Rectodelt

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Rectodelt, 100 mg, Suppositories

Prednisone

Read the Leaflet Carefully Before Using the Medication, 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 specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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. 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) that affects 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 the patient is 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 (adrenal gland tumor), which can lead to death. Pheochromocytoma is a rare adrenal gland tumor. 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 treatment with Rectodelt, the patient should discuss it with their doctor or pharmacist,

• if the patient or their parent has 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. The symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine production. The treating doctor 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 a pheochromocytoma (adrenal gland tumor) or is suspected of having one.

• if the patient or their parent 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 health.

Rectodelt and other medicines

The patient should tell their doctor or pharmacist 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.
What other medicines affect the action of Rectodelt?

• Medicines that accelerate the breakdown of other medicines in the liver (barbiturates, phenytoin, primidone [seizure medications], rifampicin [tuberculosis medication]): 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 the treating doctor may want to closely monitor the patient if they are taking these medicines (including certain HIV medications: ritonavir, cobicistat).

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

• medicines 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.
• medicines that lower blood sugar levels (antidiabetic medications): their effect on lowering blood sugar levels may be reduced.
• medicines that prevent blood clotting (oral anticoagulants, coumarin derivatives): their effect on thinning the blood may be weakened.
• certain medicines used to treat eye diseases (atropine) and substances with similar effects (other anticholinergic medications): 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 (myopathies, cardiomyopathies).
• 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) levels 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 medications (digitalis 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 medicine.
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 should only use Rectodelt if their 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 exactly as prescribed by the doctor or pharmacist. In case of doubts, consult a 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 can be repeated once. The second suppository can 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 the patient experiences severe or unusual side effects, they should consult their doctor.
In case of further doubts about the use of this medicine, consult a 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 an allergic reaction 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 (tissue swelling), increased potassium excretion, 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 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 (slow heart rate).
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine production.
Occasionally, systemic effects of glucocorticosteroids may occur after administration of Rectodelt, probably depending on the dose, duration of exposure, concurrent and previous exposure to corticosteroids, and individual sensitivity. These may include adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and increased intraocular pressure (glaucoma), as well as an increased susceptibility to infections. The ability to adapt to stress may be impaired.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they 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 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 packaging. The expiry date refers to the last day of the month.
Do not store above 30°C.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung– batch number/expiry date: see imprint.
hier öffnen– open here
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 blister packs in a cardboard box, containing 6 suppositories.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Dermapharm GmbH
Kleeblattgasse 4/13
1010 Vienna
Austria

Manufacturer:

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Trommsdorff GmbH & Co. KG
Trommsdorffstr. 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
Austrian marketing authorization number, country of export:138704
Parallel import authorization number:124/24

Date of leaflet approval: 20.03.2024

[Information about the trademark]