SINTREDIUS 1,0 MG/ML Roztwór doustny

Treść ulotki

1. Sintredius 1.0 mg/ml oral solution
   1. Sintredius: what it is and what it's for
   2. What you need to know before taking Sintredius
   3. How to take Sintredius
   4. Possible side effects
   5. How to store Sintredius
   6. Contents of the pack and other information

Sintredius 1.0 mg/ml oral solution

Prednisolone sodium phosphate

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.
• Sintredius is a steroid drug,which is prescribed for various conditions, including serious illnesses.
• It is necessary to take it regularlyto obtain the maximum benefit.
• Do not stop taking this medicinewithout consulting your doctor. It may be necessary to reduce the dose gradually.
• In some people Sintredius may cause side effects (read paragraph 4 below). Someside effectssuch as mood changes (feeling depressed or "euphoric") or stomach problems may occur immediately. If you should experience any type of discomfort, continue taking the oral solution, but see your doctor immediately.
• Some side effects appear only after weeks or months.These include weakness of the arms and legs or swelling of the face (for more information read paragraph 4).
• Keep away from people with chickenpox or shingles,if you have never had these diseases. These diseases could affect you severely. If you come into contact with people affected by chickenpox or shingles, see your doctor immediately.

and effective of this medicine that could be particularly important for you.

Sintredius - information on benefits
Sintredius belongs to a group of drugs called steroids. The full name is corticosteroids.Corticosteroids are naturally present in the body and help maintain health and well-being.
Supporting the body by administering a supplement of corticosteroids (such as prednisolone) is an effective way to treat various diseases involving the presence of an inflammatory state in the body.
Sintredius reduces inflammation, which otherwise could worsen your illness. To obtain the maximum benefit, you must take this medicine regularly.

Contents of this leaflet

• 1. Sintredius: what it is and what it is used for
• 2. What you need to know before you take Sintredius
• 3. How to take Sintredius
• 4. Possible side effects
• 5. How to store Sintredius
• 6. Contents of the pack and other information

1. Sintredius: what it is and what it's for

The full name of the medicine is "Sintredius 1.0 mg/ml Oral Solution", but in this leaflet it will be called
"Sintredius ". This medicine contains the active ingredient prednisolone, which belongs to a group of drugs
called corticosteroids or "steroids". Steroids work by reducing inflammation and lowering the body’s immune
response.
Sintredius is used to treat a variety of inflammatory conditions including severe asthma, rheumatoid arthritis,
allergic reactions, serious skin diseases and some blood disorders.

2. What you need to know before taking Sintredius

Do not take Sintredius:

• if you are allergicto prednisolone or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions include mild symptoms such as itching and/or rash. More serious symptoms include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing;
• if you have recently had a vaccinationor are due to have a vaccination;
• if you have a viral infectionsuch as measles, chickenpox or shinglesor any other infection. Inform your doctor immediatelyif you have been in contact with people affected by measles, chickenpox or shingles in the last three months;
• if you have worm infections of the tropics;
• if you have systemic fungal infections.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sintredius, especially if you currently or in the past you or
a family member has suffered from:

• severe depressionor manic-depressive illness (bipolar disorder). This includes having suffered from depression before or during treatment with steroid medicines like Sintredius;
• TB (tuberculosis);
• diabetes;
• epilepsy;
• depression or other mental illnesses;
• an eye disease caused by increased pressure inside the eye (glaucoma);
• loss of bone density (osteoporosis);
• muscle disorders during a previous treatment with steroids;
• stomach ulcers
• recent kidney failure, high blood pressure, heart failure or heart attack;
• scleroderma (also known as systemic sclerosis, an autoimmune disease) as daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and a decrease in urine production. Your doctor may advise you to have regular blood pressure and urine checks;
• liver problems of any kind;
• reduced thyroid activity (hypothyroidism).

For athletes: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

If any of the above conditions apply to you, or if you are unsure, speak to your doctor or
pharmacist before using the medicine.
Mental health problems during treatment with prednisolone
Mental health problems can occur during therapy with steroids such as prednisolone (see also
section 4, "Possible side effects").

• These illnesses can be serious.
• They usually develop within a few days or weeks of starting treatment.
• They are more likely to occur with high doses.
• Most of these problems resolve by reducing the dose or stopping the medicine. However, if these problems occur, they may require treatment.

Talk to your doctorif you (or the person taking this medicine) shows signs of mental health
problems. This is particularly important if you have depression or suicidal thoughts. In some cases, mental
health problems have also appeared when the doses have been reduced or there has been a sudden
stopping of the medicine.

Talk to your doctorif you experience blurred vision, difficulty reading, or any other changes in
vision during or after treatment.
Regular check-ups with doctors (including eye checks at intervals of three months) are recommended during
long-term treatment.

Other medicines and Sintredius
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This is particularly important if you are taking:

• Medicines for epilepsy, such as carbamazepine and phenobarbital, phenytoin or primidone;
• Antibioticssuch as rifampicin, erythromycin;
• Mifepristone(used to induce medical abortion);
• Ritonavir (used in the treatment of HIV infection);
• Oral contraceptives;
• Somatropin(used to treat growth problems);
• Medicines for diabetes,such as insulin, glibenclamide or metformin;
• Medicines used to treat high blood pressure,such as diuretics (medicines that increase urination) for example bendroflumethiazide and furosemide;
• Warfarinor other medicines used to thin the blood;
• Aspirinor similar medicines;
• Theophylline(used to treat asthma);
• Medicines to treat fungal infections,such as amphotericin, ketoconazole;
• Acetazolamide(used to treat glaucoma);
• Carbenoxolone(used to treat stomach ulcers);
• Methotrexate(used for rheumatoid arthritis, psoriasis and some types of cancer);
• Any medicine belonging to a group of medicines called sympathomimetics;
• Medicines used for the treatment of myasthenia gravis;
• Medicines used as contrast agents during X-rays;
• Cyclosporine(used to prevent the body from rejecting a bone marrow or organ transplant).

Tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Some medicines can increase the effects of Sintredius oral solution and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During pregnancy, treatment should only be started after a careful assessment of the benefit/risk. As delayed
growth and harm to the unborn child cannot be ruled out with prolonged treatment with glucocorticoids during
pregnancy, inform your doctor if you wish to become pregnant, are pregnant or believe you may be pregnant.

Breastfeeding
Glucocorticoids such as Sintredius pass into breast milk. No harm to the newborn has been reported so far. However,
when high doses of prednisolone are administered, you should avoid breastfeeding for 4 hours after a dose. Ask your doctor for advice.

Fertility
Reversible disorders of spermatogenesis have been observed after high doses of prednisolone (30 mg/day for at least
4 weeks), which have lasted for several months after stopping the medicine.

Driving and operating machinery
This medicine should not affect your ability to drive vehicles or operate machinery.

Sintredius contains sucrose and glycerol
This medicine contains 1.5 g of sucrose per dose. This must be taken into account in
patients with diabetes mellitus. If your doctor has told you that you have an intolerance to some sugars, contact
him/her before taking this medicine.
This medicine contains glycerol.

3. How to take Sintredius

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

• It is preferable to take the oral solution without diluting it.
• The solution must be taken by mouth.
• The solution should preferably be taken as a single dose in the morning. However, if necessary, divided daily doses may be used.
• In children, the medicine should preferably be taken as a single dose on alternate days.
• Shake well before use.
• If your therapy is long-term, make sure the supply of oral solution does not run out.
• Since opening several containers on the same day could lead to dosing errors, this 5 ml presentation is suitable for treatments involving daily doses not exceeding 30 mg. The dosage depends on the condition being treated and, for an adult, can vary considerably between 10 mg and 30 mg per day in divided doses. Your doctor will prescribe the minimum dose capable of acting on your condition.
• When you need to take more than two units at a time, after opening and taking the contents, each opened unit should be placed on a tray or suitable surface. This will make it easier for you to avoid dosing errors that could occur if you have lost count of the opened units.
• The package contains a measuring spoon with markings for 1.25 ml, 2.5 ml and 3.75 ml corresponding to partial doses.
• All opened units must be discarded once the necessary dose has been taken.

Instructions for use

• 1. Fold the single-dose container in both directions (see figure A).
• 2. Separate the single-dose container from the strip (see figure B).

• 3. Rotate the cap counterclockwise as shown in figure C.
• 4. Apply slight pressure to the container to dispense the medicine as prescribed (see figure D). For the 5 ml dose, drink the entire contents of the single-dose container. If a partial dose needs to be dispensed, the measuring spoon included in the package must be used to measure the 1.25 ml or 2.5 ml or 3.75 ml dose (see figure E).
• 5. After administering a partial dose, the opened container must be discarded.

A
Use in children
For the treatment of acute asthma attacks, your pediatrician may prescribe:

• For children under 2 years of age, 10 mg per day, for a maximum of three days.
• For children from 2 to 5 years of age, 20 mg per day. For treatment, a maximum duration of three days is usually sufficient, but the doctor will decide the duration of therapy based on the number of days deemed necessary.
• For children over 5 years of age, 30 mg per day or more (up to 40 mg per day). Since opening several containers on the same day could lead to dosing errors, consult your pediatrician if a daily dose greater than 30 mg has been prescribed, as a different pharmaceutical form of prednisolone (e.g. high-dose tablets) may be more appropriate.

If you feel that the effect of this medicine is too strong or too weak, consult your doctor
or pharmacist.

If you take more Sintredius than you should
If you have taken more Sintredius than prescribed, contact your doctor immediatelyor the emergency room
where you took it.

If you forget to take Sintredius
If you forgot to take Sintredius, take the missed dose as soon as you remember, unless
it is almost time to take the next dose. Do nottake a double dose to make up for the
missed dose.

If you stop taking Sintredius
Consult your doctorif you wish to stop taking the oral solution: the doctor may in fact consider it appropriate to reduce the dose gradually.

Do not stop takingthe oral solution unless you have been told to do so by your doctor, even if you feel
better, because the condition for which you are being treated may worsen. If you suddenly stop taking the oral solution,
you may develop withdrawal symptoms such as fever, nausea, muscle and joint pain,
runny nose, sore, red and sticky eyes (conjunctivitis), itching and weight loss.
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 everyone gets them.
Steroids, including prednisolone, can cause serious mental health problems, such as those
listed below. These are common in both adults and children. If you notice any of these
problems, see your doctor immediately:

• Feeling depressed, including thoughts of suicide.
• Feeling euphoric (mania) or having mood swings
• Feeling anxious, having sleep disturbances, difficulty thinking or confusion, and memory loss.
• Seeing, hearing, or feeling things that are not there (hallucinations). Having strange and frightening thoughts, changing behavior, or feeling lonely.

The following side effects may be signs of an allergic reaction. If you notice any
of the following symptoms, stop taking Sintredius and tell your
doctor immediately:

• itching or rash;
• swelling of the face, lips, or throat;
• difficulty breathing or wheezing.

In the event that steroids are administered at high doses for a long period of time, the
following side effects may occur:

• feeling generally unwell;
• feeling sick (nausea);
• hiccups;
• digestive problems or stomach pain;
• stomach ulcer (which may perforate and bleed) or esophageal ulcer;
• thrush;
• inflammation of the pancreas (pancreatitis) causing abdominal pain;
• muscle weakness;
• muscle pain;
• loss of bone density which increases the chance of fractures (osteoporosis);
• tendon damage;
• joint stiffness causing limited movement, pain, and muscle spasms;
• fluid retention resulting in swelling;
• feeling dehydrated;
• high blood pressure (hypertension);
• slow healing of wounds, thinning of the skin, bruising, acne, stretch mark-like marks;
• appearance of small red, purplish, or bluish spots on the skin surface (caused by blood vessels under the skin);
• reduced function of the adrenal gland;
• slowed growth in infants, children, and adolescents;
• irregularities or cessation of the menstrual cycle;
• puffy, rounded face (cushingoid faciesor moon face);
• excessive hair growth;
• increased appetite and weight gain;
• carbohydrate intolerance;
• mood changes, dependence, depression, sleep disturbances, worsening of schizophrenia;
• severe headaches with blurred vision or temporary visual problems in children (usually after stopping treatment);
• worsening of epilepsy;
• increased pressure inside the eyes (glaucoma), cataracts, thinning and inflammation of the cornea (part of the eye), worsening of viral or fungal eye diseases, blurred vision and impaired vision, diseases of the choroid and retina (chorioretinopathy);
• heart attack (sudden and severe chest pain);
• changes in the body's chemical parameters;
• increased number of white blood cells;
• formation of blood clots;
• porphyria;
• Stevens-Johnson syndrome;
• prolonged use of steroids at high doses can lead to a weakening of the immune system, which in turn can increase the risk that the condition you have (malignant disease) worsens.

Renal scleroderma crisis in patients already affected by scleroderma (an autoimmune disease). Signs of renal
scleroderma crisis include increased blood pressure and decreased urine production.
The appearance of Kaposi's sarcoma (a type of cancer) has also been reported in patients undergoing corticosteroid therapy. However, this condition may also disappear once treatment is stopped.
This medicine may increase susceptibility to infections that, very rarely, may also
be fatal. Infections such as chickenpox and measles may occur in a more severe form, or TB
(tuberculosis) may also recur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
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 Sintredius

Keep this medicine out of the sight and reach of children.
Store the oral solution in a safe place at a temperature below 30 °C. Store the medicine
in its original packaging.
Do not use this medicine after the expiry date which is reported on the package after "Exp". The expiry
date refers to the last day of that month.
Once opened: in case of administering partial doses, the opened container must be discarded once the
necessary dose has been extracted.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sintredius contains

• The active substance is prednisolone (as sodium phosphate). One (1) ml of oral solution contains 1 mg of prednisolone (as sodium phosphate).
• The other ingredients are: sucrose, glycerol, sodium edetate (EDTA), anhydrous disodium phosphate, sodium dihydrogen phosphate monohydrate, vanilla/cream flavour, honey flavour, masking flavour, water for injections.

Description of the appearance of Sintredius and contents of the pack
Sintredius is a homogeneous, clear, light brown-coloured solution.
It is available in single-dose polyethylene containers. One container contains 5 ml of oral solution. The
containers are grouped in strips of five. Each strip is packaged in a PET/Al/PE sachet. Each
box contains two sachets (for a total of ten single doses), a measuring spoon (with markings of 1.25 ml,
Pack of 10 single-dose containers.

Marketing Authorisation Holder
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milan - Italy

Manufacturer
GENETIC SpA - Contrada Canfora - Nucleo Industriale 84084 Fisciano - Salerno (Italy)