Rectodelt

Package Leaflet: Information for the Patient

Rectodelt, 100 mg, Suppositories

Prednisone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Rectodelt and what is it used for

Rectodelt contains the active substance prednisone, which is a glucocorticosteroid (corticosteroid) affecting metabolism, electrolyte balance, and tissue function.
Rectodelt is used in infants, young children, and children to treat acute episodes of croup (acute laryngitis and tracheitis with airway obstruction), croup, and exacerbations of asthma or acute wheezing episodes.

2. Important information before using Rectodelt

When not to use Rectodelt:

if you are allergic to prednisone or any of the other ingredients of this medicine (listed in section 6).
There are no other known contraindications to short-term use of Rectodelt in the treatment of acute conditions.

Warnings and precautions

Taking this medicine may cause a crisis in the course of a pheochromocytoma (a rare tumor of the adrenal gland), which can lead to death. A pheochromocytoma crisis may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If you experience any of these symptoms, you should immediately contact your doctor.
Before starting treatment with Rectodelt, discuss it with your doctor or pharmacist,

• if you or your child has systemic scleroderma (an autoimmune disorder also known as systemic sclerosis), as doses of at least 15 mg per day may increase the risk of a serious complication called scleroderma renal crisis. Symptoms of scleroderma renal crisis include high blood pressure and decreased urine production. Your doctor may recommend regular blood pressure and urine tests.

if you or your child experiences blurred vision or other vision disturbances.
if you or your child has been diagnosed with a pheochromocytoma (adrenal gland tumor) or is suspected of having one.

• if you or your child has been diagnosed with a pheochromocytoma (adrenal gland tumor) or is suspected of having one.

Systemic effects of corticosteroids given in suppository form may occur, especially with high doses and prolonged use. Possible systemic effects include Cushing's syndrome, Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, increased intraocular pressure (glaucoma), and, less frequently, a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children).

Incorrect use of the medicine as a doping agent

Taking Rectodelt may result in positive doping test results.
Taking Rectodelt as a doping agent may pose a risk to your health.

Rectodelt and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.
What other medicines affect the action of Rectodelt?

• Medicines that accelerate the breakdown of other medicines in the liver (barbiturates, phenytoin, primidone [medicines used to treat seizures], rifampicin [a medicine used to treat tuberculosis]): the effect of corticosteroids may be reduced.
• Certain female sex hormones (estrogens): the effect of corticosteroids may be increased.
• Certain medicines may enhance the effect of Rectodelt, and your doctor may want to monitor you closely if you are taking these medicines (including certain medicines used to treat HIV: ritonavir, cobicistat).

How does Rectodelt affect the action of other medicines?
If Rectodelt is used with:

• medicines used to treat inflammatory and rheumatic conditions (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs): the risk of stomach ulcers and gastrointestinal bleeding may be increased.
• medicines that lower blood sugar levels (antidiabetic medicines): their blood sugar-lowering effect may be reduced.
• medicines that prevent blood clotting (oral anticoagulants, coumarin derivatives): their blood-thinning effect may be weakened.
• certain medicines used to treat eye diseases (atropine) and substances with similar effects (other anticholinergic medicines): increased intraocular pressure may occur.
• certain medicines that cause muscle relaxation (non-depolarizing muscle relaxants): muscle relaxation may be prolonged.
• medicines used to treat parasitic diseases (praziquantel): their effect may be weakened.
• medicines used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine): there is an increased risk of muscle or heart muscle disease (myopathy, cardiomyopathy).
• medicines used to weaken the immune system (cyclosporin): the concentration of cyclosporin in the blood is increased, which increases the risk of seizures of cerebral origin.
• growth hormones (somatropin): their effect may be weakened.
• medicines with pituitary hormones (protyrelin): the increase in thyroid-stimulating hormone (TSH) may be reduced.
• certain medicines that lower blood pressure (angiotensin-converting enzyme inhibitors): there may be an increased risk of changes in blood morphology.
• the effect of certain heart medicines (cardiac glycosides) may be increased due to reduced blood levels. This effect can be further enhanced by concurrent use of laxatives and certain diuretics (saluretics).

Pregnancy and 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.
There are insufficient data on the use of Rectodelt in pregnant women. In animal studies, glucocorticosteroids have shown harmful effects on the unborn animal. This effect is also possible in humans. If you are pregnant, you should only use Rectodelt if your doctor considers it necessary.
The active substance in Rectodelt passes into breast milk. With high doses or prolonged use, breastfeeding should be discontinued.

Driving and using machines

Rectodelt has no influence or negligible influence on the ability to drive and use machines.

3. How to use Rectodelt

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
Recommended dose.
Infants, young children, and children are given one Rectodelt suppository, which corresponds to 100 mg of prednisone. If necessary, the administration should be repeated no more than once. A second suppository may be given within 12-24 hours. Further use is not recommended. The total dose should not exceed 2 suppositories (equivalent to 200 mg of prednisone). The duration of treatment should not exceed two days.
Method of administration:
The medicine is used rectally.
The suppository should be inserted deeply into the rectum.
Note: Do not exceed the recommended dose and duration of use, as this may result in severe side effects (Cushing's syndrome, see section 4).

Using a higher dose of Rectodelt than recommended

Rectodelt is generally well-tolerated without complications, even if large amounts are used for a short time. No special measures are required. If you experience severe or unusual side effects, consult your doctor.
In case of further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rectodelt can cause side effects, although not everybody gets them.
Apart from the possibility of hypersensitivity to Rectodelt (see section 2), no side effects are expected in the treatment of acute conditions. Prolonged administration may lead to side effects typical of corticosteroids (Cushing's syndrome symptoms), such as moon face, central obesity, edema, hypokalemia, decreased glucose tolerance, growth retardation in children, hormonal disturbances, skin changes, muscle weakness, osteoporosis, mental changes, increased blood pressure, and changes in blood morphology. Various degrees of severity of these symptoms may occur. You may also experience: gastrointestinal disorders, pancreatitis, increased vascular fragility, increased risk of infection, increased intraocular pressure (glaucoma), and blurred vision.
Frequency not known: bradycardia.
Scleroderma renal crisis in patients with systemic scleroderma. Symptoms of scleroderma renal crisis include high blood pressure and decreased urine production.
Systemic effects of glucocorticosteroids given in suppository form may occur after Rectodelt administration, probably depending on the dose, exposure time, concurrent and previous exposure to corticosteroids, and individual sensitivity. They may include: adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and increased intraocular pressure (glaucoma), as well as susceptibility to infections. The ability to adapt to stress may be impaired.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rectodelt

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rectodelt contains

• The active substance is prednisone. Each suppository contains 100 mg of prednisone.
• The other ingredient is solid fat.

What Rectodelt looks like and contents of the pack

Rectodelt is a white or almost white torpedo-shaped suppository.
Rectodelt is available in soft PVC/PE foil blisters in a carton box, in packs containing 2 suppositories.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Trommsdorff GmbH & Co. KG
Trommsdorffstr. 2 – 6
52477 Alsdorf
Germany
Date of last revision of the leaflet:06.2022