Package leaflet: Information for the patient

Rectodelt, 100 mg, suppositories
Prednisonum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. 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
pseudocroup (acute laryngotracheitis with airway narrowing), croup, and exacerbations of asthma or acute episodes of wheezing.

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 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. A pheochromocytoma is a rare tumour of the adrenal glands. 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 treatment with 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 doctor 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).
if the patient has hyperthyroidism.

Systemic effects of corticosteroids administered as suppositories may occur, particularly 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, cataracts, increased intraocular pressure (glaucoma), and, less commonly, various psychological or behavioural effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children).

Contact a doctor immediately if, during treatment with prednisone, the patient experiences muscle weakness, muscle pain, cramps, or stiffness. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with prednisone. Additional treatment may be required to alleviate this condition.

Misuse of Rectodelt as a doping agent

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

Rectodelt and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take, even 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 to treat seizures], rifampicin [a medicine used to treat 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 taken (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 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 conditions (atropine) and substances with similar effects (other anticholinergic medicines): additional increase in 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 developing muscle disorders or heart muscle disorders (myopathies, cardiomyopathies).
medicines used to suppress the body's immune system (cyclosporine): blood levels of cyclosporine are increased, raising the risk of central nervous system seizures.
growth hormones (somatropin): their effect may be reduced.
medicines containing hypothalamic hormones (protirelin): 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 blood morphology changes.
the effect of certain heart medicines (cardiac glycosides) may be increased due to reduced blood levels. This effect may be further enhanced 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 a doctor or pharmacist before using this medicine.

There is insufficient data on the use of Rectodelt in pregnant women. In animal studies, glucocorticoids have shown harmful effects on unborn animals. Such effects are also possible in humans. Rectodelt should only be used during pregnancy if the treating doctor 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 a negligible effect on the ability to drive and operate machinery.

3. How to use Rectodelt

This medicine should always be used 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 should be administered. 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 administered rectally.
The suppository should be inserted deeply into the rectum.
Warning: Do not exceed the recommended dosage and duration of use, as severe 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
short-term. No special measures are required. If the patient experiences severe or unusual adverse
reactions, medical advice should be sought.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Apart from the possibility of hypersensitivity to Rectodelt (see section 2), no adverse effects are expected in the treatment of acute conditions. Long-term administration may lead to adverse effects typical of corticosteroids (Cushing's syndrome symptoms), such as: moon face, truncal obesity, development of oedema (tissue swelling), increased potassium excretion, decreased glucose tolerance, growth suppression in children, disturbance in sex hormone secretion, skin changes, muscle weakness, osteopor游戏副本

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 carton and blister pack following "EXP".
The expiry date refers to the last day of the stated 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 no longer required. Such measures 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 hard fat.

What Rectodelt looks like and contents of the pack
Rectodelt is white or almost white torpedo-shaped suppositories.
Rectodelt is available in soft blisters made of PVC/PE foil, packed in a cardboard box,
in packs containing 2 suppositories.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +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