LODOTRA 2 Milligram Modified-release Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

PREDNISONE

Disponible desde:

Mundipharma Pharmaceuticals Limited

Designación común internacional (DCI):

PREDNISONE

Dosis:

2 Milligram

formulario farmacéutico:

Modified-release Tablets

tipo de receta:

Product subject to prescription which may not be renewed (A)

Estado de Autorización:

Authorised

Fecha de autorización:

0000-00-00

Información para el usuario

Lodotra 1 mg / 2 mg / 5 mg modified-release tablets 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

LODOTRA 1 MGMODIFIED-RELEASE TABLETS 
LODOTRA 2 MGMODIFIED-RELEASE TABLETS 
LODOTRA 5 MGMODIFIED-RELEASE TABLETS 

PREDNISONE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
-  Keep this leaflet. You may need to read it again. 
-  If you have any further questions, ask your doctor
or pharmacist. 
-  This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, 
even if their signs of illness are the same as yours. 
-  If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side 
effects not listed in this leaflet. See section 4. 

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

1. 
WHAT LODOTRA IS AND WHAT IT IS USED FOR 

Lodotra is a tablet with a delayed release behaviour of the active
compound prednisone, which is a 
corticosteroid. Corticosteroids have an anti-inflammatory action.
Anti-inflammatory medicines reduce 
pain, swelling, stiffness, redness and heat in affected joints. 

Lodotra is used to treat: 
•  moderate to severe, active rheumatoid arthritis in adults,
particularly when accompanied by 
morning stiffness 

Lodotra tablets are modified-release tablets. This means that
they are designed to release prednisone 
approximately 4 hours after swallowing. This allows you to take
Lodotra at bedtime and feel an 
improvement in your early morning symptoms such as stiffness. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LODOTRA 

DO NOT TAKE LODOTRA IF YOU ARE 
•  allergic to prednisone or any of the other ingredients of this
medicine (

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lodotra 2 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One modified-release tablet contains 2 mg of prednisone.
Excipient with known effect: lactose
Each modified-release tablet contains 41.80 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
Yellowish-white, cylindrical modified-release tablet, 9 mm in height and 5 mm in diameter, with “NP2” embossed on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lodotra is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adults particularly when
accompanied by morning stiffness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The appropriate dose depends on the severity of the condition and the individual response of the patient. In general, for
the initiation of the therapy 10 mg prednisone is recommended. In certain cases, a higher initial dose might be required
(e.g. 15 or 20 mg prednisone). Depending on the clinical symptoms and the patient’s response, the initial dose can be
reduced in steps to a lower maintenance dose.
When changing over from the standard regimen (glucocorticoid administration in the morning) to Lodotra administered
at bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be maintained. Following the change-
over, the dose may be adjusted according to the clinical situation.
For doses not realisable/practicable with this strength other strengths of this medicinal product are available. For long-
term therapy of rheumatoid arthritis, the individual dose of up to 10 mg prednisone daily should be adjusted according
to the severity of the course of the disease.
Depending on the treatment re