ПРЕДНИЗОЛОН 5 МГ Оральные диспергируемые таблетки

Содержание инструкции

1. Prednisolone Medipha Sante
2. Prednisolone sodium phosphate
   1. What is Prednisolone Medipha Sante and what is it used for
   2. What you need to know before taking Prednisolone Medipha Sante
   3. How to take Prednisolone Medipha Sante
   4. Possible side effects
   5. How to store Prednisolone Medipha Sante
   6. Contents of the pack and other information

Prednisolone Medipha Sante

5 mg soluble tablets
10 mg soluble tablets

Prednisolone sodium phosphate

Equivalent Medicinal Product (only for the 5 mg dosage)

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, pharmacist or nurse.
• 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Prednisolone Medipha Sante and what is it used for

The name of the medicine is Prednisolone Medipha Sante. Prednisolone Medipha Sante contains the
active ingredient prednisolone which belongs to a group of medicines called corticosteroids or
“steroids”. These 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
in the body of a state of inflammation. You must take this medicine regularly to
obtain the maximum benefit from it.
Steroids work by reducing inflammation and lowering the body's immune response.
Prednisolone Medipha Sante is used to treat a variety of inflammatory conditions including
severe asthma, rheumatoid arthritis, allergic reactions, bowel diseases, severe skin diseases,
kidney disorders and some blood diseases.

2. What you need to know before taking Prednisolone Medipha Sante

Do not take Prednisolone Medipha Sante

• if you are allergicto prednisolone or 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, chickenpoxor herpes zosteror any other infection. Inform your doctor immediatelyif you have been in contact with people suffering from measles, chickenpox or herpes zoster in the last three months.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisolone Medipha Sante if you suffer or have
suffered in the past from:

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

If any of the above conditions apply to you or if you are not sure, talk to your
doctor or pharmacist before using this 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. If
however these problems occur, they may require treatment.

Talk to your doctorif you (or the person taking this medicine) shows signs of problems with
mental health. 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 the
medicine has been stopped.
Talk to your doctor if you experience blurred vision and other visual disturbances during.

Other medicines and Prednisolone Medipha Sante
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including those obtained without a prescription.
This is particularly important if you are taking:
medicines for epilepsy, such as carbamazepine, phenobarbital, phenytoin or primidone;

antibioticssuch as rifampicin, erythromycin;
mifepristone (used to induce medical abortion);

oral contraceptives;
somatropin (used to treat growth problems);
medicines for diabetes, such as insulin, glibenclamide or metformin;
medicines used for the treatment of high blood pressure, such as diuretics
(medicines that increase urine production) 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 to treat myasthenia gravis;
medicines used as contrast agents during X-rays;
cyclosporine (used to prevent the body from rejecting a bone marrow or organ
transplant).

Some medicines can increase the effects of Prednisolone Medipha Sante 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.

Driving and using machines
This medicine should not affect your ability to drive or operate machinery.

Prednisolone Medipha Sante contains sodium and benzoates
Prednisolone Medipha Sante 5 mg soluble tablets
This medicine contains 5.80 mg of sodium benzoate in each tablet.
This medicine contains 24.97 mg of sodium (the main component of table salt) in each
tablet. This is equivalent to 1.25% of the recommended daily intake of sodium with
the diet of an adult.
Prednisolone Medipha Sante 10 mg soluble tablets
This medicine contains 11.60 mg of sodium benzoate in each tablet.
This medicine contains 49.94 mg of sodium (the main component of table salt) in each
tablet. This is equivalent to 2.5% of the recommended daily intake of sodium with the
diet of an adult.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to
4 weeks of age).

3. How to take Prednisolone Medipha Sante

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

Adults:
The dose will depend on the condition being treated and may vary considerably between 10 mg and 100
mg per day. The doctor will always reduce the dose to the minimum dose capable of acting on your condition.

Use in children and adolescents:
For the treatment of asthma attacks:
Children over 2 years of age - the doctor will decide the most appropriate dose to treat your
child.
Children under 2 years of age – may be treated in hospital. Treatment for up to 3 days is
usually sufficient, but may last longer.

Method of administration:
The tablets must be taken as a drinkafter being dissolved in a glass of water.
Take the tablets as a single dose in the morning, unless your doctor has told you to do
otherwise.

If you take more Prednisolone Medipha Sante than you should
If you take more Prednisolone Medipha Sante than you should, contact your doctor immediatelyor
packaging to show the doctor what you have taken.

If you forget to take Prednisolone Medipha Sante
If you forget to take Prednisolone Medipha Sante, 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
compensate for a missed dose.

If you stop taking Prednisolone Medipha Sante
Do not stoptaking the tablets unless your doctor has told you to do so, even if you
feel better, as this may make you feel unwell. This may cause you withdrawal symptoms such as fever,
nausea, muscle and joint pain, runny nose, sore, red and sticky eyes (conjunctivitis),
itching and weight loss.

Consult your doctorif you want to stop taking the tablets - your doctor may
want to reduce the dose gradually.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Steroids, including prednisolone, can cause serious mental health problems.
These are common in both adults and children. They can affect about 5 people out of 100 who
take medicines like Prednisolone Medipha Sante.
feeling of depression, including suicidal thoughts.
feeling of euphoria (mania) or mood swings
feeling of anxiety, sleep disorders, difficulty thinking or confusion and memory loss
sensing, seeing or hearing things that do not exist. Having strange and frightening thoughts, changing
behaviour or having feelings of loneliness.
If you notice any of these problems seek immediate medical attention.
If you notice:
itching or appearance of skin rashes;
swelling of the face, lips or throat;
difficulty breathing or shortness of breath.
Stop taking the tablets and inform your doctor immediately. These could be signs of an
allergic reaction.
In the event that steroids are administered at high doses for a long period of time, the
following side effects may occur: not known (frequency cannot be defined on the
basis of available data)
feeling of general malaise;
feeling unwell (nausea);
hiccups;
digestive problems or stomach pain;
stomach ulcer (which may perforate and bleed) or ulcer in the esophagus;
thrush;
inflammation of the pancreas causing abdominal pain (pancreatitis);
muscle weakness;
muscle pain;
loss of bone density which increases the likelihood of fractures (osteoporosis);
tendon damage;
joint stiffness causing limitation of movement, pain and muscle spasms;
fluid retention resulting in swelling;
feeling of dehydration;
high blood pressure (hypertension);
slowing of wound healing, 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);
decreased function of the adrenal gland;
slowing of growth in infants, children and adolescents;
irregularities or cessation of the menstrual cycle;
puffy, rounded face (Cushingoid facies);
excessive hair growth;
increased appetite and weight gain;
carbohydrate intolerance;
mood changes, dependence, depression, sleep disorders, worsening of
schizophrenia;
severe headaches with blurred vision or temporary visual problems in children (usually after
discontinuation of treatment);
worsening of epilepsy;
increased pressure inside the eyes (glaucoma), cataract, thinning and
inflammation of the cornea (a part of the eye), worsening of viral or
fungal eye diseases and impaired vision;
heart attack (sudden and severe chest pain);
changes in the chemical parameters of the body;
increased number of white blood cells;
formation of blood clots;
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;
prolonged use of steroids at high doses can lead to a weakening of the
immune system, which in turn can increase the risk of malignancy.
The occurrence of Kaposi's sarcoma (a type of tumor consisting of raised skin lesions that are red, purple or brown) has also been reported in patients undergoing corticosteroid therapy.
However, discontinuation of treatment may relieve these symptoms.
Prednisolone Medipha Sante may increase susceptibility to contracting infections which, very
rarely, can also be fatal. Infections such as chickenpox and measles may manifest
in a more severe form, or TB (tuberculosis) may also recur.
If any of the side effects becomes serious or if you notice any side effects not listed in this leaflet,
tell your doctor or pharmacist immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Prednisolone Medipha Sante

Keep this medicine out of sight and reach of children.
Store the tablets in a safe place at a temperature below 25  C.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Prednisolone Medipha Sante contains
Prednisolone Medipha Sante 5 mg soluble tablets

• The active ingredient is prednisolone sodium phosphate. Each tablet contains 5 mg of prednisolone (as sodium phosphate).
• The other ingredients are: monosodium citrate, sodium bicarbonate, povidone K30, sodium benzoate (E211), polyethylene glycol, sodium saccharin (E954), erythrosine (E127).

Prednisolone Medipha Sante 10 mg soluble tablets

• The active ingredient is prednisolone sodium phosphate. Each tablet contains 10 mg of prednisolone (as sodium phosphate).
• The other ingredients are: monosodium citrate, sodium bicarbonate, povidone K30, sodium benzoate (E211), polyethylene glycol, sodium saccharin (E954), erythrosine (E127).

Description of the appearance of Prednisolone Medipha Santee and contents of the pack
Prednisolone Medipha Sante 5 mg soluble tablets
Prednisolone Medipha Sante are pink, round, flat tablets with beveled edges, with a breaking line on one side and “5” imprinted on the other side, with a diameter of approximately 7 mm, packaged in
aluminium-aluminium blisters.
Prednisolone Medipha Sante 10 mg soluble tablets
Prednisolone Medipha Sante are pink, round, flat tablets with beveled edges, with a breaking line on one side and “10” imprinted on the other side, with a diameter of approximately 8.7 mm packaged in
aluminium-aluminium blisters.

Marketing authorisation holder and manufacturer
Medipha Santé
Les Fjords – Immeuble Oslo, 19 avenue de Norvège
91953 Courtaboeuf Cedex
France

seguenti denominazioni:>
IT: