RECTODELT 100 mg Czopek

Treść ulotki

1. Rectodelt 100 mg suppositories
   1. What is Rectodelt and what is it used for
   2. What you need to know before you use Rectodelt
   3. How to take Rectodelt
   4. Possible side effects
   5. How to store Rectodelt
   6. Contents of the pack and other information

Rectodelt 100 mg suppositories

prednisone

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Rectodelt is and what it is used for
• 2. What you need to know before you use 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 ingredient prednisone which is a glucocorticoid (corticosteroid) with effects on
metabolism, salt (electrolyte) balance and tissue function.
Rectodelt is used in newborns, infants and children for the treatment of pseudocroup (acute laryngotracheitis
with or without obstruction), croup and worsening of asthma/acute asthma attack.

2. What you need to know before you use Rectodelt

Do not use Rectodelt:
If you or your child are allergic to prednisone or any of the other ingredients of this
medicine (listed in section 6).
There are no other known contraindications for the 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 higher daily doses of 15 mg or more may increase the risk of a serious complication known as scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and reduced urine production. Your doctor may advise you to check your blood pressure and urine regularly.
• If you or your child experience blurred vision or other visual disturbances.

Systemic effects of corticosteroids administered as suppositories can occur, especially with high
doses prescribed for prolonged periods. Possible systemic effects include Cushing's syndrome,
cushingoid features, reduced kidney function, stunted growth in children and adolescents, reduced bone mineral density, opacity of the lens (cataract), increased eye pressure (glaucoma) and more rarely, a range of physiological and behavioral effects including
psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (especially in children).

Effects in case of abuse for doping purposes
For those involved in competitive sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.
The use of Rectodelt as a doping agent can be dangerous to your health.

Other medicines and Rectodelt
Tell 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 medicines in the liver (barbiturates, phenytoin, primidone [medicines for seizures], rifampicin [medicine for tuberculosis]). The effect of the corticosteroid may be reduced.
• Some female sex hormones (estrogens). The effect of the corticosteroid may be increased.
• Some medicines may increase the effects of Rectodelt and your doctor may want to carefully monitor you or your child if treated with these medicines (including some medicines for HIV: ritonavir, cobicistat).

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

• Medicines for the treatment of inflammation and rheumatism (salicylates, indometacin 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 sugar lowering effect may be reduced;
• Medicines that prevent blood clotting (oral anticoagulants, coumarin derivatives): their blood-thinning effect may be weakened.
• Some medicines for the eyes (atropine) and substances with a similar action (other anticholinergics): an additional increase in eye pressure may occur.
• Some medicines can cause 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): there is an increased risk of muscle diseases or heart muscle diseases (myopathies, cardiomyopathies).
• Medicines used to suppress the body's defense system (cyclosporine): levels of cyclosporine in the blood are increased, thereby increasing the risk of brain seizures.
• Growth hormones (somatotropin): their effect may be reduced.
• Medicines for the treatment of hypothalamic hormones (protirelin): the increase in thyroid-stimulating hormone (TSH) is reduced.
• Some medicines for lowering blood pressure (ACE inhibitors): an increased risk of changes in blood counts may occur.
• The effect of some medicines for the heart (cardiac glycosides) may be increased due to low potassium levels in the blood. The effect may be further increased by the concomitant use of laxatives and some medicines used to increase urine production (diuretics).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
There is not enough data on the use of prednisone in pregnant women. In animal studies, glucocorticoids have
been shown to have harmful effects on the unborn child. These effects are also possible with use
in humans. If you are pregnant, you can therefore only use Rectodelt if your treating doctor
considers the therapy strictly necessary.
The active ingredient contained in Rectodelt is excreted in breast milk. If high doses are used or during
long-term use, you should stop breastfeeding.

Driving and using machines
Rectodelt does not alter or alters negligibly the ability to drive vehicles and use machines.

3. How to take Rectodelt

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
In newborns, infants and children, one Rectodelt suppository should be administered, equivalent to 100 mg of
prednisone. If necessary, treatment may be repeated up to a maximum of another
administration. The second suppository can be administered within 12-24 hours. The use of a further dose is not recommended. The total dose of 2 suppositories (200 mg of prednisone) must not be exceeded.
The duration of treatment should not exceed 2 days.

Method of administration
For rectal use.
Insert the suppository deeply into the rectum.
Note: the recommendations regarding dosage and duration of treatment must not be exceeded,
as in such cases serious adverse effects are expected (Cushing's syndrome, see also paragraph 4).

If you take more Rectodelt than you should
The use of Rectodelt is generally well tolerated and free of complications even in case of use of large
quantities for short periods of time. No specific actions are required. If you notice more
intense or unusual side effects, consult your doctor for advice.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In addition to the possibility of hypersensitivity reactions to Rectodelt (see section 2), no side effects are
expected in acute treatment. Prolonged administration may determine
side effects typical of corticosteroids (signs of Cushing's syndrome), expected with varying degrees of
severity, such as: moon face, central obesity, formation of edema (tissue swelling),
increased potassium excretion, reduced glucose tolerance, growth inhibition in children,
alteration of sex hormone secretion, skin changes, muscle atrophy, osteoporosis,
physiological changes, increased blood pressure, changes in blood counts. The following reactions may also occur:
stomach pain, pancreatitis, increased vascular fragility, increased risk of
infection, increased intraocular pressure (glaucoma), blurred vision.
Sclerodermic renal crisis in patients already affected by scleroderma (an autoimmune disease).
Signs of sclerodermic renal crisis include increased blood pressure and reduced urine production.
Occasionally, signs and symptoms of systemic side effects associated with
glucocorticoids with Rectodelt may occur, dependent on the dose, duration of exposure, exposure
concomitant or previous 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 pressure inside the eye (glaucoma)
and susceptibility to infections. The ability to adapt to stress may be compromised.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rectodelt contains

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

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

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium: Prednisone mibe 100 mg suppositories
Germany: Prednison mibe 100 mg suppositories
Italy: Rectodelt 100 mg suppositories
Netherlands: Prednison mibe 100 mg suppositories
Spain: Prednisona mibe 100 mg suppositories