Rectodelt

Leaflet attached to the packaging: patient information

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

Rectodelt, 100 mg, suppositories

Prednisone

You should carefully read the contents of the leaflet before using the medicine, 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 medicine has been prescribed to a specific person. Do not pass it on to others. The medicine 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. Contents of the packaging 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 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 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

Using this medicine 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 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 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 (an 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, symptoms of Cushing's syndrome, 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 medicine as a doping agent

Using Rectodelt may result in positive doping test results.
Using 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 [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 the attending physician may want to closely monitor the patient if they 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 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 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 medicines): there may be an additional increase in intraocular pressure.
• 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 (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 changes in blood morphology.
• the effect of certain heart medicines (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 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 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 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, 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 administration can be repeated at most 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 deep into the rectum.
Note: The dosage and duration of use recommendations should not be exceeded, as otherwise serious side effects (Cushing's syndrome, see section 4) can be expected.

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 the use of this medicine, the patient should consult their 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. Long-term administration may lead to side effects typical of corticosteroids (symptoms of Cushing's syndrome), such as: moon face, central obesity, edema (swelling of tissues), increased potassium excretion, decreased glucose tolerance, growth retardation in children, hormonal disturbances, skin changes, muscle weakness, osteoporosis, mental changes, increased blood pressure, 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), blurred vision.
Frequency not known: bradycardia.
Scleroderma renal crisis in patients with scleroderma (an autoimmune disorder). The symptoms of scleroderma renal crisis include elevated blood pressure and decreased urine production.
Systemic effects of glucocorticosteroids after administration of Rectodelt may occur, probably depending on the dose, duration of exposure, 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 the patient experiences any side effects, including any side effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rectodelt

The medicine should be stored 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 month stated.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 packaging contains

Rectodelt is a white or almost white suppository in the shape of a torpedo.
Rectodelt is available in soft PVC/PE blisters in a cardboard box, in packs 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 Spain, the country of export:

Mibe Pharma España S.L.U.
C/Amaltea 9, 4ª planta, letra 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
Spanish marketing authorization number, country of export:725323.5
Parallel import authorization number:341/24

Date of leaflet approval: 18.09.2024

[Information about the trademark]