Solupred ro 5 mg
1. WHAT Solupred 5 mg orodispersible tablets ARE AND WHAT THEY ARE USED FOR ?
GLUCOCORTICOIDS – SYSTEMIC USE.
(H: systemic hormonal preparations, excl. sex hormones)
This medicine is a corticosteroid.
It is prescribed for certain diseases, in which it is used for its antiinflammatory effect
2. BEFORE YOU USE Solupred 5 mg orodispersible tablets :
Do not use Solupred 5 mg orodispersible tablets in the following situations:
* most infections,
* certain active viral diseases (viral hepatitis, herpes, chickenpox, shingles),
⦁ certain untreated mental disorders,
⦁ vaccination with live vaccines,
⦁ allergy to prednisolone or to any of the other ingredients,
* phenylketonuria (a hereditary disease screened for at birth), as this medicine contains aspartame.
IF YOU ARE UNSURE OF ANYTHING, IT IS ESSENTIAL THAT YOU ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Take special care with Solupred 5 mg orodispersible tablets:
This medicine must be taken under close medical monitoring.
Inform your doctor in the event of recent vaccination, stomach ulcer, colon disease, recent intestinal surgery, diabetes, high blood pressure, infection (especially a history of tuberculosis). liver
or kidney failure, osteoporosrs or myasthenia gravis (muscle disease with muscle fatigue) . Inform your doctor if you have spent time in
tropical or subtropical regions or in Southern Europe, due to the risk of parasitic infection ..
Taking this medicine with live attenuated vaccines or anti-inflammatory doses of aspirin (I.e., 2: 1 g per dose and/or 2: 3 g per day) must be. avoided (see Section “Taking or usmg other medicines).
DURING AND AFTER TREATMENT:
Avoid contact with people who have chickenpox or measles.
If treatment is long-term, never stop using the medicine suddenly, but follow your doctor’s recommendations on reducing doses.
While using the medicine and in the year following treatment, tell your doctor that you are taking or have taken a corticosteroid in the event of surgery or in situations stressful on the body (fever, illness).
Oral or injedable corticosteroids can increase the risk of tendon disease, or even tendon rupture (In exceptional cases). Tell the doctor in case of tendon pain.
Precautions for use
During treatment, your doctor may recommend a special diet that is low in salt and sugar and high in protein.
During long-term treatment, calcium and vitamin 0 supplements will be prescribed.
IF YOU ARE UNSURE OF ANYTHING, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Taking or using other medicines .
Taking this medicine with live attenuated vaccines or anti-inflamrnatorv doses of aspirin (i.e., 2: 1 g per dose and/or 2: 3 g per day) must be avoided (see “Take special care with Solupred 5 mg
orodispersible tablets” Section).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
This medicine should only be used during pregnancy if necessary. If you discover that you are pregnant, consult your doctor as only he/she can decide whether it is necessary to pursue treatment.
You should avoid breast-feeding during treatment with this drug as it is excreted in breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
This medicine contains an active substance that may cause a positive reaction in anti-doping tests. List of excipients with a specific effect: aspartame.
3. HOW TO USE Solupred 5 mg orodispersible tablets :
The dose to be used is determined by your doctor, based on bodyweight and the disease treated. Dosage depends strictly on each individual patient. It is very important that the medicine be taken
regularly and not changed or suddenly stopped without aski ng you doctor for advice.
Method of administration
The orodispersible tablet dissolves rapidly in the mouth through contact with saliva. Place the orodispersible tablet in the mouth, allow it to melt, swallow it and then drink a glass of water. For children under the age of 6 years, the tablet can be dissolved first in some water and then swallowed.
To prevent a bitter taste in the mouth, the tablet should not be chewed.
Treatment duration is determined by your doctor. In the event of long-term treatment, do not stop using the medicine suddenly, but follow your doctor’s recommendations on reducing doses.
If you forget to take Solupred 5 mg orodispersible tablets
To be effective, this medicine must be used regularly. However, if you forget to take a dose, continue treatment as normal.
4. POSSIBLE SIDE EFFECTS :
Like all medicines, Solupred 5 mg orodispersible tablets can cause side effects, although not everybody gets them.
This medicine, which is essential, is usually well tolerated when the recommendations, especially those concerning diet, are followed (see “Take special care with Solupred 5 mg orodispersible
tablets”). However, depending on the dose and treatment duration, it may have effects which cause varying degrees of discomfort.
The most common effects are:
⦁ Change in levels of certain substances in the body (salt, sugar, potassium) that may require a special diet or additional treatment.
⦁ Increased blood pressure, water and salt retention that can lead to heart failure.
⦁ Mood disturbances: (excitement, euphoria), sleep disturbances.
Cushing syndrome: treatment with corticosteroids can lead to weight gain, swelling and redness of the face and excessive body hair growth.
* Bone fragility: osteoporosis, fractures.
⦁ Painful bone damage at the hip joint (osteonecrosis).
Other much rarer effects have been observed:
⦁ Risk of insufficient secretion by the adrenal gland.
⦁ Growth problems in children.
⦁ Menstrual problems.
⦁ Muscle weakness, tendon rupture, particularly when the medicine is taken along with fluoroq u inolones (a nti biotics). ⦁ Digestive disorders: stomach ulcers, gastrointestinal bleeding and perforation, and pancreatitis, particularly in children.
⦁ Skin fragility, delayed healing, acne.
⦁ Confusion, seizure, feeling depressed on stopping treatment.
* Certain types of glaucoma (increased pressure inside the eye) and cataract (cloudiness of the lens of the eye).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Solupred 5 mg orodispersible tablets :
Keep out of the reach and sight of children. Do not use Solupred 5 mg orodispersible tablets after the expiry date which is stated on the box. The expiry date refers to the last day of that
month. Store at a temperature no higher than 30°C. Medicines should not be disposed of via wastewater or household waste. Ask you r pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION :
What Solupred 5 mg orodispersible tablets contain The active substance is:
Prednisolone metasulfobenzoate sodium …. 7.86 mg
Equivalent quantity of prednisolone. 5.00 mg
for one orodispersible tablet.
The other ingredients are:
30% polyacrylate dispersion (Eudragir” NE 30 D), hydrophobic colloidal silica (Aerosil” R972), mannitol (granules), mannitol (powder), crospovidone, aspartame, magnesium stearate.
What Solupred 5 mg orodispersible tablets look like and contents of the pack
This medicine is available as orodispersible tablets.
Box of 30 tablets.
Marketing Authorization Holder and Operating Company
sanofi-aventis France 1-13, boulevard Romain Rolland
Sanofi Winthrop Industrie France