Lodotra 1mg modified-release tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
17-06-2018
Summary of Product characteristics
(SPC)
17-06-2018
Active ingredient:
Prednisone
Available from:
Napp Pharmaceuticals Ltd
ATC code:
H02AB07
INN (International Name):
Prednisone
Dosage:
1mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 06030200; GTIN: 5012854031159
Patient Information leaflet
PACKAGE LEAFLET : INFORMATION FOR THE USER _LODOTRA_® 1 MG, 2 MG AND
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. Antiinflammatory
medicines reduce pain, swelling, stiffness, redness and heat in
affected joints.
These tablets are used to treat:
moderate to severe, active rheumatoid arthritis, particularly when
accompanied by
morning stiffness, in adults.
These 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 (hypersensitive) to prednisone or any of the other
ingredients of
these tablets (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking these tablets.
TAKE SPECIAL CARE WITH _LODOTRA _
You must tell your doctor if you have (at the moment) or have had (in
the past) any of the
following conditio
Read the complete document
Summary of Product characteristics
OBJECT 1
LODOTRA 1 MG MODIFIED-RELEASE TABLETS
Summary of Product Characteristics Updated 07-Mar-2018 | Napp
Pharmaceuticals Limited
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, 5 mm in
height and 9 mm in diameter, with
“NP1” embossed on one side.
_LODOTRA_ 2 mg:
Yellowish-white, cylindrical modified-release tablet, 5 mm in height
and 9 mm in diameter, with “NP2”
embossed on one side.
_LODOTRA _5 mg:
Light yellow, cylindrical modified-release tablet, 5 mm in height and
9 mm in diameter, with “NP5”
embossed on one side.
4. Clinical particulars
4.1 Therapeutic indications
_LODOTRA_ is indicated for the treatment of moderate to severe, active
rheumatoid arthritis, particularly when
accompanied by morning stiffness, in adults.
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 reg
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