Patient Information Leaflet: Information for the User

Prednisolone Medipha Sante

5 mg soluble tablets
10 mg soluble tablets
Prednisolone sodium phosphate
Equivalent Medicine (only for the 5 mg dosage)
Please 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Prednisolone Medipha Sante is and what it is used for
What you need to know before taking Prednisolone Medipha Sante
How to take Prednisolone Medipha Sante
Possible side effects
How to store Prednisolone Medipha Sante
Contents of the pack and other information

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

The name of the medicine is Prednisolone Medipha Sante. Prednisolone Medipha Sante contains the active substance prednisolone, which belongs to a group of medicines called corticosteroids or "steroids". These corticosteroids occur naturally in the body and help maintain health and well-being. Supporting the body by administering an additional supply of corticosteroids (such as prednisolone) is an effective way to treat various conditions involving inflammation in the body. You must take this medicine regularly to obtain the maximum benefit from it.
Steroids work by reducing inflammation and suppressing 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 disorders, kidney disorders, and certain blood disorders.

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

Do not take Prednisolone Medipha Sante

if you are allergic to 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 skin rash. More severe symptoms include swelling of the face, lips, tongue and/or throat, with difficulty swallowing or breathing);
if you have recently received a vaccination or are due to have one;
if you have a viral infection such as measles, chickenpox, or shingles or any other infection. Inform your doctor immediately if you have been in contact with people affected by measles, chickenpox or shingles in the last three months.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisolone Medipha Sante if you have or have
previously had:
severe depression or manic-depressive illness (bipolar disorder). This includes having
experienced depression before or during treatment with steroid medicines such as Prednisolone
Medipha Sante;
TB (tuberculosis);
diabetes;
epilepsy;
depression or other mental illnesses;
an eye disease caused by increased internal eye pressure (glaucoma);
osteoporosis (loss of bone density);
muscle disorders during previous treatment with steroids;
stomach ulcers;
high blood pressure, heart failure or recent heart attack;
liver or kidney problems;
scleroderma (also known as systemic sclerosis, an autoimmune disease), as daily doses equal to or exceeding 15 mg may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and reduced urine output. Your doctor may advise regular monitoring of blood pressure and urine.
If any of the conditions listed above apply to you or if you are unsure, talk to your doctor or
pharmacist before using this medicine.
Mental health problems during treatment with prednisolone
Mental health problems may occur during treatment with steroids such as prednisolone
(see also section 4, “Possible side effects”).
these conditions can be serious
they usually appear within a few days or weeks after 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, treatment may be required.
Talk to your doctor if you (or the person taking this medicine) show signs of mental health problems. This is particularly important in cases of depression or suicidal thoughts. In some cases, mental health problems have occurred even when doses were being reduced or the medicine had been stopped.
Talk to your doctor if you experience blurred vision or other vision disturbances.

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, phenobarbitone, phenytoin or primidone;
antibiotics such as rifampicin, erythromycin;
mifepristone (used to induce termination of pregnancy);
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 urine production), for example bendroflumethiazide and furosemide;
warfarin or other medicines used to thin the blood;
aspirin or 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 rejecting a bone marrow or organ transplant).
Some medicines may increase the effects of Prednisolone Medipha Sante and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
If you are pregnant, think 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.

Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.

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 corresponds to 1.25% of the maximum daily sodium intake recommended in the adult diet.

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 corresponds to 2.5% of the maximum daily sodium intake recommended in the adult diet.

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 exactly as your doctor or pharmacist has told you. 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. Your doctor will always reduce the dose to the lowest dose effective for your condition.
Use in children and adolescents:
For the treatment of asthma attacks:
Children over 2 years of age – your doctor will decide the most appropriate dose to treat your child.
Children under 2 years of age – treatment may be given 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 drink after dissolving them in a glass of water.
Take the tablets as a single dose in the morning, unless your doctor has told you otherwise.
If you take more Prednisolone Medipha Sante than you should
If you take more Prednisolone Medipha Sante than you should, contact immediately your doctor or
the nearest hospital emergency department. Remember to bring this leaflet and/or the
packaging with you 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 for your next dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Prednisolone Medipha Sante
Do not stop taking the tablets unless your doctor has told you to, even if you
feel better, because this may make you unwell. This could cause withdrawal symptoms such as fever,
nausea, muscle and joint pain, runny nose, painful, red and sticky eyes (conjunctivitis),
itching, and weight loss.
Consult your doctor if you wish to stop taking the tablets – your doctor may want to gradually
reduce the dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist or
nurse.

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.
These are common in both adults and children. They may affect about 5 out of 100 people who take medicines such as Prednisolone Medipha Sante.

feeling depressed, including suicidal thoughts;
feeling euphoric (mania) or having mood swings;
feeling anxious, sleep disturbances, difficulty thinking or confusion, and memory loss;
hearing, seeing, or feeling things that do not exist; having strange and frightening thoughts, changes in behaviour, or feelings of isolation.

If you notice any of these problems, contact your doctor immediately.

If you notice:

itching or skin rash;
swelling of the face, lips, or throat;
difficulty breathing or shortness of breath,

stop taking the tablets and contact your doctor immediately. These may be signs of an allergic reaction.

When steroids are administered at high doses for a prolonged period, the following side effects may occur: not known (frequency cannot be estimated from available data):

general feeling of being unwell;
feeling unwell (nausea);
hiccups;
digestive problems or stomach ache;
stomach ulcer (which may perforate and bleed) or oesophageal ulcer;
oral thrush;
inflammation of the pancreas causing abdominal pain (pancreatitis);
muscle weakness;
muscle pain;
loss of bone density increasing the risk of fractures (osteoporosis);
tendon damage;
joint stiffness causing limited movement, pain, and muscle spasms;
fluid retention leading to swelling;
feeling dehydrated;
high blood pressure (hypertension);
slow wound healing, thinning of the skin, easy bruising, acne, stretch mark-like lesions;
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;
irregular or absent menstrual periods;
puffy, rounded face (Cushingoid facies);
excessive hair growth;
increased appetite and weight gain;
carbohydrate intolerance;
mood changes, dependency, 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 internal eye pressure (glaucoma), cataract, thinning and inflammation of the cornea (a part of the eye), worsening of viral or fungal eye infections, and impaired vision;
heart attack (sudden, severe chest pain);
changes in the body's chemical parameters;
increased number of white blood cells in the blood;
blood clot formation;
blurred vision;
scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of scleroderma renal crisis include increased blood pressure and reduced urine output;
prolonged use of high-dose steroids may lead to weakening of the immune system, which in turn may increase the risk of malignancy.

In patients receiving corticosteroid therapy, Kaposi's sarcoma (a type of tumour presenting as raised red, purple, or brown skin lesions) has also been reported. However, discontinuation of treatment may relieve these symptoms.

Prednisolone Medipha Sante may increase susceptibility to infections, which very rarely may even be fatal. Infections such as chickenpox and measles may present in a more severe form, or tuberculosis (TB) may reactivate.

If any of the side effects becomes severe, or if you notice side effects not listed in this leaflet, contact your doctor or pharmacist immediately.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 the sight and reach of children.
Store the tablets in a safe place at a temperature not exceeding 25 °C.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Prednisolone Medipha Sante contains
Prednisolone Medipha Sante 5 mg soluble tablets

The active substance is prednisolone sodium phosphate. Each tablet contains 5 mg of prednisolone (as sodium phosphate).
The other components 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 substance is prednisolone sodium phosphate. Each tablet contains 10 mg of prednisolone (as sodium phosphate).
The other components are: monosodium citrate, sodium bicarbonate, povidone K30, sodium benzoate (E211), polyethylene glycol, sodium saccharin (E954), erythrosine (E127).

Description of the appearance of Prednisolone Medipha Sante and contents of the pack
Prednisolone Medipha Sante 5 mg soluble tablets
Prednisolone Medipha Sante are pink, round, flat tablets with bevelled edges, with a score line on one side and "5" engraved on the other side, approximately 7 mm in diameter, packed in aluminium-aluminium blisters.
Prednisolone Medipha Sante 10 mg soluble tablets
Prednisolone Medipha Sante are pink, round, flat tablets with bevelled edges, with a score line on one side and "10" engraved on the other side, approximately 8.7 mm in diameter, packed in aluminium-aluminium blisters.
Marketing Authorization Holder and Manufacturer
Medipha Santé
Les Fjords – Immeuble Oslo, 19 avenue de Norvège
91953 Courtaboeuf Cedex
France

The following country-specific information applies:>
IT: