Rectodelt

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Rectodelt (Rectodelt 100), 100 mg, suppositories

Prednisone
Rectodelt and Rectodelt 100 are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents and other information

1. What is Rectodelt and what is it used for

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

2. Important information before using Rectodelt

When not to use Rectodelt:

if the patient is allergic to prednisone or any of the other ingredients of this drug (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 drug may cause a crisis in the course of a pheochromocytoma (pheochromocytoma crisis), which can lead to death. Pheochromocytoma is a rare tumor of the adrenal gland. A crisis in its course may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If the patient experiences any of these symptoms, they should immediately contact their doctor.
Before starting to use Rectodelt, the patient should discuss it with their doctor or pharmacist,

• if the patient or their parent 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.

Renal crisis symptoms include high blood pressure and decreased urine production. The attending physician may recommend regular blood pressure and urine tests.

• if the patient or their parent experiences blurred vision or other vision disturbances.
• if the patient or their parent has been diagnosed with pheochromocytoma (adrenal gland tumor) or is suspected of having it.

Systemic effects of corticosteroids given in the form of suppositories may occur, especially in high doses and for a long time. Possible systemic effects include Cushing's syndrome, Cushing's syndrome symptoms, adrenal insufficiency, 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 drug as doping

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

Rectodelt and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take, including those available without a prescription.
What other drugs affect the action of Rectodelt?

• Drugs that accelerate the breakdown of other drugs in the liver (barbiturates, phenytoin, primidone [drugs used to treat seizures], rifampicin [a drug used to treat tuberculosis]): the effect of corticosteroids may be reduced.
• Certain female sex hormones (estrogens): the effect of corticosteroids may be increased.
• Certain drugs may enhance the effect of Rectodelt, and the attending physician may want to closely monitor the patient if they are taking these drugs (including certain HIV drugs: ritonavir, cobicistat). How does Rectodelt affect the action of other drugs?If Rectodelt is used together with:
• drugs used to treat inflammatory and rheumatic conditions (salicylates, indomethacin, and other nonsteroidal anti-inflammatory drugs): the risk of stomach ulcers and gastrointestinal bleeding may be increased.
• drugs that lower blood sugar levels (antidiabetic drugs): their effect on lowering blood sugar levels may be reduced.
• drugs that prevent blood clotting (oral anticoagulants, coumarin derivatives): their blood-thinning effect may be weakened.
• certain eye drugs (atropine) and substances with similar effects (other anticholinergic drugs): increased intraocular pressure may occur.
• certain muscle relaxants (non-depolarizing muscle relaxants): muscle relaxation may be prolonged.
• drugs used to treat parasitic diseases (praziquantel): their effect may be weakened.
• drugs used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine): there is an increased risk of muscle or heart muscle disease (myopathies, cardiomyopathies).
• drugs 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.
• drugs with pituitary hormones (protyrelin): the increase in thyroid-stimulating hormone (TSH) levels may be reduced.
• certain blood pressure-lowering drugs (angiotensin-converting enzyme inhibitors): there may be an increased risk of changes in blood morphology.
• the effect of certain heart drugs (cardiac glycosides) may be increased due to decreased blood levels. This effect can be further enhanced by concurrent use of laxatives and certain diuretics (saluretics).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
There is 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 the patient is pregnant, they may only use Rectodelt if their doctor considers it necessary.
The active substance in Rectodelt passes into breast milk. If high doses or long-term use are planned, breastfeeding should be discontinued.

Driving and operating machinery

Rectodelt has no influence or negligible influence on the ability to drive and operate machinery.

3. How to use Rectodelt

This drug should always be used as directed by a doctor or pharmacist. In case of doubts, the patient should consult their 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 dose can be repeated only once. The second suppository can be administered 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 drug is administered rectally.
The suppository should be inserted deeply into the rectum.
Note: The dosage and duration of use recommendations should not be exceeded, 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 the patient experiences severe or unusual side effects, they should consult their doctor.
In case of any further doubts about using this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Rectodelt can cause side effects, although not everyone will experience them.
Apart from the possibility of an allergic reaction to Rectodelt (see section 2), no side effects are expected in the treatment of acute conditions. Long-term administration may lead to side effects typical of corticosteroids (Cushing's syndrome symptoms), such as: moon face, central obesity, edema (tissue swelling), increased potassium excretion, decreased glucose tolerance, growth retardation in children, hormonal imbalance, skin changes, muscle weakness, osteoporosis, mental changes, increased blood pressure, and changes in blood morphology. Various degrees of these symptoms can be expected. The following may also occur: 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 (an autoimmune disorder). Renal crisis symptoms include high blood pressure and decreased urine production.
Occasional systemic effects of glucocorticosteroids after Rectodelt administration are possible, probably depending on the dose, exposure time, concurrent and previous exposure to corticosteroids, and individual sensitivity. They may include: adrenal insufficiency, 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 any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. 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 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the drug.

5. How to store Rectodelt

The drug should be stored out of sight and reach of children.
The drug should not be used after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
The drug should not be stored at temperatures above 25°C.
Translation of some information on the immediate packaging:
Ch.-B./Verwendbar bis: siehe Prägung– batch number/expiration date: see imprint.
hier öffnen– open here
Drugs should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Rectodelt contains

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

What Rectodelt looks like and what the package contains

Rectodelt is a white or almost white torpedo-shaped suppository.
Rectodelt is available in PVC/PE blisters in a cardboard box, in packages containing 2, 4, or 6 suppositories.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Trommsdorff GmbH & Co. KG
Trommsdorffstraße 2 – 6
52477 Alsdorf
Germany

Manufacturer:

Trommsdorff GmbH & Co. KG
Trommsdorffstraße 2 – 6
52477 Alsdorf
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
German export license number:6329964.00.00
Parallel import license number:168/25

Date of leaflet approval: 08.05.2025

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