Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Rectodelt, 100 mg, suppositories
Prednisonum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of Contents

What is Rectodelt and what is it used for
Important information before using Rectodelt
How to use Rectodelt
Possible side effects
How to store Rectodelt
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 for the treatment of acute
croup (acute laryngotracheitis with airway narrowing), croup, and acute exacerbations of asthma or acute episodes of wheezing.

2. 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 for short-term use of Rectodelt in the treatment of
acute conditions.
Warnings and precautions

Use of this medicine may cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumour of the adrenal gland. A pheochromocytoma crisis may present with headache, excessive sweating, palpitations, and increased blood pressure. If any of these symptoms occur, the patient should contact a doctor immediately.

Before starting Rectodelt, discuss the following with your doctor or pharmacist:

if the patient or their parent has scleroderma (an autoimmune disorder also known as systemic sclerosis), because 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 elevated blood pressure and reduced urine output. The treating physician may recommend regular monitoring of blood pressure and urine.
if the patient or their parent experiences blurred vision or other visual disturbances.
if the patient or their parent has been diagnosed with, or is suspected of having, a pheochromocytoma (adrenal gland tumour).

Systemic effects of corticosteroids administered as suppositories may occur, especially with high doses and prolonged use. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, lens opacities (cataracts), increased intraocular pressure (glaucoma), and less commonly, a range of psychological or behavioural effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children).

Misuse of Rectodelt as a doping agent
Use of Rectodelt may lead to positive results in anti-doping tests. Using Rectodelt as a doping agent may pose a health risk.

Rectodelt and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.

Which other medicines affect the action of Rectodelt?

Medicines that increase the breakdown of other drugs in the liver (barbiturates, phenytoin, primidone [medicines used in the treatment of seizures], rifampicin [used in the treatment of tuberculosis]): the effect of corticosteroids may be reduced.
Certain female sex hormones (oestrogens): the effect of corticosteroids may be increased.
Some medicines may enhance the effect of Rectodelt, and the treating doctor may wish to monitor the patient closely if these medicines are used (including certain medicines used in HIV infection: ritonavir, cobicistat).

How does Rectodelt affect other medicines?
If Rectodelt is used at the same time as:

medicines used to treat inflammatory and rheumatic conditions (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs): the risk of gastric ulceration 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 in eye diseases (atropine) and substances with similar effects (other anticholinergic medicines): increased intraocular pressure may occur.
certain medicines causing muscle relaxation (non-depolarising muscle relaxants): muscle relaxation may be prolonged.
medicines used to treat parasitic infections (praziquantel): their effect may be reduced.
medicines used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine): there is an increased risk of muscle disorders or heart muscle disorders (myopathies, cardiomyopathies).
medicines used to suppress the immune system (cyclosporine): blood levels of cyclosporine may increase, raising the risk of seizures.
growth hormones (somatropin): their effect may be reduced.
medicines containing hypothalamic hormones (protirelin): the increase in thyroid-stimulating hormone (TSH) concentration may be reduced.
certain medicines that lower blood pressure (angiotensin-converting enzyme inhibitors): there may be an increased risk of blood morphology changes.
the effect of certain cardiac glycosides may be enhanced due to reduced blood levels. This effect may be further intensified by concomitant use of laxatives and certain diuretics (saluretics).

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 her 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 unborn animals. Such effects are also possible in humans. Rectodelt should be used during pregnancy only if the treating physician considers it necessary.
The active substance in Rectodelt passes into breast milk. If high doses are used or treatment is prolonged, breastfeeding should be discontinued.

Driving and operating machinery
Rectodelt has no effect or negligible effect on the ability to drive and operate machinery.

3. How to use Rectodelt

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
For infants, young children, and children, one Rectodelt suppository corresponding to 100 mg
of prednisone is recommended. If necessary, administration may be repeated once at most. 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 for rectal use.
The suppository should be inserted deeply into the rectum.
Warning: Do not exceed the recommended dosage and duration of use, as serious adverse reactions (Cushing's syndrome, see section 4) may otherwise be expected.
Use of a higher than recommended dose of Rectodelt
Rectodelt is generally well tolerated without complications, even if large amounts have been used briefly.
No special measures are required. If the patient experiences severe or unusual adverse reactions, medical advice should be sought.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Apart from the possibility of hypersensitivity to Rectodelt (see section 2), adverse reactions are not expected during treatment of acute conditions. Long-term administration may lead to adverse effects typical of corticosteroids (Cushing's syndrome symptoms), such as: moon face, trunk obesity, development of edema (tissue swelling), increased potassium excretion, reduced glucose tolerance, growth suppression in children, disturbance in sex hormone secretion, skin changes, muscle weakness, osteoporosis, psychiatric changes, increased blood pressure, changes in blood morphology. Various degrees of severity of these symptoms may occur. Additionally, gastrointestinal complaints, pancreatitis, increased fragility of blood vessels, increased risk of infection, increased intraocular pressure (glaucoma), and blurred vision may occur.
Frequency unknown: bradycardia.
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). Symptoms of scleroderma renal crisis include elevated blood pressure and reduced urine production.
Systemic adverse effects of glucocorticoids may rarely occur after administration of Rectodelt, likely depending on dose, duration of exposure, concomitant and prior exposure to corticosteroids, and individual sensitivity. These may include: adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, lens opacities (cataract), increased intraocular pressure (glaucoma), and increased susceptibility to infections. The ability to adapt to stress may be impaired.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continuous monitoring of the medicine's safety and helps to provide more information on its safe use.

5. How to store Rectodelt

Keep this medicine out of 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 stated month.
Do not store above 30°C.
Translation of some information on the immediate packaging:
Lot:/EXP: ver lateral – batch number/expiry date: see on the side
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Rectodelt contains

The active substance is prednisone.

Each suppository contains 100 mg of prednisone.

The other ingredient is hard 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 blisters in cardboard boxes containing 2, 4 or 6 suppositories.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, country of export:
Mibe Pharma España S.L.U.
C/Amaltea 9, 4th floor, letter B,
28045, Madrid
Spain
Manufacturer:
Mibe GmbH Arzneimittel
Münchener Str. 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
Marketing authorisation number in Spain, country of export: 725323.5
Parallel import authorisation number: 341/24