric lavage is recommended.
If a larger than recommended dose is taken or if suppositories are accidentally swallowed, 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 anus may occasionally occur, especially if the skin is significantly damaged.
With prolonged use, systemic adverse effects caused by hydrocortisone may occur.
Adverse reactions occurring with unknown frequency: blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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.: +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 this medicine out of sight and reach of children.
Store below 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 stated month.

6. Contents of the pack and other information

What Proktosedon contains
The active substances are: hydrocortisone acetate, cinchocaine hydrochloride, esculin and neomycin sulfate.
Each suppository 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 hemihydrate (Esculinum)
Excipient:
hard fat (Witepsol)

What Proktosedon looks like and contents of the pack
A cardboard box containing 12 suppositories in 2 blisters of 6 pieces each.

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

Manufacturer
Fulton Medicinali S.p.A., Via Marconi 28/9, Arese (MI), Italy