Package leaflet: Information for the patient

Rectodelt 100 mg suppositories

prednisone
Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rectodelt is and what it is used for
What you need to know before using Rectodelt
How to use Rectodelt
Possible side effects
How to store Rectodelt
Contents of the pack and other information

1. What Rectodelt is and what it is used for

Rectodelt contains the active substance prednisone, which is a glucocorticoid (corticosteroid) with effects on metabolism, electrolyte balance, and tissue functions.
Rectodelt is used in neonates, infants, and children for the treatment of pseudocroup (acute laryngotracheitis with obstruction), croup, and acute exacerbation of asthma/acute asthma attack.

2. What you should know before using Rectodelt

Do not use Rectodelt:
If you or your child are allergic to prednisone or to any of the other ingredients of this
medicinal product (listed in section 6).
There are no other known contraindications for short-term use of Rectodelt in the context of
acute treatment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rectodelt:

If you or your child have scleroderma (an autoimmune disease also known as systemic sclerosis), as daily doses greater than or equal to 15 mg may increase the risk of a serious complication known as scleroderma renal crisis. Signs of scleroderma renal crisis include elevated blood pressure and reduced urine output. Your doctor may advise you to monitor blood pressure and urine regularly.
If you or your child experience blurred vision or other visual disturbances.
If you have an overactive thyroid (hyperthyroidism).

Systemic effects of corticosteroids administered as suppositories may occur, especially with high doses prescribed for prolonged periods. Possible systemic effects include Cushing's syndrome, cushingoid features, reduced kidney function, impaired growth in children and adolescents, decreased bone mineral density, lens opacity (cataract), increased intraocular pressure (glaucoma), and more rarely, a range of physiological and behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children).
Contact your doctor immediately if you develop muscle weakness, muscle pain, cramps, or stiffness while using prednisone. These may be symptoms of a condition called "thyrotoxic periodic paralysis," which may occur in patients with an overactive thyroid (hyperthyroidism) treated with prednisone. Additional treatment may be required to manage this condition.

Effects in case of misuse for doping purposes
For individuals engaged in sports: using this medication without therapeutic need constitutes doping and may lead to a positive anti-doping test.
The use of Rectodelt as a doping agent may be harmful to health.

Other medicines and Rectodelt
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Which other medicines affect the action of Rectodelt?

Medicines that accelerate the breakdown of other drugs in the liver (barbiturates, phenytoin, primidone [anticonvulsants], rifampicin [a medicine for tuberculosis]). The effect of the corticosteroid may be reduced.
Certain female sex hormones (estrogens). The effect of the corticosteroid may be increased.
Some medicines may increase the effects of Rectodelt, and your doctor may wish to closely monitor you or your child if treated with these medicines (including some HIV medicines: ritonavir, cobicistat).

How Rectodelt affects the action of other medicines?
If Rectodelt is used concurrently with:

Medicines for the treatment of inflammation and rheumatism (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs): the risk of stomach ulceration and gastrointestinal bleeding may be increased.
Medicines that lower blood sugar levels (antidiabetics): their blood glucose-lowering effect may be reduced.
Medicines that prevent blood clotting (oral anticoagulants, coumarin derivatives): their blood-thinning effect may be weakened.
Certain eye medicines (atropine) and substances with similar action (other anticholinergics): additional increase in intraocular pressure may occur.
Medicines causing muscle relaxation (non-depolarizing muscle relaxants): muscle relaxation may be prolonged.
Medicines for worm infections (praziquantel): the effect of these medicines may be reduced.
Medicines for malaria and rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine): increased risk of developing muscle disorders or heart muscle diseases (myopathies, cardiomyopathies).
Medicines used to suppress the body's immune system (cyclosporine): cyclosporine blood levels are increased, thereby increasing the risk of seizures.
Growth hormones (somatotropin): their effect may be reduced.
Medicines for hypothalamic hormones (protirelin): the increase in thyroid-stimulating hormone (TSH) is reduced.
Some medicines to lower blood pressure (ACE inhibitors): an increased risk of blood count changes may occur.
The effect of certain heart medicines (cardiac glycosides) may be enhanced due to low potassium levels in the blood. This effect may be further increased by concomitant use of laxatives and certain medicines used to increase urine production (diuretics).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There are insufficient data on the use of prednisone in pregnant women. Animal studies have shown that glucocorticoids can have harmful effects on offspring. These effects may also occur in humans. Therefore, Rectodelt should only be used during pregnancy if your treating physician considers the therapy strictly necessary.
The active ingredient in Rectodelt is excreted in breast milk. If high doses are used or treatment is long-term, breastfeeding must be discontinued.

Driving and using machines
Rectodelt does not affect or affects negligibly the ability to drive vehicles and use machinery.

3. How to take Rectodelt

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose:
For newborns, infants, and children, one suppository of Rectodelt, equivalent to 100 mg of
prednisone, should be administered. If necessary, treatment may be repeated up to a maximum of one additional
administration. The second suppository may be given within 12–24 hours. Use of an additional dose is not recommended. The total dose of 2 suppositories (200 mg of prednisone) must not be exceeded. The duration of treatment must not exceed 2 days.
Method of administration
For rectal use.
Insert the suppository deeply into the rectum.
Note: dosage and treatment duration recommendations must not be exceeded,
as serious adverse effects (Cushing's syndrome, see section 4) may otherwise occur.
If you take more Rectodelt than you should
Rectodelt is generally well tolerated and free of complications, even when large amounts are used for short periods of time. No specific actions are required. If you notice more intense or unusual adverse effects, consult your doctor for advice.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
In addition to the possibility of hypersensitivity reactions to Rectodelt (see section 2), no side effects are expected during acute treatment. Prolonged administration may cause side effects typical of corticosteroids (signs of Cushing's syndrome), which may occur with varying degrees of severity, such as: moon-shaped face, central (truncal) obesity, development of edema (tissue swelling), increased potassium excretion, reduced glucose tolerance, inhibition of growth in children, altered secretion of sex hormones, skin changes, muscle atrophy, osteoporosis, physiological changes, increased blood pressure, and changes in blood count. The following reactions may also occur: stomach discomfort, pancreatitis, increased vascular fragility, increased risk of infection, increased intraocular pressure (glaucoma), blurred vision.
Frequency not known: Slowing of the heart rate.
Scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease).
Signs of scleroderma renal crisis include elevated blood pressure and reduced urine production.
Occasionally, signs and symptoms of systemic side effects associated with glucocorticoids may occur with Rectodelt, depending on dose, duration of exposure, concomitant or previous exposure to corticosteroids, and individual sensitivity. These may include reduced adrenal function, delayed growth in children and adolescents, decreased bone mineral density, lens opacity (cataract), increased intraocular pressure (glaucoma), and increased susceptibility to infections. The ability to respond to stress may be impaired.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rectodelt

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rectodelt contains

The active substance is prednisone. Each suppository contains 100 mg of prednisone.
The other component is solid fat.

Description of the appearance of Rectodelt and package contents
Rectodelt is a torpedo-shaped suppository, white to off-white in colour.
Rectodelt is available in rigid PVC/PE laminated sheets, opaque white in colour, packed in cardboard cartons containing 2, 4 or 6 suppositories.
Not all pack sizes may be marketed.

Marketing Authorization Holder
mibe pharma Italia S.r.l.
Via Leonardo Da Vinci, 20/B
39100 Bolzano
Italy

Manufacturer
Trommsdorff GmbH & Co. KG
Trommsdorffstr. 2-6
52477 Alsdorf
Germany
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Belgium: Prednisone mibe 100 mg suppositories
Germany: Prednison mibe 100 mg Zäpfchen
Italy: Rectodelt 100 mg supposte
Netherlands: Prednison mibe 100 mg zetpillen
Spain: Rectodelt 100 mg supositorios