Lodotra 1mg modified-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PREDNISONE

Available from:

Mundipharma Corporation Limited Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, United Kingdom

ATC code:

H02AB07

INN (International Name):

PREDNISONE 1 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

PREDNISONE 1 mg

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2013-03-28

Patient Information leaflet

Page 1 of 9 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

LODOTRA 1 MG MODIFIED-RELEASE TABLETS 
LODOTRA 2 MG MODIFIED-RELEASE TABLETS 
LODOTRA 5 MG MODIFIED-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 (listed in section 6). 

WARNINGS AND PRE

Summary of Product characteristics

Page 1 of 12 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Lodotra 1 mg modified-release tablets 

Lodotra 2 mg modified-release tablets 

Lodotra 5 mg modified-release tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Lodotra 1 mg: 
 One modified-release tablet contains 1 mg of prednisone.  

Lodotra 2 mg: 
 One modified-release tablet contains 2 mg of prednisone.  

Lodotra 5 mg: 
 One modified-release tablet contains 5 mg of prednisone.  

Excipient with known effect: lactose  

Lodotra 1 mg: 
Each modified-release tablet contains  42.80 mg of lactose.  

Lodotra 2 mg: 
Each modified-release tablet contains  41.80 mg of lactose.  

Lodotra 5 mg: 
Each modified-release tablet contains  38.80  mg of lactose.  

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Modified-release tablet 

Lodotra 1 mg:  
Pale yellowish-white, cylindrical modified-release tablet , 9
mm in height and 5 mm in diametre, with “NP1” 
embossed on one side.  

Lodotra 2 mg: 
Yellowish-white, cylindrical modified-release tablet , 9 mm in
height and 5 mm in diametre, with “NP2” 
embossed on one side.  

Lodotra 5 mg:  
Light yellow, cylindrical modified-release tablet , 9 mm in height
and 5 mm in diametre, with “NP5” 
embossed on one side.  

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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